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idK160082_s0_e2000

K160082.txt

measurand

Not applicable.

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for laboratory culture of bacteria and yeast. C. Measurand: Not applicable. D. Type of Test: Collection and transport culture medium device E. Applicant: Puritan Medical Products, LLC F. Proprietary and Established Names: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System G. Regulatory Information: 1. Regulation section: 866.2390; Transport Culture Medium 2. Classification: Class I 3. Product code: JSM; Culture Media, Non-Propagating Transport LIO: Device, Specimen Collection 2 JTW: System, Transport, Aerobic 4. Panel: 83- Microbiology H. Intended Use: 1. Intended use(s): The Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: None. I. Device Description: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System is comprised of a peel pouch containing a rayon tipped swab applicator for collecting specimens and a polypropylene, round-bottomed, capped tube containing 5 ml of a semi-solid Cary-Blair medium. Cary-Blair medium is a non-nutritive balanced salt solution containing disodium phosphate to provide buffering capability, sodium chloride and calcium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semisolid texture to the medium. Sodium thioglycollate helps maintained an oxygen-reduced environment to help maintain the viability of enteric bacteria during the transport to the laboratory. The semi-solid Cary Blair medium is composed of the following components: · Sodium chloride 5.0 g/L · Disodium Phosphate, 1.1 g/L 3 · Sodium thioglycollate 1.5 g/L · Calcium chloride, 0.09 g/L · Bacteriological agar, 5.6 g/L · Deionized water 1 L J. Substantial Equivalence Information: 1. Predicate device name(s): Copan Venturi Transystem Cary-Blair Medium product (132C) 2. Predicate 510(k) number(s): k946286 3. Comparison with predicate: Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Intended Use The Puritan Opti-Tranz Cary- Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. Copan Venturi Transystem Cary-Blair Medium product (132C) is a sterile ready-to-use system intended for the safe collection, transport, and preservation of clinical specimens for bacteriological examination. Product 132C is supplied with a plastic applicator swab. The Venturi Transystem with Cary-Blair Transport Medium is recommended for the collection and transport of fecal and rectal swab samples for the investigation of enteric pathogenic bacteria. 4 Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Specimen Storage Up to 48 h at 20 – 25 oC and up to 72 h at refrigerated conditions 2 – 8 oC Same Tube Polypropylene, round bottom Same Medium Volume 5 mL Same Single Use Device Yes Same Packaging Peel pouch Same Swab Rayon Same Medium Formulation Sodium chloride 5.0 g/L Disodium Phosphate, 1.1 g/L Sodium thioglycollate 1.5 g/L Calcium chloride, 0.09 g/L Bacteriological agar, 5.6 g/L Deionized water 1 L Same Differences Item Device Predicate Organisms Tested Campylobacter jejuni Enterococcus faecalis Escherichia coli Salmonella typhimurium Shigella sonnei Vibrio parahaemolyticus Yersinia enterocolitica Campylobacter jejuni Escherichia coli Shigella flexneri Yersinia enterocolitica pH 6.9 – 7.5 8.4 ± 0.2 Shelf life 20 months 24 months K. Standard/Guidance Document Referenced (if applicable): Quality Control of Microbiological Transport Systems; Approved Standard – Second Edition, M40-A2, Clinical and Laboratory Standards Institute (CLSI), Wayne, PA, 2014. L. Test Principle: Not applicable. M. Performance Characteristics (if/when applicable): 5 1. Analytical performance: Analytical studies were conducted to determine the ability of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System to maintain the viability of enteric microorganisms. The performance of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System was determined using quantitative colony enumeration techniques outlined in the Clinical and Laboratory Standards Institute (CLSI) M40-A2 document. Bacterial viability studies were performed. The swabs from each transport system were inoculated with 100 µL of select bacterial concentrations prepared in a fecal matrix and/or 0.85% phosphate buffered saline (PBS). To facilitate testing, a homogeneous fecal matrix was prepared by diluting pre-screened negative fresh clinical fecal material in 0.85% PBS to a 30% concentration by volume. Once inoculated, the swabs were then placed in their respective transport tubes and held at various time intervals; at the designated time intervals the swabs were removed and processed. To test the viability at various time intervals the inoculated swabs were held at room temperature for 0, 24, and 48 hours and refrigerated for 0, 24, 48, and 72 hours. The eight ATCC strains listed in Table 1 below were used to evaluate the performance of the Puritan Opti-Tranz Cary-Blair Collection and Transport System. This device was tested using the swabs included with the transport kit. Viability studies were conducted in duplicate at 0, 24, and 48 at room temperature (20-25°C) and at 0, 24, 48, and 72 hours at refrigerated temperatures (2-8°C) using the Roll-Plate and Swab Elution Methods. * ‘NO’ indicates that strain was not tested in the column heading matrix; ‘YES’ indicates that the strain was tested in the column heading matrix. Roll-Plate Method: Bacterial suspensions were prepared from fresh18-24 hour cultures of each microorganism in a separate vial containing 10 mL of fecal matrix or 0.85% sterile saline to obtain 1.5 x 108 CFU/mL suspensions. One log10 serial dilutions were made and 100 µL aliquots of dilutions were absorbed into the swabs and immediately placed into the Table 1: Enteric bacteria evaluated for stability in Puritan Opti-Tranz Cary- Blair Collection and Transport System Microorganism ATCC # Fecal Matrix* 0.85% Saline* Campylobacter jejuni ATCC 33291 NO YES Escherichia coli ATCC 25922 NO YES Escherichia coli 0157:H7 ATCC 700728 YES YES Salmonella typhimurium ATCC 14028 YES YES Shigella sonnei ATCC 12022 NO YES Vibrio parahaemolyticus ATCC 17802 YES YES Vancomycin-resistant Enterococcus faecalis (VRE) ATCC 51299 NO YES Yersinia enterocolitica ATCC 9610 NO YES 6 Puritan Opti-Tranz Cary-Blair medium. For fecal specimens, the final dilution prior to swab inoculation was done with fecal matrix to maximize the amount of fecal material on the swab. After incubation at each time point, the swabs were removed from the transport tubes and used to inoculate the entire surface of the appropriate agar plate. The plates were incubated in appropriate culture conditions for 24-48 hours or until countable colonies were visible. Manual colony counts were conducted for each time interval for each swab- organism combination. The dilution yielding colony counts nearest to zero (not to exceed 250 CFU) was reported. Log10 increases or decreases in survival are based on a comparison between time-zero and the last time point collected for each Measurand:

idK160082_s0_e2000

K160082.txt

type of test

Collection and transport culture medium device

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for laboratory culture of bacteria and yeast. C. Measurand: Not applicable. D. Type of Test: Collection and transport culture medium device E. Applicant: Puritan Medical Products, LLC F. Proprietary and Established Names: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System G. Regulatory Information: 1. Regulation section: 866.2390; Transport Culture Medium 2. Classification: Class I 3. Product code: JSM; Culture Media, Non-Propagating Transport LIO: Device, Specimen Collection 2 JTW: System, Transport, Aerobic 4. Panel: 83- Microbiology H. Intended Use: 1. Intended use(s): The Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: None. I. Device Description: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System is comprised of a peel pouch containing a rayon tipped swab applicator for collecting specimens and a polypropylene, round-bottomed, capped tube containing 5 ml of a semi-solid Cary-Blair medium. Cary-Blair medium is a non-nutritive balanced salt solution containing disodium phosphate to provide buffering capability, sodium chloride and calcium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semisolid texture to the medium. Sodium thioglycollate helps maintained an oxygen-reduced environment to help maintain the viability of enteric bacteria during the transport to the laboratory. The semi-solid Cary Blair medium is composed of the following components: · Sodium chloride 5.0 g/L · Disodium Phosphate, 1.1 g/L 3 · Sodium thioglycollate 1.5 g/L · Calcium chloride, 0.09 g/L · Bacteriological agar, 5.6 g/L · Deionized water 1 L J. Substantial Equivalence Information: 1. Predicate device name(s): Copan Venturi Transystem Cary-Blair Medium product (132C) 2. Predicate 510(k) number(s): k946286 3. Comparison with predicate: Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Intended Use The Puritan Opti-Tranz Cary- Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. Copan Venturi Transystem Cary-Blair Medium product (132C) is a sterile ready-to-use system intended for the safe collection, transport, and preservation of clinical specimens for bacteriological examination. Product 132C is supplied with a plastic applicator swab. The Venturi Transystem with Cary-Blair Transport Medium is recommended for the collection and transport of fecal and rectal swab samples for the investigation of enteric pathogenic bacteria. 4 Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Specimen Storage Up to 48 h at 20 – 25 oC and up to 72 h at refrigerated conditions 2 – 8 oC Same Tube Polypropylene, round bottom Same Medium Volume 5 mL Same Single Use Device Yes Same Packaging Peel pouch Same Swab Rayon Same Medium Formulation Sodium chloride 5.0 g/L Disodium Phosphate, 1.1 g/L Sodium thioglycollate 1.5 g/L Calcium chloride, 0.09 g/L Bacteriological agar, 5.6 g/L Deionized water 1 L Same Differences Item Device Predicate Organisms Tested Campylobacter jejuni Enterococcus faecalis Escherichia coli Salmonella typhimurium Shigella sonnei Vibrio parahaemolyticus Yersinia enterocolitica Campylobacter jejuni Escherichia coli Shigella flexneri Yersinia enterocolitica pH 6.9 – 7.5 8.4 ± 0.2 Shelf life 20 months 24 months K. Standard/Guidance Document Referenced (if applicable): Quality Control of Microbiological Transport Systems; Approved Standard – Second Edition, M40-A2, Clinical and Laboratory Standards Institute (CLSI), Wayne, PA, 2014. L. Test Principle: Not applicable. M. Performance Characteristics (if/when applicable): 5 1. Analytical performance: Analytical studies were conducted to determine the ability of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System to maintain the viability of enteric microorganisms. The performance of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System was determined using quantitative colony enumeration techniques outlined in the Clinical and Laboratory Standards Institute (CLSI) M40-A2 document. Bacterial viability studies were performed. The swabs from each transport system were inoculated with 100 µL of select bacterial concentrations prepared in a fecal matrix and/or 0.85% phosphate buffered saline (PBS). To facilitate testing, a homogeneous fecal matrix was prepared by diluting pre-screened negative fresh clinical fecal material in 0.85% PBS to a 30% concentration by volume. Once inoculated, the swabs were then placed in their respective transport tubes and held at various time intervals; at the designated time intervals the swabs were removed and processed. To test the viability at various time intervals the inoculated swabs were held at room temperature for 0, 24, and 48 hours and refrigerated for 0, 24, 48, and 72 hours. The eight ATCC strains listed in Table 1 below were used to evaluate the performance of the Puritan Opti-Tranz Cary-Blair Collection and Transport System. This device was tested using the swabs included with the transport kit. Viability studies were conducted in duplicate at 0, 24, and 48 at room temperature (20-25°C) and at 0, 24, 48, and 72 hours at refrigerated temperatures (2-8°C) using the Roll-Plate and Swab Elution Methods. * ‘NO’ indicates that strain was not tested in the column heading matrix; ‘YES’ indicates that the strain was tested in the column heading matrix. Roll-Plate Method: Bacterial suspensions were prepared from fresh18-24 hour cultures of each microorganism in a separate vial containing 10 mL of fecal matrix or 0.85% sterile saline to obtain 1.5 x 108 CFU/mL suspensions. One log10 serial dilutions were made and 100 µL aliquots of dilutions were absorbed into the swabs and immediately placed into the Table 1: Enteric bacteria evaluated for stability in Puritan Opti-Tranz Cary- Blair Collection and Transport System Microorganism ATCC # Fecal Matrix* 0.85% Saline* Campylobacter jejuni ATCC 33291 NO YES Escherichia coli ATCC 25922 NO YES Escherichia coli 0157:H7 ATCC 700728 YES YES Salmonella typhimurium ATCC 14028 YES YES Shigella sonnei ATCC 12022 NO YES Vibrio parahaemolyticus ATCC 17802 YES YES Vancomycin-resistant Enterococcus faecalis (VRE) ATCC 51299 NO YES Yersinia enterocolitica ATCC 9610 NO YES 6 Puritan Opti-Tranz Cary-Blair medium. For fecal specimens, the final dilution prior to swab inoculation was done with fecal matrix to maximize the amount of fecal material on the swab. After incubation at each time point, the swabs were removed from the transport tubes and used to inoculate the entire surface of the appropriate agar plate. The plates were incubated in appropriate culture conditions for 24-48 hours or until countable colonies were visible. Manual colony counts were conducted for each time interval for each swab- organism combination. The dilution yielding colony counts nearest to zero (not to exceed 250 CFU) was reported. Log10 increases or decreases in survival are based on a comparison between time-zero and the last time point collected for each Type of test:

idK160082_s0_e2000

K160082.txt

classification

Class I

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for laboratory culture of bacteria and yeast. C. Measurand: Not applicable. D. Type of Test: Collection and transport culture medium device E. Applicant: Puritan Medical Products, LLC F. Proprietary and Established Names: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System G. Regulatory Information: 1. Regulation section: 866.2390; Transport Culture Medium 2. Classification: Class I 3. Product code: JSM; Culture Media, Non-Propagating Transport LIO: Device, Specimen Collection 2 JTW: System, Transport, Aerobic 4. Panel: 83- Microbiology H. Intended Use: 1. Intended use(s): The Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: None. I. Device Description: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System is comprised of a peel pouch containing a rayon tipped swab applicator for collecting specimens and a polypropylene, round-bottomed, capped tube containing 5 ml of a semi-solid Cary-Blair medium. Cary-Blair medium is a non-nutritive balanced salt solution containing disodium phosphate to provide buffering capability, sodium chloride and calcium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semisolid texture to the medium. Sodium thioglycollate helps maintained an oxygen-reduced environment to help maintain the viability of enteric bacteria during the transport to the laboratory. The semi-solid Cary Blair medium is composed of the following components: · Sodium chloride 5.0 g/L · Disodium Phosphate, 1.1 g/L 3 · Sodium thioglycollate 1.5 g/L · Calcium chloride, 0.09 g/L · Bacteriological agar, 5.6 g/L · Deionized water 1 L J. Substantial Equivalence Information: 1. Predicate device name(s): Copan Venturi Transystem Cary-Blair Medium product (132C) 2. Predicate 510(k) number(s): k946286 3. Comparison with predicate: Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Intended Use The Puritan Opti-Tranz Cary- Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. Copan Venturi Transystem Cary-Blair Medium product (132C) is a sterile ready-to-use system intended for the safe collection, transport, and preservation of clinical specimens for bacteriological examination. Product 132C is supplied with a plastic applicator swab. The Venturi Transystem with Cary-Blair Transport Medium is recommended for the collection and transport of fecal and rectal swab samples for the investigation of enteric pathogenic bacteria. 4 Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Specimen Storage Up to 48 h at 20 – 25 oC and up to 72 h at refrigerated conditions 2 – 8 oC Same Tube Polypropylene, round bottom Same Medium Volume 5 mL Same Single Use Device Yes Same Packaging Peel pouch Same Swab Rayon Same Medium Formulation Sodium chloride 5.0 g/L Disodium Phosphate, 1.1 g/L Sodium thioglycollate 1.5 g/L Calcium chloride, 0.09 g/L Bacteriological agar, 5.6 g/L Deionized water 1 L Same Differences Item Device Predicate Organisms Tested Campylobacter jejuni Enterococcus faecalis Escherichia coli Salmonella typhimurium Shigella sonnei Vibrio parahaemolyticus Yersinia enterocolitica Campylobacter jejuni Escherichia coli Shigella flexneri Yersinia enterocolitica pH 6.9 – 7.5 8.4 ± 0.2 Shelf life 20 months 24 months K. Standard/Guidance Document Referenced (if applicable): Quality Control of Microbiological Transport Systems; Approved Standard – Second Edition, M40-A2, Clinical and Laboratory Standards Institute (CLSI), Wayne, PA, 2014. L. Test Principle: Not applicable. M. Performance Characteristics (if/when applicable): 5 1. Analytical performance: Analytical studies were conducted to determine the ability of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System to maintain the viability of enteric microorganisms. The performance of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System was determined using quantitative colony enumeration techniques outlined in the Clinical and Laboratory Standards Institute (CLSI) M40-A2 document. Bacterial viability studies were performed. The swabs from each transport system were inoculated with 100 µL of select bacterial concentrations prepared in a fecal matrix and/or 0.85% phosphate buffered saline (PBS). To facilitate testing, a homogeneous fecal matrix was prepared by diluting pre-screened negative fresh clinical fecal material in 0.85% PBS to a 30% concentration by volume. Once inoculated, the swabs were then placed in their respective transport tubes and held at various time intervals; at the designated time intervals the swabs were removed and processed. To test the viability at various time intervals the inoculated swabs were held at room temperature for 0, 24, and 48 hours and refrigerated for 0, 24, 48, and 72 hours. The eight ATCC strains listed in Table 1 below were used to evaluate the performance of the Puritan Opti-Tranz Cary-Blair Collection and Transport System. This device was tested using the swabs included with the transport kit. Viability studies were conducted in duplicate at 0, 24, and 48 at room temperature (20-25°C) and at 0, 24, 48, and 72 hours at refrigerated temperatures (2-8°C) using the Roll-Plate and Swab Elution Methods. * ‘NO’ indicates that strain was not tested in the column heading matrix; ‘YES’ indicates that the strain was tested in the column heading matrix. Roll-Plate Method: Bacterial suspensions were prepared from fresh18-24 hour cultures of each microorganism in a separate vial containing 10 mL of fecal matrix or 0.85% sterile saline to obtain 1.5 x 108 CFU/mL suspensions. One log10 serial dilutions were made and 100 µL aliquots of dilutions were absorbed into the swabs and immediately placed into the Table 1: Enteric bacteria evaluated for stability in Puritan Opti-Tranz Cary- Blair Collection and Transport System Microorganism ATCC # Fecal Matrix* 0.85% Saline* Campylobacter jejuni ATCC 33291 NO YES Escherichia coli ATCC 25922 NO YES Escherichia coli 0157:H7 ATCC 700728 YES YES Salmonella typhimurium ATCC 14028 YES YES Shigella sonnei ATCC 12022 NO YES Vibrio parahaemolyticus ATCC 17802 YES YES Vancomycin-resistant Enterococcus faecalis (VRE) ATCC 51299 NO YES Yersinia enterocolitica ATCC 9610 NO YES 6 Puritan Opti-Tranz Cary-Blair medium. For fecal specimens, the final dilution prior to swab inoculation was done with fecal matrix to maximize the amount of fecal material on the swab. After incubation at each time point, the swabs were removed from the transport tubes and used to inoculate the entire surface of the appropriate agar plate. The plates were incubated in appropriate culture conditions for 24-48 hours or until countable colonies were visible. Manual colony counts were conducted for each time interval for each swab- organism combination. The dilution yielding colony counts nearest to zero (not to exceed 250 CFU) was reported. Log10 increases or decreases in survival are based on a comparison between time-zero and the last time point collected for each Classification:

idK160082_s0_e2000

K160082.txt

panel

83- Microbiology

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for laboratory culture of bacteria and yeast. C. Measurand: Not applicable. D. Type of Test: Collection and transport culture medium device E. Applicant: Puritan Medical Products, LLC F. Proprietary and Established Names: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System G. Regulatory Information: 1. Regulation section: 866.2390; Transport Culture Medium 2. Classification: Class I 3. Product code: JSM; Culture Media, Non-Propagating Transport LIO: Device, Specimen Collection 2 JTW: System, Transport, Aerobic 4. Panel: 83- Microbiology H. Intended Use: 1. Intended use(s): The Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: None. I. Device Description: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System is comprised of a peel pouch containing a rayon tipped swab applicator for collecting specimens and a polypropylene, round-bottomed, capped tube containing 5 ml of a semi-solid Cary-Blair medium. Cary-Blair medium is a non-nutritive balanced salt solution containing disodium phosphate to provide buffering capability, sodium chloride and calcium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semisolid texture to the medium. Sodium thioglycollate helps maintained an oxygen-reduced environment to help maintain the viability of enteric bacteria during the transport to the laboratory. The semi-solid Cary Blair medium is composed of the following components: · Sodium chloride 5.0 g/L · Disodium Phosphate, 1.1 g/L 3 · Sodium thioglycollate 1.5 g/L · Calcium chloride, 0.09 g/L · Bacteriological agar, 5.6 g/L · Deionized water 1 L J. Substantial Equivalence Information: 1. Predicate device name(s): Copan Venturi Transystem Cary-Blair Medium product (132C) 2. Predicate 510(k) number(s): k946286 3. Comparison with predicate: Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Intended Use The Puritan Opti-Tranz Cary- Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. Copan Venturi Transystem Cary-Blair Medium product (132C) is a sterile ready-to-use system intended for the safe collection, transport, and preservation of clinical specimens for bacteriological examination. Product 132C is supplied with a plastic applicator swab. The Venturi Transystem with Cary-Blair Transport Medium is recommended for the collection and transport of fecal and rectal swab samples for the investigation of enteric pathogenic bacteria. 4 Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Specimen Storage Up to 48 h at 20 – 25 oC and up to 72 h at refrigerated conditions 2 – 8 oC Same Tube Polypropylene, round bottom Same Medium Volume 5 mL Same Single Use Device Yes Same Packaging Peel pouch Same Swab Rayon Same Medium Formulation Sodium chloride 5.0 g/L Disodium Phosphate, 1.1 g/L Sodium thioglycollate 1.5 g/L Calcium chloride, 0.09 g/L Bacteriological agar, 5.6 g/L Deionized water 1 L Same Differences Item Device Predicate Organisms Tested Campylobacter jejuni Enterococcus faecalis Escherichia coli Salmonella typhimurium Shigella sonnei Vibrio parahaemolyticus Yersinia enterocolitica Campylobacter jejuni Escherichia coli Shigella flexneri Yersinia enterocolitica pH 6.9 – 7.5 8.4 ± 0.2 Shelf life 20 months 24 months K. Standard/Guidance Document Referenced (if applicable): Quality Control of Microbiological Transport Systems; Approved Standard – Second Edition, M40-A2, Clinical and Laboratory Standards Institute (CLSI), Wayne, PA, 2014. L. Test Principle: Not applicable. M. Performance Characteristics (if/when applicable): 5 1. Analytical performance: Analytical studies were conducted to determine the ability of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System to maintain the viability of enteric microorganisms. The performance of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System was determined using quantitative colony enumeration techniques outlined in the Clinical and Laboratory Standards Institute (CLSI) M40-A2 document. Bacterial viability studies were performed. The swabs from each transport system were inoculated with 100 µL of select bacterial concentrations prepared in a fecal matrix and/or 0.85% phosphate buffered saline (PBS). To facilitate testing, a homogeneous fecal matrix was prepared by diluting pre-screened negative fresh clinical fecal material in 0.85% PBS to a 30% concentration by volume. Once inoculated, the swabs were then placed in their respective transport tubes and held at various time intervals; at the designated time intervals the swabs were removed and processed. To test the viability at various time intervals the inoculated swabs were held at room temperature for 0, 24, and 48 hours and refrigerated for 0, 24, 48, and 72 hours. The eight ATCC strains listed in Table 1 below were used to evaluate the performance of the Puritan Opti-Tranz Cary-Blair Collection and Transport System. This device was tested using the swabs included with the transport kit. Viability studies were conducted in duplicate at 0, 24, and 48 at room temperature (20-25°C) and at 0, 24, 48, and 72 hours at refrigerated temperatures (2-8°C) using the Roll-Plate and Swab Elution Methods. * ‘NO’ indicates that strain was not tested in the column heading matrix; ‘YES’ indicates that the strain was tested in the column heading matrix. Roll-Plate Method: Bacterial suspensions were prepared from fresh18-24 hour cultures of each microorganism in a separate vial containing 10 mL of fecal matrix or 0.85% sterile saline to obtain 1.5 x 108 CFU/mL suspensions. One log10 serial dilutions were made and 100 µL aliquots of dilutions were absorbed into the swabs and immediately placed into the Table 1: Enteric bacteria evaluated for stability in Puritan Opti-Tranz Cary- Blair Collection and Transport System Microorganism ATCC # Fecal Matrix* 0.85% Saline* Campylobacter jejuni ATCC 33291 NO YES Escherichia coli ATCC 25922 NO YES Escherichia coli 0157:H7 ATCC 700728 YES YES Salmonella typhimurium ATCC 14028 YES YES Shigella sonnei ATCC 12022 NO YES Vibrio parahaemolyticus ATCC 17802 YES YES Vancomycin-resistant Enterococcus faecalis (VRE) ATCC 51299 NO YES Yersinia enterocolitica ATCC 9610 NO YES 6 Puritan Opti-Tranz Cary-Blair medium. For fecal specimens, the final dilution prior to swab inoculation was done with fecal matrix to maximize the amount of fecal material on the swab. After incubation at each time point, the swabs were removed from the transport tubes and used to inoculate the entire surface of the appropriate agar plate. The plates were incubated in appropriate culture conditions for 24-48 hours or until countable colonies were visible. Manual colony counts were conducted for each time interval for each swab- organism combination. The dilution yielding colony counts nearest to zero (not to exceed 250 CFU) was reported. Log10 increases or decreases in survival are based on a comparison between time-zero and the last time point collected for each Panel:

idK160082_s0_e2000

K160082.txt

intended use

The Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for laboratory culture of bacteria and yeast. C. Measurand: Not applicable. D. Type of Test: Collection and transport culture medium device E. Applicant: Puritan Medical Products, LLC F. Proprietary and Established Names: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System G. Regulatory Information: 1. Regulation section: 866.2390; Transport Culture Medium 2. Classification: Class I 3. Product code: JSM; Culture Media, Non-Propagating Transport LIO: Device, Specimen Collection 2 JTW: System, Transport, Aerobic 4. Panel: 83- Microbiology H. Intended Use: 1. Intended use(s): The Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: None. I. Device Description: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System is comprised of a peel pouch containing a rayon tipped swab applicator for collecting specimens and a polypropylene, round-bottomed, capped tube containing 5 ml of a semi-solid Cary-Blair medium. Cary-Blair medium is a non-nutritive balanced salt solution containing disodium phosphate to provide buffering capability, sodium chloride and calcium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semisolid texture to the medium. Sodium thioglycollate helps maintained an oxygen-reduced environment to help maintain the viability of enteric bacteria during the transport to the laboratory. The semi-solid Cary Blair medium is composed of the following components: · Sodium chloride 5.0 g/L · Disodium Phosphate, 1.1 g/L 3 · Sodium thioglycollate 1.5 g/L · Calcium chloride, 0.09 g/L · Bacteriological agar, 5.6 g/L · Deionized water 1 L J. Substantial Equivalence Information: 1. Predicate device name(s): Copan Venturi Transystem Cary-Blair Medium product (132C) 2. Predicate 510(k) number(s): k946286 3. Comparison with predicate: Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Intended Use The Puritan Opti-Tranz Cary- Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. Copan Venturi Transystem Cary-Blair Medium product (132C) is a sterile ready-to-use system intended for the safe collection, transport, and preservation of clinical specimens for bacteriological examination. Product 132C is supplied with a plastic applicator swab. The Venturi Transystem with Cary-Blair Transport Medium is recommended for the collection and transport of fecal and rectal swab samples for the investigation of enteric pathogenic bacteria. 4 Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Specimen Storage Up to 48 h at 20 – 25 oC and up to 72 h at refrigerated conditions 2 – 8 oC Same Tube Polypropylene, round bottom Same Medium Volume 5 mL Same Single Use Device Yes Same Packaging Peel pouch Same Swab Rayon Same Medium Formulation Sodium chloride 5.0 g/L Disodium Phosphate, 1.1 g/L Sodium thioglycollate 1.5 g/L Calcium chloride, 0.09 g/L Bacteriological agar, 5.6 g/L Deionized water 1 L Same Differences Item Device Predicate Organisms Tested Campylobacter jejuni Enterococcus faecalis Escherichia coli Salmonella typhimurium Shigella sonnei Vibrio parahaemolyticus Yersinia enterocolitica Campylobacter jejuni Escherichia coli Shigella flexneri Yersinia enterocolitica pH 6.9 – 7.5 8.4 ± 0.2 Shelf life 20 months 24 months K. Standard/Guidance Document Referenced (if applicable): Quality Control of Microbiological Transport Systems; Approved Standard – Second Edition, M40-A2, Clinical and Laboratory Standards Institute (CLSI), Wayne, PA, 2014. L. Test Principle: Not applicable. M. Performance Characteristics (if/when applicable): 5 1. Analytical performance: Analytical studies were conducted to determine the ability of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System to maintain the viability of enteric microorganisms. The performance of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System was determined using quantitative colony enumeration techniques outlined in the Clinical and Laboratory Standards Institute (CLSI) M40-A2 document. Bacterial viability studies were performed. The swabs from each transport system were inoculated with 100 µL of select bacterial concentrations prepared in a fecal matrix and/or 0.85% phosphate buffered saline (PBS). To facilitate testing, a homogeneous fecal matrix was prepared by diluting pre-screened negative fresh clinical fecal material in 0.85% PBS to a 30% concentration by volume. Once inoculated, the swabs were then placed in their respective transport tubes and held at various time intervals; at the designated time intervals the swabs were removed and processed. To test the viability at various time intervals the inoculated swabs were held at room temperature for 0, 24, and 48 hours and refrigerated for 0, 24, 48, and 72 hours. The eight ATCC strains listed in Table 1 below were used to evaluate the performance of the Puritan Opti-Tranz Cary-Blair Collection and Transport System. This device was tested using the swabs included with the transport kit. Viability studies were conducted in duplicate at 0, 24, and 48 at room temperature (20-25°C) and at 0, 24, 48, and 72 hours at refrigerated temperatures (2-8°C) using the Roll-Plate and Swab Elution Methods. * ‘NO’ indicates that strain was not tested in the column heading matrix; ‘YES’ indicates that the strain was tested in the column heading matrix. Roll-Plate Method: Bacterial suspensions were prepared from fresh18-24 hour cultures of each microorganism in a separate vial containing 10 mL of fecal matrix or 0.85% sterile saline to obtain 1.5 x 108 CFU/mL suspensions. One log10 serial dilutions were made and 100 µL aliquots of dilutions were absorbed into the swabs and immediately placed into the Table 1: Enteric bacteria evaluated for stability in Puritan Opti-Tranz Cary- Blair Collection and Transport System Microorganism ATCC # Fecal Matrix* 0.85% Saline* Campylobacter jejuni ATCC 33291 NO YES Escherichia coli ATCC 25922 NO YES Escherichia coli 0157:H7 ATCC 700728 YES YES Salmonella typhimurium ATCC 14028 YES YES Shigella sonnei ATCC 12022 NO YES Vibrio parahaemolyticus ATCC 17802 YES YES Vancomycin-resistant Enterococcus faecalis (VRE) ATCC 51299 NO YES Yersinia enterocolitica ATCC 9610 NO YES 6 Puritan Opti-Tranz Cary-Blair medium. For fecal specimens, the final dilution prior to swab inoculation was done with fecal matrix to maximize the amount of fecal material on the swab. After incubation at each time point, the swabs were removed from the transport tubes and used to inoculate the entire surface of the appropriate agar plate. The plates were incubated in appropriate culture conditions for 24-48 hours or until countable colonies were visible. Manual colony counts were conducted for each time interval for each swab- organism combination. The dilution yielding colony counts nearest to zero (not to exceed 250 CFU) was reported. Log10 increases or decreases in survival are based on a comparison between time-zero and the last time point collected for each Intended use:

idK160082_s0_e2000

K160082.txt

predicate device name

Copan Venturi Transystem Cary-Blair Medium product (132C)

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for laboratory culture of bacteria and yeast. C. Measurand: Not applicable. D. Type of Test: Collection and transport culture medium device E. Applicant: Puritan Medical Products, LLC F. Proprietary and Established Names: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System G. Regulatory Information: 1. Regulation section: 866.2390; Transport Culture Medium 2. Classification: Class I 3. Product code: JSM; Culture Media, Non-Propagating Transport LIO: Device, Specimen Collection 2 JTW: System, Transport, Aerobic 4. Panel: 83- Microbiology H. Intended Use: 1. Intended use(s): The Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: None. I. Device Description: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System is comprised of a peel pouch containing a rayon tipped swab applicator for collecting specimens and a polypropylene, round-bottomed, capped tube containing 5 ml of a semi-solid Cary-Blair medium. Cary-Blair medium is a non-nutritive balanced salt solution containing disodium phosphate to provide buffering capability, sodium chloride and calcium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semisolid texture to the medium. Sodium thioglycollate helps maintained an oxygen-reduced environment to help maintain the viability of enteric bacteria during the transport to the laboratory. The semi-solid Cary Blair medium is composed of the following components: · Sodium chloride 5.0 g/L · Disodium Phosphate, 1.1 g/L 3 · Sodium thioglycollate 1.5 g/L · Calcium chloride, 0.09 g/L · Bacteriological agar, 5.6 g/L · Deionized water 1 L J. Substantial Equivalence Information: 1. Predicate device name(s): Copan Venturi Transystem Cary-Blair Medium product (132C) 2. Predicate 510(k) number(s): k946286 3. Comparison with predicate: Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Intended Use The Puritan Opti-Tranz Cary- Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. Copan Venturi Transystem Cary-Blair Medium product (132C) is a sterile ready-to-use system intended for the safe collection, transport, and preservation of clinical specimens for bacteriological examination. Product 132C is supplied with a plastic applicator swab. The Venturi Transystem with Cary-Blair Transport Medium is recommended for the collection and transport of fecal and rectal swab samples for the investigation of enteric pathogenic bacteria. 4 Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Specimen Storage Up to 48 h at 20 – 25 oC and up to 72 h at refrigerated conditions 2 – 8 oC Same Tube Polypropylene, round bottom Same Medium Volume 5 mL Same Single Use Device Yes Same Packaging Peel pouch Same Swab Rayon Same Medium Formulation Sodium chloride 5.0 g/L Disodium Phosphate, 1.1 g/L Sodium thioglycollate 1.5 g/L Calcium chloride, 0.09 g/L Bacteriological agar, 5.6 g/L Deionized water 1 L Same Differences Item Device Predicate Organisms Tested Campylobacter jejuni Enterococcus faecalis Escherichia coli Salmonella typhimurium Shigella sonnei Vibrio parahaemolyticus Yersinia enterocolitica Campylobacter jejuni Escherichia coli Shigella flexneri Yersinia enterocolitica pH 6.9 – 7.5 8.4 ± 0.2 Shelf life 20 months 24 months K. Standard/Guidance Document Referenced (if applicable): Quality Control of Microbiological Transport Systems; Approved Standard – Second Edition, M40-A2, Clinical and Laboratory Standards Institute (CLSI), Wayne, PA, 2014. L. Test Principle: Not applicable. M. Performance Characteristics (if/when applicable): 5 1. Analytical performance: Analytical studies were conducted to determine the ability of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System to maintain the viability of enteric microorganisms. The performance of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System was determined using quantitative colony enumeration techniques outlined in the Clinical and Laboratory Standards Institute (CLSI) M40-A2 document. Bacterial viability studies were performed. The swabs from each transport system were inoculated with 100 µL of select bacterial concentrations prepared in a fecal matrix and/or 0.85% phosphate buffered saline (PBS). To facilitate testing, a homogeneous fecal matrix was prepared by diluting pre-screened negative fresh clinical fecal material in 0.85% PBS to a 30% concentration by volume. Once inoculated, the swabs were then placed in their respective transport tubes and held at various time intervals; at the designated time intervals the swabs were removed and processed. To test the viability at various time intervals the inoculated swabs were held at room temperature for 0, 24, and 48 hours and refrigerated for 0, 24, 48, and 72 hours. The eight ATCC strains listed in Table 1 below were used to evaluate the performance of the Puritan Opti-Tranz Cary-Blair Collection and Transport System. This device was tested using the swabs included with the transport kit. Viability studies were conducted in duplicate at 0, 24, and 48 at room temperature (20-25°C) and at 0, 24, 48, and 72 hours at refrigerated temperatures (2-8°C) using the Roll-Plate and Swab Elution Methods. * ‘NO’ indicates that strain was not tested in the column heading matrix; ‘YES’ indicates that the strain was tested in the column heading matrix. Roll-Plate Method: Bacterial suspensions were prepared from fresh18-24 hour cultures of each microorganism in a separate vial containing 10 mL of fecal matrix or 0.85% sterile saline to obtain 1.5 x 108 CFU/mL suspensions. One log10 serial dilutions were made and 100 µL aliquots of dilutions were absorbed into the swabs and immediately placed into the Table 1: Enteric bacteria evaluated for stability in Puritan Opti-Tranz Cary- Blair Collection and Transport System Microorganism ATCC # Fecal Matrix* 0.85% Saline* Campylobacter jejuni ATCC 33291 NO YES Escherichia coli ATCC 25922 NO YES Escherichia coli 0157:H7 ATCC 700728 YES YES Salmonella typhimurium ATCC 14028 YES YES Shigella sonnei ATCC 12022 NO YES Vibrio parahaemolyticus ATCC 17802 YES YES Vancomycin-resistant Enterococcus faecalis (VRE) ATCC 51299 NO YES Yersinia enterocolitica ATCC 9610 NO YES 6 Puritan Opti-Tranz Cary-Blair medium. For fecal specimens, the final dilution prior to swab inoculation was done with fecal matrix to maximize the amount of fecal material on the swab. After incubation at each time point, the swabs were removed from the transport tubes and used to inoculate the entire surface of the appropriate agar plate. The plates were incubated in appropriate culture conditions for 24-48 hours or until countable colonies were visible. Manual colony counts were conducted for each time interval for each swab- organism combination. The dilution yielding colony counts nearest to zero (not to exceed 250 CFU) was reported. Log10 increases or decreases in survival are based on a comparison between time-zero and the last time point collected for each Predicate device name:

idK160082_s0_e2000

K160082.txt

applicant

Puritan Medical Products, LLC

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for laboratory culture of bacteria and yeast. C. Measurand: Not applicable. D. Type of Test: Collection and transport culture medium device E. Applicant: Puritan Medical Products, LLC F. Proprietary and Established Names: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System G. Regulatory Information: 1. Regulation section: 866.2390; Transport Culture Medium 2. Classification: Class I 3. Product code: JSM; Culture Media, Non-Propagating Transport LIO: Device, Specimen Collection 2 JTW: System, Transport, Aerobic 4. Panel: 83- Microbiology H. Intended Use: 1. Intended use(s): The Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: None. I. Device Description: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System is comprised of a peel pouch containing a rayon tipped swab applicator for collecting specimens and a polypropylene, round-bottomed, capped tube containing 5 ml of a semi-solid Cary-Blair medium. Cary-Blair medium is a non-nutritive balanced salt solution containing disodium phosphate to provide buffering capability, sodium chloride and calcium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semisolid texture to the medium. Sodium thioglycollate helps maintained an oxygen-reduced environment to help maintain the viability of enteric bacteria during the transport to the laboratory. The semi-solid Cary Blair medium is composed of the following components: · Sodium chloride 5.0 g/L · Disodium Phosphate, 1.1 g/L 3 · Sodium thioglycollate 1.5 g/L · Calcium chloride, 0.09 g/L · Bacteriological agar, 5.6 g/L · Deionized water 1 L J. Substantial Equivalence Information: 1. Predicate device name(s): Copan Venturi Transystem Cary-Blair Medium product (132C) 2. Predicate 510(k) number(s): k946286 3. Comparison with predicate: Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Intended Use The Puritan Opti-Tranz Cary- Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. Copan Venturi Transystem Cary-Blair Medium product (132C) is a sterile ready-to-use system intended for the safe collection, transport, and preservation of clinical specimens for bacteriological examination. Product 132C is supplied with a plastic applicator swab. The Venturi Transystem with Cary-Blair Transport Medium is recommended for the collection and transport of fecal and rectal swab samples for the investigation of enteric pathogenic bacteria. 4 Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Specimen Storage Up to 48 h at 20 – 25 oC and up to 72 h at refrigerated conditions 2 – 8 oC Same Tube Polypropylene, round bottom Same Medium Volume 5 mL Same Single Use Device Yes Same Packaging Peel pouch Same Swab Rayon Same Medium Formulation Sodium chloride 5.0 g/L Disodium Phosphate, 1.1 g/L Sodium thioglycollate 1.5 g/L Calcium chloride, 0.09 g/L Bacteriological agar, 5.6 g/L Deionized water 1 L Same Differences Item Device Predicate Organisms Tested Campylobacter jejuni Enterococcus faecalis Escherichia coli Salmonella typhimurium Shigella sonnei Vibrio parahaemolyticus Yersinia enterocolitica Campylobacter jejuni Escherichia coli Shigella flexneri Yersinia enterocolitica pH 6.9 – 7.5 8.4 ± 0.2 Shelf life 20 months 24 months K. Standard/Guidance Document Referenced (if applicable): Quality Control of Microbiological Transport Systems; Approved Standard – Second Edition, M40-A2, Clinical and Laboratory Standards Institute (CLSI), Wayne, PA, 2014. L. Test Principle: Not applicable. M. Performance Characteristics (if/when applicable): 5 1. Analytical performance: Analytical studies were conducted to determine the ability of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System to maintain the viability of enteric microorganisms. The performance of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System was determined using quantitative colony enumeration techniques outlined in the Clinical and Laboratory Standards Institute (CLSI) M40-A2 document. Bacterial viability studies were performed. The swabs from each transport system were inoculated with 100 µL of select bacterial concentrations prepared in a fecal matrix and/or 0.85% phosphate buffered saline (PBS). To facilitate testing, a homogeneous fecal matrix was prepared by diluting pre-screened negative fresh clinical fecal material in 0.85% PBS to a 30% concentration by volume. Once inoculated, the swabs were then placed in their respective transport tubes and held at various time intervals; at the designated time intervals the swabs were removed and processed. To test the viability at various time intervals the inoculated swabs were held at room temperature for 0, 24, and 48 hours and refrigerated for 0, 24, 48, and 72 hours. The eight ATCC strains listed in Table 1 below were used to evaluate the performance of the Puritan Opti-Tranz Cary-Blair Collection and Transport System. This device was tested using the swabs included with the transport kit. Viability studies were conducted in duplicate at 0, 24, and 48 at room temperature (20-25°C) and at 0, 24, 48, and 72 hours at refrigerated temperatures (2-8°C) using the Roll-Plate and Swab Elution Methods. * ‘NO’ indicates that strain was not tested in the column heading matrix; ‘YES’ indicates that the strain was tested in the column heading matrix. Roll-Plate Method: Bacterial suspensions were prepared from fresh18-24 hour cultures of each microorganism in a separate vial containing 10 mL of fecal matrix or 0.85% sterile saline to obtain 1.5 x 108 CFU/mL suspensions. One log10 serial dilutions were made and 100 µL aliquots of dilutions were absorbed into the swabs and immediately placed into the Table 1: Enteric bacteria evaluated for stability in Puritan Opti-Tranz Cary- Blair Collection and Transport System Microorganism ATCC # Fecal Matrix* 0.85% Saline* Campylobacter jejuni ATCC 33291 NO YES Escherichia coli ATCC 25922 NO YES Escherichia coli 0157:H7 ATCC 700728 YES YES Salmonella typhimurium ATCC 14028 YES YES Shigella sonnei ATCC 12022 NO YES Vibrio parahaemolyticus ATCC 17802 YES YES Vancomycin-resistant Enterococcus faecalis (VRE) ATCC 51299 NO YES Yersinia enterocolitica ATCC 9610 NO YES 6 Puritan Opti-Tranz Cary-Blair medium. For fecal specimens, the final dilution prior to swab inoculation was done with fecal matrix to maximize the amount of fecal material on the swab. After incubation at each time point, the swabs were removed from the transport tubes and used to inoculate the entire surface of the appropriate agar plate. The plates were incubated in appropriate culture conditions for 24-48 hours or until countable colonies were visible. Manual colony counts were conducted for each time interval for each swab- organism combination. The dilution yielding colony counts nearest to zero (not to exceed 250 CFU) was reported. Log10 increases or decreases in survival are based on a comparison between time-zero and the last time point collected for each Applicant:

idK160082_s0_e2000

K160082.txt

proprietary and established names

Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System

IAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for laboratory culture of bacteria and yeast. C. Measurand: Not applicable. D. Type of Test: Collection and transport culture medium device E. Applicant: Puritan Medical Products, LLC F. Proprietary and Established Names: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System G. Regulatory Information: 1. Regulation section: 866.2390; Transport Culture Medium 2. Classification: Class I 3. Product code: JSM; Culture Media, Non-Propagating Transport LIO: Device, Specimen Collection 2 JTW: System, Transport, Aerobic 4. Panel: 83- Microbiology H. Intended Use: 1. Intended use(s): The Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: None. I. Device Description: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System is comprised of a peel pouch containing a rayon tipped swab applicator for collecting specimens and a polypropylene, round-bottomed, capped tube containing 5 ml of a semi-solid Cary-Blair medium. Cary-Blair medium is a non-nutritive balanced salt solution containing disodium phosphate to provide buffering capability, sodium chloride and calcium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semisolid texture to the medium. Sodium thioglycollate helps maintained an oxygen-reduced environment to help maintain the viability of enteric bacteria during the transport to the laboratory. The semi-solid Cary Blair medium is composed of the following components: · Sodium chloride 5.0 g/L · Disodium Phosphate, 1.1 g/L 3 · Sodium thioglycollate 1.5 g/L · Calcium chloride, 0.09 g/L · Bacteriological agar, 5.6 g/L · Deionized water 1 L J. Substantial Equivalence Information: 1. Predicate device name(s): Copan Venturi Transystem Cary-Blair Medium product (132C) 2. Predicate 510(k) number(s): k946286 3. Comparison with predicate: Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Intended Use The Puritan Opti-Tranz Cary- Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. Copan Venturi Transystem Cary-Blair Medium product (132C) is a sterile ready-to-use system intended for the safe collection, transport, and preservation of clinical specimens for bacteriological examination. Product 132C is supplied with a plastic applicator swab. The Venturi Transystem with Cary-Blair Transport Medium is recommended for the collection and transport of fecal and rectal swab samples for the investigation of enteric pathogenic bacteria. 4 Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Specimen Storage Up to 48 h at 20 – 25 oC and up to 72 h at refrigerated conditions 2 – 8 oC Same Tube Polypropylene, round bottom Same Medium Volume 5 mL Same Single Use Device Yes Same Packaging Peel pouch Same Swab Rayon Same Medium Formulation Sodium chloride 5.0 g/L Disodium Phosphate, 1.1 g/L Sodium thioglycollate 1.5 g/L Calcium chloride, 0.09 g/L Bacteriological agar, 5.6 g/L Deionized water 1 L Same Differences Item Device Predicate Organisms Tested Campylobacter jejuni Enterococcus faecalis Escherichia coli Salmonella typhimurium Shigella sonnei Vibrio parahaemolyticus Yersinia enterocolitica Campylobacter jejuni Escherichia coli Shigella flexneri Yersinia enterocolitica pH 6.9 – 7.5 8.4 ± 0.2 Shelf life 20 months 24 months K. Standard/Guidance Document Referenced (if applicable): Quality Control of Microbiological Transport Systems; Approved Standard – Second Edition, M40-A2, Clinical and Laboratory Standards Institute (CLSI), Wayne, PA, 2014. L. Test Principle: Not applicable. M. Performance Characteristics (if/when applicable): 5 1. Analytical performance: Analytical studies were conducted to determine the ability of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System to maintain the viability of enteric microorganisms. The performance of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System was determined using quantitative colony enumeration techniques outlined in the Clinical and Laboratory Standards Institute (CLSI) M40-A2 document. Bacterial viability studies were performed. The swabs from each transport system were inoculated with 100 µL of select bacterial concentrations prepared in a fecal matrix and/or 0.85% phosphate buffered saline (PBS). To facilitate testing, a homogeneous fecal matrix was prepared by diluting pre-screened negative fresh clinical fecal material in 0.85% PBS to a 30% concentration by volume. Once inoculated, the swabs were then placed in their respective transport tubes and held at various time intervals; at the designated time intervals the swabs were removed and processed. To test the viability at various time intervals the inoculated swabs were held at room temperature for 0, 24, and 48 hours and refrigerated for 0, 24, 48, and 72 hours. The eight ATCC strains listed in Table 1 below were used to evaluate the performance of the Puritan Opti-Tranz Cary-Blair Collection and Transport System. This device was tested using the swabs included with the transport kit. Viability studies were conducted in duplicate at 0, 24, and 48 at room temperature (20-25°C) and at 0, 24, 48, and 72 hours at refrigerated temperatures (2-8°C) using the Roll-Plate and Swab Elution Methods. * ‘NO’ indicates that strain was not tested in the column heading matrix; ‘YES’ indicates that the strain was tested in the column heading matrix. Roll-Plate Method: Bacterial suspensions were prepared from fresh18-24 hour cultures of each microorganism in a separate vial containing 10 mL of fecal matrix or 0.85% sterile saline to obtain 1.5 x 108 CFU/mL suspensions. One log10 serial dilutions were made and 100 µL aliquots of dilutions were absorbed into the swabs and immediately placed into the Table 1: Enteric bacteria evaluated for stability in Puritan Opti-Tranz Cary- Blair Collection and Transport System Microorganism ATCC # Fecal Matrix* 0.85% Saline* Campylobacter jejuni ATCC 33291 NO YES Escherichia coli ATCC 25922 NO YES Escherichia coli 0157:H7 ATCC 700728 YES YES Salmonella typhimurium ATCC 14028 YES YES Shigella sonnei ATCC 12022 NO YES Vibrio parahaemolyticus ATCC 17802 YES YES Vancomycin-resistant Enterococcus faecalis (VRE) ATCC 51299 NO YES Yersinia enterocolitica ATCC 9610 NO YES 6 Puritan Opti-Tranz Cary-Blair medium. For fecal specimens, the final dilution prior to swab inoculation was done with fecal matrix to maximize the amount of fecal material on the swab. After incubation at each time point, the swabs were removed from the transport tubes and used to inoculate the entire surface of the appropriate agar plate. The plates were incubated in appropriate culture conditions for 24-48 hours or until countable colonies were visible. Manual colony counts were conducted for each time interval for each swab- organism combination. The dilution yielding colony counts nearest to zero (not to exceed 250 CFU) was reported. Log10 increases or decreases in survival are based on a comparison between time-zero and the last time point collected for each Proprietary and established names:

idK160082_s0_e2000

K160082.txt

regulation section

866.2390; Transport Culture Medium

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for laboratory culture of bacteria and yeast. C. Measurand: Not applicable. D. Type of Test: Collection and transport culture medium device E. Applicant: Puritan Medical Products, LLC F. Proprietary and Established Names: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System G. Regulatory Information: 1. Regulation section: 866.2390; Transport Culture Medium 2. Classification: Class I 3. Product code: JSM; Culture Media, Non-Propagating Transport LIO: Device, Specimen Collection 2 JTW: System, Transport, Aerobic 4. Panel: 83- Microbiology H. Intended Use: 1. Intended use(s): The Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: None. I. Device Description: Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System is comprised of a peel pouch containing a rayon tipped swab applicator for collecting specimens and a polypropylene, round-bottomed, capped tube containing 5 ml of a semi-solid Cary-Blair medium. Cary-Blair medium is a non-nutritive balanced salt solution containing disodium phosphate to provide buffering capability, sodium chloride and calcium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semisolid texture to the medium. Sodium thioglycollate helps maintained an oxygen-reduced environment to help maintain the viability of enteric bacteria during the transport to the laboratory. The semi-solid Cary Blair medium is composed of the following components: · Sodium chloride 5.0 g/L · Disodium Phosphate, 1.1 g/L 3 · Sodium thioglycollate 1.5 g/L · Calcium chloride, 0.09 g/L · Bacteriological agar, 5.6 g/L · Deionized water 1 L J. Substantial Equivalence Information: 1. Predicate device name(s): Copan Venturi Transystem Cary-Blair Medium product (132C) 2. Predicate 510(k) number(s): k946286 3. Comparison with predicate: Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Intended Use The Puritan Opti-Tranz Cary- Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. Copan Venturi Transystem Cary-Blair Medium product (132C) is a sterile ready-to-use system intended for the safe collection, transport, and preservation of clinical specimens for bacteriological examination. Product 132C is supplied with a plastic applicator swab. The Venturi Transystem with Cary-Blair Transport Medium is recommended for the collection and transport of fecal and rectal swab samples for the investigation of enteric pathogenic bacteria. 4 Similarities Item Device Predicate Puritan® Opti-Tranz™ Cary- Blair Collection and Transport System (k160082) Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) Specimen Storage Up to 48 h at 20 – 25 oC and up to 72 h at refrigerated conditions 2 – 8 oC Same Tube Polypropylene, round bottom Same Medium Volume 5 mL Same Single Use Device Yes Same Packaging Peel pouch Same Swab Rayon Same Medium Formulation Sodium chloride 5.0 g/L Disodium Phosphate, 1.1 g/L Sodium thioglycollate 1.5 g/L Calcium chloride, 0.09 g/L Bacteriological agar, 5.6 g/L Deionized water 1 L Same Differences Item Device Predicate Organisms Tested Campylobacter jejuni Enterococcus faecalis Escherichia coli Salmonella typhimurium Shigella sonnei Vibrio parahaemolyticus Yersinia enterocolitica Campylobacter jejuni Escherichia coli Shigella flexneri Yersinia enterocolitica pH 6.9 – 7.5 8.4 ± 0.2 Shelf life 20 months 24 months K. Standard/Guidance Document Referenced (if applicable): Quality Control of Microbiological Transport Systems; Approved Standard – Second Edition, M40-A2, Clinical and Laboratory Standards Institute (CLSI), Wayne, PA, 2014. L. Test Principle: Not applicable. M. Performance Characteristics (if/when applicable): 5 1. Analytical performance: Analytical studies were conducted to determine the ability of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System to maintain the viability of enteric microorganisms. The performance of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System was determined using quantitative colony enumeration techniques outlined in the Clinical and Laboratory Standards Institute (CLSI) M40-A2 document. Bacterial viability studies were performed. The swabs from each transport system were inoculated with 100 µL of select bacterial concentrations prepared in a fecal matrix and/or 0.85% phosphate buffered saline (PBS). To facilitate testing, a homogeneous fecal matrix was prepared by diluting pre-screened negative fresh clinical fecal material in 0.85% PBS to a 30% concentration by volume. Once inoculated, the swabs were then placed in their respective transport tubes and held at various time intervals; at the designated time intervals the swabs were removed and processed. To test the viability at various time intervals the inoculated swabs were held at room temperature for 0, 24, and 48 hours and refrigerated for 0, 24, 48, and 72 hours. The eight ATCC strains listed in Table 1 below were used to evaluate the performance of the Puritan Opti-Tranz Cary-Blair Collection and Transport System. This device was tested using the swabs included with the transport kit. Viability studies were conducted in duplicate at 0, 24, and 48 at room temperature (20-25°C) and at 0, 24, 48, and 72 hours at refrigerated temperatures (2-8°C) using the Roll-Plate and Swab Elution Methods. * ‘NO’ indicates that strain was not tested in the column heading matrix; ‘YES’ indicates that the strain was tested in the column heading matrix. Roll-Plate Method: Bacterial suspensions were prepared from fresh18-24 hour cultures of each microorganism in a separate vial containing 10 mL of fecal matrix or 0.85% sterile saline to obtain 1.5 x 108 CFU/mL suspensions. One log10 serial dilutions were made and 100 µL aliquots of dilutions were absorbed into the swabs and immediately placed into the Table 1: Enteric bacteria evaluated for stability in Puritan Opti-Tranz Cary- Blair Collection and Transport System Microorganism ATCC # Fecal Matrix* 0.85% Saline* Campylobacter jejuni ATCC 33291 NO YES Escherichia coli ATCC 25922 NO YES Escherichia coli 0157:H7 ATCC 700728 YES YES Salmonella typhimurium ATCC 14028 YES YES Shigella sonnei ATCC 12022 NO YES Vibrio parahaemolyticus ATCC 17802 YES YES Vancomycin-resistant Enterococcus faecalis (VRE) ATCC 51299 NO YES Yersinia enterocolitica ATCC 9610 NO YES 6 Puritan Opti-Tranz Cary-Blair medium. For fecal specimens, the final dilution prior to swab inoculation was done with fecal matrix to maximize the amount of fecal material on the swab. After incubation at each time point, the swabs were removed from the transport tubes and used to inoculate the entire surface of the appropriate agar plate. The plates were incubated in appropriate culture conditions for 24-48 hours or until countable colonies were visible. Manual colony counts were conducted for each time interval for each swab- organism combination. The dilution yielding colony counts nearest to zero (not to exceed 250 CFU) was reported. Log10 increases or decreases in survival are based on a comparison between time-zero and the last time point collected for each Regulation section:

idK160082_s6000_e8000

K160082.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

5 X 105 3.3 X 105 2.1 X 105 -0.35 Puritan - 151105 5.3 X 105 7.4 X 105 3.6 X 105 2.7 X 105 -0.29 Vibrio parahaemolyticus ATCC 17802 1:10 Puritan - 151002 4.6 X 105 5.8 X 105 3.7 X 105 2.0 X 105 -0.36 Puritan - 151026 6.9 X 105 7.2 X 105 5.4 X 105 3.7 X 105 -0.27 Puritan - 151105 5.7 X 105 6.0 X 105 4.0 X 105 2.8 X 105 -0.31 Vancomycin- resistant Enterococcus faecalis (VRE) ATCC 51299 1:10 Puritan - 151002 3.3 X 105 1.6 X 105 1.3 X 105 9.0 X 104 -0.56 Puritan - 151026 3.7 X 105 1.9 X 105 1.2 X 105 6.0 X 104 -0.79 Puritan - 151105 4.0 X 105 2.0 X 105 1.5 X 105 1.2 X 105 -0.52 Yersinia enterocolitica ATCC 9610 1:10 Puritan - 151002 4.3 X 105 5.4 X 105 3.8 X 105 2.3 X 105 -0.27 Puritan - 151026 5.7 X 105 7.1 X 105 4.7 X 105 3.5 X 105 -0 .21 Puritan - 151105 4.9 X 105 6.7 X 105 4.2 X 105 3.4 X 105 -0.16 a. Precision/Reproducibility: Not applicable. b. Linearity/assay reportable range: Not applicable. 13 c. Traceability, Stability, Expected values (controls, calibrators, or methods): Shelf-life Stability: Shelf life stability tests were performed successfully on three lots of products stored for 20 months at room temperature. Recovery of microorganisms from fecal matrix was assessed by the Roll Plate method, as described in section M.1 above (see Table 10 below for results). Table 10. Roll plate recovery results for Puritan Opti-Tranz Cary-Blair Collection and Transport System stored for 20 months then inoculated with specified organism in fecal matrix and stored at 20-25°C Microorganism 0.5 McFarland microorganism suspension diluted with saline Product Lot Numbers Average CFUs Recovered: Time 0 h Average CFUs Recovered: Time 24 h Average CFUs Recovered: Time 48 h Escherichia coli 0157:H7 ATCC 700728 Diluted 10-4 Puritan - 151002 86 183 260 Puritan - 151026 91 198 257 Puritan - 151105 77 186 249 Salmonella typhimurium ATCC 14028 Diluted 10-4 Puritan - 151002 82 151 303 Puritan - 151026 68 135 294 Puritan - 151105 61 129 288 Vibrio parahaemolyticus ATCC 17802 Diluted 10-4 Puritan - 151002 93 258 117 Puritan - 151026 82 232 111 Puritan - 151105 59 226 104 pH Stability: The pH of the test device was measured at predetermined time intervals for up to 20 months after manufacturing date. The test was performed using calibrated pH meter with random samples from three different lots of Puritan Opti-Tranz Cary- Blair Collection and Transport System. All samples tested were found to maintain pH within the specified range of pH 6.90 to 7.50. Cytotoxicity: Cytotoxicity testing was conducted to evaluate the glue, shaft and rayon tipped swabs for potential cytotoxicity effects following ISO Elution Method- 1X MEM Extract. No evidence of cytotoxicity was detected. Sterilization: Puritan Opti-Tranz Cary-Blair Collection and Transport System are sterilized by gamma irradiation and validated following ANSI/ AAMI/ISO 11137:2006, Sterilization of health care products Radiation guidelines. d. Detection limit: Not applicable. e. Analytical specificity: 14 Not applicable. f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: Not applicable. b. Matrix comparison: Not applicable. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable. 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: Not applicable. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK160082_s6000_e8000

