VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 13, 2020 BioMerieux, Inc. Jolyn Tenllado Regulatory Affairs Expert 595 Anglum Road Hazelwood, Missouri 63042 ## Re: K193572 Trade/Device Name: VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - ≥16/4 μg/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON, LTW, LTT Dated: December 20, 2019 Received: December 23, 2019 Dear Jolyn Tenllado: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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Sincerely, Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue circle on top of a yellow and green gradient circle. The word "BIOMÉRIEUX" is written in white letters inside the blue circle. #### 510(k) SUMMARY ## VITEK® 2 AST-GN Imipenem/Relebactam #### A. 510(k) Submission Information: | Submitter's Name: | bioMérieux, Inc. | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------| | Address: | 595 Anglum Road<br>Hazelwood, MO 63042 | | Contact Person: | Jolyn Tenllado<br>Regulatory Affairs Expert | | Phone Number: | 314-731-8386 | | Fax Number: | 314-731-8689 | | Date of Preparation: | December 20, 2019 | | <b>B. Device Name:</b> | | | Formal/Trade Name: | VITEK® 2 AST- Gram Negative<br>Imipenem/Relebactam (≤ 0.25/4 - ≥ 16/4 µg/mL) | | Classification Name: | 21 CFR 866.1645<br>Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility System<br>Product Code LON | | Common Name: | VITEK® 2 AST-GN Imipenem/Relebactam | | <b>C. Predicate Device:</b> | VITEK® 2 AST-GN Imipenem (K183415) | #### D. Device Description: The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh () and Gerlach (2). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique (3). Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a green and yellow bottom half. The word "BIOMÉRIEUX" is written in white letters in the center of the blue half of the circle. premeasured portions of a specific antibiotic combined with culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. 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 contained on the card. VITEK® 2 AST-GN Imipenem/Relebactam has the following concentrations in the card: 0.25/4, 1/4, 4/4 and 16/4 ug/mL (equivalent standard method concentration by efficacy in ug/mL). ## E. Substantial Equivalence Information The similarities and differences of the VITEK 2 AST-GN Imipenem/Relebactam when compared to the predicate device, VITEK 2 AST-GN Imipenem (K183415), are described in the following table. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for bioMerieux. The logo is a circle that is split into two halves. The top half is blue and contains the word "BIOMERIEUX" in white letters. The bottom half of the circle is yellow and green. | Item | Device:<br>VITEK® 2 AST-GN<br>Imipenem/Relebactam | Predicate:<br>VITEK® 2 AST-GN Imipenem<br>(K183415) | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Similarities | | | | Intended Use | VITEK® 2 AST-Gram Negative<br>Imipenem/Relebactam is designed for<br>antimicrobial susceptibility testing of<br>Gram negative bacilli and is intended for<br>use with the VITEK® 2 and VITEK® 2<br>Compact Systems as a laboratory aid in<br>the determination of in vitro susceptibility<br>to antimicrobial agents. VITEK® 2 AST-<br>Gram Negative Imipenem/Relebactam is<br>a quantitative test.<br>Imipenem/Relebactam has been shown to<br>be active against most strains of the<br>microorganisms listed below, according<br>to the FDA label for this antimicrobial.<br>Active in vitro and in clinical infections:<br>Klebsiella (Enterobacter) aerogenes<br>Enterobacter cloacae<br>Escherichia coli<br>Klebsiella pneumoniae<br>Pseudomonas aeruginosa<br>Citrobacter freundii<br>Klebsiella oxytoca<br>In vitro data are available, but clinical<br>significance is unknown<br>Citrobacter koseri<br>Enterobacter asburiae | VITEK® 2 AST-Gram Negative<br>Imipenem is designed for antimicrobial<br>susceptibility testing of Gram negative<br>bacilli and is intended for use with the<br>VITEK® 2 and VITEK® 2 Compact<br>Systems as a laboratory aid in the<br>determination of in vitro susceptibility to<br>antimicrobial agents. VITEK® 2 AST-<br>Gram Negative Imipenem is a<br>quantitative test. Imipenem has been<br>shown to be active against most strains of<br>the microorganisms listed below,<br>according to the FDA label for this<br>antimicrobial.