K160082.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

6.5 X 105 3.3 X 105 2.1 X 105 -0.35 Puritan - 151105 5.3 X 105 7.4 X 105 3.6 X 105 2.7 X 105 -0.29 Vibrio parahaemolyticus ATCC 17802 1:10 Puritan - 151002 4.6 X 105 5.8 X 105 3.7 X 105 2.0 X 105 -0.36 Puritan - 151026 6.9 X 105 7.2 X 105 5.4 X 105 3.7 X 105 -0.27 Puritan - 151105 5.7 X 105 6.0 X 105 4.0 X 105 2.8 X 105 -0.31 Vancomycin- resistant Enterococcus faecalis (VRE) ATCC 51299 1:10 Puritan - 151002 3.3 X 105 1.6 X 105 1.3 X 105 9.0 X 104 -0.56 Puritan - 151026 3.7 X 105 1.9 X 105 1.2 X 105 6.0 X 104 -0.79 Puritan - 151105 4.0 X 105 2.0 X 105 1.5 X 105 1.2 X 105 -0.52 Yersinia enterocolitica ATCC 9610 1:10 Puritan - 151002 4.3 X 105 5.4 X 105 3.8 X 105 2.3 X 105 -0.27 Puritan - 151026 5.7 X 105 7.1 X 105 4.7 X 105 3.5 X 105 -0 .21 Puritan - 151105 4.9 X 105 6.7 X 105 4.2 X 105 3.4 X 105 -0.16 a. Precision/Reproducibility: Not applicable. b. Linearity/assay reportable range: Not applicable. 13 c. Traceability, Stability, Expected values (controls, calibrators, or methods): Shelf-life Stability: Shelf life stability tests were performed successfully on three lots of products stored for 20 months at room temperature. Recovery of microorganisms from fecal matrix was assessed by the Roll Plate method, as described in section M.1 above (see Table 10 below for results). Table 10. Roll plate recovery results for Puritan Opti-Tranz Cary-Blair Collection and Transport System stored for 20 months then inoculated with specified organism in fecal matrix and stored at 20-25°C Microorganism 0.5 McFarland microorganism suspension diluted with saline Product Lot Numbers Average CFUs Recovered: Time 0 h Average CFUs Recovered: Time 24 h Average CFUs Recovered: Time 48 h Escherichia coli 0157:H7 ATCC 700728 Diluted 10-4 Puritan - 151002 86 183 260 Puritan - 151026 91 198 257 Puritan - 151105 77 186 249 Salmonella typhimurium ATCC 14028 Diluted 10-4 Puritan - 151002 82 151 303 Puritan - 151026 68 135 294 Puritan - 151105 61 129 288 Vibrio parahaemolyticus ATCC 17802 Diluted 10-4 Puritan - 151002 93 258 117 Puritan - 151026 82 232 111 Puritan - 151105 59 226 104 pH Stability: The pH of the test device was measured at predetermined time intervals for up to 20 months after manufacturing date. The test was performed using calibrated pH meter with random samples from three different lots of Puritan Opti-Tranz Cary- Blair Collection and Transport System. All samples tested were found to maintain pH within the specified range of pH 6.90 to 7.50. Cytotoxicity: Cytotoxicity testing was conducted to evaluate the glue, shaft and rayon tipped swabs for potential cytotoxicity effects following ISO Elution Method- 1X MEM Extract. No evidence of cytotoxicity was detected. Sterilization: Puritan Opti-Tranz Cary-Blair Collection and Transport System are sterilized by gamma irradiation and validated following ANSI/ AAMI/ISO 11137:2006, Sterilization of health care products Radiation guidelines. d. Detection limit: Not applicable. e. Analytical specificity: 14 Not applicable. f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: Not applicable. b. Matrix comparison: Not applicable. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable. 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: Not applicable. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK161510_s0_e2000

K161510.txt

purpose for submission

To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST-Gram Negative card contains the following concentrations of Ceftolozane/Tazobactam: 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result reporting range for the card is ≤0.25 - ≥32 µg/mL. D. Type of Test: Automated quantitative or qualitative antimicrobial susceptibility test for Ceftolozane/Tazobactam E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-GN Ceftolozane/Tazobactam (≤0.25 - ≥32 µg/mL) G. Regulatory Information: 1. Regulation section: 221 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code(s): 2 LON - Fully automated short-term incubation cycle antimicrobial susceptibility system. LTW – Susceptibility Test Cards, Antimicrobial LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK®2 Gram Negative Ceftolozane/Tazobactam is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK®2 and VITEK®2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK®2 Gram Negative Ceftolozane/Tazobactam is a quantitative test. Ceftolozane/Tazobactam has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for the antimicrobial. Active in vitro and in clinical infections: Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa In vitro data available but clinical significance is unknown: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Proteus vulgaris Providencia stuartii Serratia liquefacians The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of 3 isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 3. Special conditions for use statement(s): Prescription use only Limitation: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing. · Ceftolozane/Tazobactam: Citrobacter koseri, Proteus mirabilis, Proteus vulgaris, and Serratia Liquefacians.” 4. Special instrument requirements: VITEK® 2 and VITEK®2 Compact Systems I. Device Description: The VITEK 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Ceftolozane/Tazobactam has the following concentrations in the card: 0.5/4, 1/4, 4/4, 8/4, and 32/4µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for the VITEK 2 card is ≤0.25 - ≥32 µg/mL. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 VITEK®2 AST-GN Doxycycline 2. Predicate 510(k) number(s): K121546 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device VITEK 2 AST-GN Ceftolozane/Tazobactam K161510 Predicate VITEK®2 AST-GN Doxycyline K121546 Intended Use The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. Same Test Method Automated quantitative antimicrobial susceptibility test for use with the VITEK®2 and VITEK®2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Same Inoculum Saline suspension of organisms Same Test Card VITEK® 2 Gram Negative Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Detection Method Light optics using optical scanner Same Report Automatically generated and contains the MIC value with an interpretive category (S, I, R) for each antimicrobial on the test card Same 5 Differences Item Device Predicate Antimicrobial Ceftolozane/Tazobactam Doxycycline Antimicrobial Concentration 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL 1, 4, 6 µg/mL Algorithm Analysis Growth pattern analysis- Unique to Ceftolozane/Tazobactam Discriminate analysis-Unique to Doxycycline Reporting Range ≤0.25 - ≥32 µg/mL ≤0.5 - ≥ 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI M100-S24: Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fourth Informational Supplement, Vol. 33 No. 1 (January 2014) · CLSI M07-A9: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard-Ninth Edition” Vol. 32 No, 2 (January 2012) · Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009) L. Test Principle: The VITEK 2 and VITEK 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics is based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic on the card. M. Performance Characteristics (if/when Purpose for submission:

idK161510_s0_e2000

K161510.txt

type of test

Automated quantitative or qualitative antimicrobial susceptibility test for Ceftolozane/Tazobactam

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST-Gram Negative card contains the following concentrations of Ceftolozane/Tazobactam: 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result reporting range for the card is ≤0.25 - ≥32 µg/mL. D. Type of Test: Automated quantitative or qualitative antimicrobial susceptibility test for Ceftolozane/Tazobactam E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-GN Ceftolozane/Tazobactam (≤0.25 - ≥32 µg/mL) G. Regulatory Information: 1. Regulation section: 221 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code(s): 2 LON - Fully automated short-term incubation cycle antimicrobial susceptibility system. LTW – Susceptibility Test Cards, Antimicrobial LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK®2 Gram Negative Ceftolozane/Tazobactam is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK®2 and VITEK®2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK®2 Gram Negative Ceftolozane/Tazobactam is a quantitative test. Ceftolozane/Tazobactam has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for the antimicrobial. Active in vitro and in clinical infections: Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa In vitro data available but clinical significance is unknown: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Proteus vulgaris Providencia stuartii Serratia liquefacians The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of 3 isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 3. Special conditions for use statement(s): Prescription use only Limitation: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing. · Ceftolozane/Tazobactam: Citrobacter koseri, Proteus mirabilis, Proteus vulgaris, and Serratia Liquefacians.” 4. Special instrument requirements: VITEK® 2 and VITEK®2 Compact Systems I. Device Description: The VITEK 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Ceftolozane/Tazobactam has the following concentrations in the card: 0.5/4, 1/4, 4/4, 8/4, and 32/4µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for the VITEK 2 card is ≤0.25 - ≥32 µg/mL. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 VITEK®2 AST-GN Doxycycline 2. Predicate 510(k) number(s): K121546 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device VITEK 2 AST-GN Ceftolozane/Tazobactam K161510 Predicate VITEK®2 AST-GN Doxycyline K121546 Intended Use The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. Same Test Method Automated quantitative antimicrobial susceptibility test for use with the VITEK®2 and VITEK®2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Same Inoculum Saline suspension of organisms Same Test Card VITEK® 2 Gram Negative Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Detection Method Light optics using optical scanner Same Report Automatically generated and contains the MIC value with an interpretive category (S, I, R) for each antimicrobial on the test card Same 5 Differences Item Device Predicate Antimicrobial Ceftolozane/Tazobactam Doxycycline Antimicrobial Concentration 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL 1, 4, 6 µg/mL Algorithm Analysis Growth pattern analysis- Unique to Ceftolozane/Tazobactam Discriminate analysis-Unique to Doxycycline Reporting Range ≤0.25 - ≥32 µg/mL ≤0.5 - ≥ 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI M100-S24: Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fourth Informational Supplement, Vol. 33 No. 1 (January 2014) · CLSI M07-A9: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard-Ninth Edition” Vol. 32 No, 2 (January 2012) · Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009) L. Test Principle: The VITEK 2 and VITEK 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics is based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic on the card. M. Performance Characteristics (if/when Type of test:

idK161510_s0_e2000

K161510.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST-Gram Negative card contains the following concentrations of Ceftolozane/Tazobactam: 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result reporting range for the card is ≤0.25 - ≥32 µg/mL. D. Type of Test: Automated quantitative or qualitative antimicrobial susceptibility test for Ceftolozane/Tazobactam E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-GN Ceftolozane/Tazobactam (≤0.25 - ≥32 µg/mL) G. Regulatory Information: 1. Regulation section: 221 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code(s): 2 LON - Fully automated short-term incubation cycle antimicrobial susceptibility system. LTW – Susceptibility Test Cards, Antimicrobial LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK®2 Gram Negative Ceftolozane/Tazobactam is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK®2 and VITEK®2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK®2 Gram Negative Ceftolozane/Tazobactam is a quantitative test. Ceftolozane/Tazobactam has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for the antimicrobial. Active in vitro and in clinical infections: Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa In vitro data available but clinical significance is unknown: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Proteus vulgaris Providencia stuartii Serratia liquefacians The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of 3 isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 3. Special conditions for use statement(s): Prescription use only Limitation: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing. · Ceftolozane/Tazobactam: Citrobacter koseri, Proteus mirabilis, Proteus vulgaris, and Serratia Liquefacians.” 4. Special instrument requirements: VITEK® 2 and VITEK®2 Compact Systems I. Device Description: The VITEK 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Ceftolozane/Tazobactam has the following concentrations in the card: 0.5/4, 1/4, 4/4, 8/4, and 32/4µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for the VITEK 2 card is ≤0.25 - ≥32 µg/mL. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 VITEK®2 AST-GN Doxycycline 2. Predicate 510(k) number(s): K121546 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device VITEK 2 AST-GN Ceftolozane/Tazobactam K161510 Predicate VITEK®2 AST-GN Doxycyline K121546 Intended Use The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. Same Test Method Automated quantitative antimicrobial susceptibility test for use with the VITEK®2 and VITEK®2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Same Inoculum Saline suspension of organisms Same Test Card VITEK® 2 Gram Negative Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Detection Method Light optics using optical scanner Same Report Automatically generated and contains the MIC value with an interpretive category (S, I, R) for each antimicrobial on the test card Same 5 Differences Item Device Predicate Antimicrobial Ceftolozane/Tazobactam Doxycycline Antimicrobial Concentration 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL 1, 4, 6 µg/mL Algorithm Analysis Growth pattern analysis- Unique to Ceftolozane/Tazobactam Discriminate analysis-Unique to Doxycycline Reporting Range ≤0.25 - ≥32 µg/mL ≤0.5 - ≥ 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI M100-S24: Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fourth Informational Supplement, Vol. 33 No. 1 (January 2014) · CLSI M07-A9: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard-Ninth Edition” Vol. 32 No, 2 (January 2012) · Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009) L. Test Principle: The VITEK 2 and VITEK 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics is based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic on the card. M. Performance Characteristics (if/when Classification:

idK161510_s0_e2000

K161510.txt

panel

Microbiology (83)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST-Gram Negative card contains the following concentrations of Ceftolozane/Tazobactam: 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result reporting range for the card is ≤0.25 - ≥32 µg/mL. D. Type of Test: Automated quantitative or qualitative antimicrobial susceptibility test for Ceftolozane/Tazobactam E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-GN Ceftolozane/Tazobactam (≤0.25 - ≥32 µg/mL) G. Regulatory Information: 1. Regulation section: 221 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code(s): 2 LON - Fully automated short-term incubation cycle antimicrobial susceptibility system. LTW – Susceptibility Test Cards, Antimicrobial LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK®2 Gram Negative Ceftolozane/Tazobactam is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK®2 and VITEK®2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK®2 Gram Negative Ceftolozane/Tazobactam is a quantitative test. Ceftolozane/Tazobactam has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for the antimicrobial. Active in vitro and in clinical infections: Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa In vitro data available but clinical significance is unknown: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Proteus vulgaris Providencia stuartii Serratia liquefacians The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of 3 isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 3. Special conditions for use statement(s): Prescription use only Limitation: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing. · Ceftolozane/Tazobactam: Citrobacter koseri, Proteus mirabilis, Proteus vulgaris, and Serratia Liquefacians.” 4. Special instrument requirements: VITEK® 2 and VITEK®2 Compact Systems I. Device Description: The VITEK 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Ceftolozane/Tazobactam has the following concentrations in the card: 0.5/4, 1/4, 4/4, 8/4, and 32/4µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for the VITEK 2 card is ≤0.25 - ≥32 µg/mL. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 VITEK®2 AST-GN Doxycycline 2. Predicate 510(k) number(s): K121546 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device VITEK 2 AST-GN Ceftolozane/Tazobactam K161510 Predicate VITEK®2 AST-GN Doxycyline K121546 Intended Use The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. Same Test Method Automated quantitative antimicrobial susceptibility test for use with the VITEK®2 and VITEK®2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Same Inoculum Saline suspension of organisms Same Test Card VITEK® 2 Gram Negative Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Detection Method Light optics using optical scanner Same Report Automatically generated and contains the MIC value with an interpretive category (S, I, R) for each antimicrobial on the test card Same 5 Differences Item Device Predicate Antimicrobial Ceftolozane/Tazobactam Doxycycline Antimicrobial Concentration 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL 1, 4, 6 µg/mL Algorithm Analysis Growth pattern analysis- Unique to Ceftolozane/Tazobactam Discriminate analysis-Unique to Doxycycline Reporting Range ≤0.25 - ≥32 µg/mL ≤0.5 - ≥ 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI M100-S24: Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fourth Informational Supplement, Vol. 33 No. 1 (January 2014) · CLSI M07-A9: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard-Ninth Edition” Vol. 32 No, 2 (January 2012) · Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009) L. Test Principle: The VITEK 2 and VITEK 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics is based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic on the card. M. Performance Characteristics (if/when Panel:

idK161510_s0_e2000

K161510.txt

intended use

The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST-Gram Negative card contains the following concentrations of Ceftolozane/Tazobactam: 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result reporting range for the card is ≤0.25 - ≥32 µg/mL. D. Type of Test: Automated quantitative or qualitative antimicrobial susceptibility test for Ceftolozane/Tazobactam E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-GN Ceftolozane/Tazobactam (≤0.25 - ≥32 µg/mL) G. Regulatory Information: 1. Regulation section: 221 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code(s): 2 LON - Fully automated short-term incubation cycle antimicrobial susceptibility system. LTW – Susceptibility Test Cards, Antimicrobial LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK®2 Gram Negative Ceftolozane/Tazobactam is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK®2 and VITEK®2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK®2 Gram Negative Ceftolozane/Tazobactam is a quantitative test. Ceftolozane/Tazobactam has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for the antimicrobial. Active in vitro and in clinical infections: Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa In vitro data available but clinical significance is unknown: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Proteus vulgaris Providencia stuartii Serratia liquefacians The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of 3 isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 3. Special conditions for use statement(s): Prescription use only Limitation: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing. · Ceftolozane/Tazobactam: Citrobacter koseri, Proteus mirabilis, Proteus vulgaris, and Serratia Liquefacians.” 4. Special instrument requirements: VITEK® 2 and VITEK®2 Compact Systems I. Device Description: The VITEK 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Ceftolozane/Tazobactam has the following concentrations in the card: 0.5/4, 1/4, 4/4, 8/4, and 32/4µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for the VITEK 2 card is ≤0.25 - ≥32 µg/mL. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 VITEK®2 AST-GN Doxycycline 2. Predicate 510(k) number(s): K121546 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device VITEK 2 AST-GN Ceftolozane/Tazobactam K161510 Predicate VITEK®2 AST-GN Doxycyline K121546 Intended Use The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. Same Test Method Automated quantitative antimicrobial susceptibility test for use with the VITEK®2 and VITEK®2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Same Inoculum Saline suspension of organisms Same Test Card VITEK® 2 Gram Negative Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Detection Method Light optics using optical scanner Same Report Automatically generated and contains the MIC value with an interpretive category (S, I, R) for each antimicrobial on the test card Same 5 Differences Item Device Predicate Antimicrobial Ceftolozane/Tazobactam Doxycycline Antimicrobial Concentration 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL 1, 4, 6 µg/mL Algorithm Analysis Growth pattern analysis- Unique to Ceftolozane/Tazobactam Discriminate analysis-Unique to Doxycycline Reporting Range ≤0.25 - ≥32 µg/mL ≤0.5 - ≥ 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI M100-S24: Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fourth Informational Supplement, Vol. 33 No. 1 (January 2014) · CLSI M07-A9: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard-Ninth Edition” Vol. 32 No, 2 (January 2012) · Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009) L. Test Principle: The VITEK 2 and VITEK 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics is based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic on the card. M. Performance Characteristics (if/when Intended use:

idK161510_s0_e2000

K161510.txt

predicate device name

VITEK®2 AST-GN Doxycycline

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST-Gram Negative card contains the following concentrations of Ceftolozane/Tazobactam: 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result reporting range for the card is ≤0.25 - ≥32 µg/mL. D. Type of Test: Automated quantitative or qualitative antimicrobial susceptibility test for Ceftolozane/Tazobactam E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-GN Ceftolozane/Tazobactam (≤0.25 - ≥32 µg/mL) G. Regulatory Information: 1. Regulation section: 221 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code(s): 2 LON - Fully automated short-term incubation cycle antimicrobial susceptibility system. LTW – Susceptibility Test Cards, Antimicrobial LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK®2 Gram Negative Ceftolozane/Tazobactam is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK®2 and VITEK®2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK®2 Gram Negative Ceftolozane/Tazobactam is a quantitative test. Ceftolozane/Tazobactam has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for the antimicrobial. Active in vitro and in clinical infections: Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa In vitro data available but clinical significance is unknown: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Proteus vulgaris Providencia stuartii Serratia liquefacians The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of 3 isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 3. Special conditions for use statement(s): Prescription use only Limitation: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing. · Ceftolozane/Tazobactam: Citrobacter koseri, Proteus mirabilis, Proteus vulgaris, and Serratia Liquefacians.” 4. Special instrument requirements: VITEK® 2 and VITEK®2 Compact Systems I. Device Description: The VITEK 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Ceftolozane/Tazobactam has the following concentrations in the card: 0.5/4, 1/4, 4/4, 8/4, and 32/4µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for the VITEK 2 card is ≤0.25 - ≥32 µg/mL. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 VITEK®2 AST-GN Doxycycline 2. Predicate 510(k) number(s): K121546 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device VITEK 2 AST-GN Ceftolozane/Tazobactam K161510 Predicate VITEK®2 AST-GN Doxycyline K121546 Intended Use The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. Same Test Method Automated quantitative antimicrobial susceptibility test for use with the VITEK®2 and VITEK®2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Same Inoculum Saline suspension of organisms Same Test Card VITEK® 2 Gram Negative Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Detection Method Light optics using optical scanner Same Report Automatically generated and contains the MIC value with an interpretive category (S, I, R) for each antimicrobial on the test card Same 5 Differences Item Device Predicate Antimicrobial Ceftolozane/Tazobactam Doxycycline Antimicrobial Concentration 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL 1, 4, 6 µg/mL Algorithm Analysis Growth pattern analysis- Unique to Ceftolozane/Tazobactam Discriminate analysis-Unique to Doxycycline Reporting Range ≤0.25 - ≥32 µg/mL ≤0.5 - ≥ 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI M100-S24: Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fourth Informational Supplement, Vol. 33 No. 1 (January 2014) · CLSI M07-A9: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard-Ninth Edition” Vol. 32 No, 2 (January 2012) · Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009) L. Test Principle: The VITEK 2 and VITEK 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics is based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic on the card. M. Performance Characteristics (if/when Predicate device name:

idK161510_s0_e2000

K161510.txt

applicant

bioMérieux, Inc.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST-Gram Negative card contains the following concentrations of Ceftolozane/Tazobactam: 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result reporting range for the card is ≤0.25 - ≥32 µg/mL. D. Type of Test: Automated quantitative or qualitative antimicrobial susceptibility test for Ceftolozane/Tazobactam E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-GN Ceftolozane/Tazobactam (≤0.25 - ≥32 µg/mL) G. Regulatory Information: 1. Regulation section: 221 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code(s): 2 LON - Fully automated short-term incubation cycle antimicrobial susceptibility system. LTW – Susceptibility Test Cards, Antimicrobial LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK®2 Gram Negative Ceftolozane/Tazobactam is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK®2 and VITEK®2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK®2 Gram Negative Ceftolozane/Tazobactam is a quantitative test. Ceftolozane/Tazobactam has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for the antimicrobial. Active in vitro and in clinical infections: Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa In vitro data available but clinical significance is unknown: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Proteus vulgaris Providencia stuartii Serratia liquefacians The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of 3 isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 3. Special conditions for use statement(s): Prescription use only Limitation: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing. · Ceftolozane/Tazobactam: Citrobacter koseri, Proteus mirabilis, Proteus vulgaris, and Serratia Liquefacians.” 4. Special instrument requirements: VITEK® 2 and VITEK®2 Compact Systems I. Device Description: The VITEK 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Ceftolozane/Tazobactam has the following concentrations in the card: 0.5/4, 1/4, 4/4, 8/4, and 32/4µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for the VITEK 2 card is ≤0.25 - ≥32 µg/mL. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 VITEK®2 AST-GN Doxycycline 2. Predicate 510(k) number(s): K121546 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device VITEK 2 AST-GN Ceftolozane/Tazobactam K161510 Predicate VITEK®2 AST-GN Doxycyline K121546 Intended Use The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. Same Test Method Automated quantitative antimicrobial susceptibility test for use with the VITEK®2 and VITEK®2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Same Inoculum Saline suspension of organisms Same Test Card VITEK® 2 Gram Negative Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Detection Method Light optics using optical scanner Same Report Automatically generated and contains the MIC value with an interpretive category (S, I, R) for each antimicrobial on the test card Same 5 Differences Item Device Predicate Antimicrobial Ceftolozane/Tazobactam Doxycycline Antimicrobial Concentration 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL 1, 4, 6 µg/mL Algorithm Analysis Growth pattern analysis- Unique to Ceftolozane/Tazobactam Discriminate analysis-Unique to Doxycycline Reporting Range ≤0.25 - ≥32 µg/mL ≤0.5 - ≥ 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI M100-S24: Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fourth Informational Supplement, Vol. 33 No. 1 (January 2014) · CLSI M07-A9: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard-Ninth Edition” Vol. 32 No, 2 (January 2012) · Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009) L. Test Principle: The VITEK 2 and VITEK 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics is based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic on the card. M. Performance Characteristics (if/when Applicant:

idK161510_s0_e2000

K161510.txt

proprietary and established names

VITEK 2 AST-GN Ceftolozane/Tazobactam (≤0.25 - ≥32 µg/mL)

IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST-Gram Negative card contains the following concentrations of Ceftolozane/Tazobactam: 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result reporting range for the card is ≤0.25 - ≥32 µg/mL. D. Type of Test: Automated quantitative or qualitative antimicrobial susceptibility test for Ceftolozane/Tazobactam E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-GN Ceftolozane/Tazobactam (≤0.25 - ≥32 µg/mL) G. Regulatory Information: 1. Regulation section: 221 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code(s): 2 LON - Fully automated short-term incubation cycle antimicrobial susceptibility system. LTW – Susceptibility Test Cards, Antimicrobial LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK®2 Gram Negative Ceftolozane/Tazobactam is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK®2 and VITEK®2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK®2 Gram Negative Ceftolozane/Tazobactam is a quantitative test. Ceftolozane/Tazobactam has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for the antimicrobial. Active in vitro and in clinical infections: Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa In vitro data available but clinical significance is unknown: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Proteus vulgaris Providencia stuartii Serratia liquefacians The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of 3 isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 3. Special conditions for use statement(s): Prescription use only Limitation: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing. · Ceftolozane/Tazobactam: Citrobacter koseri, Proteus mirabilis, Proteus vulgaris, and Serratia Liquefacians.” 4. Special instrument requirements: VITEK® 2 and VITEK®2 Compact Systems I. Device Description: The VITEK 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Ceftolozane/Tazobactam has the following concentrations in the card: 0.5/4, 1/4, 4/4, 8/4, and 32/4µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for the VITEK 2 card is ≤0.25 - ≥32 µg/mL. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 VITEK®2 AST-GN Doxycycline 2. Predicate 510(k) number(s): K121546 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device VITEK 2 AST-GN Ceftolozane/Tazobactam K161510 Predicate VITEK®2 AST-GN Doxycyline K121546 Intended Use The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. Same Test Method Automated quantitative antimicrobial susceptibility test for use with the VITEK®2 and VITEK®2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Same Inoculum Saline suspension of organisms Same Test Card VITEK® 2 Gram Negative Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Detection Method Light optics using optical scanner Same Report Automatically generated and contains the MIC value with an interpretive category (S, I, R) for each antimicrobial on the test card Same 5 Differences Item Device Predicate Antimicrobial Ceftolozane/Tazobactam Doxycycline Antimicrobial Concentration 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL 1, 4, 6 µg/mL Algorithm Analysis Growth pattern analysis- Unique to Ceftolozane/Tazobactam Discriminate analysis-Unique to Doxycycline Reporting Range ≤0.25 - ≥32 µg/mL ≤0.5 - ≥ 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI M100-S24: Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fourth Informational Supplement, Vol. 33 No. 1 (January 2014) · CLSI M07-A9: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard-Ninth Edition” Vol. 32 No, 2 (January 2012) · Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009) L. Test Principle: The VITEK 2 and VITEK 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics is based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic on the card. M. Performance Characteristics (if/when Proprietary and established names:

idK161510_s0_e2000

K161510.txt

regulation section

221 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161510 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftolozane/Tazobactam for testing non-fastidious gram negative organisms on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST-Gram Negative card contains the following concentrations of Ceftolozane/Tazobactam: 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result reporting range for the card is ≤0.25 - ≥32 µg/mL. D. Type of Test: Automated quantitative or qualitative antimicrobial susceptibility test for Ceftolozane/Tazobactam E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-GN Ceftolozane/Tazobactam (≤0.25 - ≥32 µg/mL) G. Regulatory Information: 1. Regulation section: 221 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code(s): 2 LON - Fully automated short-term incubation cycle antimicrobial susceptibility system. LTW – Susceptibility Test Cards, Antimicrobial LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK®2 Gram Negative Ceftolozane/Tazobactam is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK®2 and VITEK®2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK®2 Gram Negative Ceftolozane/Tazobactam is a quantitative test. Ceftolozane/Tazobactam has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for the antimicrobial. Active in vitro and in clinical infections: Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa In vitro data available but clinical significance is unknown: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Proteus vulgaris Providencia stuartii Serratia liquefacians The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of 3 isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 3. Special conditions for use statement(s): Prescription use only Limitation: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing. · Ceftolozane/Tazobactam: Citrobacter koseri, Proteus mirabilis, Proteus vulgaris, and Serratia Liquefacians.” 4. Special instrument requirements: VITEK® 2 and VITEK®2 Compact Systems I. Device Description: The VITEK 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Ceftolozane/Tazobactam has the following concentrations in the card: 0.5/4, 1/4, 4/4, 8/4, and 32/4µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for the VITEK 2 card is ≤0.25 - ≥32 µg/mL. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 VITEK®2 AST-GN Doxycycline 2. Predicate 510(k) number(s): K121546 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device VITEK 2 AST-GN Ceftolozane/Tazobactam K161510 Predicate VITEK®2 AST-GN Doxycyline K121546 Intended Use The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. Same Test Method Automated quantitative antimicrobial susceptibility test for use with the VITEK®2 and VITEK®2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Same Inoculum Saline suspension of organisms Same Test Card VITEK® 2 Gram Negative Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Detection Method Light optics using optical scanner Same Report Automatically generated and contains the MIC value with an interpretive category (S, I, R) for each antimicrobial on the test card Same 5 Differences Item Device Predicate Antimicrobial Ceftolozane/Tazobactam Doxycycline Antimicrobial Concentration 0.5/4, 1/4, 4/4, 8/4, and 32/4 µg/mL 1, 4, 6 µg/mL Algorithm Analysis Growth pattern analysis- Unique to Ceftolozane/Tazobactam Discriminate analysis-Unique to Doxycycline Reporting Range ≤0.25 - ≥32 µg/mL ≤0.5 - ≥ 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI M100-S24: Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fourth Informational Supplement, Vol. 33 No. 1 (January 2014) · CLSI M07-A9: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard-Ninth Edition” Vol. 32 No, 2 (January 2012) · Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009) L. Test Principle: The VITEK 2 and VITEK 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics is based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic on the card. M. Performance Characteristics (if/when Regulation section:

idK161510_s6000_e8000

K161510.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

for potential major errors. This trending and the potential for occurrence of major error(s) for Ceftolozane/Tazobactam when testing clinical and challenge isolate results with the VITEK 2 System, was addressed by adding the following footnote in the labeling (Product Information Manual): “VITEK 2 Ceftolozane/Tazobactam MIC values tended to be in exact agreement or at least one doubling dilution higher when testing P. aeruginosa compared to the reference broth micro-dilution”. b. Matrix comparison: Not Applicable 3. Clinical studies: a. Clinical Sensitivity: Not Applicable b. Clinical specificity: Not Applicable c. Other clinical supportive data (when a. and b. are not applicable): Not Applicable 14 4. Clinical cut-off: Not Applicable 5. Expected values/Reference range: Table 7: FDA Interpretive Criteria for Ceftolozane/Tazobactam Organism MIC (µg/mL) S I R Enterobacteriaceae ≤2/4 4/4 ≥8/4 Pseudomonas aeruginosa ≤4/4 8/4 ≥16/4 N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK161510_s6000_e8000

K161510.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

raises concerns for potential major errors. This trending and the potential for occurrence of major error(s) for Ceftolozane/Tazobactam when testing clinical and challenge isolate results with the VITEK 2 System, was addressed by adding the following footnote in the labeling (Product Information Manual): “VITEK 2 Ceftolozane/Tazobactam MIC values tended to be in exact agreement or at least one doubling dilution higher when testing P. aeruginosa compared to the reference broth micro-dilution”. b. Matrix comparison: Not Applicable 3. Clinical studies: a. Clinical Sensitivity: Not Applicable b. Clinical specificity: Not Applicable c. Other clinical supportive data (when a. and b. are not applicable): Not Applicable 14 4. Clinical cut-off: Not Applicable 5. Expected values/Reference range: Table 7: FDA Interpretive Criteria for Ceftolozane/Tazobactam Organism MIC (µg/mL) S I R Enterobacteriaceae ≤2/4 4/4 ≥8/4 Pseudomonas aeruginosa ≤4/4 8/4 ≥16/4 N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK152614_s0_e2000

K152614.txt

purpose for submission

To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems) in the qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequence from colonies.

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems) in the qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequence from colonies. C. Measurand: Target DNA sequence of the following genes: blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP D. Type of Test: Qualitative real-time polymerase chain reaction (PCR) assay E. Applicant: Cepheid F. Proprietary and Established Names: Proprietary Name: Xpert® Carba-R Common Name: Xpert Carba-R Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640 (Antimicrobial susceptibility test powder) 2. Classification: Class II 2 3. Product code: PMY- System, nucleic acid amplification test, DNA, carbapenem non-susceptible gram negative organism, colony OOI-Real-time nucleic acid amplification system 4. Panel: 83-Microbiology H. Intended Use: 1. Intended use(s): The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non- susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non-susceptible bacterial infections. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only. Organisms should be identified and carbapenem non-susceptibility status should be determined prior to testing with the Xpert Carba-R Assay. The Xpert Carba-R Assay detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP from pure colonies and is not for bacterial identification. The performance of the Xpert Carba-R Assay with bacteria other than Enterobacteriaceae, Pseudomonas aeruginosa or Acinetobacter baumannii has not been evaluated. 3 The Xpert Carba-R Assay is not a sub-typing tool and does not report variants of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP genes. The detection of other OXA-carbapenemase genes, besides blaOXA-48 and blaOXA-181, has not been evaluated in the study. 4. Special instrument requirements: The Xpert Carba-R Assay uses PCR technology on the GeneXpert Instrument Systems, which extract, amplify, and detect the target DNA. I. Device Description: The Xpert Carba-R Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences from pure colonies of carbapenem non-susceptible Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii. The Xpert Carba-R Assay is intended as an aid for infection control to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The assay is performed on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument Systems utilize single-use, disposable cartridges (Xpert Carba-R cartridges) containing PCR reagents and allows for automated sample preparation, amplification, and real-time detection of gene targets in approximately 50 minutes. A Sample Processing Control (SPC) and a Probe Check Control (PCC) have been incorporated into the assay design to address key failure modes that could result in a false negative determination. The GeneXpert Instrument Systems (GeneXpert Dx Systems and the GeneXpert Infinity Systems) have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample processing and real-time PCR and RT-PCR tests. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized. J. Substantial Equivalence Information: 1. Predicate device name(s): Xpert ® vanA Assay 2. Predicate 510(k) number(s): K092953 3. Comparison with predicate: 4 Similarities Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) Intended Use The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non- susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non- susceptible bacterial infections. The Cepheid Xpert® vanA Assay performed in the GeneXpert® Dx System is a qualitative in vitro diagnostic test designed for rapid detection of the vanA gene sequence associated with vancomycin resistance in bacteria obtained from rectal swab specimens from patients at risk for intestinal colonization with vancomycin-resistant bacteria. The test utilizes automated real-time polymerase chain reaction (PCR) to detect the vanA gene that is frequently associated with vancomycin-resistant enterococci (VRE). The Xpert vanA Assay is intended to aid in the recognition, prevention, and control of vancomycin resistant organisms that colonize patients in healthcare settings. The Xpert vanA Assay is not intended to diagnose infections caused by vancomycin-resistant bacteria nor to guide or monitor treatment for vancomycin-resistant bacterial infections. Concomitant cultures are necessary to recover organisms for confirmatory identification of vancomycin- resistant bacteria, antimicrobial susceptibility testing, and for epidemiological typing. Technological Principles Fully-automated nucleic acid amplification (DNA); real-time PCR Same Test Cartridge Disposable single-use, multi-chambered fluidic cartridge Same Detection Probes TaqMan® Probes Same Controls Internal sample processing control (SPC) and probe Same Time to obtain test results 5 Similarities Approximately 50 minutes to results Approximately 45 minutes to results Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) check control (PCC) External controls available Interpretation of test results Diagnostic software Same Differences Item Device Predicate Sample Type Bacterial isolates from culture Rectal swabs Assay Targets Detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences Purpose for submission:

idK152614_s0_e2000

K152614.txt

measurand

blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems) in the qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequence from colonies. C. Measurand: Target DNA sequence of the following genes: blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP D. Type of Test: Qualitative real-time polymerase chain reaction (PCR) assay E. Applicant: Cepheid F. Proprietary and Established Names: Proprietary Name: Xpert® Carba-R Common Name: Xpert Carba-R Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640 (Antimicrobial susceptibility test powder) 2. Classification: Class II 2 3. Product code: PMY- System, nucleic acid amplification test, DNA, carbapenem non-susceptible gram negative organism, colony OOI-Real-time nucleic acid amplification system 4. Panel: 83-Microbiology H. Intended Use: 1. Intended use(s): The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non- susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non-susceptible bacterial infections. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only. Organisms should be identified and carbapenem non-susceptibility status should be determined prior to testing with the Xpert Carba-R Assay. The Xpert Carba-R Assay detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP from pure colonies and is not for bacterial identification. The performance of the Xpert Carba-R Assay with bacteria other than Enterobacteriaceae, Pseudomonas aeruginosa or Acinetobacter baumannii has not been evaluated. 3 The Xpert Carba-R Assay is not a sub-typing tool and does not report variants of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP genes. The detection of other OXA-carbapenemase genes, besides blaOXA-48 and blaOXA-181, has not been evaluated in the study. 4. Special instrument requirements: The Xpert Carba-R Assay uses PCR technology on the GeneXpert Instrument Systems, which extract, amplify, and detect the target DNA. I. Device Description: The Xpert Carba-R Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences from pure colonies of carbapenem non-susceptible Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii. The Xpert Carba-R Assay is intended as an aid for infection control to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The assay is performed on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument Systems utilize single-use, disposable cartridges (Xpert Carba-R cartridges) containing PCR reagents and allows for automated sample preparation, amplification, and real-time detection of gene targets in approximately 50 minutes. A Sample Processing Control (SPC) and a Probe Check Control (PCC) have been incorporated into the assay design to address key failure modes that could result in a false negative determination. The GeneXpert Instrument Systems (GeneXpert Dx Systems and the GeneXpert Infinity Systems) have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample processing and real-time PCR and RT-PCR tests. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized. J. Substantial Equivalence Information: 1. Predicate device name(s): Xpert ® vanA Assay 2. Predicate 510(k) number(s): K092953 3. Comparison with predicate: 4 Similarities Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) Intended Use The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non- susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non- susceptible bacterial infections. The Cepheid Xpert® vanA Assay performed in the GeneXpert® Dx System is a qualitative in vitro diagnostic test designed for rapid detection of the vanA gene sequence associated with vancomycin resistance in bacteria obtained from rectal swab specimens from patients at risk for intestinal colonization with vancomycin-resistant bacteria. The test utilizes automated real-time polymerase chain reaction (PCR) to detect the vanA gene that is frequently associated with vancomycin-resistant enterococci (VRE). The Xpert vanA Assay is intended to aid in the recognition, prevention, and control of vancomycin resistant organisms that colonize patients in healthcare settings. The Xpert vanA Assay is not intended to diagnose infections caused by vancomycin-resistant bacteria nor to guide or monitor treatment for vancomycin-resistant bacterial infections. Concomitant cultures are necessary to recover organisms for confirmatory identification of vancomycin- resistant bacteria, antimicrobial susceptibility testing, and for epidemiological typing. Technological Principles Fully-automated nucleic acid amplification (DNA); real-time PCR Same Test Cartridge Disposable single-use, multi-chambered fluidic cartridge Same Detection Probes TaqMan® Probes Same Controls Internal sample processing control (SPC) and probe Same Time to obtain test results 5 Similarities Approximately 50 minutes to results Approximately 45 minutes to results Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) check control (PCC) External controls available Interpretation of test results Diagnostic software Same Differences Item Device Predicate Sample Type Bacterial isolates from culture Rectal swabs Assay Targets Detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences Measurand:

idK152614_s0_e2000

K152614.txt

type of test

Qualitative real-time polymerase chain reaction (PCR) assay

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems) in the qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequence from colonies. C. Measurand: Target DNA sequence of the following genes: blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP D. Type of Test: Qualitative real-time polymerase chain reaction (PCR) assay E. Applicant: Cepheid F. Proprietary and Established Names: Proprietary Name: Xpert® Carba-R Common Name: Xpert Carba-R Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640 (Antimicrobial susceptibility test powder) 2. Classification: Class II 2 3. Product code: PMY- System, nucleic acid amplification test, DNA, carbapenem non-susceptible gram negative organism, colony OOI-Real-time nucleic acid amplification system 4. Panel: 83-Microbiology H. Intended Use: 1. Intended use(s): The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non- susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non-susceptible bacterial infections. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only. Organisms should be identified and carbapenem non-susceptibility status should be determined prior to testing with the Xpert Carba-R Assay. The Xpert Carba-R Assay detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP from pure colonies and is not for bacterial identification. The performance of the Xpert Carba-R Assay with bacteria other than Enterobacteriaceae, Pseudomonas aeruginosa or Acinetobacter baumannii has not been evaluated. 3 The Xpert Carba-R Assay is not a sub-typing tool and does not report variants of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP genes. The detection of other OXA-carbapenemase genes, besides blaOXA-48 and blaOXA-181, has not been evaluated in the study. 4. Special instrument requirements: The Xpert Carba-R Assay uses PCR technology on the GeneXpert Instrument Systems, which extract, amplify, and detect the target DNA. I. Device Description: The Xpert Carba-R Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences from pure colonies of carbapenem non-susceptible Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii. The Xpert Carba-R Assay is intended as an aid for infection control to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The assay is performed on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument Systems utilize single-use, disposable cartridges (Xpert Carba-R cartridges) containing PCR reagents and allows for automated sample preparation, amplification, and real-time detection of gene targets in approximately 50 minutes. A Sample Processing Control (SPC) and a Probe Check Control (PCC) have been incorporated into the assay design to address key failure modes that could result in a false negative determination. The GeneXpert Instrument Systems (GeneXpert Dx Systems and the GeneXpert Infinity Systems) have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample processing and real-time PCR and RT-PCR tests. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized. J. Substantial Equivalence Information: 1. Predicate device name(s): Xpert ® vanA Assay 2. Predicate 510(k) number(s): K092953 3. Comparison with predicate: 4 Similarities Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) Intended Use The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non- susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non- susceptible bacterial infections. The Cepheid Xpert® vanA Assay performed in the GeneXpert® Dx System is a qualitative in vitro diagnostic test designed for rapid detection of the vanA gene sequence associated with vancomycin resistance in bacteria obtained from rectal swab specimens from patients at risk for intestinal colonization with vancomycin-resistant bacteria. The test utilizes automated real-time polymerase chain reaction (PCR) to detect the vanA gene that is frequently associated with vancomycin-resistant enterococci (VRE). The Xpert vanA Assay is intended to aid in the recognition, prevention, and control of vancomycin resistant organisms that colonize patients in healthcare settings. The Xpert vanA Assay is not intended to diagnose infections caused by vancomycin-resistant bacteria nor to guide or monitor treatment for vancomycin-resistant bacterial infections. Concomitant cultures are necessary to recover organisms for confirmatory identification of vancomycin- resistant bacteria, antimicrobial susceptibility testing, and for epidemiological typing. Technological Principles Fully-automated nucleic acid amplification (DNA); real-time PCR Same Test Cartridge Disposable single-use, multi-chambered fluidic cartridge Same Detection Probes TaqMan® Probes Same Controls Internal sample processing control (SPC) and probe Same Time to obtain test results 5 Similarities Approximately 50 minutes to results Approximately 45 minutes to results Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) check control (PCC) External controls available Interpretation of test results Diagnostic software Same Differences Item Device Predicate Sample Type Bacterial isolates from culture Rectal swabs Assay Targets Detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences Type of test:

idK152614_s0_e2000

K152614.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems) in the qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequence from colonies. C. Measurand: Target DNA sequence of the following genes: blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP D. Type of Test: Qualitative real-time polymerase chain reaction (PCR) assay E. Applicant: Cepheid F. Proprietary and Established Names: Proprietary Name: Xpert® Carba-R Common Name: Xpert Carba-R Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640 (Antimicrobial susceptibility test powder) 2. Classification: Class II 2 3. Product code: PMY- System, nucleic acid amplification test, DNA, carbapenem non-susceptible gram negative organism, colony OOI-Real-time nucleic acid amplification system 4. Panel: 83-Microbiology H. Intended Use: 1. Intended use(s): The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non- susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non-susceptible bacterial infections. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only. Organisms should be identified and carbapenem non-susceptibility status should be determined prior to testing with the Xpert Carba-R Assay. The Xpert Carba-R Assay detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP from pure colonies and is not for bacterial identification. The performance of the Xpert Carba-R Assay with bacteria other than Enterobacteriaceae, Pseudomonas aeruginosa or Acinetobacter baumannii has not been evaluated. 3 The Xpert Carba-R Assay is not a sub-typing tool and does not report variants of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP genes. The detection of other OXA-carbapenemase genes, besides blaOXA-48 and blaOXA-181, has not been evaluated in the study. 4. Special instrument requirements: The Xpert Carba-R Assay uses PCR technology on the GeneXpert Instrument Systems, which extract, amplify, and detect the target DNA. I. Device Description: The Xpert Carba-R Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences from pure colonies of carbapenem non-susceptible Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii. The Xpert Carba-R Assay is intended as an aid for infection control to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The assay is performed on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument Systems utilize single-use, disposable cartridges (Xpert Carba-R cartridges) containing PCR reagents and allows for automated sample preparation, amplification, and real-time detection of gene targets in approximately 50 minutes. A Sample Processing Control (SPC) and a Probe Check Control (PCC) have been incorporated into the assay design to address key failure modes that could result in a false negative determination. The GeneXpert Instrument Systems (GeneXpert Dx Systems and the GeneXpert Infinity Systems) have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample processing and real-time PCR and RT-PCR tests. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized. J. Substantial Equivalence Information: 1. Predicate device name(s): Xpert ® vanA Assay 2. Predicate 510(k) number(s): K092953 3. Comparison with predicate: 4 Similarities Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) Intended Use The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non- susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non- susceptible bacterial infections. The Cepheid Xpert® vanA Assay performed in the GeneXpert® Dx System is a qualitative in vitro diagnostic test designed for rapid detection of the vanA gene sequence associated with vancomycin resistance in bacteria obtained from rectal swab specimens from patients at risk for intestinal colonization with vancomycin-resistant bacteria. The test utilizes automated real-time polymerase chain reaction (PCR) to detect the vanA gene that is frequently associated with vancomycin-resistant enterococci (VRE). The Xpert vanA Assay is intended to aid in the recognition, prevention, and control of vancomycin resistant organisms that colonize patients in healthcare settings. The Xpert vanA Assay is not intended to diagnose infections caused by vancomycin-resistant bacteria nor to guide or monitor treatment for vancomycin-resistant bacterial infections. Concomitant cultures are necessary to recover organisms for confirmatory identification of vancomycin- resistant bacteria, antimicrobial susceptibility testing, and for epidemiological typing. Technological Principles Fully-automated nucleic acid amplification (DNA); real-time PCR Same Test Cartridge Disposable single-use, multi-chambered fluidic cartridge Same Detection Probes TaqMan® Probes Same Controls Internal sample processing control (SPC) and probe Same Time to obtain test results 5 Similarities Approximately 50 minutes to results Approximately 45 minutes to results Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) check control (PCC) External controls available Interpretation of test results Diagnostic software Same Differences Item Device Predicate Sample Type Bacterial isolates from culture Rectal swabs Assay Targets Detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences Classification:

idK152614_s0_e2000

K152614.txt

panel

83-Microbiology

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems) in the qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequence from colonies. C. Measurand: Target DNA sequence of the following genes: blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP D. Type of Test: Qualitative real-time polymerase chain reaction (PCR) assay E. Applicant: Cepheid F. Proprietary and Established Names: Proprietary Name: Xpert® Carba-R Common Name: Xpert Carba-R Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640 (Antimicrobial susceptibility test powder) 2. Classification: Class II 2 3. Product code: PMY- System, nucleic acid amplification test, DNA, carbapenem non-susceptible gram negative organism, colony OOI-Real-time nucleic acid amplification system 4. Panel: 83-Microbiology H. Intended Use: 1. Intended use(s): The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non- susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non-susceptible bacterial infections. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only. Organisms should be identified and carbapenem non-susceptibility status should be determined prior to testing with the Xpert Carba-R Assay. The Xpert Carba-R Assay detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP from pure colonies and is not for bacterial identification. The performance of the Xpert Carba-R Assay with bacteria other than Enterobacteriaceae, Pseudomonas aeruginosa or Acinetobacter baumannii has not been evaluated. 3 The Xpert Carba-R Assay is not a sub-typing tool and does not report variants of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP genes. The detection of other OXA-carbapenemase genes, besides blaOXA-48 and blaOXA-181, has not been evaluated in the study. 4. Special instrument requirements: The Xpert Carba-R Assay uses PCR technology on the GeneXpert Instrument Systems, which extract, amplify, and detect the target DNA. I. Device Description: The Xpert Carba-R Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences from pure colonies of carbapenem non-susceptible Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii. The Xpert Carba-R Assay is intended as an aid for infection control to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The assay is performed on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument Systems utilize single-use, disposable cartridges (Xpert Carba-R cartridges) containing PCR reagents and allows for automated sample preparation, amplification, and real-time detection of gene targets in approximately 50 minutes. A Sample Processing Control (SPC) and a Probe Check Control (PCC) have been incorporated into the assay design to address key failure modes that could result in a false negative determination. The GeneXpert Instrument Systems (GeneXpert Dx Systems and the GeneXpert Infinity Systems) have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample processing and real-time PCR and RT-PCR tests. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized. J. Substantial Equivalence Information: 1. Predicate device name(s): Xpert ® vanA Assay 2. Predicate 510(k) number(s): K092953 3. Comparison with predicate: 4 Similarities Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) Intended Use The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non- susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non- susceptible bacterial infections. The Cepheid Xpert® vanA Assay performed in the GeneXpert® Dx System is a qualitative in vitro diagnostic test designed for rapid detection of the vanA gene sequence associated with vancomycin resistance in bacteria obtained from rectal swab specimens from patients at risk for intestinal colonization with vancomycin-resistant bacteria. The test utilizes automated real-time polymerase chain reaction (PCR) to detect the vanA gene that is frequently associated with vancomycin-resistant enterococci (VRE). The Xpert vanA Assay is intended to aid in the recognition, prevention, and control of vancomycin resistant organisms that colonize patients in healthcare settings. The Xpert vanA Assay is not intended to diagnose infections caused by vancomycin-resistant bacteria nor to guide or monitor treatment for vancomycin-resistant bacterial infections. Concomitant cultures are necessary to recover organisms for confirmatory identification of vancomycin- resistant bacteria, antimicrobial susceptibility testing, and for epidemiological typing. Technological Principles Fully-automated nucleic acid amplification (DNA); real-time PCR Same Test Cartridge Disposable single-use, multi-chambered fluidic cartridge Same Detection Probes TaqMan® Probes Same Controls Internal sample processing control (SPC) and probe Same Time to obtain test results 5 Similarities Approximately 50 minutes to results Approximately 45 minutes to results Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) check control (PCC) External controls available Interpretation of test results Diagnostic software Same Differences Item Device Predicate Sample Type Bacterial isolates from culture Rectal swabs Assay Targets Detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences Panel:

idK152614_s0_e2000

K152614.txt

predicate device name

Xpert ® vanA Assay

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems) in the qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequence from colonies. C. Measurand: Target DNA sequence of the following genes: blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP D. Type of Test: Qualitative real-time polymerase chain reaction (PCR) assay E. Applicant: Cepheid F. Proprietary and Established Names: Proprietary Name: Xpert® Carba-R Common Name: Xpert Carba-R Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640 (Antimicrobial susceptibility test powder) 2. Classification: Class II 2 3. Product code: PMY- System, nucleic acid amplification test, DNA, carbapenem non-susceptible gram negative organism, colony OOI-Real-time nucleic acid amplification system 4. Panel: 83-Microbiology H. Intended Use: 1. Intended use(s): The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non- susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non-susceptible bacterial infections. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only. Organisms should be identified and carbapenem non-susceptibility status should be determined prior to testing with the Xpert Carba-R Assay. The Xpert Carba-R Assay detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP from pure colonies and is not for bacterial identification. The performance of the Xpert Carba-R Assay with bacteria other than Enterobacteriaceae, Pseudomonas aeruginosa or Acinetobacter baumannii has not been evaluated. 3 The Xpert Carba-R Assay is not a sub-typing tool and does not report variants of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP genes. The detection of other OXA-carbapenemase genes, besides blaOXA-48 and blaOXA-181, has not been evaluated in the study. 4. Special instrument requirements: The Xpert Carba-R Assay uses PCR technology on the GeneXpert Instrument Systems, which extract, amplify, and detect the target DNA. I. Device Description: The Xpert Carba-R Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences from pure colonies of carbapenem non-susceptible Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii. The Xpert Carba-R Assay is intended as an aid for infection control to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The assay is performed on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument Systems utilize single-use, disposable cartridges (Xpert Carba-R cartridges) containing PCR reagents and allows for automated sample preparation, amplification, and real-time detection of gene targets in approximately 50 minutes. A Sample Processing Control (SPC) and a Probe Check Control (PCC) have been incorporated into the assay design to address key failure modes that could result in a false negative determination. The GeneXpert Instrument Systems (GeneXpert Dx Systems and the GeneXpert Infinity Systems) have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample processing and real-time PCR and RT-PCR tests. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized. J. Substantial Equivalence Information: 1. Predicate device name(s): Xpert ® vanA Assay 2. Predicate 510(k) number(s): K092953 3. Comparison with predicate: 4 Similarities Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) Intended Use The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non- susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non- susceptible bacterial infections. The Cepheid Xpert® vanA Assay performed in the GeneXpert® Dx System is a qualitative in vitro diagnostic test designed for rapid detection of the vanA gene sequence associated with vancomycin resistance in bacteria obtained from rectal swab specimens from patients at risk for intestinal colonization with vancomycin-resistant bacteria. The test utilizes automated real-time polymerase chain reaction (PCR) to detect the vanA gene that is frequently associated with vancomycin-resistant enterococci (VRE). The Xpert vanA Assay is intended to aid in the recognition, prevention, and control of vancomycin resistant organisms that colonize patients in healthcare settings. The Xpert vanA Assay is not intended to diagnose infections caused by vancomycin-resistant bacteria nor to guide or monitor treatment for vancomycin-resistant bacterial infections. Concomitant cultures are necessary to recover organisms for confirmatory identification of vancomycin- resistant bacteria, antimicrobial susceptibility testing, and for epidemiological typing. Technological Principles Fully-automated nucleic acid amplification (DNA); real-time PCR Same Test Cartridge Disposable single-use, multi-chambered fluidic cartridge Same Detection Probes TaqMan® Probes Same Controls Internal sample processing control (SPC) and probe Same Time to obtain test results 5 Similarities Approximately 50 minutes to results Approximately 45 minutes to results Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) check control (PCC) External controls available Interpretation of test results Diagnostic software Same Differences Item Device Predicate Sample Type Bacterial isolates from culture Rectal swabs Assay Targets Detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences Predicate device name:

idK152614_s0_e2000

K152614.txt

applicant

Cepheid

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems) in the qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequence from colonies. C. Measurand: Target DNA sequence of the following genes: blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP D. Type of Test: Qualitative real-time polymerase chain reaction (PCR) assay E. Applicant: Cepheid F. Proprietary and Established Names: Proprietary Name: Xpert® Carba-R Common Name: Xpert Carba-R Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640 (Antimicrobial susceptibility test powder) 2. Classification: Class II 2 3. Product code: PMY- System, nucleic acid amplification test, DNA, carbapenem non-susceptible gram negative organism, colony OOI-Real-time nucleic acid amplification system 4. Panel: 83-Microbiology H. Intended Use: 1. Intended use(s): The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non- susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non-susceptible bacterial infections. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only. Organisms should be identified and carbapenem non-susceptibility status should be determined prior to testing with the Xpert Carba-R Assay. The Xpert Carba-R Assay detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP from pure colonies and is not for bacterial identification. The performance of the Xpert Carba-R Assay with bacteria other than Enterobacteriaceae, Pseudomonas aeruginosa or Acinetobacter baumannii has not been evaluated. 3 The Xpert Carba-R Assay is not a sub-typing tool and does not report variants of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP genes. The detection of other OXA-carbapenemase genes, besides blaOXA-48 and blaOXA-181, has not been evaluated in the study. 4. Special instrument requirements: The Xpert Carba-R Assay uses PCR technology on the GeneXpert Instrument Systems, which extract, amplify, and detect the target DNA. I. Device Description: The Xpert Carba-R Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences from pure colonies of carbapenem non-susceptible Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii. The Xpert Carba-R Assay is intended as an aid for infection control to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The assay is performed on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument Systems utilize single-use, disposable cartridges (Xpert Carba-R cartridges) containing PCR reagents and allows for automated sample preparation, amplification, and real-time detection of gene targets in approximately 50 minutes. A Sample Processing Control (SPC) and a Probe Check Control (PCC) have been incorporated into the assay design to address key failure modes that could result in a false negative determination. The GeneXpert Instrument Systems (GeneXpert Dx Systems and the GeneXpert Infinity Systems) have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample processing and real-time PCR and RT-PCR tests. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized. J. Substantial Equivalence Information: 1. Predicate device name(s): Xpert ® vanA Assay 2. Predicate 510(k) number(s): K092953 3. Comparison with predicate: 4 Similarities Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) Intended Use The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non- susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non- susceptible bacterial infections. The Cepheid Xpert® vanA Assay performed in the GeneXpert® Dx System is a qualitative in vitro diagnostic test designed for rapid detection of the vanA gene sequence associated with vancomycin resistance in bacteria obtained from rectal swab specimens from patients at risk for intestinal colonization with vancomycin-resistant bacteria. The test utilizes automated real-time polymerase chain reaction (PCR) to detect the vanA gene that is frequently associated with vancomycin-resistant enterococci (VRE). The Xpert vanA Assay is intended to aid in the recognition, prevention, and control of vancomycin resistant organisms that colonize patients in healthcare settings. The Xpert vanA Assay is not intended to diagnose infections caused by vancomycin-resistant bacteria nor to guide or monitor treatment for vancomycin-resistant bacterial infections. Concomitant cultures are necessary to recover organisms for confirmatory identification of vancomycin- resistant bacteria, antimicrobial susceptibility testing, and for epidemiological typing. Technological Principles Fully-automated nucleic acid amplification (DNA); real-time PCR Same Test Cartridge Disposable single-use, multi-chambered fluidic cartridge Same Detection Probes TaqMan® Probes Same Controls Internal sample processing control (SPC) and probe Same Time to obtain test results 5 Similarities Approximately 50 minutes to results Approximately 45 minutes to results Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) check control (PCC) External controls available Interpretation of test results Diagnostic software Same Differences Item Device Predicate Sample Type Bacterial isolates from culture Rectal swabs Assay Targets Detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences Applicant:

idK152614_s0_e2000

K152614.txt

proprietary and established names

Xpert® Carba-R

IAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems) in the qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequence from colonies. C. Measurand: Target DNA sequence of the following genes: blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP D. Type of Test: Qualitative real-time polymerase chain reaction (PCR) assay E. Applicant: Cepheid F. Proprietary and Established Names: Proprietary Name: Xpert® Carba-R Common Name: Xpert Carba-R Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640 (Antimicrobial susceptibility test powder) 2. Classification: Class II 2 3. Product code: PMY- System, nucleic acid amplification test, DNA, carbapenem non-susceptible gram negative organism, colony OOI-Real-time nucleic acid amplification system 4. Panel: 83-Microbiology H. Intended Use: 1. Intended use(s): The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non- susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non-susceptible bacterial infections. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only. Organisms should be identified and carbapenem non-susceptibility status should be determined prior to testing with the Xpert Carba-R Assay. The Xpert Carba-R Assay detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP from pure colonies and is not for bacterial identification. The performance of the Xpert Carba-R Assay with bacteria other than Enterobacteriaceae, Pseudomonas aeruginosa or Acinetobacter baumannii has not been evaluated. 3 The Xpert Carba-R Assay is not a sub-typing tool and does not report variants of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP genes. The detection of other OXA-carbapenemase genes, besides blaOXA-48 and blaOXA-181, has not been evaluated in the study. 4. Special instrument requirements: The Xpert Carba-R Assay uses PCR technology on the GeneXpert Instrument Systems, which extract, amplify, and detect the target DNA. I. Device Description: The Xpert Carba-R Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences from pure colonies of carbapenem non-susceptible Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii. The Xpert Carba-R Assay is intended as an aid for infection control to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The assay is performed on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument Systems utilize single-use, disposable cartridges (Xpert Carba-R cartridges) containing PCR reagents and allows for automated sample preparation, amplification, and real-time detection of gene targets in approximately 50 minutes. A Sample Processing Control (SPC) and a Probe Check Control (PCC) have been incorporated into the assay design to address key failure modes that could result in a false negative determination. The GeneXpert Instrument Systems (GeneXpert Dx Systems and the GeneXpert Infinity Systems) have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample processing and real-time PCR and RT-PCR tests. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized. J. Substantial Equivalence Information: 1. Predicate device name(s): Xpert ® vanA Assay 2. Predicate 510(k) number(s): K092953 3. Comparison with predicate: 4 Similarities Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) Intended Use The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non- susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non- susceptible bacterial infections. The Cepheid Xpert® vanA Assay performed in the GeneXpert® Dx System is a qualitative in vitro diagnostic test designed for rapid detection of the vanA gene sequence associated with vancomycin resistance in bacteria obtained from rectal swab specimens from patients at risk for intestinal colonization with vancomycin-resistant bacteria. The test utilizes automated real-time polymerase chain reaction (PCR) to detect the vanA gene that is frequently associated with vancomycin-resistant enterococci (VRE). The Xpert vanA Assay is intended to aid in the recognition, prevention, and control of vancomycin resistant organisms that colonize patients in healthcare settings. The Xpert vanA Assay is not intended to diagnose infections caused by vancomycin-resistant bacteria nor to guide or monitor treatment for vancomycin-resistant bacterial infections. Concomitant cultures are necessary to recover organisms for confirmatory identification of vancomycin- resistant bacteria, antimicrobial susceptibility testing, and for epidemiological typing. Technological Principles Fully-automated nucleic acid amplification (DNA); real-time PCR Same Test Cartridge Disposable single-use, multi-chambered fluidic cartridge Same Detection Probes TaqMan® Probes Same Controls Internal sample processing control (SPC) and probe Same Time to obtain test results 5 Similarities Approximately 50 minutes to results Approximately 45 minutes to results Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) check control (PCC) External controls available Interpretation of test results Diagnostic software Same Differences Item Device Predicate Sample Type Bacterial isolates from culture Rectal swabs Assay Targets Detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences Proprietary and established names:

idK152614_s0_e2000

K152614.txt

regulation section

21 CFR 866.1640 (Antimicrobial susceptibility test powder)

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K152614 B. Purpose for Submission: To obtain a substantial equivalence determination for the Xpert® Carba-R Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems) in the qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequence from colonies. C. Measurand: Target DNA sequence of the following genes: blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP D. Type of Test: Qualitative real-time polymerase chain reaction (PCR) assay E. Applicant: Cepheid F. Proprietary and Established Names: Proprietary Name: Xpert® Carba-R Common Name: Xpert Carba-R Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640 (Antimicrobial susceptibility test powder) 2. Classification: Class II 2 3. Product code: PMY- System, nucleic acid amplification test, DNA, carbapenem non-susceptible gram negative organism, colony OOI-Real-time nucleic acid amplification system 4. Panel: 83-Microbiology H. Intended Use: 1. Intended use(s): The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non- susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non-susceptible bacterial infections. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only. Organisms should be identified and carbapenem non-susceptibility status should be determined prior to testing with the Xpert Carba-R Assay. The Xpert Carba-R Assay detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP from pure colonies and is not for bacterial identification. The performance of the Xpert Carba-R Assay with bacteria other than Enterobacteriaceae, Pseudomonas aeruginosa or Acinetobacter baumannii has not been evaluated. 3 The Xpert Carba-R Assay is not a sub-typing tool and does not report variants of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP genes. The detection of other OXA-carbapenemase genes, besides blaOXA-48 and blaOXA-181, has not been evaluated in the study. 4. Special instrument requirements: The Xpert Carba-R Assay uses PCR technology on the GeneXpert Instrument Systems, which extract, amplify, and detect the target DNA. I. Device Description: The Xpert Carba-R Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for qualitative detection of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences from pure colonies of carbapenem non-susceptible Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii. The Xpert Carba-R Assay is intended as an aid for infection control to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The assay is performed on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument Systems utilize single-use, disposable cartridges (Xpert Carba-R cartridges) containing PCR reagents and allows for automated sample preparation, amplification, and real-time detection of gene targets in approximately 50 minutes. A Sample Processing Control (SPC) and a Probe Check Control (PCC) have been incorporated into the assay design to address key failure modes that could result in a false negative determination. The GeneXpert Instrument Systems (GeneXpert Dx Systems and the GeneXpert Infinity Systems) have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample processing and real-time PCR and RT-PCR tests. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized. J. Substantial Equivalence Information: 1. Predicate device name(s): Xpert ® vanA Assay 2. Predicate 510(k) number(s): K092953 3. Comparison with predicate: 4 Similarities Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) Intended Use The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR). A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non- susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non- susceptible bacterial infections. The Cepheid Xpert® vanA Assay performed in the GeneXpert® Dx System is a qualitative in vitro diagnostic test designed for rapid detection of the vanA gene sequence associated with vancomycin resistance in bacteria obtained from rectal swab specimens from patients at risk for intestinal colonization with vancomycin-resistant bacteria. The test utilizes automated real-time polymerase chain reaction (PCR) to detect the vanA gene that is frequently associated with vancomycin-resistant enterococci (VRE). The Xpert vanA Assay is intended to aid in the recognition, prevention, and control of vancomycin resistant organisms that colonize patients in healthcare settings. The Xpert vanA Assay is not intended to diagnose infections caused by vancomycin-resistant bacteria nor to guide or monitor treatment for vancomycin-resistant bacterial infections. Concomitant cultures are necessary to recover organisms for confirmatory identification of vancomycin- resistant bacteria, antimicrobial susceptibility testing, and for epidemiological typing. Technological Principles Fully-automated nucleic acid amplification (DNA); real-time PCR Same Test Cartridge Disposable single-use, multi-chambered fluidic cartridge Same Detection Probes TaqMan® Probes Same Controls Internal sample processing control (SPC) and probe Same Time to obtain test results 5 Similarities Approximately 50 minutes to results Approximately 45 minutes to results Item Device Xpert® Carba-R Assay (K152614) Predicate Cepheid Xpert® vanA (K092953) check control (PCC) External controls available Interpretation of test results Diagnostic software Same Differences Item Device Predicate Sample Type Bacterial isolates from culture Rectal swabs Assay Targets Detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences Regulation section:

idK152614_s16000_e18000

K152614.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

for this line of product types: Yes ____X____ or No ________ 3. Specimen Identification: Similar to previously cleared system. 4. Specimen Sampling and Handling: A bacterial suspension equivalent to a 0.5 McFarland suspension is prepared and a 10 μl loop of suspension is transferred to 5 ml of Xpert Carba-R Sample Reagent. An aliquot of sample (1.7 ml) is then transferred to the sample chamber of the disposable, single-use fluidic cartridge (Xpert Carba-R cartridge). The user initiates a test from the system user interface and places the cartridge into the GeneXpert Instrument System. Additional sample preparation, amplification, and real-time detection are all fully-automated and completed by the instrument system. 5. Calibration: No calibration is required by the user. 6. Quality Control: Quality control is addressed for each separately cleared assay to be run on the instrument. See section M1(c) for information on internal and external controls. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Not applicable Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. 27 R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK152614_s16000_e18000

K152614.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

development processes for this line of product types: Yes ____X____ or No ________ 3. Specimen Identification: Similar to previously cleared system. 4. Specimen Sampling and Handling: A bacterial suspension equivalent to a 0.5 McFarland suspension is prepared and a 10 μl loop of suspension is transferred to 5 ml of Xpert Carba-R Sample Reagent. An aliquot of sample (1.7 ml) is then transferred to the sample chamber of the disposable, single-use fluidic cartridge (Xpert Carba-R cartridge). The user initiates a test from the system user interface and places the cartridge into the GeneXpert Instrument System. Additional sample preparation, amplification, and real-time detection are all fully-automated and completed by the instrument system. 5. Calibration: No calibration is required by the user. 6. Quality Control: Quality control is addressed for each separately cleared assay to be run on the instrument. See section M1(c) for information on internal and external controls. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Not applicable Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. 27 R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK180264_s0_e2000

K180264.txt

measurand

Anti-Borrelia burgdorferi (IgM and IgG) antibodies

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180264 B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device. C. Measurand: Anti-Borrelia burgdorferi (IgM and IgG) antibodies D. Type of Test: Enzyme Immunoassay E. Applicant: Gold Standard Diagnostics F. Proprietary and Established Names: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit G. Regulatory Information: 1. Regulation section: 21 CFR 866.3830; Treponema pallidum treponemal test reagents. 2. Classification: Class II 3. Product code: LSR; Reagent, Borrelia Serological Reagent 4. Panel: Microbiology H. Intended Use: 1. Intended use(s): The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: N/A I. Device Description: The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM test consists of antigenic proteins specific for B. burgdorferi (sensu stricto) which are either purified or cloned and expressed in the surrogate host E.coli. The individual antigens are transferred to polystyrene 96 well microtiter plates. 2 During the test procedure, antibodies to B. burgdorferi (sensu stricto) if present in the human serum sample will bind to the antigens coated onto the wells forming antigen-antibody complexes. Excess antibodies are removed by washing. A conjugate of goat anti-human IgG/IgM antibodies conjugated with horseradish peroxidase are then added, which binds to the antigen-antibody complexes. Excess conjugate is removed by washing. This is followed by the addition of a chromogenic substrate, tetramethylbenzidine (TMB). If specific antibodies to the antigen are present in the patients’ serum, a blue color will develop. The enzymatic reaction is then stopped with a stopping solution causing the contents of the well to turn yellow. The wells are read photometrically with a microplate reader at 450nm. J. Substantial Equivalence Information: 1. Predicate device name(s): Trinity Biotech Captia Borrelia burgdorferi IgG/IgM ELISA Test Kit. 2. Predicate 510(k) number(s): K033070 3. Comparison with predicate: Similarities Item Device Predicate (K033070) Intended Use The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay. Trinity Biotech Captia Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended for the qualitative presumptive (first-step) detection of total (IgG/IgM) antibodies to B. burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot (second step) procedure. Positive supplemental (second-step) results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The diagnosis of Lyme 3 Similarities Item Device Predicate (K033070) disease must be made based on history, signs (such as erythema migrans), symptoms, and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first or second step) should not be used to exclude Lyme disease. Assay Format Antigen coated microtiter plate – 96 wells. Same Technology ELISA Same Sample Matrix Human serum Same Controls Provided Positive, Cut-off, Negative Same Reagents Provided Diluent, Wash, Conjugate, Substrate, Stop Solution Same Reported Results Positive, Equivocal, Negative Same Interpretation Optical density readings from Spectrophotometer Same Differences Item Device Predicate Sample Processing Dilute Samples 1:100 in Diluent Dilute Samples 1:20 in Diluent Volumes 100ul sample, 50ul substrate, 50ul stop solution 100ul sample, 100ul substrate, 100ul stop solution Incubation 15/15/15 minutes at room temperature 25/25/10-15 minutes at room temperature Antigens B. burgdorferi B31 strain, B. burgdorferi 2591 strain, B. burgdorferi recombinant VlsE, B31 strain B. burgdorferi B31 strain Results Interpretation Convert to units. Negative: <9 Equivocal: 9.0-11.0 Positive: >11.0 Convert to units. Negative: ≤0.90 Equivocal: 0.91-1.09 Positive: ≥1.10 4 K. Standard/Guidance Document Referenced (if applicable): N/A L. Test Principle: Enzyme Immunoassay M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision: To determine the precision of the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test, a within-lab precision study was conducted. A precision panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested in-house. The sample panel was masked and randomized. Each of the panel members was tested in duplicate, twice per day, for 12 days. The results are summarized in the following table. Table 1: Precision Study Sample N Mean Units Within-Run Between-Run Between-Day Total Moderate Positive 48 19.6 SD 0.815 1.534 1.472 1.737 CV 4.2% 7.8% 7.5% 8.9% Low Positive 48 12.1 SD 0.267 1.417 1.248 1.442 CV 2.2% 11.7% 10.3% 11.9% High Negative 48 6.1 SD 0.211 0.662 0.642 0.695 CV 3.4% 10.8% 10.5% 11.4% Negative 48 1.7 SD 0.113 0.164 0.151 0.199 CV 6.6% 9.6% 8.8% 11.6% Reproducibility: A reproducibility panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested at three different sites. The sample panel was masked and randomized. Each of the panel members was tested in triplicate, twice per day, for five days. The Within-Run, Between-Run, Between-Days, and Between-Sites Standard Deviation and Coefficients of Variation (CV) were calculated. The results are summarized in the following table. Table 2: Reproducibility Study Sample N Mean Units Within- Run Between- Run Between- Day Between- Sites Total Moderate Positive 90 21.1 SD 1.117 1.543 1.434 0.386 1.905 CV 5.3% 7.3% 6.8% 1.8% 9.0% Low Positive 90 13.8 SD 0.591 1.155 1.026 0.404 1.297 CV 4.3% 8.4% 7.5% 2.9% 9.4% 5 High Negative 90 6.4 SD 0.323 0.756 0.715 0.237 0.822 CV 5.0% 11.7% 11.1% 3.7% 12.8% Negative 90 1.6 SD 0.145 0.335 0.312 0.347 0.365 CV 9.1% 21.1% 19.6% 21.8% 23.0% b. Linearity/assay reportable range: N/A c. Traceability, Stability, Expected values (controls, calibrators, or methods): N/A d. Detection limit: N/A e. Analytical specificity: Analytical Specificity: The analytical specificity was determined by testing 210 asymptomatic individuals’ samples from endemic (Pennsylvania) and non-endemic (Arizona) regions. The Gold Standard Diagnostics Borrelia burgdorferi lgG/IgM EL Measurand:

idK180264_s0_e2000

K180264.txt

type of test

Enzyme Immunoassay

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180264 B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device. C. Measurand: Anti-Borrelia burgdorferi (IgM and IgG) antibodies D. Type of Test: Enzyme Immunoassay E. Applicant: Gold Standard Diagnostics F. Proprietary and Established Names: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit G. Regulatory Information: 1. Regulation section: 21 CFR 866.3830; Treponema pallidum treponemal test reagents. 2. Classification: Class II 3. Product code: LSR; Reagent, Borrelia Serological Reagent 4. Panel: Microbiology H. Intended Use: 1. Intended use(s): The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: N/A I. Device Description: The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM test consists of antigenic proteins specific for B. burgdorferi (sensu stricto) which are either purified or cloned and expressed in the surrogate host E.coli. The individual antigens are transferred to polystyrene 96 well microtiter plates. 2 During the test procedure, antibodies to B. burgdorferi (sensu stricto) if present in the human serum sample will bind to the antigens coated onto the wells forming antigen-antibody complexes. Excess antibodies are removed by washing. A conjugate of goat anti-human IgG/IgM antibodies conjugated with horseradish peroxidase are then added, which binds to the antigen-antibody complexes. Excess conjugate is removed by washing. This is followed by the addition of a chromogenic substrate, tetramethylbenzidine (TMB). If specific antibodies to the antigen are present in the patients’ serum, a blue color will develop. The enzymatic reaction is then stopped with a stopping solution causing the contents of the well to turn yellow. The wells are read photometrically with a microplate reader at 450nm. J. Substantial Equivalence Information: 1. Predicate device name(s): Trinity Biotech Captia Borrelia burgdorferi IgG/IgM ELISA Test Kit. 2. Predicate 510(k) number(s): K033070 3. Comparison with predicate: Similarities Item Device Predicate (K033070) Intended Use The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay. Trinity Biotech Captia Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended for the qualitative presumptive (first-step) detection of total (IgG/IgM) antibodies to B. burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot (second step) procedure. Positive supplemental (second-step) results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The diagnosis of Lyme 3 Similarities Item Device Predicate (K033070) disease must be made based on history, signs (such as erythema migrans), symptoms, and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first or second step) should not be used to exclude Lyme disease. Assay Format Antigen coated microtiter plate – 96 wells. Same Technology ELISA Same Sample Matrix Human serum Same Controls Provided Positive, Cut-off, Negative Same Reagents Provided Diluent, Wash, Conjugate, Substrate, Stop Solution Same Reported Results Positive, Equivocal, Negative Same Interpretation Optical density readings from Spectrophotometer Same Differences Item Device Predicate Sample Processing Dilute Samples 1:100 in Diluent Dilute Samples 1:20 in Diluent Volumes 100ul sample, 50ul substrate, 50ul stop solution 100ul sample, 100ul substrate, 100ul stop solution Incubation 15/15/15 minutes at room temperature 25/25/10-15 minutes at room temperature Antigens B. burgdorferi B31 strain, B. burgdorferi 2591 strain, B. burgdorferi recombinant VlsE, B31 strain B. burgdorferi B31 strain Results Interpretation Convert to units. Negative: <9 Equivocal: 9.0-11.0 Positive: >11.0 Convert to units. Negative: ≤0.90 Equivocal: 0.91-1.09 Positive: ≥1.10 4 K. Standard/Guidance Document Referenced (if applicable): N/A L. Test Principle: Enzyme Immunoassay M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision: To determine the precision of the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test, a within-lab precision study was conducted. A precision panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested in-house. The sample panel was masked and randomized. Each of the panel members was tested in duplicate, twice per day, for 12 days. The results are summarized in the following table. Table 1: Precision Study Sample N Mean Units Within-Run Between-Run Between-Day Total Moderate Positive 48 19.6 SD 0.815 1.534 1.472 1.737 CV 4.2% 7.8% 7.5% 8.9% Low Positive 48 12.1 SD 0.267 1.417 1.248 1.442 CV 2.2% 11.7% 10.3% 11.9% High Negative 48 6.1 SD 0.211 0.662 0.642 0.695 CV 3.4% 10.8% 10.5% 11.4% Negative 48 1.7 SD 0.113 0.164 0.151 0.199 CV 6.6% 9.6% 8.8% 11.6% Reproducibility: A reproducibility panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested at three different sites. The sample panel was masked and randomized. Each of the panel members was tested in triplicate, twice per day, for five days. The Within-Run, Between-Run, Between-Days, and Between-Sites Standard Deviation and Coefficients of Variation (CV) were calculated. The results are summarized in the following table. Table 2: Reproducibility Study Sample N Mean Units Within- Run Between- Run Between- Day Between- Sites Total Moderate Positive 90 21.1 SD 1.117 1.543 1.434 0.386 1.905 CV 5.3% 7.3% 6.8% 1.8% 9.0% Low Positive 90 13.8 SD 0.591 1.155 1.026 0.404 1.297 CV 4.3% 8.4% 7.5% 2.9% 9.4% 5 High Negative 90 6.4 SD 0.323 0.756 0.715 0.237 0.822 CV 5.0% 11.7% 11.1% 3.7% 12.8% Negative 90 1.6 SD 0.145 0.335 0.312 0.347 0.365 CV 9.1% 21.1% 19.6% 21.8% 23.0% b. Linearity/assay reportable range: N/A c. Traceability, Stability, Expected values (controls, calibrators, or methods): N/A d. Detection limit: N/A e. Analytical specificity: Analytical Specificity: The analytical specificity was determined by testing 210 asymptomatic individuals’ samples from endemic (Pennsylvania) and non-endemic (Arizona) regions. The Gold Standard Diagnostics Borrelia burgdorferi lgG/IgM EL Type of test:

idK180264_s0_e2000

K180264.txt

classification

Class II

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180264 B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device. C. Measurand: Anti-Borrelia burgdorferi (IgM and IgG) antibodies D. Type of Test: Enzyme Immunoassay E. Applicant: Gold Standard Diagnostics F. Proprietary and Established Names: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit G. Regulatory Information: 1. Regulation section: 21 CFR 866.3830; Treponema pallidum treponemal test reagents. 2. Classification: Class II 3. Product code: LSR; Reagent, Borrelia Serological Reagent 4. Panel: Microbiology H. Intended Use: 1. Intended use(s): The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: N/A I. Device Description: The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM test consists of antigenic proteins specific for B. burgdorferi (sensu stricto) which are either purified or cloned and expressed in the surrogate host E.coli. The individual antigens are transferred to polystyrene 96 well microtiter plates. 2 During the test procedure, antibodies to B. burgdorferi (sensu stricto) if present in the human serum sample will bind to the antigens coated onto the wells forming antigen-antibody complexes. Excess antibodies are removed by washing. A conjugate of goat anti-human IgG/IgM antibodies conjugated with horseradish peroxidase are then added, which binds to the antigen-antibody complexes. Excess conjugate is removed by washing. This is followed by the addition of a chromogenic substrate, tetramethylbenzidine (TMB). If specific antibodies to the antigen are present in the patients’ serum, a blue color will develop. The enzymatic reaction is then stopped with a stopping solution causing the contents of the well to turn yellow. The wells are read photometrically with a microplate reader at 450nm. J. Substantial Equivalence Information: 1. Predicate device name(s): Trinity Biotech Captia Borrelia burgdorferi IgG/IgM ELISA Test Kit. 2. Predicate 510(k) number(s): K033070 3. Comparison with predicate: Similarities Item Device Predicate (K033070) Intended Use The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay. Trinity Biotech Captia Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended for the qualitative presumptive (first-step) detection of total (IgG/IgM) antibodies to B. burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot (second step) procedure. Positive supplemental (second-step) results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The diagnosis of Lyme 3 Similarities Item Device Predicate (K033070) disease must be made based on history, signs (such as erythema migrans), symptoms, and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first or second step) should not be used to exclude Lyme disease. Assay Format Antigen coated microtiter plate – 96 wells. Same Technology ELISA Same Sample Matrix Human serum Same Controls Provided Positive, Cut-off, Negative Same Reagents Provided Diluent, Wash, Conjugate, Substrate, Stop Solution Same Reported Results Positive, Equivocal, Negative Same Interpretation Optical density readings from Spectrophotometer Same Differences Item Device Predicate Sample Processing Dilute Samples 1:100 in Diluent Dilute Samples 1:20 in Diluent Volumes 100ul sample, 50ul substrate, 50ul stop solution 100ul sample, 100ul substrate, 100ul stop solution Incubation 15/15/15 minutes at room temperature 25/25/10-15 minutes at room temperature Antigens B. burgdorferi B31 strain, B. burgdorferi 2591 strain, B. burgdorferi recombinant VlsE, B31 strain B. burgdorferi B31 strain Results Interpretation Convert to units. Negative: <9 Equivocal: 9.0-11.0 Positive: >11.0 Convert to units. Negative: ≤0.90 Equivocal: 0.91-1.09 Positive: ≥1.10 4 K. Standard/Guidance Document Referenced (if applicable): N/A L. Test Principle: Enzyme Immunoassay M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision: To determine the precision of the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test, a within-lab precision study was conducted. A precision panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested in-house. The sample panel was masked and randomized. Each of the panel members was tested in duplicate, twice per day, for 12 days. The results are summarized in the following table. Table 1: Precision Study Sample N Mean Units Within-Run Between-Run Between-Day Total Moderate Positive 48 19.6 SD 0.815 1.534 1.472 1.737 CV 4.2% 7.8% 7.5% 8.9% Low Positive 48 12.1 SD 0.267 1.417 1.248 1.442 CV 2.2% 11.7% 10.3% 11.9% High Negative 48 6.1 SD 0.211 0.662 0.642 0.695 CV 3.4% 10.8% 10.5% 11.4% Negative 48 1.7 SD 0.113 0.164 0.151 0.199 CV 6.6% 9.6% 8.8% 11.6% Reproducibility: A reproducibility panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested at three different sites. The sample panel was masked and randomized. Each of the panel members was tested in triplicate, twice per day, for five days. The Within-Run, Between-Run, Between-Days, and Between-Sites Standard Deviation and Coefficients of Variation (CV) were calculated. The results are summarized in the following table. Table 2: Reproducibility Study Sample N Mean Units Within- Run Between- Run Between- Day Between- Sites Total Moderate Positive 90 21.1 SD 1.117 1.543 1.434 0.386 1.905 CV 5.3% 7.3% 6.8% 1.8% 9.0% Low Positive 90 13.8 SD 0.591 1.155 1.026 0.404 1.297 CV 4.3% 8.4% 7.5% 2.9% 9.4% 5 High Negative 90 6.4 SD 0.323 0.756 0.715 0.237 0.822 CV 5.0% 11.7% 11.1% 3.7% 12.8% Negative 90 1.6 SD 0.145 0.335 0.312 0.347 0.365 CV 9.1% 21.1% 19.6% 21.8% 23.0% b. Linearity/assay reportable range: N/A c. Traceability, Stability, Expected values (controls, calibrators, or methods): N/A d. Detection limit: N/A e. Analytical specificity: Analytical Specificity: The analytical specificity was determined by testing 210 asymptomatic individuals’ samples from endemic (Pennsylvania) and non-endemic (Arizona) regions. The Gold Standard Diagnostics Borrelia burgdorferi lgG/IgM EL Classification:

idK180264_s0_e2000

K180264.txt

product code

LSR; Reagent, Borrelia Serological Reagent

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180264 B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device. C. Measurand: Anti-Borrelia burgdorferi (IgM and IgG) antibodies D. Type of Test: Enzyme Immunoassay E. Applicant: Gold Standard Diagnostics F. Proprietary and Established Names: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit G. Regulatory Information: 1. Regulation section: 21 CFR 866.3830; Treponema pallidum treponemal test reagents. 2. Classification: Class II 3. Product code: LSR; Reagent, Borrelia Serological Reagent 4. Panel: Microbiology H. Intended Use: 1. Intended use(s): The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: N/A I. Device Description: The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM test consists of antigenic proteins specific for B. burgdorferi (sensu stricto) which are either purified or cloned and expressed in the surrogate host E.coli. The individual antigens are transferred to polystyrene 96 well microtiter plates. 2 During the test procedure, antibodies to B. burgdorferi (sensu stricto) if present in the human serum sample will bind to the antigens coated onto the wells forming antigen-antibody complexes. Excess antibodies are removed by washing. A conjugate of goat anti-human IgG/IgM antibodies conjugated with horseradish peroxidase are then added, which binds to the antigen-antibody complexes. Excess conjugate is removed by washing. This is followed by the addition of a chromogenic substrate, tetramethylbenzidine (TMB). If specific antibodies to the antigen are present in the patients’ serum, a blue color will develop. The enzymatic reaction is then stopped with a stopping solution causing the contents of the well to turn yellow. The wells are read photometrically with a microplate reader at 450nm. J. Substantial Equivalence Information: 1. Predicate device name(s): Trinity Biotech Captia Borrelia burgdorferi IgG/IgM ELISA Test Kit. 2. Predicate 510(k) number(s): K033070 3. Comparison with predicate: Similarities Item Device Predicate (K033070) Intended Use The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay. Trinity Biotech Captia Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended for the qualitative presumptive (first-step) detection of total (IgG/IgM) antibodies to B. burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot (second step) procedure. Positive supplemental (second-step) results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The diagnosis of Lyme 3 Similarities Item Device Predicate (K033070) disease must be made based on history, signs (such as erythema migrans), symptoms, and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first or second step) should not be used to exclude Lyme disease. Assay Format Antigen coated microtiter plate – 96 wells. Same Technology ELISA Same Sample Matrix Human serum Same Controls Provided Positive, Cut-off, Negative Same Reagents Provided Diluent, Wash, Conjugate, Substrate, Stop Solution Same Reported Results Positive, Equivocal, Negative Same Interpretation Optical density readings from Spectrophotometer Same Differences Item Device Predicate Sample Processing Dilute Samples 1:100 in Diluent Dilute Samples 1:20 in Diluent Volumes 100ul sample, 50ul substrate, 50ul stop solution 100ul sample, 100ul substrate, 100ul stop solution Incubation 15/15/15 minutes at room temperature 25/25/10-15 minutes at room temperature Antigens B. burgdorferi B31 strain, B. burgdorferi 2591 strain, B. burgdorferi recombinant VlsE, B31 strain B. burgdorferi B31 strain Results Interpretation Convert to units. Negative: <9 Equivocal: 9.0-11.0 Positive: >11.0 Convert to units. Negative: ≤0.90 Equivocal: 0.91-1.09 Positive: ≥1.10 4 K. Standard/Guidance Document Referenced (if applicable): N/A L. Test Principle: Enzyme Immunoassay M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision: To determine the precision of the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test, a within-lab precision study was conducted. A precision panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested in-house. The sample panel was masked and randomized. Each of the panel members was tested in duplicate, twice per day, for 12 days. The results are summarized in the following table. Table 1: Precision Study Sample N Mean Units Within-Run Between-Run Between-Day Total Moderate Positive 48 19.6 SD 0.815 1.534 1.472 1.737 CV 4.2% 7.8% 7.5% 8.9% Low Positive 48 12.1 SD 0.267 1.417 1.248 1.442 CV 2.2% 11.7% 10.3% 11.9% High Negative 48 6.1 SD 0.211 0.662 0.642 0.695 CV 3.4% 10.8% 10.5% 11.4% Negative 48 1.7 SD 0.113 0.164 0.151 0.199 CV 6.6% 9.6% 8.8% 11.6% Reproducibility: A reproducibility panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested at three different sites. The sample panel was masked and randomized. Each of the panel members was tested in triplicate, twice per day, for five days. The Within-Run, Between-Run, Between-Days, and Between-Sites Standard Deviation and Coefficients of Variation (CV) were calculated. The results are summarized in the following table. Table 2: Reproducibility Study Sample N Mean Units Within- Run Between- Run Between- Day Between- Sites Total Moderate Positive 90 21.1 SD 1.117 1.543 1.434 0.386 1.905 CV 5.3% 7.3% 6.8% 1.8% 9.0% Low Positive 90 13.8 SD 0.591 1.155 1.026 0.404 1.297 CV 4.3% 8.4% 7.5% 2.9% 9.4% 5 High Negative 90 6.4 SD 0.323 0.756 0.715 0.237 0.822 CV 5.0% 11.7% 11.1% 3.7% 12.8% Negative 90 1.6 SD 0.145 0.335 0.312 0.347 0.365 CV 9.1% 21.1% 19.6% 21.8% 23.0% b. Linearity/assay reportable range: N/A c. Traceability, Stability, Expected values (controls, calibrators, or methods): N/A d. Detection limit: N/A e. Analytical specificity: Analytical Specificity: The analytical specificity was determined by testing 210 asymptomatic individuals’ samples from endemic (Pennsylvania) and non-endemic (Arizona) regions. The Gold Standard Diagnostics Borrelia burgdorferi lgG/IgM EL Product code:

idK180264_s0_e2000

K180264.txt

panel

Microbiology

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180264 B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device. C. Measurand: Anti-Borrelia burgdorferi (IgM and IgG) antibodies D. Type of Test: Enzyme Immunoassay E. Applicant: Gold Standard Diagnostics F. Proprietary and Established Names: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit G. Regulatory Information: 1. Regulation section: 21 CFR 866.3830; Treponema pallidum treponemal test reagents. 2. Classification: Class II 3. Product code: LSR; Reagent, Borrelia Serological Reagent 4. Panel: Microbiology H. Intended Use: 1. Intended use(s): The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: N/A I. Device Description: The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM test consists of antigenic proteins specific for B. burgdorferi (sensu stricto) which are either purified or cloned and expressed in the surrogate host E.coli. The individual antigens are transferred to polystyrene 96 well microtiter plates. 2 During the test procedure, antibodies to B. burgdorferi (sensu stricto) if present in the human serum sample will bind to the antigens coated onto the wells forming antigen-antibody complexes. Excess antibodies are removed by washing. A conjugate of goat anti-human IgG/IgM antibodies conjugated with horseradish peroxidase are then added, which binds to the antigen-antibody complexes. Excess conjugate is removed by washing. This is followed by the addition of a chromogenic substrate, tetramethylbenzidine (TMB). If specific antibodies to the antigen are present in the patients’ serum, a blue color will develop. The enzymatic reaction is then stopped with a stopping solution causing the contents of the well to turn yellow. The wells are read photometrically with a microplate reader at 450nm. J. Substantial Equivalence Information: 1. Predicate device name(s): Trinity Biotech Captia Borrelia burgdorferi IgG/IgM ELISA Test Kit. 2. Predicate 510(k) number(s): K033070 3. Comparison with predicate: Similarities Item Device Predicate (K033070) Intended Use The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay. Trinity Biotech Captia Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended for the qualitative presumptive (first-step) detection of total (IgG/IgM) antibodies to B. burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot (second step) procedure. Positive supplemental (second-step) results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The diagnosis of Lyme 3 Similarities Item Device Predicate (K033070) disease must be made based on history, signs (such as erythema migrans), symptoms, and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first or second step) should not be used to exclude Lyme disease. Assay Format Antigen coated microtiter plate – 96 wells. Same Technology ELISA Same Sample Matrix Human serum Same Controls Provided Positive, Cut-off, Negative Same Reagents Provided Diluent, Wash, Conjugate, Substrate, Stop Solution Same Reported Results Positive, Equivocal, Negative Same Interpretation Optical density readings from Spectrophotometer Same Differences Item Device Predicate Sample Processing Dilute Samples 1:100 in Diluent Dilute Samples 1:20 in Diluent Volumes 100ul sample, 50ul substrate, 50ul stop solution 100ul sample, 100ul substrate, 100ul stop solution Incubation 15/15/15 minutes at room temperature 25/25/10-15 minutes at room temperature Antigens B. burgdorferi B31 strain, B. burgdorferi 2591 strain, B. burgdorferi recombinant VlsE, B31 strain B. burgdorferi B31 strain Results Interpretation Convert to units. Negative: <9 Equivocal: 9.0-11.0 Positive: >11.0 Convert to units. Negative: ≤0.90 Equivocal: 0.91-1.09 Positive: ≥1.10 4 K. Standard/Guidance Document Referenced (if applicable): N/A L. Test Principle: Enzyme Immunoassay M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision: To determine the precision of the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test, a within-lab precision study was conducted. A precision panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested in-house. The sample panel was masked and randomized. Each of the panel members was tested in duplicate, twice per day, for 12 days. The results are summarized in the following table. Table 1: Precision Study Sample N Mean Units Within-Run Between-Run Between-Day Total Moderate Positive 48 19.6 SD 0.815 1.534 1.472 1.737 CV 4.2% 7.8% 7.5% 8.9% Low Positive 48 12.1 SD 0.267 1.417 1.248 1.442 CV 2.2% 11.7% 10.3% 11.9% High Negative 48 6.1 SD 0.211 0.662 0.642 0.695 CV 3.4% 10.8% 10.5% 11.4% Negative 48 1.7 SD 0.113 0.164 0.151 0.199 CV 6.6% 9.6% 8.8% 11.6% Reproducibility: A reproducibility panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested at three different sites. The sample panel was masked and randomized. Each of the panel members was tested in triplicate, twice per day, for five days. The Within-Run, Between-Run, Between-Days, and Between-Sites Standard Deviation and Coefficients of Variation (CV) were calculated. The results are summarized in the following table. Table 2: Reproducibility Study Sample N Mean Units Within- Run Between- Run Between- Day Between- Sites Total Moderate Positive 90 21.1 SD 1.117 1.543 1.434 0.386 1.905 CV 5.3% 7.3% 6.8% 1.8% 9.0% Low Positive 90 13.8 SD 0.591 1.155 1.026 0.404 1.297 CV 4.3% 8.4% 7.5% 2.9% 9.4% 5 High Negative 90 6.4 SD 0.323 0.756 0.715 0.237 0.822 CV 5.0% 11.7% 11.1% 3.7% 12.8% Negative 90 1.6 SD 0.145 0.335 0.312 0.347 0.365 CV 9.1% 21.1% 19.6% 21.8% 23.0% b. Linearity/assay reportable range: N/A c. Traceability, Stability, Expected values (controls, calibrators, or methods): N/A d. Detection limit: N/A e. Analytical specificity: Analytical Specificity: The analytical specificity was determined by testing 210 asymptomatic individuals’ samples from endemic (Pennsylvania) and non-endemic (Arizona) regions. The Gold Standard Diagnostics Borrelia burgdorferi lgG/IgM EL Panel:

idK180264_s0_e2000

K180264.txt

intended use

The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180264 B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device. C. Measurand: Anti-Borrelia burgdorferi (IgM and IgG) antibodies D. Type of Test: Enzyme Immunoassay E. Applicant: Gold Standard Diagnostics F. Proprietary and Established Names: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit G. Regulatory Information: 1. Regulation section: 21 CFR 866.3830; Treponema pallidum treponemal test reagents. 2. Classification: Class II 3. Product code: LSR; Reagent, Borrelia Serological Reagent 4. Panel: Microbiology H. Intended Use: 1. Intended use(s): The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: N/A I. Device Description: The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM test consists of antigenic proteins specific for B. burgdorferi (sensu stricto) which are either purified or cloned and expressed in the surrogate host E.coli. The individual antigens are transferred to polystyrene 96 well microtiter plates. 2 During the test procedure, antibodies to B. burgdorferi (sensu stricto) if present in the human serum sample will bind to the antigens coated onto the wells forming antigen-antibody complexes. Excess antibodies are removed by washing. A conjugate of goat anti-human IgG/IgM antibodies conjugated with horseradish peroxidase are then added, which binds to the antigen-antibody complexes. Excess conjugate is removed by washing. This is followed by the addition of a chromogenic substrate, tetramethylbenzidine (TMB). If specific antibodies to the antigen are present in the patients’ serum, a blue color will develop. The enzymatic reaction is then stopped with a stopping solution causing the contents of the well to turn yellow. The wells are read photometrically with a microplate reader at 450nm. J. Substantial Equivalence Information: 1. Predicate device name(s): Trinity Biotech Captia Borrelia burgdorferi IgG/IgM ELISA Test Kit. 2. Predicate 510(k) number(s): K033070 3. Comparison with predicate: Similarities Item Device Predicate (K033070) Intended Use The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay. Trinity Biotech Captia Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended for the qualitative presumptive (first-step) detection of total (IgG/IgM) antibodies to B. burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot (second step) procedure. Positive supplemental (second-step) results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The diagnosis of Lyme 3 Similarities Item Device Predicate (K033070) disease must be made based on history, signs (such as erythema migrans), symptoms, and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first or second step) should not be used to exclude Lyme disease. Assay Format Antigen coated microtiter plate – 96 wells. Same Technology ELISA Same Sample Matrix Human serum Same Controls Provided Positive, Cut-off, Negative Same Reagents Provided Diluent, Wash, Conjugate, Substrate, Stop Solution Same Reported Results Positive, Equivocal, Negative Same Interpretation Optical density readings from Spectrophotometer Same Differences Item Device Predicate Sample Processing Dilute Samples 1:100 in Diluent Dilute Samples 1:20 in Diluent Volumes 100ul sample, 50ul substrate, 50ul stop solution 100ul sample, 100ul substrate, 100ul stop solution Incubation 15/15/15 minutes at room temperature 25/25/10-15 minutes at room temperature Antigens B. burgdorferi B31 strain, B. burgdorferi 2591 strain, B. burgdorferi recombinant VlsE, B31 strain B. burgdorferi B31 strain Results Interpretation Convert to units. Negative: <9 Equivocal: 9.0-11.0 Positive: >11.0 Convert to units. Negative: ≤0.90 Equivocal: 0.91-1.09 Positive: ≥1.10 4 K. Standard/Guidance Document Referenced (if applicable): N/A L. Test Principle: Enzyme Immunoassay M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision: To determine the precision of the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test, a within-lab precision study was conducted. A precision panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested in-house. The sample panel was masked and randomized. Each of the panel members was tested in duplicate, twice per day, for 12 days. The results are summarized in the following table. Table 1: Precision Study Sample N Mean Units Within-Run Between-Run Between-Day Total Moderate Positive 48 19.6 SD 0.815 1.534 1.472 1.737 CV 4.2% 7.8% 7.5% 8.9% Low Positive 48 12.1 SD 0.267 1.417 1.248 1.442 CV 2.2% 11.7% 10.3% 11.9% High Negative 48 6.1 SD 0.211 0.662 0.642 0.695 CV 3.4% 10.8% 10.5% 11.4% Negative 48 1.7 SD 0.113 0.164 0.151 0.199 CV 6.6% 9.6% 8.8% 11.6% Reproducibility: A reproducibility panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested at three different sites. The sample panel was masked and randomized. Each of the panel members was tested in triplicate, twice per day, for five days. The Within-Run, Between-Run, Between-Days, and Between-Sites Standard Deviation and Coefficients of Variation (CV) were calculated. The results are summarized in the following table. Table 2: Reproducibility Study Sample N Mean Units Within- Run Between- Run Between- Day Between- Sites Total Moderate Positive 90 21.1 SD 1.117 1.543 1.434 0.386 1.905 CV 5.3% 7.3% 6.8% 1.8% 9.0% Low Positive 90 13.8 SD 0.591 1.155 1.026 0.404 1.297 CV 4.3% 8.4% 7.5% 2.9% 9.4% 5 High Negative 90 6.4 SD 0.323 0.756 0.715 0.237 0.822 CV 5.0% 11.7% 11.1% 3.7% 12.8% Negative 90 1.6 SD 0.145 0.335 0.312 0.347 0.365 CV 9.1% 21.1% 19.6% 21.8% 23.0% b. Linearity/assay reportable range: N/A c. Traceability, Stability, Expected values (controls, calibrators, or methods): N/A d. Detection limit: N/A e. Analytical specificity: Analytical Specificity: The analytical specificity was determined by testing 210 asymptomatic individuals’ samples from endemic (Pennsylvania) and non-endemic (Arizona) regions. The Gold Standard Diagnostics Borrelia burgdorferi lgG/IgM EL Intended use:

idK180264_s0_e2000

K180264.txt

applicant

Gold Standard Diagnostics

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180264 B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device. C. Measurand: Anti-Borrelia burgdorferi (IgM and IgG) antibodies D. Type of Test: Enzyme Immunoassay E. Applicant: Gold Standard Diagnostics F. Proprietary and Established Names: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit G. Regulatory Information: 1. Regulation section: 21 CFR 866.3830; Treponema pallidum treponemal test reagents. 2. Classification: Class II 3. Product code: LSR; Reagent, Borrelia Serological Reagent 4. Panel: Microbiology H. Intended Use: 1. Intended use(s): The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: N/A I. Device Description: The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM test consists of antigenic proteins specific for B. burgdorferi (sensu stricto) which are either purified or cloned and expressed in the surrogate host E.coli. The individual antigens are transferred to polystyrene 96 well microtiter plates. 2 During the test procedure, antibodies to B. burgdorferi (sensu stricto) if present in the human serum sample will bind to the antigens coated onto the wells forming antigen-antibody complexes. Excess antibodies are removed by washing. A conjugate of goat anti-human IgG/IgM antibodies conjugated with horseradish peroxidase are then added, which binds to the antigen-antibody complexes. Excess conjugate is removed by washing. This is followed by the addition of a chromogenic substrate, tetramethylbenzidine (TMB). If specific antibodies to the antigen are present in the patients’ serum, a blue color will develop. The enzymatic reaction is then stopped with a stopping solution causing the contents of the well to turn yellow. The wells are read photometrically with a microplate reader at 450nm. J. Substantial Equivalence Information: 1. Predicate device name(s): Trinity Biotech Captia Borrelia burgdorferi IgG/IgM ELISA Test Kit. 2. Predicate 510(k) number(s): K033070 3. Comparison with predicate: Similarities Item Device Predicate (K033070) Intended Use The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay. Trinity Biotech Captia Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended for the qualitative presumptive (first-step) detection of total (IgG/IgM) antibodies to B. burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot (second step) procedure. Positive supplemental (second-step) results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The diagnosis of Lyme 3 Similarities Item Device Predicate (K033070) disease must be made based on history, signs (such as erythema migrans), symptoms, and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first or second step) should not be used to exclude Lyme disease. Assay Format Antigen coated microtiter plate – 96 wells. Same Technology ELISA Same Sample Matrix Human serum Same Controls Provided Positive, Cut-off, Negative Same Reagents Provided Diluent, Wash, Conjugate, Substrate, Stop Solution Same Reported Results Positive, Equivocal, Negative Same Interpretation Optical density readings from Spectrophotometer Same Differences Item Device Predicate Sample Processing Dilute Samples 1:100 in Diluent Dilute Samples 1:20 in Diluent Volumes 100ul sample, 50ul substrate, 50ul stop solution 100ul sample, 100ul substrate, 100ul stop solution Incubation 15/15/15 minutes at room temperature 25/25/10-15 minutes at room temperature Antigens B. burgdorferi B31 strain, B. burgdorferi 2591 strain, B. burgdorferi recombinant VlsE, B31 strain B. burgdorferi B31 strain Results Interpretation Convert to units. Negative: <9 Equivocal: 9.0-11.0 Positive: >11.0 Convert to units. Negative: ≤0.90 Equivocal: 0.91-1.09 Positive: ≥1.10 4 K. Standard/Guidance Document Referenced (if applicable): N/A L. Test Principle: Enzyme Immunoassay M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision: To determine the precision of the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test, a within-lab precision study was conducted. A precision panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested in-house. The sample panel was masked and randomized. Each of the panel members was tested in duplicate, twice per day, for 12 days. The results are summarized in the following table. Table 1: Precision Study Sample N Mean Units Within-Run Between-Run Between-Day Total Moderate Positive 48 19.6 SD 0.815 1.534 1.472 1.737 CV 4.2% 7.8% 7.5% 8.9% Low Positive 48 12.1 SD 0.267 1.417 1.248 1.442 CV 2.2% 11.7% 10.3% 11.9% High Negative 48 6.1 SD 0.211 0.662 0.642 0.695 CV 3.4% 10.8% 10.5% 11.4% Negative 48 1.7 SD 0.113 0.164 0.151 0.199 CV 6.6% 9.6% 8.8% 11.6% Reproducibility: A reproducibility panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested at three different sites. The sample panel was masked and randomized. Each of the panel members was tested in triplicate, twice per day, for five days. The Within-Run, Between-Run, Between-Days, and Between-Sites Standard Deviation and Coefficients of Variation (CV) were calculated. The results are summarized in the following table. Table 2: Reproducibility Study Sample N Mean Units Within- Run Between- Run Between- Day Between- Sites Total Moderate Positive 90 21.1 SD 1.117 1.543 1.434 0.386 1.905 CV 5.3% 7.3% 6.8% 1.8% 9.0% Low Positive 90 13.8 SD 0.591 1.155 1.026 0.404 1.297 CV 4.3% 8.4% 7.5% 2.9% 9.4% 5 High Negative 90 6.4 SD 0.323 0.756 0.715 0.237 0.822 CV 5.0% 11.7% 11.1% 3.7% 12.8% Negative 90 1.6 SD 0.145 0.335 0.312 0.347 0.365 CV 9.1% 21.1% 19.6% 21.8% 23.0% b. Linearity/assay reportable range: N/A c. Traceability, Stability, Expected values (controls, calibrators, or methods): N/A d. Detection limit: N/A e. Analytical specificity: Analytical Specificity: The analytical specificity was determined by testing 210 asymptomatic individuals’ samples from endemic (Pennsylvania) and non-endemic (Arizona) regions. The Gold Standard Diagnostics Borrelia burgdorferi lgG/IgM EL Applicant:

idK180264_s0_e2000

K180264.txt

regulation section

21 CFR 866.3830; Treponema pallidum treponemal test reagents.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180264 B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device. C. Measurand: Anti-Borrelia burgdorferi (IgM and IgG) antibodies D. Type of Test: Enzyme Immunoassay E. Applicant: Gold Standard Diagnostics F. Proprietary and Established Names: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit G. Regulatory Information: 1. Regulation section: 21 CFR 866.3830; Treponema pallidum treponemal test reagents. 2. Classification: Class II 3. Product code: LSR; Reagent, Borrelia Serological Reagent 4. Panel: Microbiology H. Intended Use: 1. Intended use(s): The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: N/A I. Device Description: The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM test consists of antigenic proteins specific for B. burgdorferi (sensu stricto) which are either purified or cloned and expressed in the surrogate host E.coli. The individual antigens are transferred to polystyrene 96 well microtiter plates. 2 During the test procedure, antibodies to B. burgdorferi (sensu stricto) if present in the human serum sample will bind to the antigens coated onto the wells forming antigen-antibody complexes. Excess antibodies are removed by washing. A conjugate of goat anti-human IgG/IgM antibodies conjugated with horseradish peroxidase are then added, which binds to the antigen-antibody complexes. Excess conjugate is removed by washing. This is followed by the addition of a chromogenic substrate, tetramethylbenzidine (TMB). If specific antibodies to the antigen are present in the patients’ serum, a blue color will develop. The enzymatic reaction is then stopped with a stopping solution causing the contents of the well to turn yellow. The wells are read photometrically with a microplate reader at 450nm. J. Substantial Equivalence Information: 1. Predicate device name(s): Trinity Biotech Captia Borrelia burgdorferi IgG/IgM ELISA Test Kit. 2. Predicate 510(k) number(s): K033070 3. Comparison with predicate: Similarities Item Device Predicate (K033070) Intended Use The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay. Trinity Biotech Captia Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended for the qualitative presumptive (first-step) detection of total (IgG/IgM) antibodies to B. burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot (second step) procedure. Positive supplemental (second-step) results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The diagnosis of Lyme 3 Similarities Item Device Predicate (K033070) disease must be made based on history, signs (such as erythema migrans), symptoms, and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first or second step) should not be used to exclude Lyme disease. Assay Format Antigen coated microtiter plate – 96 wells. Same Technology ELISA Same Sample Matrix Human serum Same Controls Provided Positive, Cut-off, Negative Same Reagents Provided Diluent, Wash, Conjugate, Substrate, Stop Solution Same Reported Results Positive, Equivocal, Negative Same Interpretation Optical density readings from Spectrophotometer Same Differences Item Device Predicate Sample Processing Dilute Samples 1:100 in Diluent Dilute Samples 1:20 in Diluent Volumes 100ul sample, 50ul substrate, 50ul stop solution 100ul sample, 100ul substrate, 100ul stop solution Incubation 15/15/15 minutes at room temperature 25/25/10-15 minutes at room temperature Antigens B. burgdorferi B31 strain, B. burgdorferi 2591 strain, B. burgdorferi recombinant VlsE, B31 strain B. burgdorferi B31 strain Results Interpretation Convert to units. Negative: <9 Equivocal: 9.0-11.0 Positive: >11.0 Convert to units. Negative: ≤0.90 Equivocal: 0.91-1.09 Positive: ≥1.10 4 K. Standard/Guidance Document Referenced (if applicable): N/A L. Test Principle: Enzyme Immunoassay M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision: To determine the precision of the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test, a within-lab precision study was conducted. A precision panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested in-house. The sample panel was masked and randomized. Each of the panel members was tested in duplicate, twice per day, for 12 days. The results are summarized in the following table. Table 1: Precision Study Sample N Mean Units Within-Run Between-Run Between-Day Total Moderate Positive 48 19.6 SD 0.815 1.534 1.472 1.737 CV 4.2% 7.8% 7.5% 8.9% Low Positive 48 12.1 SD 0.267 1.417 1.248 1.442 CV 2.2% 11.7% 10.3% 11.9% High Negative 48 6.1 SD 0.211 0.662 0.642 0.695 CV 3.4% 10.8% 10.5% 11.4% Negative 48 1.7 SD 0.113 0.164 0.151 0.199 CV 6.6% 9.6% 8.8% 11.6% Reproducibility: A reproducibility panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested at three different sites. The sample panel was masked and randomized. Each of the panel members was tested in triplicate, twice per day, for five days. The Within-Run, Between-Run, Between-Days, and Between-Sites Standard Deviation and Coefficients of Variation (CV) were calculated. The results are summarized in the following table. Table 2: Reproducibility Study Sample N Mean Units Within- Run Between- Run Between- Day Between- Sites Total Moderate Positive 90 21.1 SD 1.117 1.543 1.434 0.386 1.905 CV 5.3% 7.3% 6.8% 1.8% 9.0% Low Positive 90 13.8 SD 0.591 1.155 1.026 0.404 1.297 CV 4.3% 8.4% 7.5% 2.9% 9.4% 5 High Negative 90 6.4 SD 0.323 0.756 0.715 0.237 0.822 CV 5.0% 11.7% 11.1% 3.7% 12.8% Negative 90 1.6 SD 0.145 0.335 0.312 0.347 0.365 CV 9.1% 21.1% 19.6% 21.8% 23.0% b. Linearity/assay reportable range: N/A c. Traceability, Stability, Expected values (controls, calibrators, or methods): N/A d. Detection limit: N/A e. Analytical specificity: Analytical Specificity: The analytical specificity was determined by testing 210 asymptomatic individuals’ samples from endemic (Pennsylvania) and non-endemic (Arizona) regions. The Gold Standard Diagnostics Borrelia burgdorferi lgG/IgM EL Regulation section:

idK180264_s2000_e4000

K180264.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.