<br>Active in vitro and in clinical infections:<br>Acinetobacter spp.<br>Citrobacter spp.<br>Enterobacter spp. (excluding E.<br>aerogenes)<br>Escherichia coli<br>Klebsiella spp.<br>Pseudomonas aeruginosa<br>The VITEK® 2 Gram-Negative<br>Susceptibility Card is intended for use<br>with the VITEK® 2 Systems in clinical<br>laboratories as an in vitro test to<br>determine the susceptibility of clinically<br>significant aerobic Gram-negative bacilli<br>to antimicrobial agents when used as<br>instructed. | | Item | Device:<br>VITEK® 2 AST-GN<br>Imipenem/Relebactam | Predicate:<br>VITEK® 2 AST-GN Imipenem<br>(K183415) | | Similarities | | | | Intended Use<br>(Cont.) | The VITEK® 2 Gram-Negative<br>Susceptibility Card is intended for use<br>with the VITEK® 2 Systems in clinical<br>laboratories as an in vitro test to<br>determine the susceptibility of clinically<br>significant aerobic Gram-negative bacilli<br>to antimicrobial agents when used as<br>instructed. | | | Test<br>Methodology | Automated quantitative antimicrobial<br>susceptibility test for use with the<br>VITEK® 2 and VITEK® 2 Compact<br>Systems to determine the in vitro<br>susceptibility of Gram negative bacilli | Same | | Inoculum | Saline suspension of organism | Same | | Test Card | VITEK® 2 Gram Negative Susceptibility<br>Test Card | Same | | Instrument | VITEK® 2 and VITEK® 2<br>Compact Systems | Same | | Analysis<br>Algorithms | Growth Pattern Analysis | Same | | Differences | | | | Antimicrobial<br>Agent | Imipenem/Relebactam | Imipenem | | Antimicrobial<br>Concentration | 0.25/4, 1/4, 4/4, 16/4 | 0.5, 2, 8, 16 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle that is split into two halves. The top half is blue and contains the word "BIOMÉRIEUX" in white letters. The bottom half is yellow and green. # F. Intended Use: {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue circle on top and a green circle on the bottom. The word "BIOMÉRIEUX" is written in white letters in the center of the blue circle. VITEK® 2 AST-Gram Negative Imipenem/Relebactam 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 AST-Gram Negative Imipenem/Relebactam is a quantitative test. Imipenem/Relebactam has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Klebsiella (Enterobacter) aerogenes Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa Citrobacter freundii Klebsiella oxytoca In vitro data are available, but clinical significance is unknown Citrobacter koseri Enterobacter asburiae The VITEK® 2 Gram-Negative Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. ## F. Performance Overview and Conclusion: VITEK® 2 AST-GN Imipenem/Relebactam demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009). The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST- GN Imipenem/Relebactam. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 AST-GN Imipenem/Relebactam by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 {7}------------------------------------------------ hours. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-GN Imipenem/Relebactam demonstrated acceptable performance of 95.3% Essential Agreement and 98.9% Category Agreement for Enterobacteriaceae and 96.2% Essential Agreement and 95.5% Category Agreement for P. aeruginosa with the reference method. Overall performance for Enterobacteriaceae and P. aeruginosa combined was 95.6% Essential Agreement and 98.0% Category Agreement. Reproducibility and Quality Control demonstrated acceptable results. #### References: - 1. MacLowry, J.D. and Marsh, H.H., Semi-automatic Microtechnique for Serial Dilution Antibiotic Sensitivity Testing in the Clinical laboratory, Journal of Laboratory Clinical Medicine, 72:685-687, 1968. - 2. Gerlach, E.H., Microdilution 1: A Comparative Study, p. 63-76. Current Techniques for Antibiotic Susceptibility Testing. A. Balows (ed.), Charles C. Thomas, Springfield, IL, 1974. - 3. Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, Philadelphia, PA, 1976.