in the following table. Table 3: Analytical Specificity Study Number of Samples Number Positive/Equivocal Analytical Specificity Endemic Region 110 3 97.3% Non-endemic Region 100 2 98.0% Cross Reactivity: A study using 221 samples was conducted to evaluate potential cross reactivity from different disease conditions. The samples were obtained from serum vendors who confirmed their positivity for each respective marker. The samples were tested on the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test. The results are summarized in the following table. Table 4: Cross-Reactivity Study Infection / Diagnosis Number of Sera Tested # Positive / (%) Tick-borne Relapsing Fever 26 2 / (7.7%) Treponemal Infections 23 2* / (8.7%) Rickettsia 10 0 / (0%) Ehrlichiosis 10 0 / (0%) Babesiosis 11 0 / (0%) Leptospirosis 11 0 / (0%) Parvovirus B19 12 0 / (0%) Influenza A&B 10 0 / (0%) Epstein-Barr Virus 10 0 / (0%) Cytomegalovirus 19 0 / (0%) H. pylori 11 0 / (0%) 6 Fibromyalgia 10 1/ (10%) Rheumatoid Arthritis 11 0 / (0%) Herpes Simplex Virus 13 0 / (0%) Varicella Zoster Virus 12 0 / (0%) Autoimmune Disease 22 0 / (0%) *Also positive on the predicate device Interfering Substances: The effect of potential interfering substances on samples using the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test was evaluated. Three samples, a negative, a low positive, and a moderate positive were spiked with high levels of interferants and were tested along with serum without spiked interferants. The recommended concentrations from the guideline “Interference Testing in Clinical Chemistry EP7-A2” from the Clinical and Laboratory Standards Institute were used. The tested substances did not affect the performance of the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test. Table 5: Interfering Substances Study f. Assay cut-off: Determination of the Assay Cut-off: The cut-off was determined by testing a total of 200 normal sera which consisted of 100 sera from an endemic region of Lyme disease and 100 sera from a non-endemic region. The mean plus two standard deviations was used to determine the assay cut-off. After the cut-off was determined 125 characterized Lyme disease samples were tested. An ROC analysis was then generated with the 325 samples (200 normal and 125 characterized samples) to verify the chosen cut-off. The analysis confirmed that the assay cut-off provided an optimal level of sensitivity and specificity. 2. Comparison studies: a. Method comparison with predicate device: Comparison with Predicate Device: Comparison studies were conducted at three sites (one internal and two external reference laboratories) using prospective samples submitted for Lyme serology testing. Five hundred and twenty (520) serum samples were tested on both the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test and on the predicate B. burgdorferi IgG/IgM ELISA Test. The results are summarized in the following table. Substance Concentration Interference Albumin 120 g/L None detected Bilirubin 342 µmol/L None detected Cholesterol 13 mmol/L None detected Hemoglobin 2 g/L None detected Triglycerides 37 mmol/L None detected 7 Table 6: Percent Agreement with Predicate Device Predicate IgG/IgM ELISA Positive Equivocal* Negative Total Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit Positive 55 7 2 64 Equivocal 8 2 9 19 Negative 2 1 434 437 Total 65 10 445 520 *Equivocal samples counted as positive Positive percent agreement = 96.0% (72/75) 95% CI (88.8% - 99.2%) Negative percent agreement = 97.5% (434/445) 95% CI (95.6% - 98.8%) b. Matrix comparison: N/A 3. Clinical studies: a. Clinical Sensitivity: Sensitivity Study: A sensitivity study was performed on 89 clinically characterized samples. The samples encompass early, disseminated, and late stages of Lyme disease. The samples were tested on both the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test and on the predicate B. burgdorferi IgG/IgM ELISA Test. The results are summarized in the following table. Table 7: Case Confirmed Lyme Disease Samples Disease Stage n Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit Predicate IgG/IgM ELISA Early 38 76.3% (29/38) 78.9% (30/38) Disseminated 15 100.0% (15/15) 100.0% (15/15) Late 36 97.2% (35/36) 94.4% (34/36) CDC Panel: A standard panel of positive and negative specimens provided by the Center of Disease Control (CDC) for Lyme disease detection was tested on both the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test and on the predicate device. The results are summarized in the following table. 8 Table 8: Testing of CDC Lyme Disease Panel Disease Stage n Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit Predicate IgG/IgM ELISA Positive or Equivocal % Agreement with Clinical Diagnosis Positive or Equivocal % Agreement with Clinical Diagnosis Healthy 5 0 100% 0 100% Early (0-2 months) 15 13 86.7% 12 80.0% Convalescent (3-12 months) 13 7 53.8% 7 53.8% Late (>1 year) 7 7 100% 7 100% b. Clinical specificity: N/A c. Other clinical supportive data (when a. and b. are not applicable): N/A 4. Clinical cut-off: N/A 5. Expected values/Reference range: The range of values and positivity rate among different studies and populations for the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test are as follows. Table 9: Expected Values Population #Samples Unit Results Qualitative Results Mean Range Std. Dev. #Positive/ Equivocal %Positive/ Equivocal Normal Endemic 110 5.8 06.- 11.3 2.075 3 2.7% Normal Non-Endemic 100 4.2 0.9- 12.3 2.077 2 2.0% Prospective Study 520 6.3 0.70-32.3 5.407 83 16.0% Sensitivity Study 89 25.0 3.6-34.9 8.449 79 88.8% Note: It is recommended that each laboratory determine its own normal range based on the population. 9 N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK180264_s2000_e4000

K180264.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

are summarized in the following table. Table 3: Analytical Specificity Study Number of Samples Number Positive/Equivocal Analytical Specificity Endemic Region 110 3 97.3% Non-endemic Region 100 2 98.0% Cross Reactivity: A study using 221 samples was conducted to evaluate potential cross reactivity from different disease conditions. The samples were obtained from serum vendors who confirmed their positivity for each respective marker. The samples were tested on the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test. The results are summarized in the following table. Table 4: Cross-Reactivity Study Infection / Diagnosis Number of Sera Tested # Positive / (%) Tick-borne Relapsing Fever 26 2 / (7.7%) Treponemal Infections 23 2* / (8.7%) Rickettsia 10 0 / (0%) Ehrlichiosis 10 0 / (0%) Babesiosis 11 0 / (0%) Leptospirosis 11 0 / (0%) Parvovirus B19 12 0 / (0%) Influenza A&B 10 0 / (0%) Epstein-Barr Virus 10 0 / (0%) Cytomegalovirus 19 0 / (0%) H. pylori 11 0 / (0%) 6 Fibromyalgia 10 1/ (10%) Rheumatoid Arthritis 11 0 / (0%) Herpes Simplex Virus 13 0 / (0%) Varicella Zoster Virus 12 0 / (0%) Autoimmune Disease 22 0 / (0%) *Also positive on the predicate device Interfering Substances: The effect of potential interfering substances on samples using the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test was evaluated. Three samples, a negative, a low positive, and a moderate positive were spiked with high levels of interferants and were tested along with serum without spiked interferants. The recommended concentrations from the guideline “Interference Testing in Clinical Chemistry EP7-A2” from the Clinical and Laboratory Standards Institute were used. The tested substances did not affect the performance of the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test. Table 5: Interfering Substances Study f. Assay cut-off: Determination of the Assay Cut-off: The cut-off was determined by testing a total of 200 normal sera which consisted of 100 sera from an endemic region of Lyme disease and 100 sera from a non-endemic region. The mean plus two standard deviations was used to determine the assay cut-off. After the cut-off was determined 125 characterized Lyme disease samples were tested. An ROC analysis was then generated with the 325 samples (200 normal and 125 characterized samples) to verify the chosen cut-off. The analysis confirmed that the assay cut-off provided an optimal level of sensitivity and specificity. 2. Comparison studies: a. Method comparison with predicate device: Comparison with Predicate Device: Comparison studies were conducted at three sites (one internal and two external reference laboratories) using prospective samples submitted for Lyme serology testing. Five hundred and twenty (520) serum samples were tested on both the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test and on the predicate B. burgdorferi IgG/IgM ELISA Test. The results are summarized in the following table. Substance Concentration Interference Albumin 120 g/L None detected Bilirubin 342 µmol/L None detected Cholesterol 13 mmol/L None detected Hemoglobin 2 g/L None detected Triglycerides 37 mmol/L None detected 7 Table 6: Percent Agreement with Predicate Device Predicate IgG/IgM ELISA Positive Equivocal* Negative Total Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit Positive 55 7 2 64 Equivocal 8 2 9 19 Negative 2 1 434 437 Total 65 10 445 520 *Equivocal samples counted as positive Positive percent agreement = 96.0% (72/75) 95% CI (88.8% - 99.2%) Negative percent agreement = 97.5% (434/445) 95% CI (95.6% - 98.8%) b. Matrix comparison: N/A 3. Clinical studies: a. Clinical Sensitivity: Sensitivity Study: A sensitivity study was performed on 89 clinically characterized samples. The samples encompass early, disseminated, and late stages of Lyme disease. The samples were tested on both the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test and on the predicate B. burgdorferi IgG/IgM ELISA Test. The results are summarized in the following table. Table 7: Case Confirmed Lyme Disease Samples Disease Stage n Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit Predicate IgG/IgM ELISA Early 38 76.3% (29/38) 78.9% (30/38) Disseminated 15 100.0% (15/15) 100.0% (15/15) Late 36 97.2% (35/36) 94.4% (34/36) CDC Panel: A standard panel of positive and negative specimens provided by the Center of Disease Control (CDC) for Lyme disease detection was tested on both the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test and on the predicate device. The results are summarized in the following table. 8 Table 8: Testing of CDC Lyme Disease Panel Disease Stage n Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit Predicate IgG/IgM ELISA Positive or Equivocal % Agreement with Clinical Diagnosis Positive or Equivocal % Agreement with Clinical Diagnosis Healthy 5 0 100% 0 100% Early (0-2 months) 15 13 86.7% 12 80.0% Convalescent (3-12 months) 13 7 53.8% 7 53.8% Late (>1 year) 7 7 100% 7 100% b. Clinical specificity: N/A c. Other clinical supportive data (when a. and b. are not applicable): N/A 4. Clinical cut-off: N/A 5. Expected values/Reference range: The range of values and positivity rate among different studies and populations for the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test are as follows. Table 9: Expected Values Population #Samples Unit Results Qualitative Results Mean Range Std. Dev. #Positive/ Equivocal %Positive/ Equivocal Normal Endemic 110 5.8 06.- 11.3 2.075 3 2.7% Normal Non-Endemic 100 4.2 0.9- 12.3 2.077 2 2.0% Prospective Study 520 6.3 0.70-32.3 5.407 83 16.0% Sensitivity Study 89 25.0 3.6-34.9 8.449 79 88.8% Note: It is recommended that each laboratory determine its own normal range based on the population. 9 N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK143502_s0_e2000

K143502.txt

purpose for submission

New device

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k143502 B. Purpose for Submission: New device C. Measurand: Opiates D. Type of Test: Qualitative and semi-quantitative homogeneous enzyme immunoassay E. Applicant: Immunalysis Corporation F. Proprietary and Established Names: Immunalysis Opiates Enzyme Immunoassay Immunalysis Opiates Urine Calibrators 300 Immunalysis Opiates Urine Calibrators 2000 Immunalysis Multi-Drug Controls G. Regulatory Information: Product Code Classification Regulation Section Panel DJG – Opiate Test System II 862.3650 91 – Toxicology DLJ– Clinical Toxicology Calibrator II 862.3200 91 – Toxicology DIF – Clinical Toxicology Control Material I, reserved 862.3280 91 – Toxicology H. Intended Use: 1. Intended use(s): See Indication(s) for use below. 2 2. Indication(s) for use: The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 300ng/mL and 2000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. This in-vitro diagnostic device is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures. The Immunalysis Opiates Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methadone, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam for Immunalysis Multi-Drug Controls 1 and Benzoylecgonine, Methamphetamine and Morphine for Immunalysis Multi-Drug Controls 2. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 2000 consists of 4 levels, with Level 1 containing 1000ng/mL, Level 2 containing 2000ng/mL, Level 3 containing 4000ng/mL and Level 4 containing 6000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. 3. Special conditions for use statement(s): For prescription use only. 3 4. Special instrument requirements: Performance data was obtained using the Beckman AU400e clinical chemistry analyzer. I. Device Description: The Immunalysis Opiates Urine Enzyme Immunoassay Kit contains two reagents, which are provided as ready-to-use: · Antibody/Substrate Reagent (RA) – This reagent contains monoclonal antibodies to morphine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. · Enzyme Conjugate Reagent (RE) – This reagent contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with morphine in Tris buffer with Sodium Azide as a preservative. The Immunalysis Opiates Urine Calibrators 300, the Immunalysis Opiates Urine Calibrators 2000, and the Immunalysis Multi-Drug Controls are sold as individual bottles and are liquid and ready-to-use. The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. Each calibrator and control level contains a known concentration of a specific drug analyte spiked into the negative calibrator matrix (see tables below). Immunalysis Opiates Urine Calibrators 300 Analyte Level 1 Level 2 Level 3 Level 4 Morphine 100 ng/mL 300 ng/mL 500 ng/mL 1000 ng/mL Immunalysis Opiates Urine Calibrators 2000 Analyte Level 1 Level 2 Level 3 Level 4 Morphine 1000 ng/mL 2000 ng/mL 4000 ng/mL 6000 ng/mL Immunalysis Multi-Drug Controls 1 Analyte LOW Control 1 HIGH Control 1 Benzoylecgonine 112.5 ng/mL 187.5 ng/mL Methadone 225 ng/mL 375 ng/mL Methamphetamine 375 ng/mL 625 ng/mL Morphine 225 ng/mL 375 ng/mL PCP 19 ng/mL 31 ng/mL Secobarbital 150 ng/mL 250 ng/mL Oxazepam 150 ng/mL 250 ng/mL Immunalysis Multi-Drug Controls 2 Analyte LOW Control 2 HIGH Control 2 Benzoylecgonine 225 ng/mL 375 ng/mL Methamphetamine 750 ng/mL 1250 ng/mL Morphine 1500 ng/mL 2500 ng/mL 4 J. Substantial Equivalence Information: 1. Predicate device name(s): DRI DAU Opiate Assay LZI Multiple Analyte Urine Drugs of Abuse Calibrators and Controls 2. Predicate 510(k) number(s): k011150 k051088 3. Comparison with predicate: Opiates Assay Item Immunalysis Opiates Urine EIA DAU Opiate Assay k011150 Intended Use For the qualitative and semi-quantitative determination of the presence of opiates in human urine at a cutoff of 300 ng/mL and 2000 ng/mL Same Type of Product Analytical Reagents Same Measured Analytes Opiates Same Test Matrix Urine Same Cutoff Levels 300 ng/mL and 2000 ng/mL of Morphine Same Test System Homogeneous Enzyme Immunoassay (EIA) Same Materials Antibody/Substrate Reagents and Enzyme Labeled Conjugate Same Mass Spectroscopy Confirmation Required for preliminary positive analytical results Same Antibody Monoclonal antibody to Opiates Same Storage 2-8°C until expiration date Same 5 Calibrators Item Immunalysis Opiates Urine Calibrators 300 and 2000 LZI Multiple Analytes Calibrators and Controls k051088 Analytes Morphine Benzoylecgonine, d- methamphetamine, methadone, morphine, oxazepam, secobarbital, phencyclidine, propxyphene Matrix Processed, drug-free synthetic urine Same Calibrator Levels 5 levels (Negative, Level 1- 4) 5 levels (Negative, Low, Cutoff, Intermediate, High) Storage 2-8°C until expiration date Same Multi-Drug Controls Item Immunalysis Multi-Drug Controls LZI Multiple Analytes Calibrators and Controls k051088 Analytes Benzoylecgonine, methadone, methamphetamine, morphine, PCP, secobarbital, oxazepam Benzoylecgonine, d- methamphetamine, methadone, morphine, oxazepam, secobarbital, phencyclidine, propxyphene Matrix Processed, drug-free synthetic urine Same Control Levels 4 levels (LOW Control 1+2, HIGH Control 1+2) 2 levels (Control Level 1+2) Storage 2-8°C until expiration date Same K. Standard/Guidance Document Referenced (if applicable): CLSI EP5-A2, “Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Second Edition” CLSI EP7-A2, “Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition” L. Test Principle: The assay is based on the competition of opiates labeled enzyme glucose-6-phosphate dehydrogenase (G6PDH) and the free drug in the urine sample for the fixed amount of 6 antibody binding sites. In the absence of the free drug in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine sample and enzyme activity. The enzyme G6PDH activity is determined at 340nm spectrophotometrically by the conversion of NAD to NADH. M. Performance Characteristics (if/when applicable): 1. Analytical performance Purpose for submission:

idK143502_s0_e2000

K143502.txt

measurand

Opiates

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k143502 B. Purpose for Submission: New device C. Measurand: Opiates D. Type of Test: Qualitative and semi-quantitative homogeneous enzyme immunoassay E. Applicant: Immunalysis Corporation F. Proprietary and Established Names: Immunalysis Opiates Enzyme Immunoassay Immunalysis Opiates Urine Calibrators 300 Immunalysis Opiates Urine Calibrators 2000 Immunalysis Multi-Drug Controls G. Regulatory Information: Product Code Classification Regulation Section Panel DJG – Opiate Test System II 862.3650 91 – Toxicology DLJ– Clinical Toxicology Calibrator II 862.3200 91 – Toxicology DIF – Clinical Toxicology Control Material I, reserved 862.3280 91 – Toxicology H. Intended Use: 1. Intended use(s): See Indication(s) for use below. 2 2. Indication(s) for use: The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 300ng/mL and 2000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. This in-vitro diagnostic device is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures. The Immunalysis Opiates Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methadone, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam for Immunalysis Multi-Drug Controls 1 and Benzoylecgonine, Methamphetamine and Morphine for Immunalysis Multi-Drug Controls 2. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 2000 consists of 4 levels, with Level 1 containing 1000ng/mL, Level 2 containing 2000ng/mL, Level 3 containing 4000ng/mL and Level 4 containing 6000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. 3. Special conditions for use statement(s): For prescription use only. 3 4. Special instrument requirements: Performance data was obtained using the Beckman AU400e clinical chemistry analyzer. I. Device Description: The Immunalysis Opiates Urine Enzyme Immunoassay Kit contains two reagents, which are provided as ready-to-use: · Antibody/Substrate Reagent (RA) – This reagent contains monoclonal antibodies to morphine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. · Enzyme Conjugate Reagent (RE) – This reagent contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with morphine in Tris buffer with Sodium Azide as a preservative. The Immunalysis Opiates Urine Calibrators 300, the Immunalysis Opiates Urine Calibrators 2000, and the Immunalysis Multi-Drug Controls are sold as individual bottles and are liquid and ready-to-use. The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. Each calibrator and control level contains a known concentration of a specific drug analyte spiked into the negative calibrator matrix (see tables below). Immunalysis Opiates Urine Calibrators 300 Analyte Level 1 Level 2 Level 3 Level 4 Morphine 100 ng/mL 300 ng/mL 500 ng/mL 1000 ng/mL Immunalysis Opiates Urine Calibrators 2000 Analyte Level 1 Level 2 Level 3 Level 4 Morphine 1000 ng/mL 2000 ng/mL 4000 ng/mL 6000 ng/mL Immunalysis Multi-Drug Controls 1 Analyte LOW Control 1 HIGH Control 1 Benzoylecgonine 112.5 ng/mL 187.5 ng/mL Methadone 225 ng/mL 375 ng/mL Methamphetamine 375 ng/mL 625 ng/mL Morphine 225 ng/mL 375 ng/mL PCP 19 ng/mL 31 ng/mL Secobarbital 150 ng/mL 250 ng/mL Oxazepam 150 ng/mL 250 ng/mL Immunalysis Multi-Drug Controls 2 Analyte LOW Control 2 HIGH Control 2 Benzoylecgonine 225 ng/mL 375 ng/mL Methamphetamine 750 ng/mL 1250 ng/mL Morphine 1500 ng/mL 2500 ng/mL 4 J. Substantial Equivalence Information: 1. Predicate device name(s): DRI DAU Opiate Assay LZI Multiple Analyte Urine Drugs of Abuse Calibrators and Controls 2. Predicate 510(k) number(s): k011150 k051088 3. Comparison with predicate: Opiates Assay Item Immunalysis Opiates Urine EIA DAU Opiate Assay k011150 Intended Use For the qualitative and semi-quantitative determination of the presence of opiates in human urine at a cutoff of 300 ng/mL and 2000 ng/mL Same Type of Product Analytical Reagents Same Measured Analytes Opiates Same Test Matrix Urine Same Cutoff Levels 300 ng/mL and 2000 ng/mL of Morphine Same Test System Homogeneous Enzyme Immunoassay (EIA) Same Materials Antibody/Substrate Reagents and Enzyme Labeled Conjugate Same Mass Spectroscopy Confirmation Required for preliminary positive analytical results Same Antibody Monoclonal antibody to Opiates Same Storage 2-8°C until expiration date Same 5 Calibrators Item Immunalysis Opiates Urine Calibrators 300 and 2000 LZI Multiple Analytes Calibrators and Controls k051088 Analytes Morphine Benzoylecgonine, d- methamphetamine, methadone, morphine, oxazepam, secobarbital, phencyclidine, propxyphene Matrix Processed, drug-free synthetic urine Same Calibrator Levels 5 levels (Negative, Level 1- 4) 5 levels (Negative, Low, Cutoff, Intermediate, High) Storage 2-8°C until expiration date Same Multi-Drug Controls Item Immunalysis Multi-Drug Controls LZI Multiple Analytes Calibrators and Controls k051088 Analytes Benzoylecgonine, methadone, methamphetamine, morphine, PCP, secobarbital, oxazepam Benzoylecgonine, d- methamphetamine, methadone, morphine, oxazepam, secobarbital, phencyclidine, propxyphene Matrix Processed, drug-free synthetic urine Same Control Levels 4 levels (LOW Control 1+2, HIGH Control 1+2) 2 levels (Control Level 1+2) Storage 2-8°C until expiration date Same K. Standard/Guidance Document Referenced (if applicable): CLSI EP5-A2, “Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Second Edition” CLSI EP7-A2, “Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition” L. Test Principle: The assay is based on the competition of opiates labeled enzyme glucose-6-phosphate dehydrogenase (G6PDH) and the free drug in the urine sample for the fixed amount of 6 antibody binding sites. In the absence of the free drug in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine sample and enzyme activity. The enzyme G6PDH activity is determined at 340nm spectrophotometrically by the conversion of NAD to NADH. M. Performance Characteristics (if/when applicable): 1. Analytical performance Measurand:

idK143502_s0_e2000

K143502.txt

type of test

Qualitative and semi-quantitative homogeneous enzyme immunoassay

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k143502 B. Purpose for Submission: New device C. Measurand: Opiates D. Type of Test: Qualitative and semi-quantitative homogeneous enzyme immunoassay E. Applicant: Immunalysis Corporation F. Proprietary and Established Names: Immunalysis Opiates Enzyme Immunoassay Immunalysis Opiates Urine Calibrators 300 Immunalysis Opiates Urine Calibrators 2000 Immunalysis Multi-Drug Controls G. Regulatory Information: Product Code Classification Regulation Section Panel DJG – Opiate Test System II 862.3650 91 – Toxicology DLJ– Clinical Toxicology Calibrator II 862.3200 91 – Toxicology DIF – Clinical Toxicology Control Material I, reserved 862.3280 91 – Toxicology H. Intended Use: 1. Intended use(s): See Indication(s) for use below. 2 2. Indication(s) for use: The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 300ng/mL and 2000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. This in-vitro diagnostic device is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures. The Immunalysis Opiates Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methadone, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam for Immunalysis Multi-Drug Controls 1 and Benzoylecgonine, Methamphetamine and Morphine for Immunalysis Multi-Drug Controls 2. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 2000 consists of 4 levels, with Level 1 containing 1000ng/mL, Level 2 containing 2000ng/mL, Level 3 containing 4000ng/mL and Level 4 containing 6000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. 3. Special conditions for use statement(s): For prescription use only. 3 4. Special instrument requirements: Performance data was obtained using the Beckman AU400e clinical chemistry analyzer. I. Device Description: The Immunalysis Opiates Urine Enzyme Immunoassay Kit contains two reagents, which are provided as ready-to-use: · Antibody/Substrate Reagent (RA) – This reagent contains monoclonal antibodies to morphine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. · Enzyme Conjugate Reagent (RE) – This reagent contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with morphine in Tris buffer with Sodium Azide as a preservative. The Immunalysis Opiates Urine Calibrators 300, the Immunalysis Opiates Urine Calibrators 2000, and the Immunalysis Multi-Drug Controls are sold as individual bottles and are liquid and ready-to-use. The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. Each calibrator and control level contains a known concentration of a specific drug analyte spiked into the negative calibrator matrix (see tables below). Immunalysis Opiates Urine Calibrators 300 Analyte Level 1 Level 2 Level 3 Level 4 Morphine 100 ng/mL 300 ng/mL 500 ng/mL 1000 ng/mL Immunalysis Opiates Urine Calibrators 2000 Analyte Level 1 Level 2 Level 3 Level 4 Morphine 1000 ng/mL 2000 ng/mL 4000 ng/mL 6000 ng/mL Immunalysis Multi-Drug Controls 1 Analyte LOW Control 1 HIGH Control 1 Benzoylecgonine 112.5 ng/mL 187.5 ng/mL Methadone 225 ng/mL 375 ng/mL Methamphetamine 375 ng/mL 625 ng/mL Morphine 225 ng/mL 375 ng/mL PCP 19 ng/mL 31 ng/mL Secobarbital 150 ng/mL 250 ng/mL Oxazepam 150 ng/mL 250 ng/mL Immunalysis Multi-Drug Controls 2 Analyte LOW Control 2 HIGH Control 2 Benzoylecgonine 225 ng/mL 375 ng/mL Methamphetamine 750 ng/mL 1250 ng/mL Morphine 1500 ng/mL 2500 ng/mL 4 J. Substantial Equivalence Information: 1. Predicate device name(s): DRI DAU Opiate Assay LZI Multiple Analyte Urine Drugs of Abuse Calibrators and Controls 2. Predicate 510(k) number(s): k011150 k051088 3. Comparison with predicate: Opiates Assay Item Immunalysis Opiates Urine EIA DAU Opiate Assay k011150 Intended Use For the qualitative and semi-quantitative determination of the presence of opiates in human urine at a cutoff of 300 ng/mL and 2000 ng/mL Same Type of Product Analytical Reagents Same Measured Analytes Opiates Same Test Matrix Urine Same Cutoff Levels 300 ng/mL and 2000 ng/mL of Morphine Same Test System Homogeneous Enzyme Immunoassay (EIA) Same Materials Antibody/Substrate Reagents and Enzyme Labeled Conjugate Same Mass Spectroscopy Confirmation Required for preliminary positive analytical results Same Antibody Monoclonal antibody to Opiates Same Storage 2-8°C until expiration date Same 5 Calibrators Item Immunalysis Opiates Urine Calibrators 300 and 2000 LZI Multiple Analytes Calibrators and Controls k051088 Analytes Morphine Benzoylecgonine, d- methamphetamine, methadone, morphine, oxazepam, secobarbital, phencyclidine, propxyphene Matrix Processed, drug-free synthetic urine Same Calibrator Levels 5 levels (Negative, Level 1- 4) 5 levels (Negative, Low, Cutoff, Intermediate, High) Storage 2-8°C until expiration date Same Multi-Drug Controls Item Immunalysis Multi-Drug Controls LZI Multiple Analytes Calibrators and Controls k051088 Analytes Benzoylecgonine, methadone, methamphetamine, morphine, PCP, secobarbital, oxazepam Benzoylecgonine, d- methamphetamine, methadone, morphine, oxazepam, secobarbital, phencyclidine, propxyphene Matrix Processed, drug-free synthetic urine Same Control Levels 4 levels (LOW Control 1+2, HIGH Control 1+2) 2 levels (Control Level 1+2) Storage 2-8°C until expiration date Same K. Standard/Guidance Document Referenced (if applicable): CLSI EP5-A2, “Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Second Edition” CLSI EP7-A2, “Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition” L. Test Principle: The assay is based on the competition of opiates labeled enzyme glucose-6-phosphate dehydrogenase (G6PDH) and the free drug in the urine sample for the fixed amount of 6 antibody binding sites. In the absence of the free drug in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine sample and enzyme activity. The enzyme G6PDH activity is determined at 340nm spectrophotometrically by the conversion of NAD to NADH. M. Performance Characteristics (if/when applicable): 1. Analytical performance Type of test:

idK143502_s0_e2000

K143502.txt

intended use

See Indication(s) for use below.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k143502 B. Purpose for Submission: New device C. Measurand: Opiates D. Type of Test: Qualitative and semi-quantitative homogeneous enzyme immunoassay E. Applicant: Immunalysis Corporation F. Proprietary and Established Names: Immunalysis Opiates Enzyme Immunoassay Immunalysis Opiates Urine Calibrators 300 Immunalysis Opiates Urine Calibrators 2000 Immunalysis Multi-Drug Controls G. Regulatory Information: Product Code Classification Regulation Section Panel DJG – Opiate Test System II 862.3650 91 – Toxicology DLJ– Clinical Toxicology Calibrator II 862.3200 91 – Toxicology DIF – Clinical Toxicology Control Material I, reserved 862.3280 91 – Toxicology H. Intended Use: 1. Intended use(s): See Indication(s) for use below. 2 2. Indication(s) for use: The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 300ng/mL and 2000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. This in-vitro diagnostic device is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures. The Immunalysis Opiates Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methadone, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam for Immunalysis Multi-Drug Controls 1 and Benzoylecgonine, Methamphetamine and Morphine for Immunalysis Multi-Drug Controls 2. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 2000 consists of 4 levels, with Level 1 containing 1000ng/mL, Level 2 containing 2000ng/mL, Level 3 containing 4000ng/mL and Level 4 containing 6000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. 3. Special conditions for use statement(s): For prescription use only. 3 4. Special instrument requirements: Performance data was obtained using the Beckman AU400e clinical chemistry analyzer. I. Device Description: The Immunalysis Opiates Urine Enzyme Immunoassay Kit contains two reagents, which are provided as ready-to-use: · Antibody/Substrate Reagent (RA) – This reagent contains monoclonal antibodies to morphine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. · Enzyme Conjugate Reagent (RE) – This reagent contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with morphine in Tris buffer with Sodium Azide as a preservative. The Immunalysis Opiates Urine Calibrators 300, the Immunalysis Opiates Urine Calibrators 2000, and the Immunalysis Multi-Drug Controls are sold as individual bottles and are liquid and ready-to-use. The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. Each calibrator and control level contains a known concentration of a specific drug analyte spiked into the negative calibrator matrix (see tables below). Immunalysis Opiates Urine Calibrators 300 Analyte Level 1 Level 2 Level 3 Level 4 Morphine 100 ng/mL 300 ng/mL 500 ng/mL 1000 ng/mL Immunalysis Opiates Urine Calibrators 2000 Analyte Level 1 Level 2 Level 3 Level 4 Morphine 1000 ng/mL 2000 ng/mL 4000 ng/mL 6000 ng/mL Immunalysis Multi-Drug Controls 1 Analyte LOW Control 1 HIGH Control 1 Benzoylecgonine 112.5 ng/mL 187.5 ng/mL Methadone 225 ng/mL 375 ng/mL Methamphetamine 375 ng/mL 625 ng/mL Morphine 225 ng/mL 375 ng/mL PCP 19 ng/mL 31 ng/mL Secobarbital 150 ng/mL 250 ng/mL Oxazepam 150 ng/mL 250 ng/mL Immunalysis Multi-Drug Controls 2 Analyte LOW Control 2 HIGH Control 2 Benzoylecgonine 225 ng/mL 375 ng/mL Methamphetamine 750 ng/mL 1250 ng/mL Morphine 1500 ng/mL 2500 ng/mL 4 J. Substantial Equivalence Information: 1. Predicate device name(s): DRI DAU Opiate Assay LZI Multiple Analyte Urine Drugs of Abuse Calibrators and Controls 2. Predicate 510(k) number(s): k011150 k051088 3. Comparison with predicate: Opiates Assay Item Immunalysis Opiates Urine EIA DAU Opiate Assay k011150 Intended Use For the qualitative and semi-quantitative determination of the presence of opiates in human urine at a cutoff of 300 ng/mL and 2000 ng/mL Same Type of Product Analytical Reagents Same Measured Analytes Opiates Same Test Matrix Urine Same Cutoff Levels 300 ng/mL and 2000 ng/mL of Morphine Same Test System Homogeneous Enzyme Immunoassay (EIA) Same Materials Antibody/Substrate Reagents and Enzyme Labeled Conjugate Same Mass Spectroscopy Confirmation Required for preliminary positive analytical results Same Antibody Monoclonal antibody to Opiates Same Storage 2-8°C until expiration date Same 5 Calibrators Item Immunalysis Opiates Urine Calibrators 300 and 2000 LZI Multiple Analytes Calibrators and Controls k051088 Analytes Morphine Benzoylecgonine, d- methamphetamine, methadone, morphine, oxazepam, secobarbital, phencyclidine, propxyphene Matrix Processed, drug-free synthetic urine Same Calibrator Levels 5 levels (Negative, Level 1- 4) 5 levels (Negative, Low, Cutoff, Intermediate, High) Storage 2-8°C until expiration date Same Multi-Drug Controls Item Immunalysis Multi-Drug Controls LZI Multiple Analytes Calibrators and Controls k051088 Analytes Benzoylecgonine, methadone, methamphetamine, morphine, PCP, secobarbital, oxazepam Benzoylecgonine, d- methamphetamine, methadone, morphine, oxazepam, secobarbital, phencyclidine, propxyphene Matrix Processed, drug-free synthetic urine Same Control Levels 4 levels (LOW Control 1+2, HIGH Control 1+2) 2 levels (Control Level 1+2) Storage 2-8°C until expiration date Same K. Standard/Guidance Document Referenced (if applicable): CLSI EP5-A2, “Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Second Edition” CLSI EP7-A2, “Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition” L. Test Principle: The assay is based on the competition of opiates labeled enzyme glucose-6-phosphate dehydrogenase (G6PDH) and the free drug in the urine sample for the fixed amount of 6 antibody binding sites. In the absence of the free drug in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine sample and enzyme activity. The enzyme G6PDH activity is determined at 340nm spectrophotometrically by the conversion of NAD to NADH. M. Performance Characteristics (if/when applicable): 1. Analytical performance Intended use:

idK143502_s0_e2000

K143502.txt

applicant

Immunalysis Corporation

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k143502 B. Purpose for Submission: New device C. Measurand: Opiates D. Type of Test: Qualitative and semi-quantitative homogeneous enzyme immunoassay E. Applicant: Immunalysis Corporation F. Proprietary and Established Names: Immunalysis Opiates Enzyme Immunoassay Immunalysis Opiates Urine Calibrators 300 Immunalysis Opiates Urine Calibrators 2000 Immunalysis Multi-Drug Controls G. Regulatory Information: Product Code Classification Regulation Section Panel DJG – Opiate Test System II 862.3650 91 – Toxicology DLJ– Clinical Toxicology Calibrator II 862.3200 91 – Toxicology DIF – Clinical Toxicology Control Material I, reserved 862.3280 91 – Toxicology H. Intended Use: 1. Intended use(s): See Indication(s) for use below. 2 2. Indication(s) for use: The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 300ng/mL and 2000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. This in-vitro diagnostic device is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures. The Immunalysis Opiates Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methadone, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam for Immunalysis Multi-Drug Controls 1 and Benzoylecgonine, Methamphetamine and Morphine for Immunalysis Multi-Drug Controls 2. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 2000 consists of 4 levels, with Level 1 containing 1000ng/mL, Level 2 containing 2000ng/mL, Level 3 containing 4000ng/mL and Level 4 containing 6000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. 3. Special conditions for use statement(s): For prescription use only. 3 4. Special instrument requirements: Performance data was obtained using the Beckman AU400e clinical chemistry analyzer. I. Device Description: The Immunalysis Opiates Urine Enzyme Immunoassay Kit contains two reagents, which are provided as ready-to-use: · Antibody/Substrate Reagent (RA) – This reagent contains monoclonal antibodies to morphine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. · Enzyme Conjugate Reagent (RE) – This reagent contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with morphine in Tris buffer with Sodium Azide as a preservative. The Immunalysis Opiates Urine Calibrators 300, the Immunalysis Opiates Urine Calibrators 2000, and the Immunalysis Multi-Drug Controls are sold as individual bottles and are liquid and ready-to-use. The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. Each calibrator and control level contains a known concentration of a specific drug analyte spiked into the negative calibrator matrix (see tables below). Immunalysis Opiates Urine Calibrators 300 Analyte Level 1 Level 2 Level 3 Level 4 Morphine 100 ng/mL 300 ng/mL 500 ng/mL 1000 ng/mL Immunalysis Opiates Urine Calibrators 2000 Analyte Level 1 Level 2 Level 3 Level 4 Morphine 1000 ng/mL 2000 ng/mL 4000 ng/mL 6000 ng/mL Immunalysis Multi-Drug Controls 1 Analyte LOW Control 1 HIGH Control 1 Benzoylecgonine 112.5 ng/mL 187.5 ng/mL Methadone 225 ng/mL 375 ng/mL Methamphetamine 375 ng/mL 625 ng/mL Morphine 225 ng/mL 375 ng/mL PCP 19 ng/mL 31 ng/mL Secobarbital 150 ng/mL 250 ng/mL Oxazepam 150 ng/mL 250 ng/mL Immunalysis Multi-Drug Controls 2 Analyte LOW Control 2 HIGH Control 2 Benzoylecgonine 225 ng/mL 375 ng/mL Methamphetamine 750 ng/mL 1250 ng/mL Morphine 1500 ng/mL 2500 ng/mL 4 J. Substantial Equivalence Information: 1. Predicate device name(s): DRI DAU Opiate Assay LZI Multiple Analyte Urine Drugs of Abuse Calibrators and Controls 2. Predicate 510(k) number(s): k011150 k051088 3. Comparison with predicate: Opiates Assay Item Immunalysis Opiates Urine EIA DAU Opiate Assay k011150 Intended Use For the qualitative and semi-quantitative determination of the presence of opiates in human urine at a cutoff of 300 ng/mL and 2000 ng/mL Same Type of Product Analytical Reagents Same Measured Analytes Opiates Same Test Matrix Urine Same Cutoff Levels 300 ng/mL and 2000 ng/mL of Morphine Same Test System Homogeneous Enzyme Immunoassay (EIA) Same Materials Antibody/Substrate Reagents and Enzyme Labeled Conjugate Same Mass Spectroscopy Confirmation Required for preliminary positive analytical results Same Antibody Monoclonal antibody to Opiates Same Storage 2-8°C until expiration date Same 5 Calibrators Item Immunalysis Opiates Urine Calibrators 300 and 2000 LZI Multiple Analytes Calibrators and Controls k051088 Analytes Morphine Benzoylecgonine, d- methamphetamine, methadone, morphine, oxazepam, secobarbital, phencyclidine, propxyphene Matrix Processed, drug-free synthetic urine Same Calibrator Levels 5 levels (Negative, Level 1- 4) 5 levels (Negative, Low, Cutoff, Intermediate, High) Storage 2-8°C until expiration date Same Multi-Drug Controls Item Immunalysis Multi-Drug Controls LZI Multiple Analytes Calibrators and Controls k051088 Analytes Benzoylecgonine, methadone, methamphetamine, morphine, PCP, secobarbital, oxazepam Benzoylecgonine, d- methamphetamine, methadone, morphine, oxazepam, secobarbital, phencyclidine, propxyphene Matrix Processed, drug-free synthetic urine Same Control Levels 4 levels (LOW Control 1+2, HIGH Control 1+2) 2 levels (Control Level 1+2) Storage 2-8°C until expiration date Same K. Standard/Guidance Document Referenced (if applicable): CLSI EP5-A2, “Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Second Edition” CLSI EP7-A2, “Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition” L. Test Principle: The assay is based on the competition of opiates labeled enzyme glucose-6-phosphate dehydrogenase (G6PDH) and the free drug in the urine sample for the fixed amount of 6 antibody binding sites. In the absence of the free drug in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine sample and enzyme activity. The enzyme G6PDH activity is determined at 340nm spectrophotometrically by the conversion of NAD to NADH. M. Performance Characteristics (if/when applicable): 1. Analytical performance Applicant:

idK143502_s6000_e8000

K143502.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

the limitations section of the labeling: “Boric Acid is not recommended as a preservative for urine. Boric Acid and Riboflavin can cause a falsely low test result.” pH and Specific Gravity For potential interference from the pH of urine, device performance in the qualitative and semi-quantitative modes was tested using a range of urine pH values (3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0 and 11.0). All test samples were prepared in drug free urine containing morphine at ± 25 of the 300ng/mL cutoff (225ng/mL and 375ng/mL) and 2000ng/mL cutoff (1500ng/mL and 2500ng/mL). No positive or negative interference was observed at urine pH values ranging from 3.0 to 11.0 for each test mode. For potential interference from the specific gravity of urine, device performance in the qualitative and semi-quantitative modes was tested using a range of urine specific gravity values (1.000, 1.002, 1.005, 1.010, 1.015, 1.020, 1.025 and 1.030). All test samples were prepared in drug free urine containing morphine at ± 25% of the 300ng/mL cutoff (225ng/mL and 375ng/mL) and 2000ng/mL cutoff (1500ng/mL and 2500ng/mL). No positive or negative interference was observed at urine specific gravity values ranging 17 from 1.000 to 1.030 for each test mode. f. Assay cut-off: Characterization of how the device performs analytically around the claimed cutoff concentrations of 300 ng/mL and 2000 ng/mL is described in the precision section, M.1.a. above. 2. Comparison studies: a. Method comparison with predicate device: 80 unaltered urine samples from clinical testing laboratories were analyzed by the candidate device in the qualitative and semi-quantitative modes on the Beckman Coulter AU400e clinical chemistry analyzer and the comparative mass spectrometry based quantitative method (LC/MS) for morphine and other opiates. The results from the study are summarized below: Assay Performance verified by LC/MS (300ng/mL Cutoff – Qualitative) Candidate Device Results Total Opiate Concentration < 150ng/mL (<50% cutoff) 150 ~ 299 ng/mL (-50% to cutoff) 300 ~ 450 ng/mL (cutoff to +50%) > 450 ng/mL (>50% cutoff) Positive 0 1 5 35 Negative 36 3 0 0 Discordant Result Summary (300ng/mL Cutoff – Qualitative) Qualitative Results LC/MS Confirmation Test Device Qualitative Total Opiate Concentration (ng/mL) Positive Negative 200 % Agreement among positives is 98%. % Agreement among negatives is 100%. Assay Performance verified by LC/MS (2000ng/mL Cutoff – Qualitative) Candidate Device Results Total Opiate Concentration < 1000ng/mL (<50% cutoff) 1000~1999 ng/mL (-50% to cutoff) 2000~3000 ng/mL (cutoff to +50%) > 3000 ng/mL (>50% cutoff) Positive 0 0 5 35 Negative 36 4 0 0 % Agreement among positives is 100%. % Agreement among negatives is 100%. 18 Assay Performance verified by LC/MS (300ng/mL Cutoff – Semi-quantitative) Candidate Device Results Total Opiate Concentration < 150ng/mL (<50% cutoff) 150 ~ 299 ng/mL (-50% to cutoff) 300 ~ 450 ng/mL (cutoff to +50%) > 450 ng/mL (>50% cutoff) Positive 0 0 5 35 Negative 36 4 0 0 % Agreement among positives is 100%. % Agreement among negatives is 100%. Assay Performance verified by LC/MS (2000ng/mL Cutoff – Semi-quantitative) Candidate Device Results Total Opiate Concentration < 1000ng/mL (<50% cutoff) 1000~1999 ng/mL (-50% to cutoff) 2000~3000 ng/mL (cutoff to +50%) > 3000 ng/mL (>50% cutoff) Positive 0 0 5 35 Negative 36 4 0 0 % Agreement among positives is 100%. % Agreement among negatives is 100%. b. Matrix comparison: Not applicable. Urine is the only claimed matrix for the candidate device. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable. 4. Clinical cut-off: Not applicable. 19 5. Expected values/Reference range: Not applicable. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK143502_s6000_e8000

K143502.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

provided in the limitations section of the labeling: “Boric Acid is not recommended as a preservative for urine. Boric Acid and Riboflavin can cause a falsely low test result.” pH and Specific Gravity For potential interference from the pH of urine, device performance in the qualitative and semi-quantitative modes was tested using a range of urine pH values (3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0 and 11.0). All test samples were prepared in drug free urine containing morphine at ± 25 of the 300ng/mL cutoff (225ng/mL and 375ng/mL) and 2000ng/mL cutoff (1500ng/mL and 2500ng/mL). No positive or negative interference was observed at urine pH values ranging from 3.0 to 11.0 for each test mode. For potential interference from the specific gravity of urine, device performance in the qualitative and semi-quantitative modes was tested using a range of urine specific gravity values (1.000, 1.002, 1.005, 1.010, 1.015, 1.020, 1.025 and 1.030). All test samples were prepared in drug free urine containing morphine at ± 25% of the 300ng/mL cutoff (225ng/mL and 375ng/mL) and 2000ng/mL cutoff (1500ng/mL and 2500ng/mL). No positive or negative interference was observed at urine specific gravity values ranging 17 from 1.000 to 1.030 for each test mode. f. Assay cut-off: Characterization of how the device performs analytically around the claimed cutoff concentrations of 300 ng/mL and 2000 ng/mL is described in the precision section, M.1.a. above. 2. Comparison studies: a. Method comparison with predicate device: 80 unaltered urine samples from clinical testing laboratories were analyzed by the candidate device in the qualitative and semi-quantitative modes on the Beckman Coulter AU400e clinical chemistry analyzer and the comparative mass spectrometry based quantitative method (LC/MS) for morphine and other opiates. The results from the study are summarized below: Assay Performance verified by LC/MS (300ng/mL Cutoff – Qualitative) Candidate Device Results Total Opiate Concentration < 150ng/mL (<50% cutoff) 150 ~ 299 ng/mL (-50% to cutoff) 300 ~ 450 ng/mL (cutoff to +50%) > 450 ng/mL (>50% cutoff) Positive 0 1 5 35 Negative 36 3 0 0 Discordant Result Summary (300ng/mL Cutoff – Qualitative) Qualitative Results LC/MS Confirmation Test Device Qualitative Total Opiate Concentration (ng/mL) Positive Negative 200 % Agreement among positives is 98%. % Agreement among negatives is 100%. Assay Performance verified by LC/MS (2000ng/mL Cutoff – Qualitative) Candidate Device Results Total Opiate Concentration < 1000ng/mL (<50% cutoff) 1000~1999 ng/mL (-50% to cutoff) 2000~3000 ng/mL (cutoff to +50%) > 3000 ng/mL (>50% cutoff) Positive 0 0 5 35 Negative 36 4 0 0 % Agreement among positives is 100%. % Agreement among negatives is 100%. 18 Assay Performance verified by LC/MS (300ng/mL Cutoff – Semi-quantitative) Candidate Device Results Total Opiate Concentration < 150ng/mL (<50% cutoff) 150 ~ 299 ng/mL (-50% to cutoff) 300 ~ 450 ng/mL (cutoff to +50%) > 450 ng/mL (>50% cutoff) Positive 0 0 5 35 Negative 36 4 0 0 % Agreement among positives is 100%. % Agreement among negatives is 100%. Assay Performance verified by LC/MS (2000ng/mL Cutoff – Semi-quantitative) Candidate Device Results Total Opiate Concentration < 1000ng/mL (<50% cutoff) 1000~1999 ng/mL (-50% to cutoff) 2000~3000 ng/mL (cutoff to +50%) > 3000 ng/mL (>50% cutoff) Positive 0 0 5 35 Negative 36 4 0 0 % Agreement among positives is 100%. % Agreement among negatives is 100%. b. Matrix comparison: Not applicable. Urine is the only claimed matrix for the candidate device. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable. 4. Clinical cut-off: Not applicable. 19 5. Expected values/Reference range: Not applicable. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK182513_s0_e2000

K182513.txt

purpose for submission

New device 510(k) clearance for the FluChip-8G Influenza A+B Assay

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182513 B. Purpose for Submission: New device 510(k) clearance for the FluChip-8G Influenza A+B Assay C. Measurand: Influenza A and influenza B viral nucleic acids. D. Type of Test: Qualitative multiplex one-step RT-PCR followed by downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm E. Applicant: InDevR, Inc. F. Proprietary and Established Names: FluChip-8G Influenza A+B Assay (FC8G assay) G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): OZE - Influenza A and influenza B multiplex nucleic acid assay (Primary) NSU - Instrumentation for clinical multiplex test systems (Subsequent) OEP - Influenza A virus subtype differentiation nucleic acid assay (Subsequent) OQW - 2009 H1N1 influenza virus (swine origin), nucleic acid or antigen, detection and 2 identification (Subsequent) 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The FluChip-8G Influenza A+B Assay is a multiplex RT-PCR in vitro diagnostic test intended for the qualitative detection and differentiation of seasonal influenza A/H3N2, seasonal influenza A/H1N1pdm09, and “non-seasonal” influenza A subtypes other than seasonal H1N1pdm09 or H3N2. The assay is also intended for the qualitative detection and differentiation of the genetic lineage of human influenza B viruses as B/Victoria or B/Yamagata. The assay is designed for use on influenza nucleic acids isolated and purified from nasopharyngeal swab and nasal swab specimens from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. This assay amplifies the hemagglutinin (HA) gene segment, neuraminidase (NA) gene segment, matrix (M) gene segment, non-structural (NS) gene segment, and nucleoprotein (NP) gene segment for detection and discrimination of influenza A, and amplifies the hemagglutinin (HA) gene segment and neuraminidase (NA) gene segment for detection and discrimination of influenza B. This assay is not intended to detect influenza C viruses. FluChip-8G Influenza A+B Assay “non-seasonal” influenza A positive results are for the presumptive detection of influenza A subtypes other than seasonal influenza A/H1N1pdm09 or A/H3N2. The definitive identification of a “non-seasonal” influenza A case requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (e.g., local or state public health departments, etc.) for whom reporting is necessary. Negative results do not preclude influenza virus infection. FluChip-8G Influenza A+B Assay “non-seasonal” influenza A negative results, even in the context of a FluChip-8G Influenza A+B Assay positive result for seasonal influenza A/H1N1pdm09 or A/H3N2, or influenza B, do not preclude “non-seasonal” influenza A infection and should not be used as the sole basis for patient management decisions. Performance characteristics of the FluChip-8G Influenza A+B Assay for detecting and differentiating seasonal influenza A viruses were established when seasonal influenza A/H3N2 was the predominant influenza A virus circulating in the United States. Performance characteristics may vary with other emerging seasonal influenza A viruses. Performance characteristics of the FluChip-8G Influenza A+B Assay for detecting and differentiating human influenza B genetic lineages were established when influenza 3 B/Victoria was the predominant influenza B virus circulating in the United States. Due to low prevalence of “non-seasonal” influenza A viruses, performance characteristics of the FluChip-8G Influenza A+B Assay for detecting “non-seasonal” influenza A viruses and distinguishing “non-seasonal” influenza A from seasonal influenza A H1N1pdm09 and H3N2 were assessed exclusively by conducting cross- validation on a total of 759 microarray images generated from bench testing contrived samples consisting of 352 unique “non-seasonal” influenza A strains representing 62 subtypes, and by bench testing contrived samples and surrogate clinical specimens consisting of 133 unique non-seasonal influenza A strains representing 46 subtypes. FluChip-8G Influenza A+B Assay performance may vary when testing “non-seasonal” influenza A strains not represented in the performance assessment. If infection with a novel influenza A virus strain is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to local or state health department(s) for testing. Viral culture should not be attempted unless a BSL 3E facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use(s) 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: • BioRad T100 endpoint thermal cycler • FluChip-8G Imaging System with FluChip-8G Software v1.0.9.0 or newer I. Device Description: Overview The FluChip-8G Influenza A+B Assay system is a molecular assay system for the detection and differentiation of influenza viruses in which a multiplexed one-step RT-PCR amplification is coupled with downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm. The system consists of the following: 1) A reagent kit comprising the reagents required to conduct RT-PCR and for performing 4 post-PCR sample processing including PCR product fragmentation, microarray hybridization, washing, fluorescent labeling, and drying. 2) An accessory kit comprising a variety of laboratory equipment and supplies for facilitating execution of the assay. 3) Other general laboratory equipment and supplies required but not provided. 4) The FluChip-8G Imaging System with pre-installed FluChip-8G Software including an image processing module, an underlying neural network-based pattern recognition algorithm for identifying patterns in microarray signals representative of certain influenza target virus groups, and a user interface to facilitate data entry/imaging and provide result reports to the end user. Materials Provided FluChip-8G Influenza A+B Assay Reagent Kit (FC-6101) Reagents Description Units Per Kit Assays Per Unit Volume Per Unit Cat. # FC8G Amplification Reagents: FC-6101A FC8G Polymerase Mix Mixture of components necessary for PCR amplification 6 vials 16 500 µL FC-5015 FC8G RT Enzyme Enzyme necessary to perform reverse transcription step 6 vials 16 35 µL FC-5014 FC8G Primer Mix Mixture of oligonucleotide primers containing sodium azide (0.02%) as a preservative 6 vials 16 40 µL FC-5004 FC8G Biotin dUTP Lyophilized biotinylated dUTP 6 vials 16 50 nmol FC-5008 FC8G Microarray Processing Reagents: FC-6101B FluChip-8G Microarray Slide Microarray slide with 16-well silicone chamber. Each well contains a single oligonucleotide microarray 6 slides 16 N/A FC-5006 Wash Buffer 1 (20x) Concentrated wash buffer containing sodium azide (0.05%) as a preservative 2 bottles 48 50 mL MI-5014 Wash Buffer 2 (20x) Concentrated wash buffer containing sodium azide (0.05%) as a preservative 2 bottles 48 50 mL MI-5015 FC8G Binding Buffer Concentrated binding buffer containing sodium azide (0.02%) as a preservative 6 vials 16 1850 µL FC-5001 FC8G Hyb Mix Protein-based hybridization solution containing hybridization positive control oligonucleotides 6 vials 16 192 µL FC-5013 5 FC8G Label Lyophilized fluorophore- streptavidin label containing sodium azide (1.5 ng) as a preservative 6 vials 16 15 µg FC-5002 FC8G Diluent Diluent containing sodium azide (0.025%) as a preservative 6 vials 16 1500 µL FC-5012 Slide Drying Sheets Absorbent sheets to remove wash buffer from the FluChip- 8G Microarray Slide 20 sheets N/A N/A FC-4005 Desiccant Pouches Desiccant provided to aid in slide drying steps 18 pouches N/A N/A FC-4013 Materials Required but Not Provided Plasticware and Consumables Material Cat. # FluChip-8G Influenza A+B Assay Accessory Kit FC-4000 Humidity Chamber (available in the FluChip-8G Influenza A+ Purpose for submission:

idK182513_s0_e2000

K182513.txt

measurand

Influenza A and influenza B viral nucleic acids.

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182513 B. Purpose for Submission: New device 510(k) clearance for the FluChip-8G Influenza A+B Assay C. Measurand: Influenza A and influenza B viral nucleic acids. D. Type of Test: Qualitative multiplex one-step RT-PCR followed by downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm E. Applicant: InDevR, Inc. F. Proprietary and Established Names: FluChip-8G Influenza A+B Assay (FC8G assay) G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): OZE - Influenza A and influenza B multiplex nucleic acid assay (Primary) NSU - Instrumentation for clinical multiplex test systems (Subsequent) OEP - Influenza A virus subtype differentiation nucleic acid assay (Subsequent) OQW - 2009 H1N1 influenza virus (swine origin), nucleic acid or antigen, detection and 2 identification (Subsequent) 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The FluChip-8G Influenza A+B Assay is a multiplex RT-PCR in vitro diagnostic test intended for the qualitative detection and differentiation of seasonal influenza A/H3N2, seasonal influenza A/H1N1pdm09, and “non-seasonal” influenza A subtypes other than seasonal H1N1pdm09 or H3N2. The assay is also intended for the qualitative detection and differentiation of the genetic lineage of human influenza B viruses as B/Victoria or B/Yamagata. The assay is designed for use on influenza nucleic acids isolated and purified from nasopharyngeal swab and nasal swab specimens from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. This assay amplifies the hemagglutinin (HA) gene segment, neuraminidase (NA) gene segment, matrix (M) gene segment, non-structural (NS) gene segment, and nucleoprotein (NP) gene segment for detection and discrimination of influenza A, and amplifies the hemagglutinin (HA) gene segment and neuraminidase (NA) gene segment for detection and discrimination of influenza B. This assay is not intended to detect influenza C viruses. FluChip-8G Influenza A+B Assay “non-seasonal” influenza A positive results are for the presumptive detection of influenza A subtypes other than seasonal influenza A/H1N1pdm09 or A/H3N2. The definitive identification of a “non-seasonal” influenza A case requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (e.g., local or state public health departments, etc.) for whom reporting is necessary. Negative results do not preclude influenza virus infection. FluChip-8G Influenza A+B Assay “non-seasonal” influenza A negative results, even in the context of a FluChip-8G Influenza A+B Assay positive result for seasonal influenza A/H1N1pdm09 or A/H3N2, or influenza B, do not preclude “non-seasonal” influenza A infection and should not be used as the sole basis for patient management decisions. Performance characteristics of the FluChip-8G Influenza A+B Assay for detecting and differentiating seasonal influenza A viruses were established when seasonal influenza A/H3N2 was the predominant influenza A virus circulating in the United States. Performance characteristics may vary with other emerging seasonal influenza A viruses. Performance characteristics of the FluChip-8G Influenza A+B Assay for detecting and differentiating human influenza B genetic lineages were established when influenza 3 B/Victoria was the predominant influenza B virus circulating in the United States. Due to low prevalence of “non-seasonal” influenza A viruses, performance characteristics of the FluChip-8G Influenza A+B Assay for detecting “non-seasonal” influenza A viruses and distinguishing “non-seasonal” influenza A from seasonal influenza A H1N1pdm09 and H3N2 were assessed exclusively by conducting cross- validation on a total of 759 microarray images generated from bench testing contrived samples consisting of 352 unique “non-seasonal” influenza A strains representing 62 subtypes, and by bench testing contrived samples and surrogate clinical specimens consisting of 133 unique non-seasonal influenza A strains representing 46 subtypes. FluChip-8G Influenza A+B Assay performance may vary when testing “non-seasonal” influenza A strains not represented in the performance assessment. If infection with a novel influenza A virus strain is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to local or state health department(s) for testing. Viral culture should not be attempted unless a BSL 3E facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use(s) 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: • BioRad T100 endpoint thermal cycler • FluChip-8G Imaging System with FluChip-8G Software v1.0.9.0 or newer I. Device Description: Overview The FluChip-8G Influenza A+B Assay system is a molecular assay system for the detection and differentiation of influenza viruses in which a multiplexed one-step RT-PCR amplification is coupled with downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm. The system consists of the following: 1) A reagent kit comprising the reagents required to conduct RT-PCR and for performing 4 post-PCR sample processing including PCR product fragmentation, microarray hybridization, washing, fluorescent labeling, and drying. 2) An accessory kit comprising a variety of laboratory equipment and supplies for facilitating execution of the assay. 3) Other general laboratory equipment and supplies required but not provided. 4) The FluChip-8G Imaging System with pre-installed FluChip-8G Software including an image processing module, an underlying neural network-based pattern recognition algorithm for identifying patterns in microarray signals representative of certain influenza target virus groups, and a user interface to facilitate data entry/imaging and provide result reports to the end user. Materials Provided FluChip-8G Influenza A+B Assay Reagent Kit (FC-6101) Reagents Description Units Per Kit Assays Per Unit Volume Per Unit Cat. # FC8G Amplification Reagents: FC-6101A FC8G Polymerase Mix Mixture of components necessary for PCR amplification 6 vials 16 500 µL FC-5015 FC8G RT Enzyme Enzyme necessary to perform reverse transcription step 6 vials 16 35 µL FC-5014 FC8G Primer Mix Mixture of oligonucleotide primers containing sodium azide (0.02%) as a preservative 6 vials 16 40 µL FC-5004 FC8G Biotin dUTP Lyophilized biotinylated dUTP 6 vials 16 50 nmol FC-5008 FC8G Microarray Processing Reagents: FC-6101B FluChip-8G Microarray Slide Microarray slide with 16-well silicone chamber. Each well contains a single oligonucleotide microarray 6 slides 16 N/A FC-5006 Wash Buffer 1 (20x) Concentrated wash buffer containing sodium azide (0.05%) as a preservative 2 bottles 48 50 mL MI-5014 Wash Buffer 2 (20x) Concentrated wash buffer containing sodium azide (0.05%) as a preservative 2 bottles 48 50 mL MI-5015 FC8G Binding Buffer Concentrated binding buffer containing sodium azide (0.02%) as a preservative 6 vials 16 1850 µL FC-5001 FC8G Hyb Mix Protein-based hybridization solution containing hybridization positive control oligonucleotides 6 vials 16 192 µL FC-5013 5 FC8G Label Lyophilized fluorophore- streptavidin label containing sodium azide (1.5 ng) as a preservative 6 vials 16 15 µg FC-5002 FC8G Diluent Diluent containing sodium azide (0.025%) as a preservative 6 vials 16 1500 µL FC-5012 Slide Drying Sheets Absorbent sheets to remove wash buffer from the FluChip- 8G Microarray Slide 20 sheets N/A N/A FC-4005 Desiccant Pouches Desiccant provided to aid in slide drying steps 18 pouches N/A N/A FC-4013 Materials Required but Not Provided Plasticware and Consumables Material Cat. # FluChip-8G Influenza A+B Assay Accessory Kit FC-4000 Humidity Chamber (available in the FluChip-8G Influenza A+ Measurand:

idK182513_s0_e2000

K182513.txt

type of test

Qualitative multiplex one-step RT-PCR followed by downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182513 B. Purpose for Submission: New device 510(k) clearance for the FluChip-8G Influenza A+B Assay C. Measurand: Influenza A and influenza B viral nucleic acids. D. Type of Test: Qualitative multiplex one-step RT-PCR followed by downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm E. Applicant: InDevR, Inc. F. Proprietary and Established Names: FluChip-8G Influenza A+B Assay (FC8G assay) G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): OZE - Influenza A and influenza B multiplex nucleic acid assay (Primary) NSU - Instrumentation for clinical multiplex test systems (Subsequent) OEP - Influenza A virus subtype differentiation nucleic acid assay (Subsequent) OQW - 2009 H1N1 influenza virus (swine origin), nucleic acid or antigen, detection and 2 identification (Subsequent) 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The FluChip-8G Influenza A+B Assay is a multiplex RT-PCR in vitro diagnostic test intended for the qualitative detection and differentiation of seasonal influenza A/H3N2, seasonal influenza A/H1N1pdm09, and “non-seasonal” influenza A subtypes other than seasonal H1N1pdm09 or H3N2. The assay is also intended for the qualitative detection and differentiation of the genetic lineage of human influenza B viruses as B/Victoria or B/Yamagata. The assay is designed for use on influenza nucleic acids isolated and purified from nasopharyngeal swab and nasal swab specimens from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. This assay amplifies the hemagglutinin (HA) gene segment, neuraminidase (NA) gene segment, matrix (M) gene segment, non-structural (NS) gene segment, and nucleoprotein (NP) gene segment for detection and discrimination of influenza A, and amplifies the hemagglutinin (HA) gene segment and neuraminidase (NA) gene segment for detection and discrimination of influenza B. This assay is not intended to detect influenza C viruses. FluChip-8G Influenza A+B Assay “non-seasonal” influenza A positive results are for the presumptive detection of influenza A subtypes other than seasonal influenza A/H1N1pdm09 or A/H3N2. The definitive identification of a “non-seasonal” influenza A case requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (e.g., local or state public health departments, etc.) for whom reporting is necessary. Negative results do not preclude influenza virus infection. FluChip-8G Influenza A+B Assay “non-seasonal” influenza A negative results, even in the context of a FluChip-8G Influenza A+B Assay positive result for seasonal influenza A/H1N1pdm09 or A/H3N2, or influenza B, do not preclude “non-seasonal” influenza A infection and should not be used as the sole basis for patient management decisions. Performance characteristics of the FluChip-8G Influenza A+B Assay for detecting and differentiating seasonal influenza A viruses were established when seasonal influenza A/H3N2 was the predominant influenza A virus circulating in the United States. Performance characteristics may vary with other emerging seasonal influenza A viruses. Performance characteristics of the FluChip-8G Influenza A+B Assay for detecting and differentiating human influenza B genetic lineages were established when influenza 3 B/Victoria was the predominant influenza B virus circulating in the United States. Due to low prevalence of “non-seasonal” influenza A viruses, performance characteristics of the FluChip-8G Influenza A+B Assay for detecting “non-seasonal” influenza A viruses and distinguishing “non-seasonal” influenza A from seasonal influenza A H1N1pdm09 and H3N2 were assessed exclusively by conducting cross- validation on a total of 759 microarray images generated from bench testing contrived samples consisting of 352 unique “non-seasonal” influenza A strains representing 62 subtypes, and by bench testing contrived samples and surrogate clinical specimens consisting of 133 unique non-seasonal influenza A strains representing 46 subtypes. FluChip-8G Influenza A+B Assay performance may vary when testing “non-seasonal” influenza A strains not represented in the performance assessment. If infection with a novel influenza A virus strain is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to local or state health department(s) for testing. Viral culture should not be attempted unless a BSL 3E facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use(s) 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: • BioRad T100 endpoint thermal cycler • FluChip-8G Imaging System with FluChip-8G Software v1.0.9.0 or newer I. Device Description: Overview The FluChip-8G Influenza A+B Assay system is a molecular assay system for the detection and differentiation of influenza viruses in which a multiplexed one-step RT-PCR amplification is coupled with downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm. The system consists of the following: 1) A reagent kit comprising the reagents required to conduct RT-PCR and for performing 4 post-PCR sample processing including PCR product fragmentation, microarray hybridization, washing, fluorescent labeling, and drying. 2) An accessory kit comprising a variety of laboratory equipment and supplies for facilitating execution of the assay. 3) Other general laboratory equipment and supplies required but not provided. 4) The FluChip-8G Imaging System with pre-installed FluChip-8G Software including an image processing module, an underlying neural network-based pattern recognition algorithm for identifying patterns in microarray signals representative of certain influenza target virus groups, and a user interface to facilitate data entry/imaging and provide result reports to the end user. Materials Provided FluChip-8G Influenza A+B Assay Reagent Kit (FC-6101) Reagents Description Units Per Kit Assays Per Unit Volume Per Unit Cat. # FC8G Amplification Reagents: FC-6101A FC8G Polymerase Mix Mixture of components necessary for PCR amplification 6 vials 16 500 µL FC-5015 FC8G RT Enzyme Enzyme necessary to perform reverse transcription step 6 vials 16 35 µL FC-5014 FC8G Primer Mix Mixture of oligonucleotide primers containing sodium azide (0.02%) as a preservative 6 vials 16 40 µL FC-5004 FC8G Biotin dUTP Lyophilized biotinylated dUTP 6 vials 16 50 nmol FC-5008 FC8G Microarray Processing Reagents: FC-6101B FluChip-8G Microarray Slide Microarray slide with 16-well silicone chamber. Each well contains a single oligonucleotide microarray 6 slides 16 N/A FC-5006 Wash Buffer 1 (20x) Concentrated wash buffer containing sodium azide (0.05%) as a preservative 2 bottles 48 50 mL MI-5014 Wash Buffer 2 (20x) Concentrated wash buffer containing sodium azide (0.05%) as a preservative 2 bottles 48 50 mL MI-5015 FC8G Binding Buffer Concentrated binding buffer containing sodium azide (0.02%) as a preservative 6 vials 16 1850 µL FC-5001 FC8G Hyb Mix Protein-based hybridization solution containing hybridization positive control oligonucleotides 6 vials 16 192 µL FC-5013 5 FC8G Label Lyophilized fluorophore- streptavidin label containing sodium azide (1.5 ng) as a preservative 6 vials 16 15 µg FC-5002 FC8G Diluent Diluent containing sodium azide (0.025%) as a preservative 6 vials 16 1500 µL FC-5012 Slide Drying Sheets Absorbent sheets to remove wash buffer from the FluChip- 8G Microarray Slide 20 sheets N/A N/A FC-4005 Desiccant Pouches Desiccant provided to aid in slide drying steps 18 pouches N/A N/A FC-4013 Materials Required but Not Provided Plasticware and Consumables Material Cat. # FluChip-8G Influenza A+B Assay Accessory Kit FC-4000 Humidity Chamber (available in the FluChip-8G Influenza A+ Type of test:

idK182513_s0_e2000

K182513.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182513 B. Purpose for Submission: New device 510(k) clearance for the FluChip-8G Influenza A+B Assay C. Measurand: Influenza A and influenza B viral nucleic acids. D. Type of Test: Qualitative multiplex one-step RT-PCR followed by downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm E. Applicant: InDevR, Inc. F. Proprietary and Established Names: FluChip-8G Influenza A+B Assay (FC8G assay) G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): OZE - Influenza A and influenza B multiplex nucleic acid assay (Primary) NSU - Instrumentation for clinical multiplex test systems (Subsequent) OEP - Influenza A virus subtype differentiation nucleic acid assay (Subsequent) OQW - 2009 H1N1 influenza virus (swine origin), nucleic acid or antigen, detection and 2 identification (Subsequent) 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The FluChip-8G Influenza A+B Assay is a multiplex RT-PCR in vitro diagnostic test intended for the qualitative detection and differentiation of seasonal influenza A/H3N2, seasonal influenza A/H1N1pdm09, and “non-seasonal” influenza A subtypes other than seasonal H1N1pdm09 or H3N2. The assay is also intended for the qualitative detection and differentiation of the genetic lineage of human influenza B viruses as B/Victoria or B/Yamagata. The assay is designed for use on influenza nucleic acids isolated and purified from nasopharyngeal swab and nasal swab specimens from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. This assay amplifies the hemagglutinin (HA) gene segment, neuraminidase (NA) gene segment, matrix (M) gene segment, non-structural (NS) gene segment, and nucleoprotein (NP) gene segment for detection and discrimination of influenza A, and amplifies the hemagglutinin (HA) gene segment and neuraminidase (NA) gene segment for detection and discrimination of influenza B. This assay is not intended to detect influenza C viruses. FluChip-8G Influenza A+B Assay “non-seasonal” influenza A positive results are for the presumptive detection of influenza A subtypes other than seasonal influenza A/H1N1pdm09 or A/H3N2. The definitive identification of a “non-seasonal” influenza A case requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (e.g., local or state public health departments, etc.) for whom reporting is necessary. Negative results do not preclude influenza virus infection. FluChip-8G Influenza A+B Assay “non-seasonal” influenza A negative results, even in the context of a FluChip-8G Influenza A+B Assay positive result for seasonal influenza A/H1N1pdm09 or A/H3N2, or influenza B, do not preclude “non-seasonal” influenza A infection and should not be used as the sole basis for patient management decisions. Performance characteristics of the FluChip-8G Influenza A+B Assay for detecting and differentiating seasonal influenza A viruses were established when seasonal influenza A/H3N2 was the predominant influenza A virus circulating in the United States. Performance characteristics may vary with other emerging seasonal influenza A viruses. Performance characteristics of the FluChip-8G Influenza A+B Assay for detecting and differentiating human influenza B genetic lineages were established when influenza 3 B/Victoria was the predominant influenza B virus circulating in the United States. Due to low prevalence of “non-seasonal” influenza A viruses, performance characteristics of the FluChip-8G Influenza A+B Assay for detecting “non-seasonal” influenza A viruses and distinguishing “non-seasonal” influenza A from seasonal influenza A H1N1pdm09 and H3N2 were assessed exclusively by conducting cross- validation on a total of 759 microarray images generated from bench testing contrived samples consisting of 352 unique “non-seasonal” influenza A strains representing 62 subtypes, and by bench testing contrived samples and surrogate clinical specimens consisting of 133 unique non-seasonal influenza A strains representing 46 subtypes. FluChip-8G Influenza A+B Assay performance may vary when testing “non-seasonal” influenza A strains not represented in the performance assessment. If infection with a novel influenza A virus strain is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to local or state health department(s) for testing. Viral culture should not be attempted unless a BSL 3E facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use(s) 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: • BioRad T100 endpoint thermal cycler • FluChip-8G Imaging System with FluChip-8G Software v1.0.9.0 or newer I. Device Description: Overview The FluChip-8G Influenza A+B Assay system is a molecular assay system for the detection and differentiation of influenza viruses in which a multiplexed one-step RT-PCR amplification is coupled with downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm. The system consists of the following: 1) A reagent kit comprising the reagents required to conduct RT-PCR and for performing 4 post-PCR sample processing including PCR product fragmentation, microarray hybridization, washing, fluorescent labeling, and drying. 2) An accessory kit comprising a variety of laboratory equipment and supplies for facilitating execution of the assay. 3) Other general laboratory equipment and supplies required but not provided. 4) The FluChip-8G Imaging System with pre-installed FluChip-8G Software including an image processing module, an underlying neural network-based pattern recognition algorithm for identifying patterns in microarray signals representative of certain influenza target virus groups, and a user interface to facilitate data entry/imaging and provide result reports to the end user. Materials Provided FluChip-8G Influenza A+B Assay Reagent Kit (FC-6101) Reagents Description Units Per Kit Assays Per Unit Volume Per Unit Cat. # FC8G Amplification Reagents: FC-6101A FC8G Polymerase Mix Mixture of components necessary for PCR amplification 6 vials 16 500 µL FC-5015 FC8G RT Enzyme Enzyme necessary to perform reverse transcription step 6 vials 16 35 µL FC-5014 FC8G Primer Mix Mixture of oligonucleotide primers containing sodium azide (0.02%) as a preservative 6 vials 16 40 µL FC-5004 FC8G Biotin dUTP Lyophilized biotinylated dUTP 6 vials 16 50 nmol FC-5008 FC8G Microarray Processing Reagents: FC-6101B FluChip-8G Microarray Slide Microarray slide with 16-well silicone chamber. Each well contains a single oligonucleotide microarray 6 slides 16 N/A FC-5006 Wash Buffer 1 (20x) Concentrated wash buffer containing sodium azide (0.05%) as a preservative 2 bottles 48 50 mL MI-5014 Wash Buffer 2 (20x) Concentrated wash buffer containing sodium azide (0.05%) as a preservative 2 bottles 48 50 mL MI-5015 FC8G Binding Buffer Concentrated binding buffer containing sodium azide (0.02%) as a preservative 6 vials 16 1850 µL FC-5001 FC8G Hyb Mix Protein-based hybridization solution containing hybridization positive control oligonucleotides 6 vials 16 192 µL FC-5013 5 FC8G Label Lyophilized fluorophore- streptavidin label containing sodium azide (1.5 ng) as a preservative 6 vials 16 15 µg FC-5002 FC8G Diluent Diluent containing sodium azide (0.025%) as a preservative 6 vials 16 1500 µL FC-5012 Slide Drying Sheets Absorbent sheets to remove wash buffer from the FluChip- 8G Microarray Slide 20 sheets N/A N/A FC-4005 Desiccant Pouches Desiccant provided to aid in slide drying steps 18 pouches N/A N/A FC-4013 Materials Required but Not Provided Plasticware and Consumables Material Cat. # FluChip-8G Influenza A+B Assay Accessory Kit FC-4000 Humidity Chamber (available in the FluChip-8G Influenza A+ Classification:

idK182513_s0_e2000

K182513.txt

panel

Microbiology (83)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182513 B. Purpose for Submission: New device 510(k) clearance for the FluChip-8G Influenza A+B Assay C. Measurand: Influenza A and influenza B viral nucleic acids. D. Type of Test: Qualitative multiplex one-step RT-PCR followed by downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm E. Applicant: InDevR, Inc. F. Proprietary and Established Names: FluChip-8G Influenza A+B Assay (FC8G assay) G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): OZE - Influenza A and influenza B multiplex nucleic acid assay (Primary) NSU - Instrumentation for clinical multiplex test systems (Subsequent) OEP - Influenza A virus subtype differentiation nucleic acid assay (Subsequent) OQW - 2009 H1N1 influenza virus (swine origin), nucleic acid or antigen, detection and 2 identification (Subsequent) 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The FluChip-8G Influenza A+B Assay is a multiplex RT-PCR in vitro diagnostic test intended for the qualitative detection and differentiation of seasonal influenza A/H3N2, seasonal influenza A/H1N1pdm09, and “non-seasonal” influenza A subtypes other than seasonal H1N1pdm09 or H3N2. The assay is also intended for the qualitative detection and differentiation of the genetic lineage of human influenza B viruses as B/Victoria or B/Yamagata. The assay is designed for use on influenza nucleic acids isolated and purified from nasopharyngeal swab and nasal swab specimens from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. This assay amplifies the hemagglutinin (HA) gene segment, neuraminidase (NA) gene segment, matrix (M) gene segment, non-structural (NS) gene segment, and nucleoprotein (NP) gene segment for detection and discrimination of influenza A, and amplifies the hemagglutinin (HA) gene segment and neuraminidase (NA) gene segment for detection and discrimination of influenza B. This assay is not intended to detect influenza C viruses. FluChip-8G Influenza A+B Assay “non-seasonal” influenza A positive results are for the presumptive detection of influenza A subtypes other than seasonal influenza A/H1N1pdm09 or A/H3N2. The definitive identification of a “non-seasonal” influenza A case requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (e.g., local or state public health departments, etc.) for whom reporting is necessary. Negative results do not preclude influenza virus infection. FluChip-8G Influenza A+B Assay “non-seasonal” influenza A negative results, even in the context of a FluChip-8G Influenza A+B Assay positive result for seasonal influenza A/H1N1pdm09 or A/H3N2, or influenza B, do not preclude “non-seasonal” influenza A infection and should not be used as the sole basis for patient management decisions. Performance characteristics of the FluChip-8G Influenza A+B Assay for detecting and differentiating seasonal influenza A viruses were established when seasonal influenza A/H3N2 was the predominant influenza A virus circulating in the United States. Performance characteristics may vary with other emerging seasonal influenza A viruses. Performance characteristics of the FluChip-8G Influenza A+B Assay for detecting and differentiating human influenza B genetic lineages were established when influenza 3 B/Victoria was the predominant influenza B virus circulating in the United States. Due to low prevalence of “non-seasonal” influenza A viruses, performance characteristics of the FluChip-8G Influenza A+B Assay for detecting “non-seasonal” influenza A viruses and distinguishing “non-seasonal” influenza A from seasonal influenza A H1N1pdm09 and H3N2 were assessed exclusively by conducting cross- validation on a total of 759 microarray images generated from bench testing contrived samples consisting of 352 unique “non-seasonal” influenza A strains representing 62 subtypes, and by bench testing contrived samples and surrogate clinical specimens consisting of 133 unique non-seasonal influenza A strains representing 46 subtypes. FluChip-8G Influenza A+B Assay performance may vary when testing “non-seasonal” influenza A strains not represented in the performance assessment. If infection with a novel influenza A virus strain is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to local or state health department(s) for testing. Viral culture should not be attempted unless a BSL 3E facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use(s) 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: • BioRad T100 endpoint thermal cycler • FluChip-8G Imaging System with FluChip-8G Software v1.0.9.0 or newer I. Device Description: Overview The FluChip-8G Influenza A+B Assay system is a molecular assay system for the detection and differentiation of influenza viruses in which a multiplexed one-step RT-PCR amplification is coupled with downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm. The system consists of the following: 1) A reagent kit comprising the reagents required to conduct RT-PCR and for performing 4 post-PCR sample processing including PCR product fragmentation, microarray hybridization, washing, fluorescent labeling, and drying. 2) An accessory kit comprising a variety of laboratory equipment and supplies for facilitating execution of the assay. 3) Other general laboratory equipment and supplies required but not provided. 4) The FluChip-8G Imaging System with pre-installed FluChip-8G Software including an image processing module, an underlying neural network-based pattern recognition algorithm for identifying patterns in microarray signals representative of certain influenza target virus groups, and a user interface to facilitate data entry/imaging and provide result reports to the end user. Materials Provided FluChip-8G Influenza A+B Assay Reagent Kit (FC-6101) Reagents Description Units Per Kit Assays Per Unit Volume Per Unit Cat. # FC8G Amplification Reagents: FC-6101A FC8G Polymerase Mix Mixture of components necessary for PCR amplification 6 vials 16 500 µL FC-5015 FC8G RT Enzyme Enzyme necessary to perform reverse transcription step 6 vials 16 35 µL FC-5014 FC8G Primer Mix Mixture of oligonucleotide primers containing sodium azide (0.02%) as a preservative 6 vials 16 40 µL FC-5004 FC8G Biotin dUTP Lyophilized biotinylated dUTP 6 vials 16 50 nmol FC-5008 FC8G Microarray Processing Reagents: FC-6101B FluChip-8G Microarray Slide Microarray slide with 16-well silicone chamber. Each well contains a single oligonucleotide microarray 6 slides 16 N/A FC-5006 Wash Buffer 1 (20x) Concentrated wash buffer containing sodium azide (0.05%) as a preservative 2 bottles 48 50 mL MI-5014 Wash Buffer 2 (20x) Concentrated wash buffer containing sodium azide (0.05%) as a preservative 2 bottles 48 50 mL MI-5015 FC8G Binding Buffer Concentrated binding buffer containing sodium azide (0.02%) as a preservative 6 vials 16 1850 µL FC-5001 FC8G Hyb Mix Protein-based hybridization solution containing hybridization positive control oligonucleotides 6 vials 16 192 µL FC-5013 5 FC8G Label Lyophilized fluorophore- streptavidin label containing sodium azide (1.5 ng) as a preservative 6 vials 16 15 µg FC-5002 FC8G Diluent Diluent containing sodium azide (0.025%) as a preservative 6 vials 16 1500 µL FC-5012 Slide Drying Sheets Absorbent sheets to remove wash buffer from the FluChip- 8G Microarray Slide 20 sheets N/A N/A FC-4005 Desiccant Pouches Desiccant provided to aid in slide drying steps 18 pouches N/A N/A FC-4013 Materials Required but Not Provided Plasticware and Consumables Material Cat. # FluChip-8G Influenza A+B Assay Accessory Kit FC-4000 Humidity Chamber (available in the FluChip-8G Influenza A+ Panel:

idK182513_s0_e2000

K182513.txt

applicant

InDevR, Inc.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182513 B. Purpose for Submission: New device 510(k) clearance for the FluChip-8G Influenza A+B Assay C. Measurand: Influenza A and influenza B viral nucleic acids. D. Type of Test: Qualitative multiplex one-step RT-PCR followed by downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm E. Applicant: InDevR, Inc. F. Proprietary and Established Names: FluChip-8G Influenza A+B Assay (FC8G assay) G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): OZE - Influenza A and influenza B multiplex nucleic acid assay (Primary) NSU - Instrumentation for clinical multiplex test systems (Subsequent) OEP - Influenza A virus subtype differentiation nucleic acid assay (Subsequent) OQW - 2009 H1N1 influenza virus (swine origin), nucleic acid or antigen, detection and 2 identification (Subsequent) 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The FluChip-8G Influenza A+B Assay is a multiplex RT-PCR in vitro diagnostic test intended for the qualitative detection and differentiation of seasonal influenza A/H3N2, seasonal influenza A/H1N1pdm09, and “non-seasonal” influenza A subtypes other than seasonal H1N1pdm09 or H3N2. The assay is also intended for the qualitative detection and differentiation of the genetic lineage of human influenza B viruses as B/Victoria or B/Yamagata. The assay is designed for use on influenza nucleic acids isolated and purified from nasopharyngeal swab and nasal swab specimens from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. This assay amplifies the hemagglutinin (HA) gene segment, neuraminidase (NA) gene segment, matrix (M) gene segment, non-structural (NS) gene segment, and nucleoprotein (NP) gene segment for detection and discrimination of influenza A, and amplifies the hemagglutinin (HA) gene segment and neuraminidase (NA) gene segment for detection and discrimination of influenza B. This assay is not intended to detect influenza C viruses. FluChip-8G Influenza A+B Assay “non-seasonal” influenza A positive results are for the presumptive detection of influenza A subtypes other than seasonal influenza A/H1N1pdm09 or A/H3N2. The definitive identification of a “non-seasonal” influenza A case requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (e.g., local or state public health departments, etc.) for whom reporting is necessary. Negative results do not preclude influenza virus infection. FluChip-8G Influenza A+B Assay “non-seasonal” influenza A negative results, even in the context of a FluChip-8G Influenza A+B Assay positive result for seasonal influenza A/H1N1pdm09 or A/H3N2, or influenza B, do not preclude “non-seasonal” influenza A infection and should not be used as the sole basis for patient management decisions. Performance characteristics of the FluChip-8G Influenza A+B Assay for detecting and differentiating seasonal influenza A viruses were established when seasonal influenza A/H3N2 was the predominant influenza A virus circulating in the United States. Performance characteristics may vary with other emerging seasonal influenza A viruses. Performance characteristics of the FluChip-8G Influenza A+B Assay for detecting and differentiating human influenza B genetic lineages were established when influenza 3 B/Victoria was the predominant influenza B virus circulating in the United States. Due to low prevalence of “non-seasonal” influenza A viruses, performance characteristics of the FluChip-8G Influenza A+B Assay for detecting “non-seasonal” influenza A viruses and distinguishing “non-seasonal” influenza A from seasonal influenza A H1N1pdm09 and H3N2 were assessed exclusively by conducting cross- validation on a total of 759 microarray images generated from bench testing contrived samples consisting of 352 unique “non-seasonal” influenza A strains representing 62 subtypes, and by bench testing contrived samples and surrogate clinical specimens consisting of 133 unique non-seasonal influenza A strains representing 46 subtypes. FluChip-8G Influenza A+B Assay performance may vary when testing “non-seasonal” influenza A strains not represented in the performance assessment. If infection with a novel influenza A virus strain is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to local or state health department(s) for testing. Viral culture should not be attempted unless a BSL 3E facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use(s) 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: • BioRad T100 endpoint thermal cycler • FluChip-8G Imaging System with FluChip-8G Software v1.0.9.0 or newer I. Device Description: Overview The FluChip-8G Influenza A+B Assay system is a molecular assay system for the detection and differentiation of influenza viruses in which a multiplexed one-step RT-PCR amplification is coupled with downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm. The system consists of the following: 1) A reagent kit comprising the reagents required to conduct RT-PCR and for performing 4 post-PCR sample processing including PCR product fragmentation, microarray hybridization, washing, fluorescent labeling, and drying. 2) An accessory kit comprising a variety of laboratory equipment and supplies for facilitating execution of the assay. 3) Other general laboratory equipment and supplies required but not provided. 4) The FluChip-8G Imaging System with pre-installed FluChip-8G Software including an image processing module, an underlying neural network-based pattern recognition algorithm for identifying patterns in microarray signals representative of certain influenza target virus groups, and a user interface to facilitate data entry/imaging and provide result reports to the end user. Materials Provided FluChip-8G Influenza A+B Assay Reagent Kit (FC-6101) Reagents Description Units Per Kit Assays Per Unit Volume Per Unit Cat. # FC8G Amplification Reagents: FC-6101A FC8G Polymerase Mix Mixture of components necessary for PCR amplification 6 vials 16 500 µL FC-5015 FC8G RT Enzyme Enzyme necessary to perform reverse transcription step 6 vials 16 35 µL FC-5014 FC8G Primer Mix Mixture of oligonucleotide primers containing sodium azide (0.02%) as a preservative 6 vials 16 40 µL FC-5004 FC8G Biotin dUTP Lyophilized biotinylated dUTP 6 vials 16 50 nmol FC-5008 FC8G Microarray Processing Reagents: FC-6101B FluChip-8G Microarray Slide Microarray slide with 16-well silicone chamber. Each well contains a single oligonucleotide microarray 6 slides 16 N/A FC-5006 Wash Buffer 1 (20x) Concentrated wash buffer containing sodium azide (0.05%) as a preservative 2 bottles 48 50 mL MI-5014 Wash Buffer 2 (20x) Concentrated wash buffer containing sodium azide (0.05%) as a preservative 2 bottles 48 50 mL MI-5015 FC8G Binding Buffer Concentrated binding buffer containing sodium azide (0.02%) as a preservative 6 vials 16 1850 µL FC-5001 FC8G Hyb Mix Protein-based hybridization solution containing hybridization positive control oligonucleotides 6 vials 16 192 µL FC-5013 5 FC8G Label Lyophilized fluorophore- streptavidin label containing sodium azide (1.5 ng) as a preservative 6 vials 16 15 µg FC-5002 FC8G Diluent Diluent containing sodium azide (0.025%) as a preservative 6 vials 16 1500 µL FC-5012 Slide Drying Sheets Absorbent sheets to remove wash buffer from the FluChip- 8G Microarray Slide 20 sheets N/A N/A FC-4005 Desiccant Pouches Desiccant provided to aid in slide drying steps 18 pouches N/A N/A FC-4013 Materials Required but Not Provided Plasticware and Consumables Material Cat. # FluChip-8G Influenza A+B Assay Accessory Kit FC-4000 Humidity Chamber (available in the FluChip-8G Influenza A+ Applicant:

idK182513_s0_e2000

K182513.txt

proprietary and established names

FluChip-8G Influenza A+B Assay (FC8G assay)

IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182513 B. Purpose for Submission: New device 510(k) clearance for the FluChip-8G Influenza A+B Assay C. Measurand: Influenza A and influenza B viral nucleic acids. D. Type of Test: Qualitative multiplex one-step RT-PCR followed by downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm E. Applicant: InDevR, Inc. F. Proprietary and Established Names: FluChip-8G Influenza A+B Assay (FC8G assay) G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): OZE - Influenza A and influenza B multiplex nucleic acid assay (Primary) NSU - Instrumentation for clinical multiplex test systems (Subsequent) OEP - Influenza A virus subtype differentiation nucleic acid assay (Subsequent) OQW - 2009 H1N1 influenza virus (swine origin), nucleic acid or antigen, detection and 2 identification (Subsequent) 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The FluChip-8G Influenza A+B Assay is a multiplex RT-PCR in vitro diagnostic test intended for the qualitative detection and differentiation of seasonal influenza A/H3N2, seasonal influenza A/H1N1pdm09, and “non-seasonal” influenza A subtypes other than seasonal H1N1pdm09 or H3N2. The assay is also intended for the qualitative detection and differentiation of the genetic lineage of human influenza B viruses as B/Victoria or B/Yamagata. The assay is designed for use on influenza nucleic acids isolated and purified from nasopharyngeal swab and nasal swab specimens from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. This assay amplifies the hemagglutinin (HA) gene segment, neuraminidase (NA) gene segment, matrix (M) gene segment, non-structural (NS) gene segment, and nucleoprotein (NP) gene segment for detection and discrimination of influenza A, and amplifies the hemagglutinin (HA) gene segment and neuraminidase (NA) gene segment for detection and discrimination of influenza B. This assay is not intended to detect influenza C viruses. FluChip-8G Influenza A+B Assay “non-seasonal” influenza A positive results are for the presumptive detection of influenza A subtypes other than seasonal influenza A/H1N1pdm09 or A/H3N2. The definitive identification of a “non-seasonal” influenza A case requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (e.g., local or state public health departments, etc.) for whom reporting is necessary. Negative results do not preclude influenza virus infection. FluChip-8G Influenza A+B Assay “non-seasonal” influenza A negative results, even in the context of a FluChip-8G Influenza A+B Assay positive result for seasonal influenza A/H1N1pdm09 or A/H3N2, or influenza B, do not preclude “non-seasonal” influenza A infection and should not be used as the sole basis for patient management decisions. Performance characteristics of the FluChip-8G Influenza A+B Assay for detecting and differentiating seasonal influenza A viruses were established when seasonal influenza A/H3N2 was the predominant influenza A virus circulating in the United States. Performance characteristics may vary with other emerging seasonal influenza A viruses. Performance characteristics of the FluChip-8G Influenza A+B Assay for detecting and differentiating human influenza B genetic lineages were established when influenza 3 B/Victoria was the predominant influenza B virus circulating in the United States. Due to low prevalence of “non-seasonal” influenza A viruses, performance characteristics of the FluChip-8G Influenza A+B Assay for detecting “non-seasonal” influenza A viruses and distinguishing “non-seasonal” influenza A from seasonal influenza A H1N1pdm09 and H3N2 were assessed exclusively by conducting cross- validation on a total of 759 microarray images generated from bench testing contrived samples consisting of 352 unique “non-seasonal” influenza A strains representing 62 subtypes, and by bench testing contrived samples and surrogate clinical specimens consisting of 133 unique non-seasonal influenza A strains representing 46 subtypes. FluChip-8G Influenza A+B Assay performance may vary when testing “non-seasonal” influenza A strains not represented in the performance assessment. If infection with a novel influenza A virus strain is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to local or state health department(s) for testing. Viral culture should not be attempted unless a BSL 3E facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use(s) 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: • BioRad T100 endpoint thermal cycler • FluChip-8G Imaging System with FluChip-8G Software v1.0.9.0 or newer I. Device Description: Overview The FluChip-8G Influenza A+B Assay system is a molecular assay system for the detection and differentiation of influenza viruses in which a multiplexed one-step RT-PCR amplification is coupled with downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm. The system consists of the following: 1) A reagent kit comprising the reagents required to conduct RT-PCR and for performing 4 post-PCR sample processing including PCR product fragmentation, microarray hybridization, washing, fluorescent labeling, and drying. 2) An accessory kit comprising a variety of laboratory equipment and supplies for facilitating execution of the assay. 3) Other general laboratory equipment and supplies required but not provided. 4) The FluChip-8G Imaging System with pre-installed FluChip-8G Software including an image processing module, an underlying neural network-based pattern recognition algorithm for identifying patterns in microarray signals representative of certain influenza target virus groups, and a user interface to facilitate data entry/imaging and provide result reports to the end user. Materials Provided FluChip-8G Influenza A+B Assay Reagent Kit (FC-6101) Reagents Description Units Per Kit Assays Per Unit Volume Per Unit Cat. # FC8G Amplification Reagents: FC-6101A FC8G Polymerase Mix Mixture of components necessary for PCR amplification 6 vials 16 500 µL FC-5015 FC8G RT Enzyme Enzyme necessary to perform reverse transcription step 6 vials 16 35 µL FC-5014 FC8G Primer Mix Mixture of oligonucleotide primers containing sodium azide (0.02%) as a preservative 6 vials 16 40 µL FC-5004 FC8G Biotin dUTP Lyophilized biotinylated dUTP 6 vials 16 50 nmol FC-5008 FC8G Microarray Processing Reagents: FC-6101B FluChip-8G Microarray Slide Microarray slide with 16-well silicone chamber. Each well contains a single oligonucleotide microarray 6 slides 16 N/A FC-5006 Wash Buffer 1 (20x) Concentrated wash buffer containing sodium azide (0.05%) as a preservative 2 bottles 48 50 mL MI-5014 Wash Buffer 2 (20x) Concentrated wash buffer containing sodium azide (0.05%) as a preservative 2 bottles 48 50 mL MI-5015 FC8G Binding Buffer Concentrated binding buffer containing sodium azide (0.02%) as a preservative 6 vials 16 1850 µL FC-5001 FC8G Hyb Mix Protein-based hybridization solution containing hybridization positive control oligonucleotides 6 vials 16 192 µL FC-5013 5 FC8G Label Lyophilized fluorophore- streptavidin label containing sodium azide (1.5 ng) as a preservative 6 vials 16 15 µg FC-5002 FC8G Diluent Diluent containing sodium azide (0.025%) as a preservative 6 vials 16 1500 µL FC-5012 Slide Drying Sheets Absorbent sheets to remove wash buffer from the FluChip- 8G Microarray Slide 20 sheets N/A N/A FC-4005 Desiccant Pouches Desiccant provided to aid in slide drying steps 18 pouches N/A N/A FC-4013 Materials Required but Not Provided Plasticware and Consumables Material Cat. # FluChip-8G Influenza A+B Assay Accessory Kit FC-4000 Humidity Chamber (available in the FluChip-8G Influenza A+ Proprietary and established names:

idK182513_s0_e2000

K182513.txt

regulation section

21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182513 B. Purpose for Submission: New device 510(k) clearance for the FluChip-8G Influenza A+B Assay C. Measurand: Influenza A and influenza B viral nucleic acids. D. Type of Test: Qualitative multiplex one-step RT-PCR followed by downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm E. Applicant: InDevR, Inc. F. Proprietary and Established Names: FluChip-8G Influenza A+B Assay (FC8G assay) G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): OZE - Influenza A and influenza B multiplex nucleic acid assay (Primary) NSU - Instrumentation for clinical multiplex test systems (Subsequent) OEP - Influenza A virus subtype differentiation nucleic acid assay (Subsequent) OQW - 2009 H1N1 influenza virus (swine origin), nucleic acid or antigen, detection and 2 identification (Subsequent) 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The FluChip-8G Influenza A+B Assay is a multiplex RT-PCR in vitro diagnostic test intended for the qualitative detection and differentiation of seasonal influenza A/H3N2, seasonal influenza A/H1N1pdm09, and “non-seasonal” influenza A subtypes other than seasonal H1N1pdm09 or H3N2. The assay is also intended for the qualitative detection and differentiation of the genetic lineage of human influenza B viruses as B/Victoria or B/Yamagata. The assay is designed for use on influenza nucleic acids isolated and purified from nasopharyngeal swab and nasal swab specimens from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. This assay amplifies the hemagglutinin (HA) gene segment, neuraminidase (NA) gene segment, matrix (M) gene segment, non-structural (NS) gene segment, and nucleoprotein (NP) gene segment for detection and discrimination of influenza A, and amplifies the hemagglutinin (HA) gene segment and neuraminidase (NA) gene segment for detection and discrimination of influenza B. This assay is not intended to detect influenza C viruses. FluChip-8G Influenza A+B Assay “non-seasonal” influenza A positive results are for the presumptive detection of influenza A subtypes other than seasonal influenza A/H1N1pdm09 or A/H3N2. The definitive identification of a “non-seasonal” influenza A case requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (e.g., local or state public health departments, etc.) for whom reporting is necessary. Negative results do not preclude influenza virus infection. FluChip-8G Influenza A+B Assay “non-seasonal” influenza A negative results, even in the context of a FluChip-8G Influenza A+B Assay positive result for seasonal influenza A/H1N1pdm09 or A/H3N2, or influenza B, do not preclude “non-seasonal” influenza A infection and should not be used as the sole basis for patient management decisions. Performance characteristics of the FluChip-8G Influenza A+B Assay for detecting and differentiating seasonal influenza A viruses were established when seasonal influenza A/H3N2 was the predominant influenza A virus circulating in the United States. Performance characteristics may vary with other emerging seasonal influenza A viruses. Performance characteristics of the FluChip-8G Influenza A+B Assay for detecting and differentiating human influenza B genetic lineages were established when influenza 3 B/Victoria was the predominant influenza B virus circulating in the United States. Due to low prevalence of “non-seasonal” influenza A viruses, performance characteristics of the FluChip-8G Influenza A+B Assay for detecting “non-seasonal” influenza A viruses and distinguishing “non-seasonal” influenza A from seasonal influenza A H1N1pdm09 and H3N2 were assessed exclusively by conducting cross- validation on a total of 759 microarray images generated from bench testing contrived samples consisting of 352 unique “non-seasonal” influenza A strains representing 62 subtypes, and by bench testing contrived samples and surrogate clinical specimens consisting of 133 unique non-seasonal influenza A strains representing 46 subtypes. FluChip-8G Influenza A+B Assay performance may vary when testing “non-seasonal” influenza A strains not represented in the performance assessment. If infection with a novel influenza A virus strain is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to local or state health department(s) for testing. Viral culture should not be attempted unless a BSL 3E facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use(s) 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: • BioRad T100 endpoint thermal cycler • FluChip-8G Imaging System with FluChip-8G Software v1.0.9.0 or newer I. Device Description: Overview The FluChip-8G Influenza A+B Assay system is a molecular assay system for the detection and differentiation of influenza viruses in which a multiplexed one-step RT-PCR amplification is coupled with downstream microarray-based hybridization, imaging, and subsequent influenza virus detection and characterization using a pattern recognition-based algorithm. The system consists of the following: 1) A reagent kit comprising the reagents required to conduct RT-PCR and for performing 4 post-PCR sample processing including PCR product fragmentation, microarray hybridization, washing, fluorescent labeling, and drying. 2) An accessory kit comprising a variety of laboratory equipment and supplies for facilitating execution of the assay. 3) Other general laboratory equipment and supplies required but not provided. 4) The FluChip-8G Imaging System with pre-installed FluChip-8G Software including an image processing module, an underlying neural network-based pattern recognition algorithm for identifying patterns in microarray signals representative of certain influenza target virus groups, and a user interface to facilitate data entry/imaging and provide result reports to the end user. Materials Provided FluChip-8G Influenza A+B Assay Reagent Kit (FC-6101) Reagents Description Units Per Kit Assays Per Unit Volume Per Unit Cat. # FC8G Amplification Reagents: FC-6101A FC8G Polymerase Mix Mixture of components necessary for PCR amplification 6 vials 16 500 µL FC-5015 FC8G RT Enzyme Enzyme necessary to perform reverse transcription step 6 vials 16 35 µL FC-5014 FC8G Primer Mix Mixture of oligonucleotide primers containing sodium azide (0.02%) as a preservative 6 vials 16 40 µL FC-5004 FC8G Biotin dUTP Lyophilized biotinylated dUTP 6 vials 16 50 nmol FC-5008 FC8G Microarray Processing Reagents: FC-6101B FluChip-8G Microarray Slide Microarray slide with 16-well silicone chamber. Each well contains a single oligonucleotide microarray 6 slides 16 N/A FC-5006 Wash Buffer 1 (20x) Concentrated wash buffer containing sodium azide (0.05%) as a preservative 2 bottles 48 50 mL MI-5014 Wash Buffer 2 (20x) Concentrated wash buffer containing sodium azide (0.05%) as a preservative 2 bottles 48 50 mL MI-5015 FC8G Binding Buffer Concentrated binding buffer containing sodium azide (0.02%) as a preservative 6 vials 16 1850 µL FC-5001 FC8G Hyb Mix Protein-based hybridization solution containing hybridization positive control oligonucleotides 6 vials 16 192 µL FC-5013 5 FC8G Label Lyophilized fluorophore- streptavidin label containing sodium azide (1.5 ng) as a preservative 6 vials 16 15 µg FC-5002 FC8G Diluent Diluent containing sodium azide (0.025%) as a preservative 6 vials 16 1500 µL FC-5012 Slide Drying Sheets Absorbent sheets to remove wash buffer from the FluChip- 8G Microarray Slide 20 sheets N/A N/A FC-4005 Desiccant Pouches Desiccant provided to aid in slide drying steps 18 pouches N/A N/A FC-4013 Materials Required but Not Provided Plasticware and Consumables Material Cat. # FluChip-8G Influenza A+B Assay Accessory Kit FC-4000 Humidity Chamber (available in the FluChip-8G Influenza A+ Regulation section:

idK182513_s12000_e14000

K182513.txt

predicate device name

CDC Human Influenza Virus Real-Time PCR Diagnostic Panel

est a valid result is generated, follow the recommended actions for that result. No Call: Assay Failure (Hybridization Control) This result is likely due to an issue in the hybridization step. Retest Specimen If upon retest a valid result is generated, follow the recommended actions for that result. No Call: Assay Failure (Labeling Control) This result is likely due to an issue in the post- hybridization labeling step. Error: Image Processing Failure This may indicate an error in microarray processing (See final wash step in assay procedure), in the placement of the FluChip-8G Microarray Slide within the FluChip-8G Imaging System, or the FluChip-8G Imaging System focus setting. . Visually inspect the back of the slide for artifacts such as dust or salt precipitates. Using a damp lint-free cloth, wipe the back of the slide and Rescan the Entire Slide. . Check for correct slide and slide holder orientation, correct any orientation errors and Rescan the Entire Slide. . See FluChip-8G Imaging System Operation Manual for instructions on confirming system focus, Rescan the Entire Slide. If upon rescan a valid result is generated for the sample that produced the error, follow the recommended actions for that result. For samples that did not produce the error upon initial scan the result from the 1st scan should be used. If upon rescan a valid result is not generated, retest the specimen. Not Analyzed Microarray designated as “EMPTY” during sample type selection in FluChip-8G software. The microarray will not be analyzed and no result will be displayed If the position was unintentionally left empty, rescan the entire slide using the correct sample ID selection. For samples that did not produce the result of “Not Analyzed” in the initial scan the result from the 1st scan should be used. 21 J. Substantial Equivalence Information: 1. Predicate device name(s): CDC Human Influenza Virus Real-Time PCR Diagnostic Panel 2. Predicate 510(k) number(s): K172091 3. Comparison with predicate: Similarities and Differences Item Device Predicate FluChip-8G Influenza A+B Assay (K182513) CDC Human Influenza Virus Real-Time PCR Diagnostic Panel (K172091) Measurand Influenza RNA Same Viruses Detected Influenza A and B viruses Same Influenza A subtype Differentiation • Seasonal influenza A/H1N1pdm09 • Seasonal influenza A/H3N2 • “Non-seasonal” influenza A • Same • Same • Influenza A/H5 (Asian Lineage) Influenza B lineage Differentiation • Influenza B/Victoria • Influenza B/Yamagata Same Assay Type Qualitative Same CLIA Complexity High Same Sample Type Nasal swab and nasopharyngeal swab specimens Upper respiratory tract specimens, including nasal swabs and nasopharyngeal swabs; lower respiratory tract specimens Sample Preparation Method Nucleic Acid Extraction Same Detection Technology Fluorescence Same Technological Principles RT-PCR followed by endpoint detection by microarray via nucleic acid probes and fluorescence Real-time RT-PCR via nucleic acid probes and fluorescence Nucleic Acid Extraction QIAamp DSP Virus Spin Kit • QIAamp Viral RNA Mini Kit, Qiagen • QIAcube with QIAamp Viral RNA Mini Kit • MagNA Pure Compact—Total Nucleic Acid Kit, Roche • MagNA Pure Compact—RNA Isolation Kit, Roche • MagNA Pure LC—RNA Isolation Kit II, Roche • NucliSENS easyMAG, bioMerieux Controls • Internal Control in each specimen • External positive control processed with each batch • External negative control processed with each batch Same Amplification Reagents Quanta Biosciences qScript One-Step RT- PCR Kit • Quanta Biosciences qScript One-Step qRT-PCR Kit, low ROX • Invitrogen SuperScript III Platinum One-Step Quantitative RT-PCR Kit 22 Similarities and Differences Item Device Predicate FluChip-8G Influenza A+B Assay (K182513) CDC Human Influenza Virus Real-Time PCR Diagnostic Panel (K172091) Results Interpretation Automated test interpretation via neural network-based algorithm using fluorescence intensities Manual test interpretation via Ct value determined from fluorescence intensities Instrumentation FluChip-8G Imaging System Applied Biosystems 7500 Dx Real-Time PCR Instrument K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The FluChip-8G Influenza A+B Assay (FC8G assay) includes a multiplex primer mix to amplify the hemagglutinin (HA), neuraminidase (NA), matrix (M), non-structural (NS), and nucleoprotein (NP) gene segments of all influenza A viruses, as well as the hemagglutinin (HA) and neuraminidase (NA) gene segments of all influenza B viruses, and a portion of the 18s gene present in eukaryotic cells as an endogenous internal control. During a one-step RT- PCR reaction, the primers and RT-PCR enzymes and reagents are utilized to amplify nucleic acids extracted from human nasal specimens while incorporating biotin for downstream fluorescence labeling. The biotinylated amplified products are then heat-fragmented and applied to the FC8G microarray for hybridization, labeling, and detection using the FluChip- 8G Imaging System. The system software is trained to identify the patterns of the influenza target virus groups using a large database of thousands of results from viruses of known characterization, and a simple result in the form of a report is returned to the end user via the software user interface. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Two independent studies: within-laboratory repeatability and external multi-site user- to-user reproducibility, were carried out to evaluate the precision and reproducibility of the FluChip-8G Influenza A+B Assay. A 45-member panel was used for the two studies. The panel was made with five viral strains that represent the five target influenza virus groups: A/New Caledonia/20/1999 (A/non-seasonal), A/California/07/2009 (A/H1N1pdm09), A/Victoria/361/2011 (A/H3N2), B/Wisconsin/01/2010 (B/Yamagata), and B/Florida/02/2006 (B/Victoria). Each strain was diluted into pooled influenza 23 negative clinical material at three different target levels: Moderate Positive (MP) (approximately 3xLoD), Low Positive (LP) (approximately 1xLoD), and High Negative (HN) (approximately 0.1xLoD). Influenza negative clinical material consisted of clinical nasopharyngeal swab samples stabilized in universal transport medium (UTM) that were determined to be negative for the presence of influenza virus via an FDA-cleared influenza molecular assay. External Multi-Site User-to-User Reproducibility Study Two operators at each of the three separate laboratory sites performed the FluChip- 8G Influenza A+B Assay (FC8G assay) according to the assay instructions for use. Performance was evaluated on six unique testing points at the three separate laboratory sites for a total of 18 testing points. Each testing point corresponds to a unique run/execution of the FC8G assay, where each member of the blinded 45-member panel of contrived samples was tested in triplicate. Two unique lots of FC8G assay reagents were evenly divided between the three sites. At each site, each of the two operators executed three testing points. Operators at each site alternated testing until all six test points/site were completed. Each testing point was separated by a minimum of one full day in which no FC8G assay processing for this study occurred. A total of 810 data points (45 samples/testing point x 18 testing points) were generated in this study. Performance was evaluated by determining the agreement with the expected results, where the MP and LP concentrations were expected to be positive for the intended target, and the HN was expected to be negative. Table 3 below shows the results of the multi-site user-to-user reproducibility study. Table 3: Multi-Site User-to-User Reproducibility Study Results Site A Site B Site C Overall % Agreement and 95% Confidence Interval by Sample (%) Count and % Agreement 95% Confidence Interval (%) Count and % Agreement 95% Confidence Interval (%) Count and % Agreement 95% Confidence Interval (%) A/H1N1 (pre-2009) (A/non-seasonal) MP (3x LoD) 18/18 100% 82.4 - 100 18/18 100% 82.4 - 100 17/18a 94% 74.2 - 99.0 53/54 98% 90.2 - 99.7 LP (1x LoD) 18/18 100% 82.4 - 100 18/18 100% 82.4 - 100 18/18 100% 82.4 - 100 54/54 100% 93.4 - 100 HN (0.1x Lo Predicate device name:

idK182513_s40000_e42000

K182513.txt

proposed labeling

The labeling supports the finding of substantial equivalence for this device.

cut-off: Not applicable. 5. Expected values/Reference range: In the FC8G assay prospective clinical study (described in the “Clinical Studies” section above), a total of 984 nasal or nasopharyngeal swab specimens prospectively collected from the 2013-2014 through 2016-2017 influenza seasons were determined to be evaluable. The number and percentage of influenza cases per specified age group, as determined by the FC8G assay, stratified by the virus groups, are presented in Table 29 and Table 30 below. Table 29: Seasonal Influenza A Positives by the FC8G Assay per Patient Age Group Age Group Number of Nasal or Nasopharyngeal Swab Specimens Number of Influenza A/H3N2 Positives Influenza A/H3N2 Positivity Rate Number of Influenza A/H1N1pdm09 Positives Influenza A/H1N1pdm09 Positivity Rate Number of Seasonal Influenza A Positives Seasonal Influenza A Positivity Rate ≤ 5 years 417 12 2.9% 4 1.0% 16 3.8% 6 to 21 years 278 29 10.4% 3 1.1% 32 11.5% 22 to 59 years 228 10 4.4% 2 0.9% 12 5.3% ≥ 60 years 61 2 3.3% 0 0.0% 2 3.3% Total 984 53 5.4% 9 0.9% 62 6.3% Table 30: Influenza B Positives by the FC8G Assay per Patient Age Group Age Group Number of Nasal or Nasopharyngeal Swab Specimens Number of Influenza B/Victoria Positives Influenza B/Victoria Positivity Rate Number of Influenza B/Yamagata Positives Influenza B/Yamagata Positivity Rate Number of Influenza B Positives Influenza B Positivity Rate ≤ 5 years 417 6 1.4% 1 0.2% 7 1.7% 6 to 21 years 278 6 2.2% 4 1.4% 12* 4.3% 22 to 59 years 228 2 0.9% 1 0.4% 3 1.3% ≥ 60 years 61 0 0.0% 2 3.3% 2 3.3% Total 984 14 1.4% 8 0.8% 24 2.4% * Two samples were Influenza B positive with no lineage identified by the FC8G assay. N. Instrument Name: BioRad T100 endpoint thermal cycler FluChip-8G Imaging System 58 O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No __X______ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes _____X___ or No ________ 3. Specimen Identification: Operator manually label each specimen container with patient ID. 4. Specimen Sampling and Handling: Manually handled using pipettes. 5. Calibration: To be qualified annually by InDevR. 6. Quality Control: Quality control is addressed for each specific FDA-cleared assay to be run on the instruments. P. Other Supportive Instrument Performance Characteristics Data Not Covered in the “Performance Characteristics” Section above: Not applicable. Q. Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. 59 R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK182513_s40000_e42000

K182513.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

. Clinical cut-off: Not applicable. 5. Expected values/Reference range: In the FC8G assay prospective clinical study (described in the “Clinical Studies” section above), a total of 984 nasal or nasopharyngeal swab specimens prospectively collected from the 2013-2014 through 2016-2017 influenza seasons were determined to be evaluable. The number and percentage of influenza cases per specified age group, as determined by the FC8G assay, stratified by the virus groups, are presented in Table 29 and Table 30 below. Table 29: Seasonal Influenza A Positives by the FC8G Assay per Patient Age Group Age Group Number of Nasal or Nasopharyngeal Swab Specimens Number of Influenza A/H3N2 Positives Influenza A/H3N2 Positivity Rate Number of Influenza A/H1N1pdm09 Positives Influenza A/H1N1pdm09 Positivity Rate Number of Seasonal Influenza A Positives Seasonal Influenza A Positivity Rate ≤ 5 years 417 12 2.9% 4 1.0% 16 3.8% 6 to 21 years 278 29 10.4% 3 1.1% 32 11.5% 22 to 59 years 228 10 4.4% 2 0.9% 12 5.3% ≥ 60 years 61 2 3.3% 0 0.0% 2 3.3% Total 984 53 5.4% 9 0.9% 62 6.3% Table 30: Influenza B Positives by the FC8G Assay per Patient Age Group Age Group Number of Nasal or Nasopharyngeal Swab Specimens Number of Influenza B/Victoria Positives Influenza B/Victoria Positivity Rate Number of Influenza B/Yamagata Positives Influenza B/Yamagata Positivity Rate Number of Influenza B Positives Influenza B Positivity Rate ≤ 5 years 417 6 1.4% 1 0.2% 7 1.7% 6 to 21 years 278 6 2.2% 4 1.4% 12* 4.3% 22 to 59 years 228 2 0.9% 1 0.4% 3 1.3% ≥ 60 years 61 0 0.0% 2 3.3% 2 3.3% Total 984 14 1.4% 8 0.8% 24 2.4% * Two samples were Influenza B positive with no lineage identified by the FC8G assay. N. Instrument Name: BioRad T100 endpoint thermal cycler FluChip-8G Imaging System 58 O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No __X______ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes _____X___ or No ________ 3. Specimen Identification: Operator manually label each specimen container with patient ID. 4. Specimen Sampling and Handling: Manually handled using pipettes. 5. Calibration: To be qualified annually by InDevR. 6. Quality Control: Quality control is addressed for each specific FDA-cleared assay to be run on the instruments. P. Other Supportive Instrument Performance Characteristics Data Not Covered in the “Performance Characteristics” Section above: Not applicable. Q. Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. 59 R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK142965_s0_e2000

K142965.txt

purpose for submission

New device

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k142965 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: Ventana Medical Systems, Inc. VirtuosoTM System for IHC PR (1E2) Using the VENTANA iScan HT D. Type of Test or Tests Performed: Manual scoring of digital images on a computer monitor of progesterone receptor (PR) (1E2) immunohistochemistry (IHC) stained slides using the VENTANA iScan HT scanner. E. System Descriptions: 1. Device Description: The Virtuoso™ System for IHC PR (1E2) Using the VENTANA iScan HT is an instrument-plus-software system designed to assist the qualified pathologist in the assessment of protein expression in IHC stained histologic sections from formalin-fixed, paraffin-embedded (FFPE) breast tissues. The system consists of a slide scanner (iScan), computer, monitor, keyboard, mouse and software with a Windows web browser-based user interface. Virtuoso is a web-based, end-to-end, IHC digital pathology software solution that allows pathology laboratories to acquire, manage, view, analyze, share, and report digital images of IHC stained slides. Using the Virtuoso software, the pathologist can view digital images, add annotations, make measurements and generate reports. The Digital Read (DR) option allows the pathologist to manually score the PR (1E2) stained slide’s digital image on a computer monitor. Hardware: The iScan HT slide scanning device captures digital images of FFPE breast tissues that are suitable for storage and viewing. The device includes a digital slide scanner, a carousel for loading glass slides, computer, scanner software, keyboard, mouse and monitor. 2 Software: The Virtuoso software is designed to complement the routine workflow of a qualified pathologist in the review of IHC stained breast tissue slides. It allows the user to select fields of view (FOVs) in the digital image for manual analysis. The software makes no independent interpretations of the data and requires competent human intervention for all steps in the analysis process. 2. Principles of Operation: Glass slides with FFPE tissue sections stained using the CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody are loaded into the VENTANA iScan HT scanner. The slides are then scanned and the resulting digitized images are displayed on a computer monitor. The pathologist reviews these images on the computer monitor and provides a qualitative PR IHC score based on the ≥1% cut-off. 3. Modes of Operation: Digital Read (DR): Manual scoring of IHC PR stained slide images on a computer monitor. Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___X_____ 4. Specimen Identification: Glass tissue slides are identified by slide label or barcode (if provided by the user) by scanning the whole slide including the label or barcode. 5. Specimen Sampling and Handling: IHC stained slides are manually loaded on to the VENTANA iScan HT slide scanner in the carousel. The slide capacity is 360 slides. Under the default setting, a thumbnail view of the slide and the area of interest (AOI) in the slide are scanned. The operator has the option of rescanning the slide after viewing the image on the computer monitor. Under the manual scanning option, the user has the ability to select the scan area for single or batch slides. 6. Calibration: The VENTANA iScan HT slide scanner is calibrated and verified at the manufacturing 3 facility before shipment. Upon installation, calibrations are performed and verified by Roche Customer Support. No additional calibration or verification is required or performed by the end user. Annual preventive maintenance performed by Roche Customer Support is recommended to ensure that the VENTANA iScan HT slide scanner is operating as intended. 7. Quality Control: Quality control is performed by the operator before releasing the images to the pathologist for review. Slides with sub-optimal images will be rescanned. Additionally, the software performs a quality check on the digital images to determine if they are suitable for further analysis using the “Image Quality Assessment” module. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes____X____ or No________ F. Regulatory Information: 1. Regulation section: 21 CFR §864.1860, Immunohistochemistry reagents and kits 2. Classification: Class II 3 Product code: OEO - Automated Digital Image Manual Interpretation Microscope 4. Panel: Pathology (88) G. Intended Use: 1. Indication(s) for Use: The VirtuosoTM system provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape. The VirtuosoTM System for IHC PR (1E2) using the VENTANA iScan HT is for the digital read application. This particular Virtuoso system is intended for use as an aid to the pathologist in the qualitative detection of progesterone receptor (PR) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is 4 indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC PR (1E2) Digital Read application is an adjunctive computer-assisted methodology for the qualified pathologist in the acquisition and interpretation of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The accuracy of the test results depends on the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read scores. The actual correlation of CONFIRM™ anti-PR antibody to clinical outcome has not been established. This device is intended for IHC slides stained on the BenchMark XT and BenchMark ULTRA stainers. For prescription use only. 2. Special Conditions for Use Statement(s): For prescription use only H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: Virtuoso™ System for IHC PR (1E2), k111869 2. Comparison with Predicate Device: Similarities Item Device Predicate Intended use The Virtuoso System provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, size, intensity, pattern and shape. The Virtuoso™ System for IHC PR (1E2) using the VENTANA iScan HT is for digital read. This particular Virtuoso system is intended for use as an aid to the pathologist in the detection and semi- quantitative measurement of progesterone receptor (PR) protein in Same 5 Similarities Item Device Predicate formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC PR (1E2) Digital Read adjunctive computer-assisted methodologies for the qualified pathologist in the acquisition and measurement of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The accuracy of the test results depends on the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read and Image Analysis scores. The actual correlation of CONFIRM™ anti-PR Purpose for submission:

idK142965_s0_e2000

K142965.txt

type of test

Manual scoring of digital images on a computer monitor of progesterone receptor (PR) (1E2) immunohistochemistry (IHC) stained slides using the VENTANA iScan HT scanner.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k142965 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: Ventana Medical Systems, Inc. VirtuosoTM System for IHC PR (1E2) Using the VENTANA iScan HT D. Type of Test or Tests Performed: Manual scoring of digital images on a computer monitor of progesterone receptor (PR) (1E2) immunohistochemistry (IHC) stained slides using the VENTANA iScan HT scanner. E. System Descriptions: 1. Device Description: The Virtuoso™ System for IHC PR (1E2) Using the VENTANA iScan HT is an instrument-plus-software system designed to assist the qualified pathologist in the assessment of protein expression in IHC stained histologic sections from formalin-fixed, paraffin-embedded (FFPE) breast tissues. The system consists of a slide scanner (iScan), computer, monitor, keyboard, mouse and software with a Windows web browser-based user interface. Virtuoso is a web-based, end-to-end, IHC digital pathology software solution that allows pathology laboratories to acquire, manage, view, analyze, share, and report digital images of IHC stained slides. Using the Virtuoso software, the pathologist can view digital images, add annotations, make measurements and generate reports. The Digital Read (DR) option allows the pathologist to manually score the PR (1E2) stained slide’s digital image on a computer monitor. Hardware: The iScan HT slide scanning device captures digital images of FFPE breast tissues that are suitable for storage and viewing. The device includes a digital slide scanner, a carousel for loading glass slides, computer, scanner software, keyboard, mouse and monitor. 2 Software: The Virtuoso software is designed to complement the routine workflow of a qualified pathologist in the review of IHC stained breast tissue slides. It allows the user to select fields of view (FOVs) in the digital image for manual analysis. The software makes no independent interpretations of the data and requires competent human intervention for all steps in the analysis process. 2. Principles of Operation: Glass slides with FFPE tissue sections stained using the CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody are loaded into the VENTANA iScan HT scanner. The slides are then scanned and the resulting digitized images are displayed on a computer monitor. The pathologist reviews these images on the computer monitor and provides a qualitative PR IHC score based on the ≥1% cut-off. 3. Modes of Operation: Digital Read (DR): Manual scoring of IHC PR stained slide images on a computer monitor. Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___X_____ 4. Specimen Identification: Glass tissue slides are identified by slide label or barcode (if provided by the user) by scanning the whole slide including the label or barcode. 5. Specimen Sampling and Handling: IHC stained slides are manually loaded on to the VENTANA iScan HT slide scanner in the carousel. The slide capacity is 360 slides. Under the default setting, a thumbnail view of the slide and the area of interest (AOI) in the slide are scanned. The operator has the option of rescanning the slide after viewing the image on the computer monitor. Under the manual scanning option, the user has the ability to select the scan area for single or batch slides. 6. Calibration: The VENTANA iScan HT slide scanner is calibrated and verified at the manufacturing 3 facility before shipment. Upon installation, calibrations are performed and verified by Roche Customer Support. No additional calibration or verification is required or performed by the end user. Annual preventive maintenance performed by Roche Customer Support is recommended to ensure that the VENTANA iScan HT slide scanner is operating as intended. 7. Quality Control: Quality control is performed by the operator before releasing the images to the pathologist for review. Slides with sub-optimal images will be rescanned. Additionally, the software performs a quality check on the digital images to determine if they are suitable for further analysis using the “Image Quality Assessment” module. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes____X____ or No________ F. Regulatory Information: 1. Regulation section: 21 CFR §864.1860, Immunohistochemistry reagents and kits 2. Classification: Class II 3 Product code: OEO - Automated Digital Image Manual Interpretation Microscope 4. Panel: Pathology (88) G. Intended Use: 1. Indication(s) for Use: The VirtuosoTM system provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape. The VirtuosoTM System for IHC PR (1E2) using the VENTANA iScan HT is for the digital read application. This particular Virtuoso system is intended for use as an aid to the pathologist in the qualitative detection of progesterone receptor (PR) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is 4 indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC PR (1E2) Digital Read application is an adjunctive computer-assisted methodology for the qualified pathologist in the acquisition and interpretation of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The accuracy of the test results depends on the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read scores. The actual correlation of CONFIRM™ anti-PR antibody to clinical outcome has not been established. This device is intended for IHC slides stained on the BenchMark XT and BenchMark ULTRA stainers. For prescription use only. 2. Special Conditions for Use Statement(s): For prescription use only H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: Virtuoso™ System for IHC PR (1E2), k111869 2. Comparison with Predicate Device: Similarities Item Device Predicate Intended use The Virtuoso System provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, size, intensity, pattern and shape. The Virtuoso™ System for IHC PR (1E2) using the VENTANA iScan HT is for digital read. This particular Virtuoso system is intended for use as an aid to the pathologist in the detection and semi- quantitative measurement of progesterone receptor (PR) protein in Same 5 Similarities Item Device Predicate formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC PR (1E2) Digital Read adjunctive computer-assisted methodologies for the qualified pathologist in the acquisition and measurement of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The accuracy of the test results depends on the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read and Image Analysis scores. The actual correlation of CONFIRM™ anti-PR Type of test:

idK142965_s0_e2000

K142965.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k142965 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: Ventana Medical Systems, Inc. VirtuosoTM System for IHC PR (1E2) Using the VENTANA iScan HT D. Type of Test or Tests Performed: Manual scoring of digital images on a computer monitor of progesterone receptor (PR) (1E2) immunohistochemistry (IHC) stained slides using the VENTANA iScan HT scanner. E. System Descriptions: 1. Device Description: The Virtuoso™ System for IHC PR (1E2) Using the VENTANA iScan HT is an instrument-plus-software system designed to assist the qualified pathologist in the assessment of protein expression in IHC stained histologic sections from formalin-fixed, paraffin-embedded (FFPE) breast tissues. The system consists of a slide scanner (iScan), computer, monitor, keyboard, mouse and software with a Windows web browser-based user interface. Virtuoso is a web-based, end-to-end, IHC digital pathology software solution that allows pathology laboratories to acquire, manage, view, analyze, share, and report digital images of IHC stained slides. Using the Virtuoso software, the pathologist can view digital images, add annotations, make measurements and generate reports. The Digital Read (DR) option allows the pathologist to manually score the PR (1E2) stained slide’s digital image on a computer monitor. Hardware: The iScan HT slide scanning device captures digital images of FFPE breast tissues that are suitable for storage and viewing. The device includes a digital slide scanner, a carousel for loading glass slides, computer, scanner software, keyboard, mouse and monitor. 2 Software: The Virtuoso software is designed to complement the routine workflow of a qualified pathologist in the review of IHC stained breast tissue slides. It allows the user to select fields of view (FOVs) in the digital image for manual analysis. The software makes no independent interpretations of the data and requires competent human intervention for all steps in the analysis process. 2. Principles of Operation: Glass slides with FFPE tissue sections stained using the CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody are loaded into the VENTANA iScan HT scanner. The slides are then scanned and the resulting digitized images are displayed on a computer monitor. The pathologist reviews these images on the computer monitor and provides a qualitative PR IHC score based on the ≥1% cut-off. 3. Modes of Operation: Digital Read (DR): Manual scoring of IHC PR stained slide images on a computer monitor. Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___X_____ 4. Specimen Identification: Glass tissue slides are identified by slide label or barcode (if provided by the user) by scanning the whole slide including the label or barcode. 5. Specimen Sampling and Handling: IHC stained slides are manually loaded on to the VENTANA iScan HT slide scanner in the carousel. The slide capacity is 360 slides. Under the default setting, a thumbnail view of the slide and the area of interest (AOI) in the slide are scanned. The operator has the option of rescanning the slide after viewing the image on the computer monitor. Under the manual scanning option, the user has the ability to select the scan area for single or batch slides. 6. Calibration: The VENTANA iScan HT slide scanner is calibrated and verified at the manufacturing 3 facility before shipment. Upon installation, calibrations are performed and verified by Roche Customer Support. No additional calibration or verification is required or performed by the end user. Annual preventive maintenance performed by Roche Customer Support is recommended to ensure that the VENTANA iScan HT slide scanner is operating as intended. 7. Quality Control: Quality control is performed by the operator before releasing the images to the pathologist for review. Slides with sub-optimal images will be rescanned. Additionally, the software performs a quality check on the digital images to determine if they are suitable for further analysis using the “Image Quality Assessment” module. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes____X____ or No________ F. Regulatory Information: 1. Regulation section: 21 CFR §864.1860, Immunohistochemistry reagents and kits 2. Classification: Class II 3 Product code: OEO - Automated Digital Image Manual Interpretation Microscope 4. Panel: Pathology (88) G. Intended Use: 1. Indication(s) for Use: The VirtuosoTM system provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape. The VirtuosoTM System for IHC PR (1E2) using the VENTANA iScan HT is for the digital read application. This particular Virtuoso system is intended for use as an aid to the pathologist in the qualitative detection of progesterone receptor (PR) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is 4 indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC PR (1E2) Digital Read application is an adjunctive computer-assisted methodology for the qualified pathologist in the acquisition and interpretation of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The accuracy of the test results depends on the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read scores. The actual correlation of CONFIRM™ anti-PR antibody to clinical outcome has not been established. This device is intended for IHC slides stained on the BenchMark XT and BenchMark ULTRA stainers. For prescription use only. 2. Special Conditions for Use Statement(s): For prescription use only H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: Virtuoso™ System for IHC PR (1E2), k111869 2. Comparison with Predicate Device: Similarities Item Device Predicate Intended use The Virtuoso System provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, size, intensity, pattern and shape. The Virtuoso™ System for IHC PR (1E2) using the VENTANA iScan HT is for digital read. This particular Virtuoso system is intended for use as an aid to the pathologist in the detection and semi- quantitative measurement of progesterone receptor (PR) protein in Same 5 Similarities Item Device Predicate formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC PR (1E2) Digital Read adjunctive computer-assisted methodologies for the qualified pathologist in the acquisition and measurement of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The accuracy of the test results depends on the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read and Image Analysis scores. The actual correlation of CONFIRM™ anti-PR Classification:

idK142965_s0_e2000

K142965.txt

product code

OEO - Automated Digital Image Manual Interpretation Microscope

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k142965 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: Ventana Medical Systems, Inc. VirtuosoTM System for IHC PR (1E2) Using the VENTANA iScan HT D. Type of Test or Tests Performed: Manual scoring of digital images on a computer monitor of progesterone receptor (PR) (1E2) immunohistochemistry (IHC) stained slides using the VENTANA iScan HT scanner. E. System Descriptions: 1. Device Description: The Virtuoso™ System for IHC PR (1E2) Using the VENTANA iScan HT is an instrument-plus-software system designed to assist the qualified pathologist in the assessment of protein expression in IHC stained histologic sections from formalin-fixed, paraffin-embedded (FFPE) breast tissues. The system consists of a slide scanner (iScan), computer, monitor, keyboard, mouse and software with a Windows web browser-based user interface. Virtuoso is a web-based, end-to-end, IHC digital pathology software solution that allows pathology laboratories to acquire, manage, view, analyze, share, and report digital images of IHC stained slides. Using the Virtuoso software, the pathologist can view digital images, add annotations, make measurements and generate reports. The Digital Read (DR) option allows the pathologist to manually score the PR (1E2) stained slide’s digital image on a computer monitor. Hardware: The iScan HT slide scanning device captures digital images of FFPE breast tissues that are suitable for storage and viewing. The device includes a digital slide scanner, a carousel for loading glass slides, computer, scanner software, keyboard, mouse and monitor. 2 Software: The Virtuoso software is designed to complement the routine workflow of a qualified pathologist in the review of IHC stained breast tissue slides. It allows the user to select fields of view (FOVs) in the digital image for manual analysis. The software makes no independent interpretations of the data and requires competent human intervention for all steps in the analysis process. 2. Principles of Operation: Glass slides with FFPE tissue sections stained using the CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody are loaded into the VENTANA iScan HT scanner. The slides are then scanned and the resulting digitized images are displayed on a computer monitor. The pathologist reviews these images on the computer monitor and provides a qualitative PR IHC score based on the ≥1% cut-off. 3. Modes of Operation: Digital Read (DR): Manual scoring of IHC PR stained slide images on a computer monitor. Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___X_____ 4. Specimen Identification: Glass tissue slides are identified by slide label or barcode (if provided by the user) by scanning the whole slide including the label or barcode. 5. Specimen Sampling and Handling: IHC stained slides are manually loaded on to the VENTANA iScan HT slide scanner in the carousel. The slide capacity is 360 slides. Under the default setting, a thumbnail view of the slide and the area of interest (AOI) in the slide are scanned. The operator has the option of rescanning the slide after viewing the image on the computer monitor. Under the manual scanning option, the user has the ability to select the scan area for single or batch slides. 6. Calibration: The VENTANA iScan HT slide scanner is calibrated and verified at the manufacturing 3 facility before shipment. Upon installation, calibrations are performed and verified by Roche Customer Support. No additional calibration or verification is required or performed by the end user. Annual preventive maintenance performed by Roche Customer Support is recommended to ensure that the VENTANA iScan HT slide scanner is operating as intended. 7. Quality Control: Quality control is performed by the operator before releasing the images to the pathologist for review. Slides with sub-optimal images will be rescanned. Additionally, the software performs a quality check on the digital images to determine if they are suitable for further analysis using the “Image Quality Assessment” module. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes____X____ or No________ F. Regulatory Information: 1. Regulation section: 21 CFR §864.1860, Immunohistochemistry reagents and kits 2. Classification: Class II 3 Product code: OEO - Automated Digital Image Manual Interpretation Microscope 4. Panel: Pathology (88) G. Intended Use: 1. Indication(s) for Use: The VirtuosoTM system provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape. The VirtuosoTM System for IHC PR (1E2) using the VENTANA iScan HT is for the digital read application. This particular Virtuoso system is intended for use as an aid to the pathologist in the qualitative detection of progesterone receptor (PR) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is 4 indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC PR (1E2) Digital Read application is an adjunctive computer-assisted methodology for the qualified pathologist in the acquisition and interpretation of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The accuracy of the test results depends on the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read scores. The actual correlation of CONFIRM™ anti-PR antibody to clinical outcome has not been established. This device is intended for IHC slides stained on the BenchMark XT and BenchMark ULTRA stainers. For prescription use only. 2. Special Conditions for Use Statement(s): For prescription use only H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: Virtuoso™ System for IHC PR (1E2), k111869 2. Comparison with Predicate Device: Similarities Item Device Predicate Intended use The Virtuoso System provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, size, intensity, pattern and shape. The Virtuoso™ System for IHC PR (1E2) using the VENTANA iScan HT is for digital read. This particular Virtuoso system is intended for use as an aid to the pathologist in the detection and semi- quantitative measurement of progesterone receptor (PR) protein in Same 5 Similarities Item Device Predicate formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC PR (1E2) Digital Read adjunctive computer-assisted methodologies for the qualified pathologist in the acquisition and measurement of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The accuracy of the test results depends on the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read and Image Analysis scores. The actual correlation of CONFIRM™ anti-PR Product code:

idK142965_s0_e2000

K142965.txt

panel

Pathology (88)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k142965 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: Ventana Medical Systems, Inc. VirtuosoTM System for IHC PR (1E2) Using the VENTANA iScan HT D. Type of Test or Tests Performed: Manual scoring of digital images on a computer monitor of progesterone receptor (PR) (1E2) immunohistochemistry (IHC) stained slides using the VENTANA iScan HT scanner. E. System Descriptions: 1. Device Description: The Virtuoso™ System for IHC PR (1E2) Using the VENTANA iScan HT is an instrument-plus-software system designed to assist the qualified pathologist in the assessment of protein expression in IHC stained histologic sections from formalin-fixed, paraffin-embedded (FFPE) breast tissues. The system consists of a slide scanner (iScan), computer, monitor, keyboard, mouse and software with a Windows web browser-based user interface. Virtuoso is a web-based, end-to-end, IHC digital pathology software solution that allows pathology laboratories to acquire, manage, view, analyze, share, and report digital images of IHC stained slides. Using the Virtuoso software, the pathologist can view digital images, add annotations, make measurements and generate reports. The Digital Read (DR) option allows the pathologist to manually score the PR (1E2) stained slide’s digital image on a computer monitor. Hardware: The iScan HT slide scanning device captures digital images of FFPE breast tissues that are suitable for storage and viewing. The device includes a digital slide scanner, a carousel for loading glass slides, computer, scanner software, keyboard, mouse and monitor. 2 Software: The Virtuoso software is designed to complement the routine workflow of a qualified pathologist in the review of IHC stained breast tissue slides. It allows the user to select fields of view (FOVs) in the digital image for manual analysis. The software makes no independent interpretations of the data and requires competent human intervention for all steps in the analysis process. 2. Principles of Operation: Glass slides with FFPE tissue sections stained using the CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody are loaded into the VENTANA iScan HT scanner. The slides are then scanned and the resulting digitized images are displayed on a computer monitor. The pathologist reviews these images on the computer monitor and provides a qualitative PR IHC score based on the ≥1% cut-off. 3. Modes of Operation: Digital Read (DR): Manual scoring of IHC PR stained slide images on a computer monitor. Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___X_____ 4. Specimen Identification: Glass tissue slides are identified by slide label or barcode (if provided by the user) by scanning the whole slide including the label or barcode. 5. Specimen Sampling and Handling: IHC stained slides are manually loaded on to the VENTANA iScan HT slide scanner in the carousel. The slide capacity is 360 slides. Under the default setting, a thumbnail view of the slide and the area of interest (AOI) in the slide are scanned. The operator has the option of rescanning the slide after viewing the image on the computer monitor. Under the manual scanning option, the user has the ability to select the scan area for single or batch slides. 6. Calibration: The VENTANA iScan HT slide scanner is calibrated and verified at the manufacturing 3 facility before shipment. Upon installation, calibrations are performed and verified by Roche Customer Support. No additional calibration or verification is required or performed by the end user. Annual preventive maintenance performed by Roche Customer Support is recommended to ensure that the VENTANA iScan HT slide scanner is operating as intended. 7. Quality Control: Quality control is performed by the operator before releasing the images to the pathologist for review. Slides with sub-optimal images will be rescanned. Additionally, the software performs a quality check on the digital images to determine if they are suitable for further analysis using the “Image Quality Assessment” module. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes____X____ or No________ F. Regulatory Information: 1. Regulation section: 21 CFR §864.1860, Immunohistochemistry reagents and kits 2. Classification: Class II 3 Product code: OEO - Automated Digital Image Manual Interpretation Microscope 4. Panel: Pathology (88) G. Intended Use: 1. Indication(s) for Use: The VirtuosoTM system provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape. The VirtuosoTM System for IHC PR (1E2) using the VENTANA iScan HT is for the digital read application. This particular Virtuoso system is intended for use as an aid to the pathologist in the qualitative detection of progesterone receptor (PR) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is 4 indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC PR (1E2) Digital Read application is an adjunctive computer-assisted methodology for the qualified pathologist in the acquisition and interpretation of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The accuracy of the test results depends on the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read scores. The actual correlation of CONFIRM™ anti-PR antibody to clinical outcome has not been established. This device is intended for IHC slides stained on the BenchMark XT and BenchMark ULTRA stainers. For prescription use only. 2. Special Conditions for Use Statement(s): For prescription use only H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: Virtuoso™ System for IHC PR (1E2), k111869 2. Comparison with Predicate Device: Similarities Item Device Predicate Intended use The Virtuoso System provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, size, intensity, pattern and shape. The Virtuoso™ System for IHC PR (1E2) using the VENTANA iScan HT is for digital read. This particular Virtuoso system is intended for use as an aid to the pathologist in the detection and semi- quantitative measurement of progesterone receptor (PR) protein in Same 5 Similarities Item Device Predicate formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC PR (1E2) Digital Read adjunctive computer-assisted methodologies for the qualified pathologist in the acquisition and measurement of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The accuracy of the test results depends on the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read and Image Analysis scores. The actual correlation of CONFIRM™ anti-PR Panel:

idK142965_s0_e2000

K142965.txt

predicate device name

Virtuoso™ System for IHC PR (1E2)

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k142965 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: Ventana Medical Systems, Inc. VirtuosoTM System for IHC PR (1E2) Using the VENTANA iScan HT D. Type of Test or Tests Performed: Manual scoring of digital images on a computer monitor of progesterone receptor (PR) (1E2) immunohistochemistry (IHC) stained slides using the VENTANA iScan HT scanner. E. System Descriptions: 1. Device Description: The Virtuoso™ System for IHC PR (1E2) Using the VENTANA iScan HT is an instrument-plus-software system designed to assist the qualified pathologist in the assessment of protein expression in IHC stained histologic sections from formalin-fixed, paraffin-embedded (FFPE) breast tissues. The system consists of a slide scanner (iScan), computer, monitor, keyboard, mouse and software with a Windows web browser-based user interface. Virtuoso is a web-based, end-to-end, IHC digital pathology software solution that allows pathology laboratories to acquire, manage, view, analyze, share, and report digital images of IHC stained slides. Using the Virtuoso software, the pathologist can view digital images, add annotations, make measurements and generate reports. The Digital Read (DR) option allows the pathologist to manually score the PR (1E2) stained slide’s digital image on a computer monitor. Hardware: The iScan HT slide scanning device captures digital images of FFPE breast tissues that are suitable for storage and viewing. The device includes a digital slide scanner, a carousel for loading glass slides, computer, scanner software, keyboard, mouse and monitor. 2 Software: The Virtuoso software is designed to complement the routine workflow of a qualified pathologist in the review of IHC stained breast tissue slides. It allows the user to select fields of view (FOVs) in the digital image for manual analysis. The software makes no independent interpretations of the data and requires competent human intervention for all steps in the analysis process. 2. Principles of Operation: Glass slides with FFPE tissue sections stained using the CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody are loaded into the VENTANA iScan HT scanner. The slides are then scanned and the resulting digitized images are displayed on a computer monitor. The pathologist reviews these images on the computer monitor and provides a qualitative PR IHC score based on the ≥1% cut-off. 3. Modes of Operation: Digital Read (DR): Manual scoring of IHC PR stained slide images on a computer monitor. Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___X_____ 4. Specimen Identification: Glass tissue slides are identified by slide label or barcode (if provided by the user) by scanning the whole slide including the label or barcode. 5. Specimen Sampling and Handling: IHC stained slides are manually loaded on to the VENTANA iScan HT slide scanner in the carousel. The slide capacity is 360 slides. Under the default setting, a thumbnail view of the slide and the area of interest (AOI) in the slide are scanned. The operator has the option of rescanning the slide after viewing the image on the computer monitor. Under the manual scanning option, the user has the ability to select the scan area for single or batch slides. 6. Calibration: The VENTANA iScan HT slide scanner is calibrated and verified at the manufacturing 3 facility before shipment. Upon installation, calibrations are performed and verified by Roche Customer Support. No additional calibration or verification is required or performed by the end user. Annual preventive maintenance performed by Roche Customer Support is recommended to ensure that the VENTANA iScan HT slide scanner is operating as intended. 7. Quality Control: Quality control is performed by the operator before releasing the images to the pathologist for review. Slides with sub-optimal images will be rescanned. Additionally, the software performs a quality check on the digital images to determine if they are suitable for further analysis using the “Image Quality Assessment” module. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes____X____ or No________ F. Regulatory Information: 1. Regulation section: 21 CFR §864.1860, Immunohistochemistry reagents and kits 2. Classification: Class II 3 Product code: OEO - Automated Digital Image Manual Interpretation Microscope 4. Panel: Pathology (88) G. Intended Use: 1. Indication(s) for Use: The VirtuosoTM system provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape. The VirtuosoTM System for IHC PR (1E2) using the VENTANA iScan HT is for the digital read application. This particular Virtuoso system is intended for use as an aid to the pathologist in the qualitative detection of progesterone receptor (PR) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is 4 indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC PR (1E2) Digital Read application is an adjunctive computer-assisted methodology for the qualified pathologist in the acquisition and interpretation of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The accuracy of the test results depends on the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read scores. The actual correlation of CONFIRM™ anti-PR antibody to clinical outcome has not been established. This device is intended for IHC slides stained on the BenchMark XT and BenchMark ULTRA stainers. For prescription use only. 2. Special Conditions for Use Statement(s): For prescription use only H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: Virtuoso™ System for IHC PR (1E2), k111869 2. Comparison with Predicate Device: Similarities Item Device Predicate Intended use The Virtuoso System provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, size, intensity, pattern and shape. The Virtuoso™ System for IHC PR (1E2) using the VENTANA iScan HT is for digital read. This particular Virtuoso system is intended for use as an aid to the pathologist in the detection and semi- quantitative measurement of progesterone receptor (PR) protein in Same 5 Similarities Item Device Predicate formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC PR (1E2) Digital Read adjunctive computer-assisted methodologies for the qualified pathologist in the acquisition and measurement of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The accuracy of the test results depends on the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read and Image Analysis scores. The actual correlation of CONFIRM™ anti-PR Predicate device name:

idK142965_s0_e2000

K142965.txt

applicant

Ventana Medical Systems, Inc.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k142965 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: Ventana Medical Systems, Inc. VirtuosoTM System for IHC PR (1E2) Using the VENTANA iScan HT D. Type of Test or Tests Performed: Manual scoring of digital images on a computer monitor of progesterone receptor (PR) (1E2) immunohistochemistry (IHC) stained slides using the VENTANA iScan HT scanner. E. System Descriptions: 1. Device Description: The Virtuoso™ System for IHC PR (1E2) Using the VENTANA iScan HT is an instrument-plus-software system designed to assist the qualified pathologist in the assessment of protein expression in IHC stained histologic sections from formalin-fixed, paraffin-embedded (FFPE) breast tissues. The system consists of a slide scanner (iScan), computer, monitor, keyboard, mouse and software with a Windows web browser-based user interface. Virtuoso is a web-based, end-to-end, IHC digital pathology software solution that allows pathology laboratories to acquire, manage, view, analyze, share, and report digital images of IHC stained slides. Using the Virtuoso software, the pathologist can view digital images, add annotations, make measurements and generate reports. The Digital Read (DR) option allows the pathologist to manually score the PR (1E2) stained slide’s digital image on a computer monitor. Hardware: The iScan HT slide scanning device captures digital images of FFPE breast tissues that are suitable for storage and viewing. The device includes a digital slide scanner, a carousel for loading glass slides, computer, scanner software, keyboard, mouse and monitor. 2 Software: The Virtuoso software is designed to complement the routine workflow of a qualified pathologist in the review of IHC stained breast tissue slides. It allows the user to select fields of view (FOVs) in the digital image for manual analysis. The software makes no independent interpretations of the data and requires competent human intervention for all steps in the analysis process. 2. Principles of Operation: Glass slides with FFPE tissue sections stained using the CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody are loaded into the VENTANA iScan HT scanner. The slides are then scanned and the resulting digitized images are displayed on a computer monitor. The pathologist reviews these images on the computer monitor and provides a qualitative PR IHC score based on the ≥1% cut-off. 3. Modes of Operation: Digital Read (DR): Manual scoring of IHC PR stained slide images on a computer monitor. Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___X_____ 4. Specimen Identification: Glass tissue slides are identified by slide label or barcode (if provided by the user) by scanning the whole slide including the label or barcode. 5. Specimen Sampling and Handling: IHC stained slides are manually loaded on to the VENTANA iScan HT slide scanner in the carousel. The slide capacity is 360 slides. Under the default setting, a thumbnail view of the slide and the area of interest (AOI) in the slide are scanned. The operator has the option of rescanning the slide after viewing the image on the computer monitor. Under the manual scanning option, the user has the ability to select the scan area for single or batch slides. 6. Calibration: The VENTANA iScan HT slide scanner is calibrated and verified at the manufacturing 3 facility before shipment. Upon installation, calibrations are performed and verified by Roche Customer Support. No additional calibration or verification is required or performed by the end user. Annual preventive maintenance performed by Roche Customer Support is recommended to ensure that the VENTANA iScan HT slide scanner is operating as intended. 7. Quality Control: Quality control is performed by the operator before releasing the images to the pathologist for review. Slides with sub-optimal images will be rescanned. Additionally, the software performs a quality check on the digital images to determine if they are suitable for further analysis using the “Image Quality Assessment” module. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes____X____ or No________ F. Regulatory Information: 1. Regulation section: 21 CFR §864.1860, Immunohistochemistry reagents and kits 2. Classification: Class II 3 Product code: OEO - Automated Digital Image Manual Interpretation Microscope 4. Panel: Pathology (88) G. Intended Use: 1. Indication(s) for Use: The VirtuosoTM system provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape. The VirtuosoTM System for IHC PR (1E2) using the VENTANA iScan HT is for the digital read application. This particular Virtuoso system is intended for use as an aid to the pathologist in the qualitative detection of progesterone receptor (PR) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is 4 indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC PR (1E2) Digital Read application is an adjunctive computer-assisted methodology for the qualified pathologist in the acquisition and interpretation of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The accuracy of the test results depends on the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read scores. The actual correlation of CONFIRM™ anti-PR antibody to clinical outcome has not been established. This device is intended for IHC slides stained on the BenchMark XT and BenchMark ULTRA stainers. For prescription use only. 2. Special Conditions for Use Statement(s): For prescription use only H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: Virtuoso™ System for IHC PR (1E2), k111869 2. Comparison with Predicate Device: Similarities Item Device Predicate Intended use The Virtuoso System provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, size, intensity, pattern and shape. The Virtuoso™ System for IHC PR (1E2) using the VENTANA iScan HT is for digital read. This particular Virtuoso system is intended for use as an aid to the pathologist in the detection and semi- quantitative measurement of progesterone receptor (PR) protein in Same 5 Similarities Item Device Predicate formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC PR (1E2) Digital Read adjunctive computer-assisted methodologies for the qualified pathologist in the acquisition and measurement of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The accuracy of the test results depends on the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read and Image Analysis scores. The actual correlation of CONFIRM™ anti-PR Applicant:

idK142965_s0_e2000

K142965.txt

regulation section

21 CFR §864.1860, Immunohistochemistry reagents and kits

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k142965 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: Ventana Medical Systems, Inc. VirtuosoTM System for IHC PR (1E2) Using the VENTANA iScan HT D. Type of Test or Tests Performed: Manual scoring of digital images on a computer monitor of progesterone receptor (PR) (1E2) immunohistochemistry (IHC) stained slides using the VENTANA iScan HT scanner. E. System Descriptions: 1. Device Description: The Virtuoso™ System for IHC PR (1E2) Using the VENTANA iScan HT is an instrument-plus-software system designed to assist the qualified pathologist in the assessment of protein expression in IHC stained histologic sections from formalin-fixed, paraffin-embedded (FFPE) breast tissues. The system consists of a slide scanner (iScan), computer, monitor, keyboard, mouse and software with a Windows web browser-based user interface. Virtuoso is a web-based, end-to-end, IHC digital pathology software solution that allows pathology laboratories to acquire, manage, view, analyze, share, and report digital images of IHC stained slides. Using the Virtuoso software, the pathologist can view digital images, add annotations, make measurements and generate reports. The Digital Read (DR) option allows the pathologist to manually score the PR (1E2) stained slide’s digital image on a computer monitor. Hardware: The iScan HT slide scanning device captures digital images of FFPE breast tissues that are suitable for storage and viewing. The device includes a digital slide scanner, a carousel for loading glass slides, computer, scanner software, keyboard, mouse and monitor. 2 Software: The Virtuoso software is designed to complement the routine workflow of a qualified pathologist in the review of IHC stained breast tissue slides. It allows the user to select fields of view (FOVs) in the digital image for manual analysis. The software makes no independent interpretations of the data and requires competent human intervention for all steps in the analysis process. 2. Principles of Operation: Glass slides with FFPE tissue sections stained using the CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody are loaded into the VENTANA iScan HT scanner. The slides are then scanned and the resulting digitized images are displayed on a computer monitor. The pathologist reviews these images on the computer monitor and provides a qualitative PR IHC score based on the ≥1% cut-off. 3. Modes of Operation: Digital Read (DR): Manual scoring of IHC PR stained slide images on a computer monitor. Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___X_____ 4. Specimen Identification: Glass tissue slides are identified by slide label or barcode (if provided by the user) by scanning the whole slide including the label or barcode. 5. Specimen Sampling and Handling: IHC stained slides are manually loaded on to the VENTANA iScan HT slide scanner in the carousel. The slide capacity is 360 slides. Under the default setting, a thumbnail view of the slide and the area of interest (AOI) in the slide are scanned. The operator has the option of rescanning the slide after viewing the image on the computer monitor. Under the manual scanning option, the user has the ability to select the scan area for single or batch slides. 6. Calibration: The VENTANA iScan HT slide scanner is calibrated and verified at the manufacturing 3 facility before shipment. Upon installation, calibrations are performed and verified by Roche Customer Support. No additional calibration or verification is required or performed by the end user. Annual preventive maintenance performed by Roche Customer Support is recommended to ensure that the VENTANA iScan HT slide scanner is operating as intended. 7. Quality Control: Quality control is performed by the operator before releasing the images to the pathologist for review. Slides with sub-optimal images will be rescanned. Additionally, the software performs a quality check on the digital images to determine if they are suitable for further analysis using the “Image Quality Assessment” module. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes____X____ or No________ F. Regulatory Information: 1. Regulation section: 21 CFR §864.1860, Immunohistochemistry reagents and kits 2. Classification: Class II 3 Product code: OEO - Automated Digital Image Manual Interpretation Microscope 4. Panel: Pathology (88) G. Intended Use: 1. Indication(s) for Use: The VirtuosoTM system provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape. The VirtuosoTM System for IHC PR (1E2) using the VENTANA iScan HT is for the digital read application. This particular Virtuoso system is intended for use as an aid to the pathologist in the qualitative detection of progesterone receptor (PR) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is 4 indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC PR (1E2) Digital Read application is an adjunctive computer-assisted methodology for the qualified pathologist in the acquisition and interpretation of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The accuracy of the test results depends on the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read scores. The actual correlation of CONFIRM™ anti-PR antibody to clinical outcome has not been established. This device is intended for IHC slides stained on the BenchMark XT and BenchMark ULTRA stainers. For prescription use only. 2. Special Conditions for Use Statement(s): For prescription use only H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: Virtuoso™ System for IHC PR (1E2), k111869 2. Comparison with Predicate Device: Similarities Item Device Predicate Intended use The Virtuoso System provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, size, intensity, pattern and shape. The Virtuoso™ System for IHC PR (1E2) using the VENTANA iScan HT is for digital read. This particular Virtuoso system is intended for use as an aid to the pathologist in the detection and semi- quantitative measurement of progesterone receptor (PR) protein in Same 5 Similarities Item Device Predicate formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC PR (1E2) Digital Read adjunctive computer-assisted methodologies for the qualified pathologist in the acquisition and measurement of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The accuracy of the test results depends on the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM™ anti- Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read and Image Analysis scores. The actual correlation of CONFIRM™ anti-PR Regulation section:

idK142965_s4000_e6000

K142965.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

evaluated. Similarly, these same 40 cases were scanned on 3 different days by the same scanner, and the same FOVs were applied to the appropriate cases to assess intra-scanner/inter-day precision. Pairwise comparisons were performed between each of the 3 sites (inter-scanner), and between each of the 3 days (sessions, intra-scanner). The precision study results are given in the tables below. 11 PR Clinical Scoring Category Agreement Between Scanners (Between Sites) All FOVs Combined SITE 1 vs SITE 2 Site 2 Clinical Scoring Category OPA >10% 1–10% 0–0.99% Total n/N % 95% CI Site 1 Clinical Scoring Category >10% 113 8 0 121 324/360 90.0 86.5-92.7 1–10% 3 30 15 48 0–0.99% 0 10 181 191 Total 116 48 196 360 SITE 1 vs SITE 3 Site 3 Clinical Scoring Category OPA >10% 1–10% 0–0.99% Total n/N % 95% CI Site 1 Clinical Scoring Category >10% 119 2 0 121 337/360 93.6 90.6-95.7 1–10% 4 34 10 48 0–0.99% 0 7 184 191 Total 123 43 194 360 SITE 2 vs SITE 3 Site 3 Clinical Scoring Category OPA >10% 1–10% 0–0.99% Total n/N % 95% CI Site 2 Clinical Scoring Category >10% 115 1 0 116 325/360 90.3 86.8-92.9 1–10% 8 28 12 48 0–0.99% 0 14 182 196 Total 123 43 194 360 12 PR Clinical Scoring Category Agreement Within Scanners (Between Days) All FOVs Combined c. Linearity: Not applicable d. Carryover: Not applicable e. Interfering Substances: Not applicable 2. Other Supportive Instrument Performance Data Not Covered Above: Not applicable DAY 1 vs DAY 2 Day 2 Clinical Scoring Category OPA >10% 1–10% 0–0.99% Total n/N % 95% CI Day 1 Clinical Scoring Category >10% 117 4 0 121 332/360 92.2 89.0-94.6 1–10% 1 33 11 45 0–0.99% 1 11 182 194 Total 119 48 193 360 DAY 1 vs DAY 3 Day 3 Clinical Scoring Category OPA >10% 1–10% 0–0.99% Total n/N % 95% CI Day 1 Clinical Scoring Category >10% 118 3 0 121 327/360 90.8 87.4-93.4 1–10% 2 29 14 45 0–0.99% 0 14 180 194 Total 120 46 194 360 DAY 2 vs DAY 3 Day 3 Clinical Scoring Category OPA >10% 1–10% 0–0.99% Total n/N % 95% CI Day 2 Clinical Scoring Category >10% 115 3 1 119 327/360 90.8 87.4-93.4 1–10% 5 31 12 48 0–0.99% 0 12 181 193 Total 120 46 194 360 13 K. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. L. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK142965_s4000_e6000

K142965.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

) and evaluated. Similarly, these same 40 cases were scanned on 3 different days by the same scanner, and the same FOVs were applied to the appropriate cases to assess intra-scanner/inter-day precision. Pairwise comparisons were performed between each of the 3 sites (inter-scanner), and between each of the 3 days (sessions, intra-scanner). The precision study results are given in the tables below. 11 PR Clinical Scoring Category Agreement Between Scanners (Between Sites) All FOVs Combined SITE 1 vs SITE 2 Site 2 Clinical Scoring Category OPA >10% 1–10% 0–0.99% Total n/N % 95% CI Site 1 Clinical Scoring Category >10% 113 8 0 121 324/360 90.0 86.5-92.7 1–10% 3 30 15 48 0–0.99% 0 10 181 191 Total 116 48 196 360 SITE 1 vs SITE 3 Site 3 Clinical Scoring Category OPA >10% 1–10% 0–0.99% Total n/N % 95% CI Site 1 Clinical Scoring Category >10% 119 2 0 121 337/360 93.6 90.6-95.7 1–10% 4 34 10 48 0–0.99% 0 7 184 191 Total 123 43 194 360 SITE 2 vs SITE 3 Site 3 Clinical Scoring Category OPA >10% 1–10% 0–0.99% Total n/N % 95% CI Site 2 Clinical Scoring Category >10% 115 1 0 116 325/360 90.3 86.8-92.9 1–10% 8 28 12 48 0–0.99% 0 14 182 196 Total 123 43 194 360 12 PR Clinical Scoring Category Agreement Within Scanners (Between Days) All FOVs Combined c. Linearity: Not applicable d. Carryover: Not applicable e. Interfering Substances: Not applicable 2. Other Supportive Instrument Performance Data Not Covered Above: Not applicable DAY 1 vs DAY 2 Day 2 Clinical Scoring Category OPA >10% 1–10% 0–0.99% Total n/N % 95% CI Day 1 Clinical Scoring Category >10% 117 4 0 121 332/360 92.2 89.0-94.6 1–10% 1 33 11 45 0–0.99% 1 11 182 194 Total 119 48 193 360 DAY 1 vs DAY 3 Day 3 Clinical Scoring Category OPA >10% 1–10% 0–0.99% Total n/N % 95% CI Day 1 Clinical Scoring Category >10% 118 3 0 121 327/360 90.8 87.4-93.4 1–10% 2 29 14 45 0–0.99% 0 14 180 194 Total 120 46 194 360 DAY 2 vs DAY 3 Day 3 Clinical Scoring Category OPA >10% 1–10% 0–0.99% Total n/N % 95% CI Day 2 Clinical Scoring Category >10% 115 3 1 119 327/360 90.8 87.4-93.4 1–10% 5 31 12 48 0–0.99% 0 12 181 193 Total 120 46 194 360 13 K. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. L. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK182389_s0_e2000

K182389.txt

purpose for submission

Expand Intended Use to include pediatric subjects under the age of 2 years old.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K182389 B. Purpose for Submission: Expand Intended Use to include pediatric subjects under the age of 2 years old. C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Performed: The Sysmex XN-L Automated Hematology Analyzer (hereafter, the XN-L analyzer) classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal (CSF), peritoneal, pleural and synovial fluids. E. System Descriptions: 1. Device Description: The XN-L analyzer is a quantitative multi-parameter automated differential cell counter that classifies and enumerates whole blood and body fluid parameters by means of electrical impedance, laser light scattering, and fluorescent labeling. Cell counts and parameters are performed on whole blood samples collected in K2EDTA or K3EDTA anticoagulant, body fluids (peritoneal, pleural and synovial) collected in K2EDTA anticoagulant and CSF collected without anticoagulant. The instrument consists of two principal units: (1) the Main Unit which will aspirate, dilute, mix, and analyze whole blood and body fluid samples and (2) the Pneumatic Unit which supplies pressure and vacuum to the analyzer. The XN-L analyzer has an external monitor with touch screen capability that is used to operate the instrument and process data from the Main Unit. The monitor also allows for operator interfacing with the instrument by use of a panel keyboard. 2. Principles of Operation: The XN-L analyzer analyzes samples using the following methods: DC Sheath Flow Detection method, Flow Cytometry method using a semiconductor laser, and SLS (cyanide-free sodium lauryl sulfate) hemoglobin method. Particle characterization and identification is based on detection of forward scatter, fluorescence, and adaptive cluster analysis. The XN-L analyzer automatically classifies cells from whole blood and body 2 fluids and carries out all processes automatically from aspiration of the sample to result output. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ____X____ 4. Specimen Identification: Specimen identification input is manual (by operator) or by barcode reader. 5. Specimen Sampling and Handling: There are two modes of sample introduction: (1) Sampler Mode; (2) Manual Mode. In the Sampler Mode the operator loads the sample tubes into a rack, which is then automatically transported and analyzed by the instrument. This mode automatically mixes, aspirates, and analyzes samples without removing their caps. The Sampler Mode is used for processing of whole blood samples. In the Manual Mode, there are two sample tube holders: (1) Normal sample tube holder; (2) Micro collection tube holder. In this mode the operator loads and mixes the samples tubes individually by hand. The samples in the Manual Mode can be analyzed with the cap on or off. The Manual Mode is used for processing whole blood and body fluid samples. 6. Calibration: The XN CAL calibrator (K160585) is used for calibration of the WBC, RBC, HGB, HCT, PLT and RET parameters. XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Calibration is performed as needed (e.g., when QC data is fluctuating) to ensure accuracy of the system. 7. Quality Control: The XN-L CHECK (K160586) is used as quality control (three levels) for Sysmex XN-L analyzers. XN-L CHECK™ is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), and stabilized platelet component(s) in a preservative medium. XN CHECK (K160590) is used as quality control (three levels) for Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. XN CHECK is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. 3 XN CHECK BF (K160588) is used as quality control (two levels) for Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC- BF, RBC-BF, MN%, PMN%, TC-BF#. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes____X____ or No________ F. Regulatory Information: 1. Regulation section: 21 CFR 864.5220, Automated differential cell counter 2. Classification: Class II 3 Product code: GKZ, Counter, Differential Cell 4. Panel: Hematology (81) G. Intended Use: 1. Indication(s) for Use: The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW- CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended. 2. Special Conditions for Use Statement(s): For prescription use only. H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzer, K112605 4 2. Comparison with Predicate Device: Similarities Item Candidate Sysmex XN-L analyzer K182389 Predicate Sysmex XN-Series (XN-10)a K112605 Intended Use The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC- BF, MN%/#, PMN%/#, and TC- BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial Purpose for submission:

idK182389_s0_e2000

K182389.txt

type of test

The Sysmex XN-L Automated Hematology Analyzer (hereafter, the XN-L analyzer) classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal (CSF), peritoneal, pleural and synovial fluids.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K182389 B. Purpose for Submission: Expand Intended Use to include pediatric subjects under the age of 2 years old. C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Performed: The Sysmex XN-L Automated Hematology Analyzer (hereafter, the XN-L analyzer) classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal (CSF), peritoneal, pleural and synovial fluids. E. System Descriptions: 1. Device Description: The XN-L analyzer is a quantitative multi-parameter automated differential cell counter that classifies and enumerates whole blood and body fluid parameters by means of electrical impedance, laser light scattering, and fluorescent labeling. Cell counts and parameters are performed on whole blood samples collected in K2EDTA or K3EDTA anticoagulant, body fluids (peritoneal, pleural and synovial) collected in K2EDTA anticoagulant and CSF collected without anticoagulant. The instrument consists of two principal units: (1) the Main Unit which will aspirate, dilute, mix, and analyze whole blood and body fluid samples and (2) the Pneumatic Unit which supplies pressure and vacuum to the analyzer. The XN-L analyzer has an external monitor with touch screen capability that is used to operate the instrument and process data from the Main Unit. The monitor also allows for operator interfacing with the instrument by use of a panel keyboard. 2. Principles of Operation: The XN-L analyzer analyzes samples using the following methods: DC Sheath Flow Detection method, Flow Cytometry method using a semiconductor laser, and SLS (cyanide-free sodium lauryl sulfate) hemoglobin method. Particle characterization and identification is based on detection of forward scatter, fluorescence, and adaptive cluster analysis. The XN-L analyzer automatically classifies cells from whole blood and body 2 fluids and carries out all processes automatically from aspiration of the sample to result output. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ____X____ 4. Specimen Identification: Specimen identification input is manual (by operator) or by barcode reader. 5. Specimen Sampling and Handling: There are two modes of sample introduction: (1) Sampler Mode; (2) Manual Mode. In the Sampler Mode the operator loads the sample tubes into a rack, which is then automatically transported and analyzed by the instrument. This mode automatically mixes, aspirates, and analyzes samples without removing their caps. The Sampler Mode is used for processing of whole blood samples. In the Manual Mode, there are two sample tube holders: (1) Normal sample tube holder; (2) Micro collection tube holder. In this mode the operator loads and mixes the samples tubes individually by hand. The samples in the Manual Mode can be analyzed with the cap on or off. The Manual Mode is used for processing whole blood and body fluid samples. 6. Calibration: The XN CAL calibrator (K160585) is used for calibration of the WBC, RBC, HGB, HCT, PLT and RET parameters. XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Calibration is performed as needed (e.g., when QC data is fluctuating) to ensure accuracy of the system. 7. Quality Control: The XN-L CHECK (K160586) is used as quality control (three levels) for Sysmex XN-L analyzers. XN-L CHECK™ is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), and stabilized platelet component(s) in a preservative medium. XN CHECK (K160590) is used as quality control (three levels) for Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. XN CHECK is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. 3 XN CHECK BF (K160588) is used as quality control (two levels) for Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC- BF, RBC-BF, MN%, PMN%, TC-BF#. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes____X____ or No________ F. Regulatory Information: 1. Regulation section: 21 CFR 864.5220, Automated differential cell counter 2. Classification: Class II 3 Product code: GKZ, Counter, Differential Cell 4. Panel: Hematology (81) G. Intended Use: 1. Indication(s) for Use: The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW- CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended. 2. Special Conditions for Use Statement(s): For prescription use only. H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzer, K112605 4 2. Comparison with Predicate Device: Similarities Item Candidate Sysmex XN-L analyzer K182389 Predicate Sysmex XN-Series (XN-10)a K112605 Intended Use The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC- BF, MN%/#, PMN%/#, and TC- BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial Type of test:

idK182389_s0_e2000

K182389.txt

classification

Class II

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K182389 B. Purpose for Submission: Expand Intended Use to include pediatric subjects under the age of 2 years old. C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Performed: The Sysmex XN-L Automated Hematology Analyzer (hereafter, the XN-L analyzer) classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal (CSF), peritoneal, pleural and synovial fluids. E. System Descriptions: 1. Device Description: The XN-L analyzer is a quantitative multi-parameter automated differential cell counter that classifies and enumerates whole blood and body fluid parameters by means of electrical impedance, laser light scattering, and fluorescent labeling. Cell counts and parameters are performed on whole blood samples collected in K2EDTA or K3EDTA anticoagulant, body fluids (peritoneal, pleural and synovial) collected in K2EDTA anticoagulant and CSF collected without anticoagulant. The instrument consists of two principal units: (1) the Main Unit which will aspirate, dilute, mix, and analyze whole blood and body fluid samples and (2) the Pneumatic Unit which supplies pressure and vacuum to the analyzer. The XN-L analyzer has an external monitor with touch screen capability that is used to operate the instrument and process data from the Main Unit. The monitor also allows for operator interfacing with the instrument by use of a panel keyboard. 2. Principles of Operation: The XN-L analyzer analyzes samples using the following methods: DC Sheath Flow Detection method, Flow Cytometry method using a semiconductor laser, and SLS (cyanide-free sodium lauryl sulfate) hemoglobin method. Particle characterization and identification is based on detection of forward scatter, fluorescence, and adaptive cluster analysis. The XN-L analyzer automatically classifies cells from whole blood and body 2 fluids and carries out all processes automatically from aspiration of the sample to result output. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ____X____ 4. Specimen Identification: Specimen identification input is manual (by operator) or by barcode reader. 5. Specimen Sampling and Handling: There are two modes of sample introduction: (1) Sampler Mode; (2) Manual Mode. In the Sampler Mode the operator loads the sample tubes into a rack, which is then automatically transported and analyzed by the instrument. This mode automatically mixes, aspirates, and analyzes samples without removing their caps. The Sampler Mode is used for processing of whole blood samples. In the Manual Mode, there are two sample tube holders: (1) Normal sample tube holder; (2) Micro collection tube holder. In this mode the operator loads and mixes the samples tubes individually by hand. The samples in the Manual Mode can be analyzed with the cap on or off. The Manual Mode is used for processing whole blood and body fluid samples. 6. Calibration: The XN CAL calibrator (K160585) is used for calibration of the WBC, RBC, HGB, HCT, PLT and RET parameters. XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Calibration is performed as needed (e.g., when QC data is fluctuating) to ensure accuracy of the system. 7. Quality Control: The XN-L CHECK (K160586) is used as quality control (three levels) for Sysmex XN-L analyzers. XN-L CHECK™ is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), and stabilized platelet component(s) in a preservative medium. XN CHECK (K160590) is used as quality control (three levels) for Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. XN CHECK is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. 3 XN CHECK BF (K160588) is used as quality control (two levels) for Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC- BF, RBC-BF, MN%, PMN%, TC-BF#. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes____X____ or No________ F. Regulatory Information: 1. Regulation section: 21 CFR 864.5220, Automated differential cell counter 2. Classification: Class II 3 Product code: GKZ, Counter, Differential Cell 4. Panel: Hematology (81) G. Intended Use: 1. Indication(s) for Use: The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW- CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended. 2. Special Conditions for Use Statement(s): For prescription use only. H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzer, K112605 4 2. Comparison with Predicate Device: Similarities Item Candidate Sysmex XN-L analyzer K182389 Predicate Sysmex XN-Series (XN-10)a K112605 Intended Use The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC- BF, MN%/#, PMN%/#, and TC- BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial Classification:

idK182389_s0_e2000

K182389.txt

product code

GKZ, Counter, Differential Cell

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K182389 B. Purpose for Submission: Expand Intended Use to include pediatric subjects under the age of 2 years old. C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Performed: The Sysmex XN-L Automated Hematology Analyzer (hereafter, the XN-L analyzer) classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal (CSF), peritoneal, pleural and synovial fluids. E. System Descriptions: 1. Device Description: The XN-L analyzer is a quantitative multi-parameter automated differential cell counter that classifies and enumerates whole blood and body fluid parameters by means of electrical impedance, laser light scattering, and fluorescent labeling. Cell counts and parameters are performed on whole blood samples collected in K2EDTA or K3EDTA anticoagulant, body fluids (peritoneal, pleural and synovial) collected in K2EDTA anticoagulant and CSF collected without anticoagulant. The instrument consists of two principal units: (1) the Main Unit which will aspirate, dilute, mix, and analyze whole blood and body fluid samples and (2) the Pneumatic Unit which supplies pressure and vacuum to the analyzer. The XN-L analyzer has an external monitor with touch screen capability that is used to operate the instrument and process data from the Main Unit. The monitor also allows for operator interfacing with the instrument by use of a panel keyboard. 2. Principles of Operation: The XN-L analyzer analyzes samples using the following methods: DC Sheath Flow Detection method, Flow Cytometry method using a semiconductor laser, and SLS (cyanide-free sodium lauryl sulfate) hemoglobin method. Particle characterization and identification is based on detection of forward scatter, fluorescence, and adaptive cluster analysis. The XN-L analyzer automatically classifies cells from whole blood and body 2 fluids and carries out all processes automatically from aspiration of the sample to result output. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ____X____ 4. Specimen Identification: Specimen identification input is manual (by operator) or by barcode reader. 5. Specimen Sampling and Handling: There are two modes of sample introduction: (1) Sampler Mode; (2) Manual Mode. In the Sampler Mode the operator loads the sample tubes into a rack, which is then automatically transported and analyzed by the instrument. This mode automatically mixes, aspirates, and analyzes samples without removing their caps. The Sampler Mode is used for processing of whole blood samples. In the Manual Mode, there are two sample tube holders: (1) Normal sample tube holder; (2) Micro collection tube holder. In this mode the operator loads and mixes the samples tubes individually by hand. The samples in the Manual Mode can be analyzed with the cap on or off. The Manual Mode is used for processing whole blood and body fluid samples. 6. Calibration: The XN CAL calibrator (K160585) is used for calibration of the WBC, RBC, HGB, HCT, PLT and RET parameters. XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Calibration is performed as needed (e.g., when QC data is fluctuating) to ensure accuracy of the system. 7. Quality Control: The XN-L CHECK (K160586) is used as quality control (three levels) for Sysmex XN-L analyzers. XN-L CHECK™ is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), and stabilized platelet component(s) in a preservative medium. XN CHECK (K160590) is used as quality control (three levels) for Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. XN CHECK is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. 3 XN CHECK BF (K160588) is used as quality control (two levels) for Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC- BF, RBC-BF, MN%, PMN%, TC-BF#. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes____X____ or No________ F. Regulatory Information: 1. Regulation section: 21 CFR 864.5220, Automated differential cell counter 2. Classification: Class II 3 Product code: GKZ, Counter, Differential Cell 4. Panel: Hematology (81) G. Intended Use: 1. Indication(s) for Use: The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW- CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended. 2. Special Conditions for Use Statement(s): For prescription use only. H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzer, K112605 4 2. Comparison with Predicate Device: Similarities Item Candidate Sysmex XN-L analyzer K182389 Predicate Sysmex XN-Series (XN-10)a K112605 Intended Use The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC- BF, MN%/#, PMN%/#, and TC- BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial Product code:

idK182389_s0_e2000

K182389.txt

panel

Hematology (81)

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K182389 B. Purpose for Submission: Expand Intended Use to include pediatric subjects under the age of 2 years old. C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Performed: The Sysmex XN-L Automated Hematology Analyzer (hereafter, the XN-L analyzer) classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal (CSF), peritoneal, pleural and synovial fluids. E. System Descriptions: 1. Device Description: The XN-L analyzer is a quantitative multi-parameter automated differential cell counter that classifies and enumerates whole blood and body fluid parameters by means of electrical impedance, laser light scattering, and fluorescent labeling. Cell counts and parameters are performed on whole blood samples collected in K2EDTA or K3EDTA anticoagulant, body fluids (peritoneal, pleural and synovial) collected in K2EDTA anticoagulant and CSF collected without anticoagulant. The instrument consists of two principal units: (1) the Main Unit which will aspirate, dilute, mix, and analyze whole blood and body fluid samples and (2) the Pneumatic Unit which supplies pressure and vacuum to the analyzer. The XN-L analyzer has an external monitor with touch screen capability that is used to operate the instrument and process data from the Main Unit. The monitor also allows for operator interfacing with the instrument by use of a panel keyboard. 2. Principles of Operation: The XN-L analyzer analyzes samples using the following methods: DC Sheath Flow Detection method, Flow Cytometry method using a semiconductor laser, and SLS (cyanide-free sodium lauryl sulfate) hemoglobin method. Particle characterization and identification is based on detection of forward scatter, fluorescence, and adaptive cluster analysis. The XN-L analyzer automatically classifies cells from whole blood and body 2 fluids and carries out all processes automatically from aspiration of the sample to result output. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ____X____ 4. Specimen Identification: Specimen identification input is manual (by operator) or by barcode reader. 5. Specimen Sampling and Handling: There are two modes of sample introduction: (1) Sampler Mode; (2) Manual Mode. In the Sampler Mode the operator loads the sample tubes into a rack, which is then automatically transported and analyzed by the instrument. This mode automatically mixes, aspirates, and analyzes samples without removing their caps. The Sampler Mode is used for processing of whole blood samples. In the Manual Mode, there are two sample tube holders: (1) Normal sample tube holder; (2) Micro collection tube holder. In this mode the operator loads and mixes the samples tubes individually by hand. The samples in the Manual Mode can be analyzed with the cap on or off. The Manual Mode is used for processing whole blood and body fluid samples. 6. Calibration: The XN CAL calibrator (K160585) is used for calibration of the WBC, RBC, HGB, HCT, PLT and RET parameters. XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Calibration is performed as needed (e.g., when QC data is fluctuating) to ensure accuracy of the system. 7. Quality Control: The XN-L CHECK (K160586) is used as quality control (three levels) for Sysmex XN-L analyzers. XN-L CHECK™ is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), and stabilized platelet component(s) in a preservative medium. XN CHECK (K160590) is used as quality control (three levels) for Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. XN CHECK is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. 3 XN CHECK BF (K160588) is used as quality control (two levels) for Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC- BF, RBC-BF, MN%, PMN%, TC-BF#. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes____X____ or No________ F. Regulatory Information: 1. Regulation section: 21 CFR 864.5220, Automated differential cell counter 2. Classification: Class II 3 Product code: GKZ, Counter, Differential Cell 4. Panel: Hematology (81) G. Intended Use: 1. Indication(s) for Use: The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW- CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended. 2. Special Conditions for Use Statement(s): For prescription use only. H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzer, K112605 4 2. Comparison with Predicate Device: Similarities Item Candidate Sysmex XN-L analyzer K182389 Predicate Sysmex XN-Series (XN-10)a K112605 Intended Use The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC- BF, MN%/#, PMN%/#, and TC- BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial Panel:

idK182389_s0_e2000

K182389.txt

predicate device name

Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzer

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K182389 B. Purpose for Submission: Expand Intended Use to include pediatric subjects under the age of 2 years old. C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Performed: The Sysmex XN-L Automated Hematology Analyzer (hereafter, the XN-L analyzer) classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal (CSF), peritoneal, pleural and synovial fluids. E. System Descriptions: 1. Device Description: The XN-L analyzer is a quantitative multi-parameter automated differential cell counter that classifies and enumerates whole blood and body fluid parameters by means of electrical impedance, laser light scattering, and fluorescent labeling. Cell counts and parameters are performed on whole blood samples collected in K2EDTA or K3EDTA anticoagulant, body fluids (peritoneal, pleural and synovial) collected in K2EDTA anticoagulant and CSF collected without anticoagulant. The instrument consists of two principal units: (1) the Main Unit which will aspirate, dilute, mix, and analyze whole blood and body fluid samples and (2) the Pneumatic Unit which supplies pressure and vacuum to the analyzer. The XN-L analyzer has an external monitor with touch screen capability that is used to operate the instrument and process data from the Main Unit. The monitor also allows for operator interfacing with the instrument by use of a panel keyboard. 2. Principles of Operation: The XN-L analyzer analyzes samples using the following methods: DC Sheath Flow Detection method, Flow Cytometry method using a semiconductor laser, and SLS (cyanide-free sodium lauryl sulfate) hemoglobin method. Particle characterization and identification is based on detection of forward scatter, fluorescence, and adaptive cluster analysis. The XN-L analyzer automatically classifies cells from whole blood and body 2 fluids and carries out all processes automatically from aspiration of the sample to result output. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ____X____ 4. Specimen Identification: Specimen identification input is manual (by operator) or by barcode reader. 5. Specimen Sampling and Handling: There are two modes of sample introduction: (1) Sampler Mode; (2) Manual Mode. In the Sampler Mode the operator loads the sample tubes into a rack, which is then automatically transported and analyzed by the instrument. This mode automatically mixes, aspirates, and analyzes samples without removing their caps. The Sampler Mode is used for processing of whole blood samples. In the Manual Mode, there are two sample tube holders: (1) Normal sample tube holder; (2) Micro collection tube holder. In this mode the operator loads and mixes the samples tubes individually by hand. The samples in the Manual Mode can be analyzed with the cap on or off. The Manual Mode is used for processing whole blood and body fluid samples. 6. Calibration: The XN CAL calibrator (K160585) is used for calibration of the WBC, RBC, HGB, HCT, PLT and RET parameters. XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Calibration is performed as needed (e.g., when QC data is fluctuating) to ensure accuracy of the system. 7. Quality Control: The XN-L CHECK (K160586) is used as quality control (three levels) for Sysmex XN-L analyzers. XN-L CHECK™ is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), and stabilized platelet component(s) in a preservative medium. XN CHECK (K160590) is used as quality control (three levels) for Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. XN CHECK is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. 3 XN CHECK BF (K160588) is used as quality control (two levels) for Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC- BF, RBC-BF, MN%, PMN%, TC-BF#. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes____X____ or No________ F. Regulatory Information: 1. Regulation section: 21 CFR 864.5220, Automated differential cell counter 2. Classification: Class II 3 Product code: GKZ, Counter, Differential Cell 4. Panel: Hematology (81) G. Intended Use: 1. Indication(s) for Use: The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW- CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended. 2. Special Conditions for Use Statement(s): For prescription use only. H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzer, K112605 4 2. Comparison with Predicate Device: Similarities Item Candidate Sysmex XN-L analyzer K182389 Predicate Sysmex XN-Series (XN-10)a K112605 Intended Use The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC- BF, MN%/#, PMN%/#, and TC- BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial Predicate device name:

idK182389_s0_e2000

K182389.txt

applicant

Sysmex America Inc.

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K182389 B. Purpose for Submission: Expand Intended Use to include pediatric subjects under the age of 2 years old. C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Performed: The Sysmex XN-L Automated Hematology Analyzer (hereafter, the XN-L analyzer) classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal (CSF), peritoneal, pleural and synovial fluids. E. System Descriptions: 1. Device Description: The XN-L analyzer is a quantitative multi-parameter automated differential cell counter that classifies and enumerates whole blood and body fluid parameters by means of electrical impedance, laser light scattering, and fluorescent labeling. Cell counts and parameters are performed on whole blood samples collected in K2EDTA or K3EDTA anticoagulant, body fluids (peritoneal, pleural and synovial) collected in K2EDTA anticoagulant and CSF collected without anticoagulant. The instrument consists of two principal units: (1) the Main Unit which will aspirate, dilute, mix, and analyze whole blood and body fluid samples and (2) the Pneumatic Unit which supplies pressure and vacuum to the analyzer. The XN-L analyzer has an external monitor with touch screen capability that is used to operate the instrument and process data from the Main Unit. The monitor also allows for operator interfacing with the instrument by use of a panel keyboard. 2. Principles of Operation: The XN-L analyzer analyzes samples using the following methods: DC Sheath Flow Detection method, Flow Cytometry method using a semiconductor laser, and SLS (cyanide-free sodium lauryl sulfate) hemoglobin method. Particle characterization and identification is based on detection of forward scatter, fluorescence, and adaptive cluster analysis. The XN-L analyzer automatically classifies cells from whole blood and body 2 fluids and carries out all processes automatically from aspiration of the sample to result output. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ____X____ 4. Specimen Identification: Specimen identification input is manual (by operator) or by barcode reader. 5. Specimen Sampling and Handling: There are two modes of sample introduction: (1) Sampler Mode; (2) Manual Mode. In the Sampler Mode the operator loads the sample tubes into a rack, which is then automatically transported and analyzed by the instrument. This mode automatically mixes, aspirates, and analyzes samples without removing their caps. The Sampler Mode is used for processing of whole blood samples. In the Manual Mode, there are two sample tube holders: (1) Normal sample tube holder; (2) Micro collection tube holder. In this mode the operator loads and mixes the samples tubes individually by hand. The samples in the Manual Mode can be analyzed with the cap on or off. The Manual Mode is used for processing whole blood and body fluid samples. 6. Calibration: The XN CAL calibrator (K160585) is used for calibration of the WBC, RBC, HGB, HCT, PLT and RET parameters. XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Calibration is performed as needed (e.g., when QC data is fluctuating) to ensure accuracy of the system. 7. Quality Control: The XN-L CHECK (K160586) is used as quality control (three levels) for Sysmex XN-L analyzers. XN-L CHECK™ is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), and stabilized platelet component(s) in a preservative medium. XN CHECK (K160590) is used as quality control (three levels) for Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. XN CHECK is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. 3 XN CHECK BF (K160588) is used as quality control (two levels) for Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC- BF, RBC-BF, MN%, PMN%, TC-BF#. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes____X____ or No________ F. Regulatory Information: 1. Regulation section: 21 CFR 864.5220, Automated differential cell counter 2. Classification: Class II 3 Product code: GKZ, Counter, Differential Cell 4. Panel: Hematology (81) G. Intended Use: 1. Indication(s) for Use: The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW- CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended. 2. Special Conditions for Use Statement(s): For prescription use only. H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzer, K112605 4 2. Comparison with Predicate Device: Similarities Item Candidate Sysmex XN-L analyzer K182389 Predicate Sysmex XN-Series (XN-10)a K112605 Intended Use The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC- BF, MN%/#, PMN%/#, and TC- BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial Applicant:

idK182389_s0_e2000

K182389.txt

regulation section

21 CFR 864.5220, Automated differential cell counter

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K182389 B. Purpose for Submission: Expand Intended Use to include pediatric subjects under the age of 2 years old. C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Performed: The Sysmex XN-L Automated Hematology Analyzer (hereafter, the XN-L analyzer) classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal (CSF), peritoneal, pleural and synovial fluids. E. System Descriptions: 1. Device Description: The XN-L analyzer is a quantitative multi-parameter automated differential cell counter that classifies and enumerates whole blood and body fluid parameters by means of electrical impedance, laser light scattering, and fluorescent labeling. Cell counts and parameters are performed on whole blood samples collected in K2EDTA or K3EDTA anticoagulant, body fluids (peritoneal, pleural and synovial) collected in K2EDTA anticoagulant and CSF collected without anticoagulant. The instrument consists of two principal units: (1) the Main Unit which will aspirate, dilute, mix, and analyze whole blood and body fluid samples and (2) the Pneumatic Unit which supplies pressure and vacuum to the analyzer. The XN-L analyzer has an external monitor with touch screen capability that is used to operate the instrument and process data from the Main Unit. The monitor also allows for operator interfacing with the instrument by use of a panel keyboard. 2. Principles of Operation: The XN-L analyzer analyzes samples using the following methods: DC Sheath Flow Detection method, Flow Cytometry method using a semiconductor laser, and SLS (cyanide-free sodium lauryl sulfate) hemoglobin method. Particle characterization and identification is based on detection of forward scatter, fluorescence, and adaptive cluster analysis. The XN-L analyzer automatically classifies cells from whole blood and body 2 fluids and carries out all processes automatically from aspiration of the sample to result output. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___X_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ____X____ 4. Specimen Identification: Specimen identification input is manual (by operator) or by barcode reader. 5. Specimen Sampling and Handling: There are two modes of sample introduction: (1) Sampler Mode; (2) Manual Mode. In the Sampler Mode the operator loads the sample tubes into a rack, which is then automatically transported and analyzed by the instrument. This mode automatically mixes, aspirates, and analyzes samples without removing their caps. The Sampler Mode is used for processing of whole blood samples. In the Manual Mode, there are two sample tube holders: (1) Normal sample tube holder; (2) Micro collection tube holder. In this mode the operator loads and mixes the samples tubes individually by hand. The samples in the Manual Mode can be analyzed with the cap on or off. The Manual Mode is used for processing whole blood and body fluid samples. 6. Calibration: The XN CAL calibrator (K160585) is used for calibration of the WBC, RBC, HGB, HCT, PLT and RET parameters. XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Calibration is performed as needed (e.g., when QC data is fluctuating) to ensure accuracy of the system. 7. Quality Control: The XN-L CHECK (K160586) is used as quality control (three levels) for Sysmex XN-L analyzers. XN-L CHECK™ is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), and stabilized platelet component(s) in a preservative medium. XN CHECK (K160590) is used as quality control (three levels) for Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. XN CHECK is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. 3 XN CHECK BF (K160588) is used as quality control (two levels) for Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC- BF, RBC-BF, MN%, PMN%, TC-BF#. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes____X____ or No________ F. Regulatory Information: 1. Regulation section: 21 CFR 864.5220, Automated differential cell counter 2. Classification: Class II 3 Product code: GKZ, Counter, Differential Cell 4. Panel: Hematology (81) G. Intended Use: 1. Indication(s) for Use: The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW- CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended. 2. Special Conditions for Use Statement(s): For prescription use only. H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzer, K112605 4 2. Comparison with Predicate Device: Similarities Item Candidate Sysmex XN-L analyzer K182389 Predicate Sysmex XN-Series (XN-10)a K112605 Intended Use The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC- BF, MN%/#, PMN%/#, and TC- BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial Regulation section:

idK182389_s6000_e8000

K182389.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

.0 4.0 – 18.0 4.0 – 19.0 EO x 103/μL 0.0 – 0.4 0.0 – 0.5 0.0 – 0.5 EO % 1.0 – 6.0 1.0 – 7.0 1.0 – 7.0 BASO x 103/μL 0.0 – 0.1 0.0 – 0.1 0.0 – 0.1 BASO % 0.0 – 1.0 0.0 – 1.0 0.0 – 1.0 RET % 0.4 – 3.7 0.4 – 4.8 0.4 – 4.8 RET x 103/μL 35.0 – 120.0 29.0 – 104.0 29.0 – 120.0 RET-He2 pg 23.9 – 30.9 22.5 – 31.8 22.5 – 31.8 IRF % 11.4 – 35.1 11.4 – 35.1 11.4 – 35.1 IG % 0.0 – 1.7 0.0 – 1.7 0.0 – 1.7 IG x 103/μL 0.00 – 0.28 0.00 – 0.28 0.0 – 0.28 1 Combined Reference Intervals (RI) - The lowest and highest value of the above female and male ranges were used to define the lower and upper range for the combined RI for pediatric subgroup birth to <2 years listed in the above table. 11 d. Bridging Studies Refer to K160538 e. Determination of limit of Blank, lower limits of detection and quantitation: Refer to K160538 K. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. L. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK182389_s6000_e8000

K182389.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

– 19.0 4.0 – 18.0 4.0 – 19.0 EO x 103/μL 0.0 – 0.4 0.0 – 0.5 0.0 – 0.5 EO % 1.0 – 6.0 1.0 – 7.0 1.0 – 7.0 BASO x 103/μL 0.0 – 0.1 0.0 – 0.1 0.0 – 0.1 BASO % 0.0 – 1.0 0.0 – 1.0 0.0 – 1.0 RET % 0.4 – 3.7 0.4 – 4.8 0.4 – 4.8 RET x 103/μL 35.0 – 120.0 29.0 – 104.0 29.0 – 120.0 RET-He2 pg 23.9 – 30.9 22.5 – 31.8 22.5 – 31.8 IRF % 11.4 – 35.1 11.4 – 35.1 11.4 – 35.1 IG % 0.0 – 1.7 0.0 – 1.7 0.0 – 1.7 IG x 103/μL 0.00 – 0.28 0.00 – 0.28 0.0 – 0.28 1 Combined Reference Intervals (RI) - The lowest and highest value of the above female and male ranges were used to define the lower and upper range for the combined RI for pediatric subgroup birth to <2 years listed in the above table. 11 d. Bridging Studies Refer to K160538 e. Determination of limit of Blank, lower limits of detection and quantitation: Refer to K160538 K. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. L. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK171974_s0_e2000

K171974.txt

purpose for submission

New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) E. Applicant: Quidel Corporation 2005 East State Street, Suite 100 Athens, OH 45701 USA F. Proprietary and Established Names: Solana RSV+hMPV Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): Primary: OCC Respiratory Viral Panel Multiplex Nucleic Acid Assay Secondary: OEM Human Metapneumovirus (hMPV) RNA Assay System 2 OOI Real Time Nucleic Acid Amplification System 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. 2. Indication(s) for use: As a diagnostic aid in patients with signs and symptoms of respiratory infection. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · For prescription use only 4. Special instrument requirements: Solana Instrument I. Device Description: An aliquot (50 μL) of patient nasal or nasopharyngeal swab specimen collected in viral transport media is transferred to a Process Buffer Tube. One Process Buffer Tube, which contains a competitive process control (PRC), is required for each specimen or control sample to be tested. The tubes are vortexed and heated in a heat block at 95°C for 5 minutes. After a 2nd vortexing step, 50 μL of the heated sample is transferred to a Reaction Tube which rehydrates its contents. The Reaction Tubes are then placed in the Solana instrument 3 for amplification and detection. Upon annealing to RSV, hMPV or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. The Solana software automatically interprets the fluorescent signal and the test results are displayed on the Solana result screen in approximately 40 minutes. The following RSV and hMPV combinations of results may be displayed: Table 1. Interpretation of Results Assay Result Interpretation RSV POSITIVE hMPV NEGATIVE RSV RNA detected RSV NEGATIVE hMPV POSITIVE hMPV RNA detected RSV POSITIVE hMPV POSITIVE RSV RNA detected and hMPV RNA detected RSV NEGATIVE hMPV NEGATIVE No RSV RNA detected/PRC detected and No hMPV RNA detected/PRC detected RSV INVALID hMPV INVALID No RSV or hMPV RNA and No PRC detected; for invalid test results, re-process another aliquot of the same sample or obtain a new sample and re-test. The results may also be printed out via an attached printer. The assay kit contains 48 Process Buffer Tubes and 48 Reaction Tubes. A maximum of 12 tests may be performed in one run. J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra RSV+hMPV Assay 2. Predicate 510(k) number(s): K131813 3. Comparison with predicate: 4 Table 2. Comparison with the predicate Similarities Item Device Predicate Solana RSV+hMPV Assay Lyra RSV+hMPV Assay (k131813) Intended Use The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub- lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Lyra RSV + hMPV Assay is a multiplex Real-Time PCR (RT- PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co- infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Quidel Molecular RSV + hMPV Assay can be performed using either the Life Technologies QuantStudio Dx RT-PCR Instrument, the Applied Biosystems 7500 Fast Dx RT-PCR 5 Similarities Item Device Predicate Instrument, or the Cepheid SmartCycler II System. Sample Types Nasal and nasopharyngeal swabs collected in transport media. Same Detection Technology Automated multiplex assay using fluorescent signal. Same Differences Item Device Predicate Viral Targets RSV: Matrix gene; hMPV: Fusion protein gene RSV: L viral polymerase and NS2 genes hMPV: RNA polymerase gene Amplification Technology Reverse Transcriptase - Helicase- Dependent Amplification (RT- HDA) Real Time RT-PCR-based system Extraction Method No extraction bioMérieux easyMAG Automated Magnetic Extraction Reagents Instrument Solana Life Technologies QuantStudio Dx, the Applied Biosystems 7500 Fast Dx, or the Cepheid SmartCycler II K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay - http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc m180307.htm Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays – https://www.fda.gov/RegulatoryInformation/Guidances/ucm180308.htm Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (Final, 3/13/2007) http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo cuments/ucm071287.pdf Guidance on Informed Consent for In Vitro Diagnostic Device Studies Leftover Human Specimens that are Not Individually Identifiable (April 2006) – http://www.fda.gov/cdrh/oivd/guidance/1588.pdf. Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device (December 2012) 6 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo Purpose for submission:

idK171974_s0_e2000

K171974.txt

measurand

Fusion Protein Gene

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) E. Applicant: Quidel Corporation 2005 East State Street, Suite 100 Athens, OH 45701 USA F. Proprietary and Established Names: Solana RSV+hMPV Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): Primary: OCC Respiratory Viral Panel Multiplex Nucleic Acid Assay Secondary: OEM Human Metapneumovirus (hMPV) RNA Assay System 2 OOI Real Time Nucleic Acid Amplification System 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. 2. Indication(s) for use: As a diagnostic aid in patients with signs and symptoms of respiratory infection. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · For prescription use only 4. Special instrument requirements: Solana Instrument I. Device Description: An aliquot (50 μL) of patient nasal or nasopharyngeal swab specimen collected in viral transport media is transferred to a Process Buffer Tube. One Process Buffer Tube, which contains a competitive process control (PRC), is required for each specimen or control sample to be tested. The tubes are vortexed and heated in a heat block at 95°C for 5 minutes. After a 2nd vortexing step, 50 μL of the heated sample is transferred to a Reaction Tube which rehydrates its contents. The Reaction Tubes are then placed in the Solana instrument 3 for amplification and detection. Upon annealing to RSV, hMPV or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. The Solana software automatically interprets the fluorescent signal and the test results are displayed on the Solana result screen in approximately 40 minutes. The following RSV and hMPV combinations of results may be displayed: Table 1. Interpretation of Results Assay Result Interpretation RSV POSITIVE hMPV NEGATIVE RSV RNA detected RSV NEGATIVE hMPV POSITIVE hMPV RNA detected RSV POSITIVE hMPV POSITIVE RSV RNA detected and hMPV RNA detected RSV NEGATIVE hMPV NEGATIVE No RSV RNA detected/PRC detected and No hMPV RNA detected/PRC detected RSV INVALID hMPV INVALID No RSV or hMPV RNA and No PRC detected; for invalid test results, re-process another aliquot of the same sample or obtain a new sample and re-test. The results may also be printed out via an attached printer. The assay kit contains 48 Process Buffer Tubes and 48 Reaction Tubes. A maximum of 12 tests may be performed in one run. J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra RSV+hMPV Assay 2. Predicate 510(k) number(s): K131813 3. Comparison with predicate: 4 Table 2. Comparison with the predicate Similarities Item Device Predicate Solana RSV+hMPV Assay Lyra RSV+hMPV Assay (k131813) Intended Use The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub- lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Lyra RSV + hMPV Assay is a multiplex Real-Time PCR (RT- PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co- infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Quidel Molecular RSV + hMPV Assay can be performed using either the Life Technologies QuantStudio Dx RT-PCR Instrument, the Applied Biosystems 7500 Fast Dx RT-PCR 5 Similarities Item Device Predicate Instrument, or the Cepheid SmartCycler II System. Sample Types Nasal and nasopharyngeal swabs collected in transport media. Same Detection Technology Automated multiplex assay using fluorescent signal. Same Differences Item Device Predicate Viral Targets RSV: Matrix gene; hMPV: Fusion protein gene RSV: L viral polymerase and NS2 genes hMPV: RNA polymerase gene Amplification Technology Reverse Transcriptase - Helicase- Dependent Amplification (RT- HDA) Real Time RT-PCR-based system Extraction Method No extraction bioMérieux easyMAG Automated Magnetic Extraction Reagents Instrument Solana Life Technologies QuantStudio Dx, the Applied Biosystems 7500 Fast Dx, or the Cepheid SmartCycler II K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay - http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc m180307.htm Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays – https://www.fda.gov/RegulatoryInformation/Guidances/ucm180308.htm Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (Final, 3/13/2007) http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo cuments/ucm071287.pdf Guidance on Informed Consent for In Vitro Diagnostic Device Studies Leftover Human Specimens that are Not Individually Identifiable (April 2006) – http://www.fda.gov/cdrh/oivd/guidance/1588.pdf. Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device (December 2012) 6 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo Measurand:

idK171974_s0_e2000

K171974.txt

type of test

Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA)

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) E. Applicant: Quidel Corporation 2005 East State Street, Suite 100 Athens, OH 45701 USA F. Proprietary and Established Names: Solana RSV+hMPV Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): Primary: OCC Respiratory Viral Panel Multiplex Nucleic Acid Assay Secondary: OEM Human Metapneumovirus (hMPV) RNA Assay System 2 OOI Real Time Nucleic Acid Amplification System 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. 2. Indication(s) for use: As a diagnostic aid in patients with signs and symptoms of respiratory infection. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · For prescription use only 4. Special instrument requirements: Solana Instrument I. Device Description: An aliquot (50 μL) of patient nasal or nasopharyngeal swab specimen collected in viral transport media is transferred to a Process Buffer Tube. One Process Buffer Tube, which contains a competitive process control (PRC), is required for each specimen or control sample to be tested. The tubes are vortexed and heated in a heat block at 95°C for 5 minutes. After a 2nd vortexing step, 50 μL of the heated sample is transferred to a Reaction Tube which rehydrates its contents. The Reaction Tubes are then placed in the Solana instrument 3 for amplification and detection. Upon annealing to RSV, hMPV or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. The Solana software automatically interprets the fluorescent signal and the test results are displayed on the Solana result screen in approximately 40 minutes. The following RSV and hMPV combinations of results may be displayed: Table 1. Interpretation of Results Assay Result Interpretation RSV POSITIVE hMPV NEGATIVE RSV RNA detected RSV NEGATIVE hMPV POSITIVE hMPV RNA detected RSV POSITIVE hMPV POSITIVE RSV RNA detected and hMPV RNA detected RSV NEGATIVE hMPV NEGATIVE No RSV RNA detected/PRC detected and No hMPV RNA detected/PRC detected RSV INVALID hMPV INVALID No RSV or hMPV RNA and No PRC detected; for invalid test results, re-process another aliquot of the same sample or obtain a new sample and re-test. The results may also be printed out via an attached printer. The assay kit contains 48 Process Buffer Tubes and 48 Reaction Tubes. A maximum of 12 tests may be performed in one run. J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra RSV+hMPV Assay 2. Predicate 510(k) number(s): K131813 3. Comparison with predicate: 4 Table 2. Comparison with the predicate Similarities Item Device Predicate Solana RSV+hMPV Assay Lyra RSV+hMPV Assay (k131813) Intended Use The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub- lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Lyra RSV + hMPV Assay is a multiplex Real-Time PCR (RT- PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co- infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Quidel Molecular RSV + hMPV Assay can be performed using either the Life Technologies QuantStudio Dx RT-PCR Instrument, the Applied Biosystems 7500 Fast Dx RT-PCR 5 Similarities Item Device Predicate Instrument, or the Cepheid SmartCycler II System. Sample Types Nasal and nasopharyngeal swabs collected in transport media. Same Detection Technology Automated multiplex assay using fluorescent signal. Same Differences Item Device Predicate Viral Targets RSV: Matrix gene; hMPV: Fusion protein gene RSV: L viral polymerase and NS2 genes hMPV: RNA polymerase gene Amplification Technology Reverse Transcriptase - Helicase- Dependent Amplification (RT- HDA) Real Time RT-PCR-based system Extraction Method No extraction bioMérieux easyMAG Automated Magnetic Extraction Reagents Instrument Solana Life Technologies QuantStudio Dx, the Applied Biosystems 7500 Fast Dx, or the Cepheid SmartCycler II K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay - http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc m180307.htm Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays – https://www.fda.gov/RegulatoryInformation/Guidances/ucm180308.htm Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (Final, 3/13/2007) http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo cuments/ucm071287.pdf Guidance on Informed Consent for In Vitro Diagnostic Device Studies Leftover Human Specimens that are Not Individually Identifiable (April 2006) – http://www.fda.gov/cdrh/oivd/guidance/1588.pdf. Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device (December 2012) 6 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo Type of test:

idK171974_s0_e2000

K171974.txt

classification

Class II

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) E. Applicant: Quidel Corporation 2005 East State Street, Suite 100 Athens, OH 45701 USA F. Proprietary and Established Names: Solana RSV+hMPV Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): Primary: OCC Respiratory Viral Panel Multiplex Nucleic Acid Assay Secondary: OEM Human Metapneumovirus (hMPV) RNA Assay System 2 OOI Real Time Nucleic Acid Amplification System 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. 2. Indication(s) for use: As a diagnostic aid in patients with signs and symptoms of respiratory infection. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · For prescription use only 4. Special instrument requirements: Solana Instrument I. Device Description: An aliquot (50 μL) of patient nasal or nasopharyngeal swab specimen collected in viral transport media is transferred to a Process Buffer Tube. One Process Buffer Tube, which contains a competitive process control (PRC), is required for each specimen or control sample to be tested. The tubes are vortexed and heated in a heat block at 95°C for 5 minutes. After a 2nd vortexing step, 50 μL of the heated sample is transferred to a Reaction Tube which rehydrates its contents. The Reaction Tubes are then placed in the Solana instrument 3 for amplification and detection. Upon annealing to RSV, hMPV or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. The Solana software automatically interprets the fluorescent signal and the test results are displayed on the Solana result screen in approximately 40 minutes. The following RSV and hMPV combinations of results may be displayed: Table 1. Interpretation of Results Assay Result Interpretation RSV POSITIVE hMPV NEGATIVE RSV RNA detected RSV NEGATIVE hMPV POSITIVE hMPV RNA detected RSV POSITIVE hMPV POSITIVE RSV RNA detected and hMPV RNA detected RSV NEGATIVE hMPV NEGATIVE No RSV RNA detected/PRC detected and No hMPV RNA detected/PRC detected RSV INVALID hMPV INVALID No RSV or hMPV RNA and No PRC detected; for invalid test results, re-process another aliquot of the same sample or obtain a new sample and re-test. The results may also be printed out via an attached printer. The assay kit contains 48 Process Buffer Tubes and 48 Reaction Tubes. A maximum of 12 tests may be performed in one run. J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra RSV+hMPV Assay 2. Predicate 510(k) number(s): K131813 3. Comparison with predicate: 4 Table 2. Comparison with the predicate Similarities Item Device Predicate Solana RSV+hMPV Assay Lyra RSV+hMPV Assay (k131813) Intended Use The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub- lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Lyra RSV + hMPV Assay is a multiplex Real-Time PCR (RT- PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co- infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Quidel Molecular RSV + hMPV Assay can be performed using either the Life Technologies QuantStudio Dx RT-PCR Instrument, the Applied Biosystems 7500 Fast Dx RT-PCR 5 Similarities Item Device Predicate Instrument, or the Cepheid SmartCycler II System. Sample Types Nasal and nasopharyngeal swabs collected in transport media. Same Detection Technology Automated multiplex assay using fluorescent signal. Same Differences Item Device Predicate Viral Targets RSV: Matrix gene; hMPV: Fusion protein gene RSV: L viral polymerase and NS2 genes hMPV: RNA polymerase gene Amplification Technology Reverse Transcriptase - Helicase- Dependent Amplification (RT- HDA) Real Time RT-PCR-based system Extraction Method No extraction bioMérieux easyMAG Automated Magnetic Extraction Reagents Instrument Solana Life Technologies QuantStudio Dx, the Applied Biosystems 7500 Fast Dx, or the Cepheid SmartCycler II K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay - http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc m180307.htm Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays – https://www.fda.gov/RegulatoryInformation/Guidances/ucm180308.htm Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (Final, 3/13/2007) http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo cuments/ucm071287.pdf Guidance on Informed Consent for In Vitro Diagnostic Device Studies Leftover Human Specimens that are Not Individually Identifiable (April 2006) – http://www.fda.gov/cdrh/oivd/guidance/1588.pdf. Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device (December 2012) 6 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo Classification:

idK171974_s0_e2000

K171974.txt

panel

Microbiology (83)

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) E. Applicant: Quidel Corporation 2005 East State Street, Suite 100 Athens, OH 45701 USA F. Proprietary and Established Names: Solana RSV+hMPV Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): Primary: OCC Respiratory Viral Panel Multiplex Nucleic Acid Assay Secondary: OEM Human Metapneumovirus (hMPV) RNA Assay System 2 OOI Real Time Nucleic Acid Amplification System 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. 2. Indication(s) for use: As a diagnostic aid in patients with signs and symptoms of respiratory infection. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · For prescription use only 4. Special instrument requirements: Solana Instrument I. Device Description: An aliquot (50 μL) of patient nasal or nasopharyngeal swab specimen collected in viral transport media is transferred to a Process Buffer Tube. One Process Buffer Tube, which contains a competitive process control (PRC), is required for each specimen or control sample to be tested. The tubes are vortexed and heated in a heat block at 95°C for 5 minutes. After a 2nd vortexing step, 50 μL of the heated sample is transferred to a Reaction Tube which rehydrates its contents. The Reaction Tubes are then placed in the Solana instrument 3 for amplification and detection. Upon annealing to RSV, hMPV or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. The Solana software automatically interprets the fluorescent signal and the test results are displayed on the Solana result screen in approximately 40 minutes. The following RSV and hMPV combinations of results may be displayed: Table 1. Interpretation of Results Assay Result Interpretation RSV POSITIVE hMPV NEGATIVE RSV RNA detected RSV NEGATIVE hMPV POSITIVE hMPV RNA detected RSV POSITIVE hMPV POSITIVE RSV RNA detected and hMPV RNA detected RSV NEGATIVE hMPV NEGATIVE No RSV RNA detected/PRC detected and No hMPV RNA detected/PRC detected RSV INVALID hMPV INVALID No RSV or hMPV RNA and No PRC detected; for invalid test results, re-process another aliquot of the same sample or obtain a new sample and re-test. The results may also be printed out via an attached printer. The assay kit contains 48 Process Buffer Tubes and 48 Reaction Tubes. A maximum of 12 tests may be performed in one run. J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra RSV+hMPV Assay 2. Predicate 510(k) number(s): K131813 3. Comparison with predicate: 4 Table 2. Comparison with the predicate Similarities Item Device Predicate Solana RSV+hMPV Assay Lyra RSV+hMPV Assay (k131813) Intended Use The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub- lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Lyra RSV + hMPV Assay is a multiplex Real-Time PCR (RT- PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co- infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Quidel Molecular RSV + hMPV Assay can be performed using either the Life Technologies QuantStudio Dx RT-PCR Instrument, the Applied Biosystems 7500 Fast Dx RT-PCR 5 Similarities Item Device Predicate Instrument, or the Cepheid SmartCycler II System. Sample Types Nasal and nasopharyngeal swabs collected in transport media. Same Detection Technology Automated multiplex assay using fluorescent signal. Same Differences Item Device Predicate Viral Targets RSV: Matrix gene; hMPV: Fusion protein gene RSV: L viral polymerase and NS2 genes hMPV: RNA polymerase gene Amplification Technology Reverse Transcriptase - Helicase- Dependent Amplification (RT- HDA) Real Time RT-PCR-based system Extraction Method No extraction bioMérieux easyMAG Automated Magnetic Extraction Reagents Instrument Solana Life Technologies QuantStudio Dx, the Applied Biosystems 7500 Fast Dx, or the Cepheid SmartCycler II K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay - http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc m180307.htm Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays – https://www.fda.gov/RegulatoryInformation/Guidances/ucm180308.htm Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (Final, 3/13/2007) http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo cuments/ucm071287.pdf Guidance on Informed Consent for In Vitro Diagnostic Device Studies Leftover Human Specimens that are Not Individually Identifiable (April 2006) – http://www.fda.gov/cdrh/oivd/guidance/1588.pdf. Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device (December 2012) 6 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo Panel:

idK171974_s0_e2000

K171974.txt

intended use

The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) E. Applicant: Quidel Corporation 2005 East State Street, Suite 100 Athens, OH 45701 USA F. Proprietary and Established Names: Solana RSV+hMPV Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): Primary: OCC Respiratory Viral Panel Multiplex Nucleic Acid Assay Secondary: OEM Human Metapneumovirus (hMPV) RNA Assay System 2 OOI Real Time Nucleic Acid Amplification System 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. 2. Indication(s) for use: As a diagnostic aid in patients with signs and symptoms of respiratory infection. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · For prescription use only 4. Special instrument requirements: Solana Instrument I. Device Description: An aliquot (50 μL) of patient nasal or nasopharyngeal swab specimen collected in viral transport media is transferred to a Process Buffer Tube. One Process Buffer Tube, which contains a competitive process control (PRC), is required for each specimen or control sample to be tested. The tubes are vortexed and heated in a heat block at 95°C for 5 minutes. After a 2nd vortexing step, 50 μL of the heated sample is transferred to a Reaction Tube which rehydrates its contents. The Reaction Tubes are then placed in the Solana instrument 3 for amplification and detection. Upon annealing to RSV, hMPV or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. The Solana software automatically interprets the fluorescent signal and the test results are displayed on the Solana result screen in approximately 40 minutes. The following RSV and hMPV combinations of results may be displayed: Table 1. Interpretation of Results Assay Result Interpretation RSV POSITIVE hMPV NEGATIVE RSV RNA detected RSV NEGATIVE hMPV POSITIVE hMPV RNA detected RSV POSITIVE hMPV POSITIVE RSV RNA detected and hMPV RNA detected RSV NEGATIVE hMPV NEGATIVE No RSV RNA detected/PRC detected and No hMPV RNA detected/PRC detected RSV INVALID hMPV INVALID No RSV or hMPV RNA and No PRC detected; for invalid test results, re-process another aliquot of the same sample or obtain a new sample and re-test. The results may also be printed out via an attached printer. The assay kit contains 48 Process Buffer Tubes and 48 Reaction Tubes. A maximum of 12 tests may be performed in one run. J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra RSV+hMPV Assay 2. Predicate 510(k) number(s): K131813 3. Comparison with predicate: 4 Table 2. Comparison with the predicate Similarities Item Device Predicate Solana RSV+hMPV Assay Lyra RSV+hMPV Assay (k131813) Intended Use The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub- lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Lyra RSV + hMPV Assay is a multiplex Real-Time PCR (RT- PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co- infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Quidel Molecular RSV + hMPV Assay can be performed using either the Life Technologies QuantStudio Dx RT-PCR Instrument, the Applied Biosystems 7500 Fast Dx RT-PCR 5 Similarities Item Device Predicate Instrument, or the Cepheid SmartCycler II System. Sample Types Nasal and nasopharyngeal swabs collected in transport media. Same Detection Technology Automated multiplex assay using fluorescent signal. Same Differences Item Device Predicate Viral Targets RSV: Matrix gene; hMPV: Fusion protein gene RSV: L viral polymerase and NS2 genes hMPV: RNA polymerase gene Amplification Technology Reverse Transcriptase - Helicase- Dependent Amplification (RT- HDA) Real Time RT-PCR-based system Extraction Method No extraction bioMérieux easyMAG Automated Magnetic Extraction Reagents Instrument Solana Life Technologies QuantStudio Dx, the Applied Biosystems 7500 Fast Dx, or the Cepheid SmartCycler II K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay - http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc m180307.htm Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays – https://www.fda.gov/RegulatoryInformation/Guidances/ucm180308.htm Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (Final, 3/13/2007) http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo cuments/ucm071287.pdf Guidance on Informed Consent for In Vitro Diagnostic Device Studies Leftover Human Specimens that are Not Individually Identifiable (April 2006) – http://www.fda.gov/cdrh/oivd/guidance/1588.pdf. Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device (December 2012) 6 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo Intended use:

idK171974_s0_e2000

K171974.txt

predicate device name

Lyra RSV+hMPV Assay

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) E. Applicant: Quidel Corporation 2005 East State Street, Suite 100 Athens, OH 45701 USA F. Proprietary and Established Names: Solana RSV+hMPV Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): Primary: OCC Respiratory Viral Panel Multiplex Nucleic Acid Assay Secondary: OEM Human Metapneumovirus (hMPV) RNA Assay System 2 OOI Real Time Nucleic Acid Amplification System 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. 2. Indication(s) for use: As a diagnostic aid in patients with signs and symptoms of respiratory infection. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · For prescription use only 4. Special instrument requirements: Solana Instrument I. Device Description: An aliquot (50 μL) of patient nasal or nasopharyngeal swab specimen collected in viral transport media is transferred to a Process Buffer Tube. One Process Buffer Tube, which contains a competitive process control (PRC), is required for each specimen or control sample to be tested. The tubes are vortexed and heated in a heat block at 95°C for 5 minutes. After a 2nd vortexing step, 50 μL of the heated sample is transferred to a Reaction Tube which rehydrates its contents. The Reaction Tubes are then placed in the Solana instrument 3 for amplification and detection. Upon annealing to RSV, hMPV or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. The Solana software automatically interprets the fluorescent signal and the test results are displayed on the Solana result screen in approximately 40 minutes. The following RSV and hMPV combinations of results may be displayed: Table 1. Interpretation of Results Assay Result Interpretation RSV POSITIVE hMPV NEGATIVE RSV RNA detected RSV NEGATIVE hMPV POSITIVE hMPV RNA detected RSV POSITIVE hMPV POSITIVE RSV RNA detected and hMPV RNA detected RSV NEGATIVE hMPV NEGATIVE No RSV RNA detected/PRC detected and No hMPV RNA detected/PRC detected RSV INVALID hMPV INVALID No RSV or hMPV RNA and No PRC detected; for invalid test results, re-process another aliquot of the same sample or obtain a new sample and re-test. The results may also be printed out via an attached printer. The assay kit contains 48 Process Buffer Tubes and 48 Reaction Tubes. A maximum of 12 tests may be performed in one run. J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra RSV+hMPV Assay 2. Predicate 510(k) number(s): K131813 3. Comparison with predicate: 4 Table 2. Comparison with the predicate Similarities Item Device Predicate Solana RSV+hMPV Assay Lyra RSV+hMPV Assay (k131813) Intended Use The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub- lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Lyra RSV + hMPV Assay is a multiplex Real-Time PCR (RT- PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co- infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Quidel Molecular RSV + hMPV Assay can be performed using either the Life Technologies QuantStudio Dx RT-PCR Instrument, the Applied Biosystems 7500 Fast Dx RT-PCR 5 Similarities Item Device Predicate Instrument, or the Cepheid SmartCycler II System. Sample Types Nasal and nasopharyngeal swabs collected in transport media. Same Detection Technology Automated multiplex assay using fluorescent signal. Same Differences Item Device Predicate Viral Targets RSV: Matrix gene; hMPV: Fusion protein gene RSV: L viral polymerase and NS2 genes hMPV: RNA polymerase gene Amplification Technology Reverse Transcriptase - Helicase- Dependent Amplification (RT- HDA) Real Time RT-PCR-based system Extraction Method No extraction bioMérieux easyMAG Automated Magnetic Extraction Reagents Instrument Solana Life Technologies QuantStudio Dx, the Applied Biosystems 7500 Fast Dx, or the Cepheid SmartCycler II K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay - http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc m180307.htm Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays – https://www.fda.gov/RegulatoryInformation/Guidances/ucm180308.htm Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (Final, 3/13/2007) http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo cuments/ucm071287.pdf Guidance on Informed Consent for In Vitro Diagnostic Device Studies Leftover Human Specimens that are Not Individually Identifiable (April 2006) – http://www.fda.gov/cdrh/oivd/guidance/1588.pdf. Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device (December 2012) 6 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo Predicate device name:

idK171974_s0_e2000

K171974.txt

applicant

Quidel Corporation

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) E. Applicant: Quidel Corporation 2005 East State Street, Suite 100 Athens, OH 45701 USA F. Proprietary and Established Names: Solana RSV+hMPV Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): Primary: OCC Respiratory Viral Panel Multiplex Nucleic Acid Assay Secondary: OEM Human Metapneumovirus (hMPV) RNA Assay System 2 OOI Real Time Nucleic Acid Amplification System 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. 2. Indication(s) for use: As a diagnostic aid in patients with signs and symptoms of respiratory infection. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · For prescription use only 4. Special instrument requirements: Solana Instrument I. Device Description: An aliquot (50 μL) of patient nasal or nasopharyngeal swab specimen collected in viral transport media is transferred to a Process Buffer Tube. One Process Buffer Tube, which contains a competitive process control (PRC), is required for each specimen or control sample to be tested. The tubes are vortexed and heated in a heat block at 95°C for 5 minutes. After a 2nd vortexing step, 50 μL of the heated sample is transferred to a Reaction Tube which rehydrates its contents. The Reaction Tubes are then placed in the Solana instrument 3 for amplification and detection. Upon annealing to RSV, hMPV or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. The Solana software automatically interprets the fluorescent signal and the test results are displayed on the Solana result screen in approximately 40 minutes. The following RSV and hMPV combinations of results may be displayed: Table 1. Interpretation of Results Assay Result Interpretation RSV POSITIVE hMPV NEGATIVE RSV RNA detected RSV NEGATIVE hMPV POSITIVE hMPV RNA detected RSV POSITIVE hMPV POSITIVE RSV RNA detected and hMPV RNA detected RSV NEGATIVE hMPV NEGATIVE No RSV RNA detected/PRC detected and No hMPV RNA detected/PRC detected RSV INVALID hMPV INVALID No RSV or hMPV RNA and No PRC detected; for invalid test results, re-process another aliquot of the same sample or obtain a new sample and re-test. The results may also be printed out via an attached printer. The assay kit contains 48 Process Buffer Tubes and 48 Reaction Tubes. A maximum of 12 tests may be performed in one run. J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra RSV+hMPV Assay 2. Predicate 510(k) number(s): K131813 3. Comparison with predicate: 4 Table 2. Comparison with the predicate Similarities Item Device Predicate Solana RSV+hMPV Assay Lyra RSV+hMPV Assay (k131813) Intended Use The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub- lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Lyra RSV + hMPV Assay is a multiplex Real-Time PCR (RT- PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co- infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Quidel Molecular RSV + hMPV Assay can be performed using either the Life Technologies QuantStudio Dx RT-PCR Instrument, the Applied Biosystems 7500 Fast Dx RT-PCR 5 Similarities Item Device Predicate Instrument, or the Cepheid SmartCycler II System. Sample Types Nasal and nasopharyngeal swabs collected in transport media. Same Detection Technology Automated multiplex assay using fluorescent signal. Same Differences Item Device Predicate Viral Targets RSV: Matrix gene; hMPV: Fusion protein gene RSV: L viral polymerase and NS2 genes hMPV: RNA polymerase gene Amplification Technology Reverse Transcriptase - Helicase- Dependent Amplification (RT- HDA) Real Time RT-PCR-based system Extraction Method No extraction bioMérieux easyMAG Automated Magnetic Extraction Reagents Instrument Solana Life Technologies QuantStudio Dx, the Applied Biosystems 7500 Fast Dx, or the Cepheid SmartCycler II K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay - http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc m180307.htm Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays – https://www.fda.gov/RegulatoryInformation/Guidances/ucm180308.htm Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (Final, 3/13/2007) http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo cuments/ucm071287.pdf Guidance on Informed Consent for In Vitro Diagnostic Device Studies Leftover Human Specimens that are Not Individually Identifiable (April 2006) – http://www.fda.gov/cdrh/oivd/guidance/1588.pdf. Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device (December 2012) 6 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo Applicant:

idK171974_s0_e2000

K171974.txt

proprietary and established names

Solana RSV+hMPV Assay

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) E. Applicant: Quidel Corporation 2005 East State Street, Suite 100 Athens, OH 45701 USA F. Proprietary and Established Names: Solana RSV+hMPV Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): Primary: OCC Respiratory Viral Panel Multiplex Nucleic Acid Assay Secondary: OEM Human Metapneumovirus (hMPV) RNA Assay System 2 OOI Real Time Nucleic Acid Amplification System 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. 2. Indication(s) for use: As a diagnostic aid in patients with signs and symptoms of respiratory infection. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · For prescription use only 4. Special instrument requirements: Solana Instrument I. Device Description: An aliquot (50 μL) of patient nasal or nasopharyngeal swab specimen collected in viral transport media is transferred to a Process Buffer Tube. One Process Buffer Tube, which contains a competitive process control (PRC), is required for each specimen or control sample to be tested. The tubes are vortexed and heated in a heat block at 95°C for 5 minutes. After a 2nd vortexing step, 50 μL of the heated sample is transferred to a Reaction Tube which rehydrates its contents. The Reaction Tubes are then placed in the Solana instrument 3 for amplification and detection. Upon annealing to RSV, hMPV or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. The Solana software automatically interprets the fluorescent signal and the test results are displayed on the Solana result screen in approximately 40 minutes. The following RSV and hMPV combinations of results may be displayed: Table 1. Interpretation of Results Assay Result Interpretation RSV POSITIVE hMPV NEGATIVE RSV RNA detected RSV NEGATIVE hMPV POSITIVE hMPV RNA detected RSV POSITIVE hMPV POSITIVE RSV RNA detected and hMPV RNA detected RSV NEGATIVE hMPV NEGATIVE No RSV RNA detected/PRC detected and No hMPV RNA detected/PRC detected RSV INVALID hMPV INVALID No RSV or hMPV RNA and No PRC detected; for invalid test results, re-process another aliquot of the same sample or obtain a new sample and re-test. The results may also be printed out via an attached printer. The assay kit contains 48 Process Buffer Tubes and 48 Reaction Tubes. A maximum of 12 tests may be performed in one run. J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra RSV+hMPV Assay 2. Predicate 510(k) number(s): K131813 3. Comparison with predicate: 4 Table 2. Comparison with the predicate Similarities Item Device Predicate Solana RSV+hMPV Assay Lyra RSV+hMPV Assay (k131813) Intended Use The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub- lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Lyra RSV + hMPV Assay is a multiplex Real-Time PCR (RT- PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co- infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Quidel Molecular RSV + hMPV Assay can be performed using either the Life Technologies QuantStudio Dx RT-PCR Instrument, the Applied Biosystems 7500 Fast Dx RT-PCR 5 Similarities Item Device Predicate Instrument, or the Cepheid SmartCycler II System. Sample Types Nasal and nasopharyngeal swabs collected in transport media. Same Detection Technology Automated multiplex assay using fluorescent signal. Same Differences Item Device Predicate Viral Targets RSV: Matrix gene; hMPV: Fusion protein gene RSV: L viral polymerase and NS2 genes hMPV: RNA polymerase gene Amplification Technology Reverse Transcriptase - Helicase- Dependent Amplification (RT- HDA) Real Time RT-PCR-based system Extraction Method No extraction bioMérieux easyMAG Automated Magnetic Extraction Reagents Instrument Solana Life Technologies QuantStudio Dx, the Applied Biosystems 7500 Fast Dx, or the Cepheid SmartCycler II K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay - http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc m180307.htm Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays – https://www.fda.gov/RegulatoryInformation/Guidances/ucm180308.htm Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (Final, 3/13/2007) http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo cuments/ucm071287.pdf Guidance on Informed Consent for In Vitro Diagnostic Device Studies Leftover Human Specimens that are Not Individually Identifiable (April 2006) – http://www.fda.gov/cdrh/oivd/guidance/1588.pdf. Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device (December 2012) 6 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo Proprietary and established names:

idK171974_s0_e2000

K171974.txt

regulation section

21 CFR 866.3980 Respiratory viral panel multiplex nucleic acid assay

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171974 B. Purpose for Submission: New device; to obtain market clearance for the Solana RSV+hMPV Assay when performed on the Solana instrument. C. Measurand: RSV RNA: Matrix Gene hMPV RNA: Fusion Protein Gene D. Type of Test: Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) E. Applicant: Quidel Corporation 2005 East State Street, Suite 100 Athens, OH 45701 USA F. Proprietary and Established Names: Solana RSV+hMPV Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code(s): Primary: OCC Respiratory Viral Panel Multiplex Nucleic Acid Assay Secondary: OEM Human Metapneumovirus (hMPV) RNA Assay System 2 OOI Real Time Nucleic Acid Amplification System 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. 2. Indication(s) for use: As a diagnostic aid in patients with signs and symptoms of respiratory infection. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · For prescription use only 4. Special instrument requirements: Solana Instrument I. Device Description: An aliquot (50 μL) of patient nasal or nasopharyngeal swab specimen collected in viral transport media is transferred to a Process Buffer Tube. One Process Buffer Tube, which contains a competitive process control (PRC), is required for each specimen or control sample to be tested. The tubes are vortexed and heated in a heat block at 95°C for 5 minutes. After a 2nd vortexing step, 50 μL of the heated sample is transferred to a Reaction Tube which rehydrates its contents. The Reaction Tubes are then placed in the Solana instrument 3 for amplification and detection. Upon annealing to RSV, hMPV or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. The Solana software automatically interprets the fluorescent signal and the test results are displayed on the Solana result screen in approximately 40 minutes. The following RSV and hMPV combinations of results may be displayed: Table 1. Interpretation of Results Assay Result Interpretation RSV POSITIVE hMPV NEGATIVE RSV RNA detected RSV NEGATIVE hMPV POSITIVE hMPV RNA detected RSV POSITIVE hMPV POSITIVE RSV RNA detected and hMPV RNA detected RSV NEGATIVE hMPV NEGATIVE No RSV RNA detected/PRC detected and No hMPV RNA detected/PRC detected RSV INVALID hMPV INVALID No RSV or hMPV RNA and No PRC detected; for invalid test results, re-process another aliquot of the same sample or obtain a new sample and re-test. The results may also be printed out via an attached printer. The assay kit contains 48 Process Buffer Tubes and 48 Reaction Tubes. A maximum of 12 tests may be performed in one run. J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra RSV+hMPV Assay 2. Predicate 510(k) number(s): K131813 3. Comparison with predicate: 4 Table 2. Comparison with the predicate Similarities Item Device Predicate Solana RSV+hMPV Assay Lyra RSV+hMPV Assay (k131813) Intended Use The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub- lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Lyra RSV + hMPV Assay is a multiplex Real-Time PCR (RT- PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co- infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Quidel Molecular RSV + hMPV Assay can be performed using either the Life Technologies QuantStudio Dx RT-PCR Instrument, the Applied Biosystems 7500 Fast Dx RT-PCR 5 Similarities Item Device Predicate Instrument, or the Cepheid SmartCycler II System. Sample Types Nasal and nasopharyngeal swabs collected in transport media. Same Detection Technology Automated multiplex assay using fluorescent signal. Same Differences Item Device Predicate Viral Targets RSV: Matrix gene; hMPV: Fusion protein gene RSV: L viral polymerase and NS2 genes hMPV: RNA polymerase gene Amplification Technology Reverse Transcriptase - Helicase- Dependent Amplification (RT- HDA) Real Time RT-PCR-based system Extraction Method No extraction bioMérieux easyMAG Automated Magnetic Extraction Reagents Instrument Solana Life Technologies QuantStudio Dx, the Applied Biosystems 7500 Fast Dx, or the Cepheid SmartCycler II K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay - http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc m180307.htm Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays – https://www.fda.gov/RegulatoryInformation/Guidances/ucm180308.htm Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (Final, 3/13/2007) http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo cuments/ucm071287.pdf Guidance on Informed Consent for In Vitro Diagnostic Device Studies Leftover Human Specimens that are Not Individually Identifiable (April 2006) – http://www.fda.gov/cdrh/oivd/guidance/1588.pdf. Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device (December 2012) 6 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo Regulation section:

idK171974_s10000_e12000

K171974.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

collected between January and May 2017 were frozen before testing. The majority of samples collected between April and May 2017 were tested fresh. The positivity rate of the Solana RSV+hMPV assay during the study period is shown below for the frozen samples and for the fresh samples, stratified by age. Table 17. Solana RSV+ hMPV Positivity Rate during the Clinical Study Age RSV hMPV Total # Total Positive Prevalence Total Positive Prevalence Fresh Specimens (N=760) (collected Apr-May 2017) <1 year 119 4 3.4% 7 5.9% 1 to 5 years 163 6 3.7% 10 6.1% 6 to 10 years 60 0 0.0% 2 3.3% 11 to 15 years 56 0 0.0% 1 1.8% 16 to 21 years 52 0 0.0% 0 0.0% 22 to 50 years 110 0 0.0% 2 1.8% 51 to 65 years 94 2 2.1% 2 2.1% > 65 years 106 0 0.0% 2 1.9% Frozen Specimens (N=1286) (collected Jan-May 2017) <1 year 116 42 36.2% 8 6.9% 1 to 5 years 227 35 15.4% 20 8.8% 6 to 10 years 126 6 4.8% 9 7.1% 11 to 15 years 69 5 7.2% 3 4.3% 16 to 21 years 57 2 3.5% 0 0.0% 22 to 50 years 248 11 4.4% 9 3.6% 51 to 65 years 165 13 7.9% 5 3.0% > 65 years 278 23 8.3% 9 3.2% 21 N. Instrument Name: Solana Instrument O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ______ or No X__ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ______ or No X__ 2. Software: The Solana instrument platform was originally reviewed under K150868. The additional information was provided in support of the Solana RSV+hMPV Assay and was reviewed and found acceptable. FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes X or No ________ 3. Specimen Identification: Specimens are identified by scanning a barcode or by manual entry. 4. Specimen Sampling and Handling: Swab specimens are collected in viral transport medium. After vortexing, 50μl of the expressed specimen is transferred to a lysis tube. After heat lysis, 50 μl of the specimen is transferred to a reaction tube on the Solana instrument for automated amplification and detection. 5. Calibration: The end user is not required to calibrate the instrument. 22 6. Quality Control: a. Process Control A competitive process control (PRC) is included in the Process Buffer Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC target is amplified by RSV and hMPV specific primers and detected by a PRC specific fluorescence probe. a. External Controls: The external controls are available from Quidel as an accessory to the assay. The control kit includes two vials of Positive Controls (inactivated strains of RSV B and of hMPV8 B2) and one vial of a Negative Control (RSV and hMPV RNA-free matrix). These controls are intended to monitor pre-analytical and environmental factors that could substantially affect reagent integrity or the instrument function. The negative control is used to detect reagent or environmental contamination of the system by RSV or hMPV RNA or amplicons. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: None Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK171974_s10000_e12000

K171974.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

of samples collected between January and May 2017 were frozen before testing. The majority of samples collected between April and May 2017 were tested fresh. The positivity rate of the Solana RSV+hMPV assay during the study period is shown below for the frozen samples and for the fresh samples, stratified by age. Table 17. Solana RSV+ hMPV Positivity Rate during the Clinical Study Age RSV hMPV Total # Total Positive Prevalence Total Positive Prevalence Fresh Specimens (N=760) (collected Apr-May 2017) <1 year 119 4 3.4% 7 5.9% 1 to 5 years 163 6 3.7% 10 6.1% 6 to 10 years 60 0 0.0% 2 3.3% 11 to 15 years 56 0 0.0% 1 1.8% 16 to 21 years 52 0 0.0% 0 0.0% 22 to 50 years 110 0 0.0% 2 1.8% 51 to 65 years 94 2 2.1% 2 2.1% > 65 years 106 0 0.0% 2 1.9% Frozen Specimens (N=1286) (collected Jan-May 2017) <1 year 116 42 36.2% 8 6.9% 1 to 5 years 227 35 15.4% 20 8.8% 6 to 10 years 126 6 4.8% 9 7.1% 11 to 15 years 69 5 7.2% 3 4.3% 16 to 21 years 57 2 3.5% 0 0.0% 22 to 50 years 248 11 4.4% 9 3.6% 51 to 65 years 165 13 7.9% 5 3.0% > 65 years 278 23 8.3% 9 3.2% 21 N. Instrument Name: Solana Instrument O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ______ or No X__ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ______ or No X__ 2. Software: The Solana instrument platform was originally reviewed under K150868. The additional information was provided in support of the Solana RSV+hMPV Assay and was reviewed and found acceptable. FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes X or No ________ 3. Specimen Identification: Specimens are identified by scanning a barcode or by manual entry. 4. Specimen Sampling and Handling: Swab specimens are collected in viral transport medium. After vortexing, 50μl of the expressed specimen is transferred to a lysis tube. After heat lysis, 50 μl of the specimen is transferred to a reaction tube on the Solana instrument for automated amplification and detection. 5. Calibration: The end user is not required to calibrate the instrument. 22 6. Quality Control: a. Process Control A competitive process control (PRC) is included in the Process Buffer Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC target is amplified by RSV and hMPV specific primers and detected by a PRC specific fluorescence probe. a. External Controls: The external controls are available from Quidel as an accessory to the assay. The control kit includes two vials of Positive Controls (inactivated strains of RSV B and of hMPV8 B2) and one vial of a Negative Control (RSV and hMPV RNA-free matrix). These controls are intended to monitor pre-analytical and environmental factors that could substantially affect reagent integrity or the instrument function. The negative control is used to detect reagent or environmental contamination of the system by RSV or hMPV RNA or amplicons. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: None Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK150144_s0_e2000

K150144.txt

purpose for submission

Clearance of a new device

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150144 B. Purpose for Submission: Clearance of a new device C. Measurand: Fibrinogen D. Type of Test: Quality Control Material, Assayed E. Applicant: Affinity Biologicals Inc. F. Proprietary and Established Names: VisuCon-F Low Fibrinogen Control Plasma G. Regulatory Information: 1. Regulation section: 21 CFR §864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: GGN, Plasma, Coagulation Control 4. Panel: 81 (Hematology) 2 H. Intended Use: 1. Intended use(s): The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended “For In Vitro Diagnostic Use”. The intended users of the VisuCon-F Low Fibrinogen Control Plasma are trained laboratory personnel working in clinical laboratories. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Not applicable I. Device Description: The VisuCon-F Low Fibrinogen Control Plasma is a pool of de-fibrinated citrated human plasma collected from a minimum of 10 donors, buffered with 0.02 M HEPES buffer. The VisuCon-F Low Fibrinogen Control Plasma is packaged frozen in boxes containing: 5 x 1mL vials, 25 x 1mL vials or 81 x 1mL vials. J. Substantial Equivalence Information: 1. Predicate device name(s): Precision Biologic Inc., Cryocheck Low Fibrinogen Control 2. Predicate 510(k) number(s): K951823 3 3. Comparison with predicate: Similarities Item Device VisuCon-F Low Fibrinogen Control Plasma Predicate Cryo Check Low Fibrinogen Control Intended Use The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended “For In Vitro Diagnostic Use”. The intended users of the VisuCon-F Low Fibrinogen Control Plasma are trained laboratory personnel working in clinical laboratories. The Cryo√ CheckTM Low Fibrinogen Control is a citrated normal human source plasma recommended for use as an abnormal control in monitoring the precision and accuracy of quantitative clottable fibrinogen assays. Analyte Fibrinogen Same Matrix Citrated human plasma Same Differences Item Device Predicate Storage ≤ -60°C -40°C to -80°C Open-Vial Stability 72 hours at 2–8°C or 8 hours on-board instrument (19–22° C) 72 hours at 2–8°C Packaging 5 x 1.0 mL 25 x 1.0 mL 81 x 1.0 mL 25 vials x 1.0 mL 80 vials x 1.0 mL K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2; Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline, 2nd Edition L. Test Principle: The VisuCon-F Low Fibrinogen control is to be utilized to monitor the performance of 4 fibrinogen assays in the low abnormal range using the Clauss clotting method in mechanical instruments. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility/Precision Study: A reproducibility study was conducted at three sites (one internal and two external), testing three individual lots at each site, two runs per day in triplicate for five non- consecutive days. At each testing site, each of the three VisuCon Low Control lots were tested by one operator using one lot of Diagnostica STA-Fibrinogen Assay (K840211) on STA Compact Analyzer (K093167). All data points from the study were pooled and analyzed in a mixed effect model with lot, test site, day and run treated as random effects. The coefficient of variation (CV) and the standard deviation (SD) for each of the random effects (variance): lot-to-lot, site-to-site, between-day, between-run, within-run and total reproducibility precision was calculated. Results show that data met pre-determined acceptance criteria and demonstrated reproducibility of the VisuCon Low Control under tested conditions. Results of the pooled data are presented below: Instrument: STA Compact Analyzer Source of Variance Standard Deviation (SD) %CV (SD/mean)*100 Lot-to-lot 0.059 7.2% Site-to-site 0.013 1.5% Between-Day 0.006 0.7% Between-Run 0 0% Within-Run (Repeatability) 0.025 3.0% Total Variability 0.07 8.0% Repeatability study/Within-Laboratory Precision Study: Three lots of VisuCon-F Low Fibrinogen Control Plasma were tested on two different Diagnostica Stago STA- Compact Analyzers using the Diagnostica Stago STA-Fibrinogen 5 assay. Testing was conducted in duplicate, two runs per day over a period of 20 days. Data from the repeatability study was pooled (n=480) and analyzed in a mixed effect model with the lot, instrument, day and run treated as random effects. Results show the data met pre-determined acceptance criteria, and are summarized below: 5 Instrument: Diagnostica Stago STA Compact Analyzer Source of Variance SD %CV Lot-to-Lot 0.066 7.8% Instrument-to-Instrument 0.004 0.5% Between-Day 0.005 0.5% Between-Run 0.00 0% Within-Run (Repeatability) 0.027 3.2% Within-Device (total) 0.072 8.4% b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Stability Study: Open Vial Stability Study: The open vial stability study was conducted at the refrigerated temperature of 2°C to 8°C and on-board temperature of 19°C to 22°C, on two lots of VisuCon-F Low Fibrinogen Control plasma. The study demonstrated the VisuCon-F Low Fibrinogen Control Plasma is stable up to 72 hours when stored at 2- 8°C and up to 8 hours at 19-22°C. The study met the pre-determined acceptance criteria. Closed Vial Stability Study: The closed vial stability study was conducted at the storage temperature of ≤ -60°C using three lots of the VisuCon-F Low Fibrinogen Control Plasma. The study demonstrated that the VisuCon-F Low Fibrinogen Control Plasma is stable up to 36 months when stored at or below -60°C. The study met the pre-determined acceptance criteria. Value Assignment: The value assignment for VisuCon-F Low Fibrinogen Control Plasmas were assigned to fibrinogen by testing 20 vials, 5 vials per day over 4 days (n=20). The ranges for the controls were assigned to fibrinogen by calculating and applying ± 2 standard deviations (SD) from the mean. Three lots were tested using the Diagnostica Stago Fibrinogen-5 Assay, which was calibrated against SSC/ISTH Secondary Coagulation Standard. The mean values assigned to each lot met the acceptance criteria and is as follows: 6 Lot 1 Vial Day 1 (g/L) Day 2 (g/L) Day 3 (g/L) Day 4 (g/L) 1 0.81 0.81 0.81 0.80 2 0.78 0.78 0.77 0.77 3 0.82 0.80 0.77 0.76 4 0.79 0.78 0.77 0.82 5 0.77 0.81 0.79 0.81 Overall Mean 0.79 g/L Overall SD 0.019 Overall %CV 2.41% Assigned range 0.75 – 0.83 g/L Lot 2 Vial Day 1 (g/L) Day 2 (g/L) Day 3 (g/L) Day 4 (g/L) 1 0.82 0.82 0.82 0.83 2 0.82 0.84 0. Purpose for submission:

idK150144_s0_e2000

K150144.txt

measurand

Fibrinogen

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150144 B. Purpose for Submission: Clearance of a new device C. Measurand: Fibrinogen D. Type of Test: Quality Control Material, Assayed E. Applicant: Affinity Biologicals Inc. F. Proprietary and Established Names: VisuCon-F Low Fibrinogen Control Plasma G. Regulatory Information: 1. Regulation section: 21 CFR §864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: GGN, Plasma, Coagulation Control 4. Panel: 81 (Hematology) 2 H. Intended Use: 1. Intended use(s): The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended “For In Vitro Diagnostic Use”. The intended users of the VisuCon-F Low Fibrinogen Control Plasma are trained laboratory personnel working in clinical laboratories. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Not applicable I. Device Description: The VisuCon-F Low Fibrinogen Control Plasma is a pool of de-fibrinated citrated human plasma collected from a minimum of 10 donors, buffered with 0.02 M HEPES buffer. The VisuCon-F Low Fibrinogen Control Plasma is packaged frozen in boxes containing: 5 x 1mL vials, 25 x 1mL vials or 81 x 1mL vials. J. Substantial Equivalence Information: 1. Predicate device name(s): Precision Biologic Inc., Cryocheck Low Fibrinogen Control 2. Predicate 510(k) number(s): K951823 3 3. Comparison with predicate: Similarities Item Device VisuCon-F Low Fibrinogen Control Plasma Predicate Cryo Check Low Fibrinogen Control Intended Use The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended “For In Vitro Diagnostic Use”. The intended users of the VisuCon-F Low Fibrinogen Control Plasma are trained laboratory personnel working in clinical laboratories. The Cryo√ CheckTM Low Fibrinogen Control is a citrated normal human source plasma recommended for use as an abnormal control in monitoring the precision and accuracy of quantitative clottable fibrinogen assays. Analyte Fibrinogen Same Matrix Citrated human plasma Same Differences Item Device Predicate Storage ≤ -60°C -40°C to -80°C Open-Vial Stability 72 hours at 2–8°C or 8 hours on-board instrument (19–22° C) 72 hours at 2–8°C Packaging 5 x 1.0 mL 25 x 1.0 mL 81 x 1.0 mL 25 vials x 1.0 mL 80 vials x 1.0 mL K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2; Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline, 2nd Edition L. Test Principle: The VisuCon-F Low Fibrinogen control is to be utilized to monitor the performance of 4 fibrinogen assays in the low abnormal range using the Clauss clotting method in mechanical instruments. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility/Precision Study: A reproducibility study was conducted at three sites (one internal and two external), testing three individual lots at each site, two runs per day in triplicate for five non- consecutive days. At each testing site, each of the three VisuCon Low Control lots were tested by one operator using one lot of Diagnostica STA-Fibrinogen Assay (K840211) on STA Compact Analyzer (K093167). All data points from the study were pooled and analyzed in a mixed effect model with lot, test site, day and run treated as random effects. The coefficient of variation (CV) and the standard deviation (SD) for each of the random effects (variance): lot-to-lot, site-to-site, between-day, between-run, within-run and total reproducibility precision was calculated. Results show that data met pre-determined acceptance criteria and demonstrated reproducibility of the VisuCon Low Control under tested conditions. Results of the pooled data are presented below: Instrument: STA Compact Analyzer Source of Variance Standard Deviation (SD) %CV (SD/mean)*100 Lot-to-lot 0.059 7.2% Site-to-site 0.013 1.5% Between-Day 0.006 0.7% Between-Run 0 0% Within-Run (Repeatability) 0.025 3.0% Total Variability 0.07 8.0% Repeatability study/Within-Laboratory Precision Study: Three lots of VisuCon-F Low Fibrinogen Control Plasma were tested on two different Diagnostica Stago STA- Compact Analyzers using the Diagnostica Stago STA-Fibrinogen 5 assay. Testing was conducted in duplicate, two runs per day over a period of 20 days. Data from the repeatability study was pooled (n=480) and analyzed in a mixed effect model with the lot, instrument, day and run treated as random effects. Results show the data met pre-determined acceptance criteria, and are summarized below: 5 Instrument: Diagnostica Stago STA Compact Analyzer Source of Variance SD %CV Lot-to-Lot 0.066 7.8% Instrument-to-Instrument 0.004 0.5% Between-Day 0.005 0.5% Between-Run 0.00 0% Within-Run (Repeatability) 0.027 3.2% Within-Device (total) 0.072 8.4% b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Stability Study: Open Vial Stability Study: The open vial stability study was conducted at the refrigerated temperature of 2°C to 8°C and on-board temperature of 19°C to 22°C, on two lots of VisuCon-F Low Fibrinogen Control plasma. The study demonstrated the VisuCon-F Low Fibrinogen Control Plasma is stable up to 72 hours when stored at 2- 8°C and up to 8 hours at 19-22°C. The study met the pre-determined acceptance criteria. Closed Vial Stability Study: The closed vial stability study was conducted at the storage temperature of ≤ -60°C using three lots of the VisuCon-F Low Fibrinogen Control Plasma. The study demonstrated that the VisuCon-F Low Fibrinogen Control Plasma is stable up to 36 months when stored at or below -60°C. The study met the pre-determined acceptance criteria. Value Assignment: The value assignment for VisuCon-F Low Fibrinogen Control Plasmas were assigned to fibrinogen by testing 20 vials, 5 vials per day over 4 days (n=20). The ranges for the controls were assigned to fibrinogen by calculating and applying ± 2 standard deviations (SD) from the mean. Three lots were tested using the Diagnostica Stago Fibrinogen-5 Assay, which was calibrated against SSC/ISTH Secondary Coagulation Standard. The mean values assigned to each lot met the acceptance criteria and is as follows: 6 Lot 1 Vial Day 1 (g/L) Day 2 (g/L) Day 3 (g/L) Day 4 (g/L) 1 0.81 0.81 0.81 0.80 2 0.78 0.78 0.77 0.77 3 0.82 0.80 0.77 0.76 4 0.79 0.78 0.77 0.82 5 0.77 0.81 0.79 0.81 Overall Mean 0.79 g/L Overall SD 0.019 Overall %CV 2.41% Assigned range 0.75 – 0.83 g/L Lot 2 Vial Day 1 (g/L) Day 2 (g/L) Day 3 (g/L) Day 4 (g/L) 1 0.82 0.82 0.82 0.83 2 0.82 0.84 0. Measurand:

idK150144_s0_e2000

K150144.txt

type of test

Quality Control Material, Assayed

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150144 B. Purpose for Submission: Clearance of a new device C. Measurand: Fibrinogen D. Type of Test: Quality Control Material, Assayed E. Applicant: Affinity Biologicals Inc. F. Proprietary and Established Names: VisuCon-F Low Fibrinogen Control Plasma G. Regulatory Information: 1. Regulation section: 21 CFR §864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: GGN, Plasma, Coagulation Control 4. Panel: 81 (Hematology) 2 H. Intended Use: 1. Intended use(s): The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended “For In Vitro Diagnostic Use”. The intended users of the VisuCon-F Low Fibrinogen Control Plasma are trained laboratory personnel working in clinical laboratories. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Not applicable I. Device Description: The VisuCon-F Low Fibrinogen Control Plasma is a pool of de-fibrinated citrated human plasma collected from a minimum of 10 donors, buffered with 0.02 M HEPES buffer. The VisuCon-F Low Fibrinogen Control Plasma is packaged frozen in boxes containing: 5 x 1mL vials, 25 x 1mL vials or 81 x 1mL vials. J. Substantial Equivalence Information: 1. Predicate device name(s): Precision Biologic Inc., Cryocheck Low Fibrinogen Control 2. Predicate 510(k) number(s): K951823 3 3. Comparison with predicate: Similarities Item Device VisuCon-F Low Fibrinogen Control Plasma Predicate Cryo Check Low Fibrinogen Control Intended Use The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended “For In Vitro Diagnostic Use”. The intended users of the VisuCon-F Low Fibrinogen Control Plasma are trained laboratory personnel working in clinical laboratories. The Cryo√ CheckTM Low Fibrinogen Control is a citrated normal human source plasma recommended for use as an abnormal control in monitoring the precision and accuracy of quantitative clottable fibrinogen assays. Analyte Fibrinogen Same Matrix Citrated human plasma Same Differences Item Device Predicate Storage ≤ -60°C -40°C to -80°C Open-Vial Stability 72 hours at 2–8°C or 8 hours on-board instrument (19–22° C) 72 hours at 2–8°C Packaging 5 x 1.0 mL 25 x 1.0 mL 81 x 1.0 mL 25 vials x 1.0 mL 80 vials x 1.0 mL K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2; Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline, 2nd Edition L. Test Principle: The VisuCon-F Low Fibrinogen control is to be utilized to monitor the performance of 4 fibrinogen assays in the low abnormal range using the Clauss clotting method in mechanical instruments. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility/Precision Study: A reproducibility study was conducted at three sites (one internal and two external), testing three individual lots at each site, two runs per day in triplicate for five non- consecutive days. At each testing site, each of the three VisuCon Low Control lots were tested by one operator using one lot of Diagnostica STA-Fibrinogen Assay (K840211) on STA Compact Analyzer (K093167). All data points from the study were pooled and analyzed in a mixed effect model with lot, test site, day and run treated as random effects. The coefficient of variation (CV) and the standard deviation (SD) for each of the random effects (variance): lot-to-lot, site-to-site, between-day, between-run, within-run and total reproducibility precision was calculated. Results show that data met pre-determined acceptance criteria and demonstrated reproducibility of the VisuCon Low Control under tested conditions. Results of the pooled data are presented below: Instrument: STA Compact Analyzer Source of Variance Standard Deviation (SD) %CV (SD/mean)*100 Lot-to-lot 0.059 7.2% Site-to-site 0.013 1.5% Between-Day 0.006 0.7% Between-Run 0 0% Within-Run (Repeatability) 0.025 3.0% Total Variability 0.07 8.0% Repeatability study/Within-Laboratory Precision Study: Three lots of VisuCon-F Low Fibrinogen Control Plasma were tested on two different Diagnostica Stago STA- Compact Analyzers using the Diagnostica Stago STA-Fibrinogen 5 assay. Testing was conducted in duplicate, two runs per day over a period of 20 days. Data from the repeatability study was pooled (n=480) and analyzed in a mixed effect model with the lot, instrument, day and run treated as random effects. Results show the data met pre-determined acceptance criteria, and are summarized below: 5 Instrument: Diagnostica Stago STA Compact Analyzer Source of Variance SD %CV Lot-to-Lot 0.066 7.8% Instrument-to-Instrument 0.004 0.5% Between-Day 0.005 0.5% Between-Run 0.00 0% Within-Run (Repeatability) 0.027 3.2% Within-Device (total) 0.072 8.4% b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Stability Study: Open Vial Stability Study: The open vial stability study was conducted at the refrigerated temperature of 2°C to 8°C and on-board temperature of 19°C to 22°C, on two lots of VisuCon-F Low Fibrinogen Control plasma. The study demonstrated the VisuCon-F Low Fibrinogen Control Plasma is stable up to 72 hours when stored at 2- 8°C and up to 8 hours at 19-22°C. The study met the pre-determined acceptance criteria. Closed Vial Stability Study: The closed vial stability study was conducted at the storage temperature of ≤ -60°C using three lots of the VisuCon-F Low Fibrinogen Control Plasma. The study demonstrated that the VisuCon-F Low Fibrinogen Control Plasma is stable up to 36 months when stored at or below -60°C. The study met the pre-determined acceptance criteria. Value Assignment: The value assignment for VisuCon-F Low Fibrinogen Control Plasmas were assigned to fibrinogen by testing 20 vials, 5 vials per day over 4 days (n=20). The ranges for the controls were assigned to fibrinogen by calculating and applying ± 2 standard deviations (SD) from the mean. Three lots were tested using the Diagnostica Stago Fibrinogen-5 Assay, which was calibrated against SSC/ISTH Secondary Coagulation Standard. The mean values assigned to each lot met the acceptance criteria and is as follows: 6 Lot 1 Vial Day 1 (g/L) Day 2 (g/L) Day 3 (g/L) Day 4 (g/L) 1 0.81 0.81 0.81 0.80 2 0.78 0.78 0.77 0.77 3 0.82 0.80 0.77 0.76 4 0.79 0.78 0.77 0.82 5 0.77 0.81 0.79 0.81 Overall Mean 0.79 g/L Overall SD 0.019 Overall %CV 2.41% Assigned range 0.75 – 0.83 g/L Lot 2 Vial Day 1 (g/L) Day 2 (g/L) Day 3 (g/L) Day 4 (g/L) 1 0.82 0.82 0.82 0.83 2 0.82 0.84 0. Type of test:

idK150144_s0_e2000

K150144.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150144 B. Purpose for Submission: Clearance of a new device C. Measurand: Fibrinogen D. Type of Test: Quality Control Material, Assayed E. Applicant: Affinity Biologicals Inc. F. Proprietary and Established Names: VisuCon-F Low Fibrinogen Control Plasma G. Regulatory Information: 1. Regulation section: 21 CFR §864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: GGN, Plasma, Coagulation Control 4. Panel: 81 (Hematology) 2 H. Intended Use: 1. Intended use(s): The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended “For In Vitro Diagnostic Use”. The intended users of the VisuCon-F Low Fibrinogen Control Plasma are trained laboratory personnel working in clinical laboratories. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Not applicable I. Device Description: The VisuCon-F Low Fibrinogen Control Plasma is a pool of de-fibrinated citrated human plasma collected from a minimum of 10 donors, buffered with 0.02 M HEPES buffer. The VisuCon-F Low Fibrinogen Control Plasma is packaged frozen in boxes containing: 5 x 1mL vials, 25 x 1mL vials or 81 x 1mL vials. J. Substantial Equivalence Information: 1. Predicate device name(s): Precision Biologic Inc., Cryocheck Low Fibrinogen Control 2. Predicate 510(k) number(s): K951823 3 3. Comparison with predicate: Similarities Item Device VisuCon-F Low Fibrinogen Control Plasma Predicate Cryo Check Low Fibrinogen Control Intended Use The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended “For In Vitro Diagnostic Use”. The intended users of the VisuCon-F Low Fibrinogen Control Plasma are trained laboratory personnel working in clinical laboratories. The Cryo√ CheckTM Low Fibrinogen Control is a citrated normal human source plasma recommended for use as an abnormal control in monitoring the precision and accuracy of quantitative clottable fibrinogen assays. Analyte Fibrinogen Same Matrix Citrated human plasma Same Differences Item Device Predicate Storage ≤ -60°C -40°C to -80°C Open-Vial Stability 72 hours at 2–8°C or 8 hours on-board instrument (19–22° C) 72 hours at 2–8°C Packaging 5 x 1.0 mL 25 x 1.0 mL 81 x 1.0 mL 25 vials x 1.0 mL 80 vials x 1.0 mL K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2; Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline, 2nd Edition L. Test Principle: The VisuCon-F Low Fibrinogen control is to be utilized to monitor the performance of 4 fibrinogen assays in the low abnormal range using the Clauss clotting method in mechanical instruments. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility/Precision Study: A reproducibility study was conducted at three sites (one internal and two external), testing three individual lots at each site, two runs per day in triplicate for five non- consecutive days. At each testing site, each of the three VisuCon Low Control lots were tested by one operator using one lot of Diagnostica STA-Fibrinogen Assay (K840211) on STA Compact Analyzer (K093167). All data points from the study were pooled and analyzed in a mixed effect model with lot, test site, day and run treated as random effects. The coefficient of variation (CV) and the standard deviation (SD) for each of the random effects (variance): lot-to-lot, site-to-site, between-day, between-run, within-run and total reproducibility precision was calculated. Results show that data met pre-determined acceptance criteria and demonstrated reproducibility of the VisuCon Low Control under tested conditions. Results of the pooled data are presented below: Instrument: STA Compact Analyzer Source of Variance Standard Deviation (SD) %CV (SD/mean)*100 Lot-to-lot 0.059 7.2% Site-to-site 0.013 1.5% Between-Day 0.006 0.7% Between-Run 0 0% Within-Run (Repeatability) 0.025 3.0% Total Variability 0.07 8.0% Repeatability study/Within-Laboratory Precision Study: Three lots of VisuCon-F Low Fibrinogen Control Plasma were tested on two different Diagnostica Stago STA- Compact Analyzers using the Diagnostica Stago STA-Fibrinogen 5 assay. Testing was conducted in duplicate, two runs per day over a period of 20 days. Data from the repeatability study was pooled (n=480) and analyzed in a mixed effect model with the lot, instrument, day and run treated as random effects. Results show the data met pre-determined acceptance criteria, and are summarized below: 5 Instrument: Diagnostica Stago STA Compact Analyzer Source of Variance SD %CV Lot-to-Lot 0.066 7.8% Instrument-to-Instrument 0.004 0.5% Between-Day 0.005 0.5% Between-Run 0.00 0% Within-Run (Repeatability) 0.027 3.2% Within-Device (total) 0.072 8.4% b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Stability Study: Open Vial Stability Study: The open vial stability study was conducted at the refrigerated temperature of 2°C to 8°C and on-board temperature of 19°C to 22°C, on two lots of VisuCon-F Low Fibrinogen Control plasma. The study demonstrated the VisuCon-F Low Fibrinogen Control Plasma is stable up to 72 hours when stored at 2- 8°C and up to 8 hours at 19-22°C. The study met the pre-determined acceptance criteria. Closed Vial Stability Study: The closed vial stability study was conducted at the storage temperature of ≤ -60°C using three lots of the VisuCon-F Low Fibrinogen Control Plasma. The study demonstrated that the VisuCon-F Low Fibrinogen Control Plasma is stable up to 36 months when stored at or below -60°C. The study met the pre-determined acceptance criteria. Value Assignment: The value assignment for VisuCon-F Low Fibrinogen Control Plasmas were assigned to fibrinogen by testing 20 vials, 5 vials per day over 4 days (n=20). The ranges for the controls were assigned to fibrinogen by calculating and applying ± 2 standard deviations (SD) from the mean. Three lots were tested using the Diagnostica Stago Fibrinogen-5 Assay, which was calibrated against SSC/ISTH Secondary Coagulation Standard. The mean values assigned to each lot met the acceptance criteria and is as follows: 6 Lot 1 Vial Day 1 (g/L) Day 2 (g/L) Day 3 (g/L) Day 4 (g/L) 1 0.81 0.81 0.81 0.80 2 0.78 0.78 0.77 0.77 3 0.82 0.80 0.77 0.76 4 0.79 0.78 0.77 0.82 5 0.77 0.81 0.79 0.81 Overall Mean 0.79 g/L Overall SD 0.019 Overall %CV 2.41% Assigned range 0.75 – 0.83 g/L Lot 2 Vial Day 1 (g/L) Day 2 (g/L) Day 3 (g/L) Day 4 (g/L) 1 0.82 0.82 0.82 0.83 2 0.82 0.84 0. Classification:

idK150144_s0_e2000

K150144.txt

product code

GGN, Plasma, Coagulation Control

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150144 B. Purpose for Submission: Clearance of a new device C. Measurand: Fibrinogen D. Type of Test: Quality Control Material, Assayed E. Applicant: Affinity Biologicals Inc. F. Proprietary and Established Names: VisuCon-F Low Fibrinogen Control Plasma G. Regulatory Information: 1. Regulation section: 21 CFR §864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: GGN, Plasma, Coagulation Control 4. Panel: 81 (Hematology) 2 H. Intended Use: 1. Intended use(s): The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended “For In Vitro Diagnostic Use”. The intended users of the VisuCon-F Low Fibrinogen Control Plasma are trained laboratory personnel working in clinical laboratories. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Not applicable I. Device Description: The VisuCon-F Low Fibrinogen Control Plasma is a pool of de-fibrinated citrated human plasma collected from a minimum of 10 donors, buffered with 0.02 M HEPES buffer. The VisuCon-F Low Fibrinogen Control Plasma is packaged frozen in boxes containing: 5 x 1mL vials, 25 x 1mL vials or 81 x 1mL vials. J. Substantial Equivalence Information: 1. Predicate device name(s): Precision Biologic Inc., Cryocheck Low Fibrinogen Control 2. Predicate 510(k) number(s): K951823 3 3. Comparison with predicate: Similarities Item Device VisuCon-F Low Fibrinogen Control Plasma Predicate Cryo Check Low Fibrinogen Control Intended Use The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended “For In Vitro Diagnostic Use”. The intended users of the VisuCon-F Low Fibrinogen Control Plasma are trained laboratory personnel working in clinical laboratories. The Cryo√ CheckTM Low Fibrinogen Control is a citrated normal human source plasma recommended for use as an abnormal control in monitoring the precision and accuracy of quantitative clottable fibrinogen assays. Analyte Fibrinogen Same Matrix Citrated human plasma Same Differences Item Device Predicate Storage ≤ -60°C -40°C to -80°C Open-Vial Stability 72 hours at 2–8°C or 8 hours on-board instrument (19–22° C) 72 hours at 2–8°C Packaging 5 x 1.0 mL 25 x 1.0 mL 81 x 1.0 mL 25 vials x 1.0 mL 80 vials x 1.0 mL K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2; Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline, 2nd Edition L. Test Principle: The VisuCon-F Low Fibrinogen control is to be utilized to monitor the performance of 4 fibrinogen assays in the low abnormal range using the Clauss clotting method in mechanical instruments. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility/Precision Study: A reproducibility study was conducted at three sites (one internal and two external), testing three individual lots at each site, two runs per day in triplicate for five non- consecutive days. At each testing site, each of the three VisuCon Low Control lots were tested by one operator using one lot of Diagnostica STA-Fibrinogen Assay (K840211) on STA Compact Analyzer (K093167). All data points from the study were pooled and analyzed in a mixed effect model with lot, test site, day and run treated as random effects. The coefficient of variation (CV) and the standard deviation (SD) for each of the random effects (variance): lot-to-lot, site-to-site, between-day, between-run, within-run and total reproducibility precision was calculated. Results show that data met pre-determined acceptance criteria and demonstrated reproducibility of the VisuCon Low Control under tested conditions. Results of the pooled data are presented below: Instrument: STA Compact Analyzer Source of Variance Standard Deviation (SD) %CV (SD/mean)*100 Lot-to-lot 0.059 7.2% Site-to-site 0.013 1.5% Between-Day 0.006 0.7% Between-Run 0 0% Within-Run (Repeatability) 0.025 3.0% Total Variability 0.07 8.0% Repeatability study/Within-Laboratory Precision Study: Three lots of VisuCon-F Low Fibrinogen Control Plasma were tested on two different Diagnostica Stago STA- Compact Analyzers using the Diagnostica Stago STA-Fibrinogen 5 assay. Testing was conducted in duplicate, two runs per day over a period of 20 days. Data from the repeatability study was pooled (n=480) and analyzed in a mixed effect model with the lot, instrument, day and run treated as random effects. Results show the data met pre-determined acceptance criteria, and are summarized below: 5 Instrument: Diagnostica Stago STA Compact Analyzer Source of Variance SD %CV Lot-to-Lot 0.066 7.8% Instrument-to-Instrument 0.004 0.5% Between-Day 0.005 0.5% Between-Run 0.00 0% Within-Run (Repeatability) 0.027 3.2% Within-Device (total) 0.072 8.4% b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Stability Study: Open Vial Stability Study: The open vial stability study was conducted at the refrigerated temperature of 2°C to 8°C and on-board temperature of 19°C to 22°C, on two lots of VisuCon-F Low Fibrinogen Control plasma. The study demonstrated the VisuCon-F Low Fibrinogen Control Plasma is stable up to 72 hours when stored at 2- 8°C and up to 8 hours at 19-22°C. The study met the pre-determined acceptance criteria. Closed Vial Stability Study: The closed vial stability study was conducted at the storage temperature of ≤ -60°C using three lots of the VisuCon-F Low Fibrinogen Control Plasma. The study demonstrated that the VisuCon-F Low Fibrinogen Control Plasma is stable up to 36 months when stored at or below -60°C. The study met the pre-determined acceptance criteria. Value Assignment: The value assignment for VisuCon-F Low Fibrinogen Control Plasmas were assigned to fibrinogen by testing 20 vials, 5 vials per day over 4 days (n=20). The ranges for the controls were assigned to fibrinogen by calculating and applying ± 2 standard deviations (SD) from the mean. Three lots were tested using the Diagnostica Stago Fibrinogen-5 Assay, which was calibrated against SSC/ISTH Secondary Coagulation Standard. The mean values assigned to each lot met the acceptance criteria and is as follows: 6 Lot 1 Vial Day 1 (g/L) Day 2 (g/L) Day 3 (g/L) Day 4 (g/L) 1 0.81 0.81 0.81 0.80 2 0.78 0.78 0.77 0.77 3 0.82 0.80 0.77 0.76 4 0.79 0.78 0.77 0.82 5 0.77 0.81 0.79 0.81 Overall Mean 0.79 g/L Overall SD 0.019 Overall %CV 2.41% Assigned range 0.75 – 0.83 g/L Lot 2 Vial Day 1 (g/L) Day 2 (g/L) Day 3 (g/L) Day 4 (g/L) 1 0.82 0.82 0.82 0.83 2 0.82 0.84 0. Product code:

idK150144_s0_e2000

K150144.txt

panel

81 (Hematology)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150144 B. Purpose for Submission: Clearance of a new device C. Measurand: Fibrinogen D. Type of Test: Quality Control Material, Assayed E. Applicant: Affinity Biologicals Inc. F. Proprietary and Established Names: VisuCon-F Low Fibrinogen Control Plasma G. Regulatory Information: 1. Regulation section: 21 CFR §864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: GGN, Plasma, Coagulation Control 4. Panel: 81 (Hematology) 2 H. Intended Use: 1. Intended use(s): The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended “For In Vitro Diagnostic Use”. The intended users of the VisuCon-F Low Fibrinogen Control Plasma are trained laboratory personnel working in clinical laboratories. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Not applicable I. Device Description: The VisuCon-F Low Fibrinogen Control Plasma is a pool of de-fibrinated citrated human plasma collected from a minimum of 10 donors, buffered with 0.02 M HEPES buffer. The VisuCon-F Low Fibrinogen Control Plasma is packaged frozen in boxes containing: 5 x 1mL vials, 25 x 1mL vials or 81 x 1mL vials. J. Substantial Equivalence Information: 1. Predicate device name(s): Precision Biologic Inc., Cryocheck Low Fibrinogen Control 2. Predicate 510(k) number(s): K951823 3 3. Comparison with predicate: Similarities Item Device VisuCon-F Low Fibrinogen Control Plasma Predicate Cryo Check Low Fibrinogen Control Intended Use The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended “For In Vitro Diagnostic Use”. The intended users of the VisuCon-F Low Fibrinogen Control Plasma are trained laboratory personnel working in clinical laboratories. The Cryo√ CheckTM Low Fibrinogen Control is a citrated normal human source plasma recommended for use as an abnormal control in monitoring the precision and accuracy of quantitative clottable fibrinogen assays. Analyte Fibrinogen Same Matrix Citrated human plasma Same Differences Item Device Predicate Storage ≤ -60°C -40°C to -80°C Open-Vial Stability 72 hours at 2–8°C or 8 hours on-board instrument (19–22° C) 72 hours at 2–8°C Packaging 5 x 1.0 mL 25 x 1.0 mL 81 x 1.0 mL 25 vials x 1.0 mL 80 vials x 1.0 mL K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2; Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline, 2nd Edition L. Test Principle: The VisuCon-F Low Fibrinogen control is to be utilized to monitor the performance of 4 fibrinogen assays in the low abnormal range using the Clauss clotting method in mechanical instruments. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility/Precision Study: A reproducibility study was conducted at three sites (one internal and two external), testing three individual lots at each site, two runs per day in triplicate for five non- consecutive days. At each testing site, each of the three VisuCon Low Control lots were tested by one operator using one lot of Diagnostica STA-Fibrinogen Assay (K840211) on STA Compact Analyzer (K093167). All data points from the study were pooled and analyzed in a mixed effect model with lot, test site, day and run treated as random effects. The coefficient of variation (CV) and the standard deviation (SD) for each of the random effects (variance): lot-to-lot, site-to-site, between-day, between-run, within-run and total reproducibility precision was calculated. Results show that data met pre-determined acceptance criteria and demonstrated reproducibility of the VisuCon Low Control under tested conditions. Results of the pooled data are presented below: Instrument: STA Compact Analyzer Source of Variance Standard Deviation (SD) %CV (SD/mean)*100 Lot-to-lot 0.059 7.2% Site-to-site 0.013 1.5% Between-Day 0.006 0.7% Between-Run 0 0% Within-Run (Repeatability) 0.025 3.0% Total Variability 0.07 8.0% Repeatability study/Within-Laboratory Precision Study: Three lots of VisuCon-F Low Fibrinogen Control Plasma were tested on two different Diagnostica Stago STA- Compact Analyzers using the Diagnostica Stago STA-Fibrinogen 5 assay. Testing was conducted in duplicate, two runs per day over a period of 20 days. Data from the repeatability study was pooled (n=480) and analyzed in a mixed effect model with the lot, instrument, day and run treated as random effects. Results show the data met pre-determined acceptance criteria, and are summarized below: 5 Instrument: Diagnostica Stago STA Compact Analyzer Source of Variance SD %CV Lot-to-Lot 0.066 7.8% Instrument-to-Instrument 0.004 0.5% Between-Day 0.005 0.5% Between-Run 0.00 0% Within-Run (Repeatability) 0.027 3.2% Within-Device (total) 0.072 8.4% b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Stability Study: Open Vial Stability Study: The open vial stability study was conducted at the refrigerated temperature of 2°C to 8°C and on-board temperature of 19°C to 22°C, on two lots of VisuCon-F Low Fibrinogen Control plasma. The study demonstrated the VisuCon-F Low Fibrinogen Control Plasma is stable up to 72 hours when stored at 2- 8°C and up to 8 hours at 19-22°C. The study met the pre-determined acceptance criteria. Closed Vial Stability Study: The closed vial stability study was conducted at the storage temperature of ≤ -60°C using three lots of the VisuCon-F Low Fibrinogen Control Plasma. The study demonstrated that the VisuCon-F Low Fibrinogen Control Plasma is stable up to 36 months when stored at or below -60°C. The study met the pre-determined acceptance criteria. Value Assignment: The value assignment for VisuCon-F Low Fibrinogen Control Plasmas were assigned to fibrinogen by testing 20 vials, 5 vials per day over 4 days (n=20). The ranges for the controls were assigned to fibrinogen by calculating and applying ± 2 standard deviations (SD) from the mean. Three lots were tested using the Diagnostica Stago Fibrinogen-5 Assay, which was calibrated against SSC/ISTH Secondary Coagulation Standard. The mean values assigned to each lot met the acceptance criteria and is as follows: 6 Lot 1 Vial Day 1 (g/L) Day 2 (g/L) Day 3 (g/L) Day 4 (g/L) 1 0.81 0.81 0.81 0.80 2 0.78 0.78 0.77 0.77 3 0.82 0.80 0.77 0.76 4 0.79 0.78 0.77 0.82 5 0.77 0.81 0.79 0.81 Overall Mean 0.79 g/L Overall SD 0.019 Overall %CV 2.41% Assigned range 0.75 – 0.83 g/L Lot 2 Vial Day 1 (g/L) Day 2 (g/L) Day 3 (g/L) Day 4 (g/L) 1 0.82 0.82 0.82 0.83 2 0.82 0.84 0. Panel:

idK150144_s0_e2000

K150144.txt

predicate device name

Precision Biologic Inc., Cryocheck Low Fibrinogen Control

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150144 B. Purpose for Submission: Clearance of a new device C. Measurand: Fibrinogen D. Type of Test: Quality Control Material, Assayed E. Applicant: Affinity Biologicals Inc. F. Proprietary and Established Names: VisuCon-F Low Fibrinogen Control Plasma G. Regulatory Information: 1. Regulation section: 21 CFR §864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: GGN, Plasma, Coagulation Control 4. Panel: 81 (Hematology) 2 H. Intended Use: 1. Intended use(s): The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended “For In Vitro Diagnostic Use”. The intended users of the VisuCon-F Low Fibrinogen Control Plasma are trained laboratory personnel working in clinical laboratories. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Not applicable I. Device Description: The VisuCon-F Low Fibrinogen Control Plasma is a pool of de-fibrinated citrated human plasma collected from a minimum of 10 donors, buffered with 0.02 M HEPES buffer. The VisuCon-F Low Fibrinogen Control Plasma is packaged frozen in boxes containing: 5 x 1mL vials, 25 x 1mL vials or 81 x 1mL vials. J. Substantial Equivalence Information: 1. Predicate device name(s): Precision Biologic Inc., Cryocheck Low Fibrinogen Control 2. Predicate 510(k) number(s): K951823 3 3. Comparison with predicate: Similarities Item Device VisuCon-F Low Fibrinogen Control Plasma Predicate Cryo Check Low Fibrinogen Control Intended Use The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended “For In Vitro Diagnostic Use”. The intended users of the VisuCon-F Low Fibrinogen Control Plasma are trained laboratory personnel working in clinical laboratories. The Cryo√ CheckTM Low Fibrinogen Control is a citrated normal human source plasma recommended for use as an abnormal control in monitoring the precision and accuracy of quantitative clottable fibrinogen assays. Analyte Fibrinogen Same Matrix Citrated human plasma Same Differences Item Device Predicate Storage ≤ -60°C -40°C to -80°C Open-Vial Stability 72 hours at 2–8°C or 8 hours on-board instrument (19–22° C) 72 hours at 2–8°C Packaging 5 x 1.0 mL 25 x 1.0 mL 81 x 1.0 mL 25 vials x 1.0 mL 80 vials x 1.0 mL K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2; Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline, 2nd Edition L. Test Principle: The VisuCon-F Low Fibrinogen control is to be utilized to monitor the performance of 4 fibrinogen assays in the low abnormal range using the Clauss clotting method in mechanical instruments. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility/Precision Study: A reproducibility study was conducted at three sites (one internal and two external), testing three individual lots at each site, two runs per day in triplicate for five non- consecutive days. At each testing site, each of the three VisuCon Low Control lots were tested by one operator using one lot of Diagnostica STA-Fibrinogen Assay (K840211) on STA Compact Analyzer (K093167). All data points from the study were pooled and analyzed in a mixed effect model with lot, test site, day and run treated as random effects. The coefficient of variation (CV) and the standard deviation (SD) for each of the random effects (variance): lot-to-lot, site-to-site, between-day, between-run, within-run and total reproducibility precision was calculated. Results show that data met pre-determined acceptance criteria and demonstrated reproducibility of the VisuCon Low Control under tested conditions. Results of the pooled data are presented below: Instrument: STA Compact Analyzer Source of Variance Standard Deviation (SD) %CV (SD/mean)*100 Lot-to-lot 0.059 7.2% Site-to-site 0.013 1.5% Between-Day 0.006 0.7% Between-Run 0 0% Within-Run (Repeatability) 0.025 3.0% Total Variability 0.07 8.0% Repeatability study/Within-Laboratory Precision Study: Three lots of VisuCon-F Low Fibrinogen Control Plasma were tested on two different Diagnostica Stago STA- Compact Analyzers using the Diagnostica Stago STA-Fibrinogen 5 assay. Testing was conducted in duplicate, two runs per day over a period of 20 days. Data from the repeatability study was pooled (n=480) and analyzed in a mixed effect model with the lot, instrument, day and run treated as random effects. Results show the data met pre-determined acceptance criteria, and are summarized below: 5 Instrument: Diagnostica Stago STA Compact Analyzer Source of Variance SD %CV Lot-to-Lot 0.066 7.8% Instrument-to-Instrument 0.004 0.5% Between-Day 0.005 0.5% Between-Run 0.00 0% Within-Run (Repeatability) 0.027 3.2% Within-Device (total) 0.072 8.4% b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Stability Study: Open Vial Stability Study: The open vial stability study was conducted at the refrigerated temperature of 2°C to 8°C and on-board temperature of 19°C to 22°C, on two lots of VisuCon-F Low Fibrinogen Control plasma. The study demonstrated the VisuCon-F Low Fibrinogen Control Plasma is stable up to 72 hours when stored at 2- 8°C and up to 8 hours at 19-22°C. The study met the pre-determined acceptance criteria. Closed Vial Stability Study: The closed vial stability study was conducted at the storage temperature of ≤ -60°C using three lots of the VisuCon-F Low Fibrinogen Control Plasma. The study demonstrated that the VisuCon-F Low Fibrinogen Control Plasma is stable up to 36 months when stored at or below -60°C. The study met the pre-determined acceptance criteria. Value Assignment: The value assignment for VisuCon-F Low Fibrinogen Control Plasmas were assigned to fibrinogen by testing 20 vials, 5 vials per day over 4 days (n=20). The ranges for the controls were assigned to fibrinogen by calculating and applying ± 2 standard deviations (SD) from the mean. Three lots were tested using the Diagnostica Stago Fibrinogen-5 Assay, which was calibrated against SSC/ISTH Secondary Coagulation Standard. The mean values assigned to each lot met the acceptance criteria and is as follows: 6 Lot 1 Vial Day 1 (g/L) Day 2 (g/L) Day 3 (g/L) Day 4 (g/L) 1 0.81 0.81 0.81 0.80 2 0.78 0.78 0.77 0.77 3 0.82 0.80 0.77 0.76 4 0.79 0.78 0.77 0.82 5 0.77 0.81 0.79 0.81 Overall Mean 0.79 g/L Overall SD 0.019 Overall %CV 2.41% Assigned range 0.75 – 0.83 g/L Lot 2 Vial Day 1 (g/L) Day 2 (g/L) Day 3 (g/L) Day 4 (g/L) 1 0.82 0.82 0.82 0.83 2 0.82 0.84 0. Predicate device name: