VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a bold, sans-serif font and the full name in a smaller, sans-serif font below it. The overall design is clean and professional, reflecting the agency's role in regulating food and drugs in the United States. February 16, 2023 bioMerieux, Inc Cherece Jones Staff Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042 ## Re: K223478 Trade/Device Name: VITEK 2 AST-Gram Negative Plazomicin (<0.5 - >16 µg/mL); VITEK® 2 AST-GN Plazomicin (≤0.5 - ≥16 µg/mL); VITEK 2 AST-GN Plazomicin Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON, LTT, LTW Dated: November 17, 2022 Received: November 18, 2022 Dear Cherece Jones: 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). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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Sincerely, # Ribhi Shawar -S Ribhi Shawar, Ph.D. (ABMM) Branch Chief. General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K223478 Device Name VITEK® 2 AST-GN Plazomicin (<0.5 - >16 ug/mL) #### Indications for Use (Describe) VITEK® 2 AST-Gram Negative Plazomicin 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 Plazomicin is a quantitative test. Plazomicin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active both in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Enterobacter cloacae In vitro data are available, but their clinical significance is unknown: Citrobacter freundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Proteus vulgaris Serratia marcescens 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 clinicaly significant aerobic bacilli to antimicrobial agents when used as instructed. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------|---------------------------------------------| | <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The word "BIOMÉRIEUX" is written in white, sans-serif font in the center of the blue portion of the circle. ## 510(k) SUMMARY # VITEK® 2 AST-Gram Negative Plazomicin (≤0.5 - ≥16 µg/mL) ## A. 510(k) Submission Information: | Submitter's Name: | bioMérieux, Inc. | |----------------------|-------------------------------------------------------------------------------------------------------| | Address: | 595 Anglum Road<br>Hazelwood, MO 63042 | | Contact Person: | Cherece L. Jones<br>Staff Regulatory Affairs Specialist | | Phone Number: | 314 -731-8684 | | Fax Number: | 314-731-8689 | | Date of Preparation: | November 17, 2022 | | B. Device Name: | | | Formal/Trade Name: | VITEK® 2 AST-Gram Negative Plazomicin (≤0.5 - ≥16<br>µg/mL) | | Classification Name: | 21 CFR 866.1645<br>Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility System | | Product Code(s): | LON, LTT, LTW | | Common Name: | VITEK® 2 AST-GN Plazomicin (≤0.5 - ≥16 µg/mL) | | C. Predicate Device: | VITEK® 2 AST-GN Gentamicin (≤ 1 –≥16 µg/mL)<br>(K163563) | #### 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(4) and Gerlach(2). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique(3). {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo is a circle divided into two sections. The top half of the circle is dark blue, and the bottom half transitions from yellow to green. The company name, "BIOMÉRIEUX", is written in white, sans-serif font in the center of the blue section. 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 premeasured portions of a specific antibiotic combined with culture media. The 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. # E. Substantial Equivalence Information: VITEK® 2 AST-GN Plazomicin (<0.5 - >16 ug/mL) is substantially equivalent to VITEK® 2 AST-GN Gentamicin (≤ 1 - ≥16 ug/mL) (K163563). A summary of the similarities and differences of the VITEK® 2 AST-GN Plazomicin (≤0.5 - ≥16 µg/mL) and VITEK® 2 AST-GN Gentamicin (≤ 1 ->16 ug/mL) (K163563) are provided in Table 1 below: | New Device and<br>Predicate Device: | New Device:<br>VITEK® 2 AST-Gram Negative<br>Plazomicin ( $\le 0.5 - \ge 16$ µg/mL) | Predicate Device:<br>VITEK® 2 AST-GN Gentamicin<br>( $\le 1 - \ge 16$ µg/mL) (K163563) | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General Device Characteristic Similarities | | | | Intended Use | The VITEK® 2 Gram-Negative<br>Susceptibility Card is intended for<br>use with the VITEK® 2 Systems in<br>clinical laboratories as an <i>in vitro</i> test<br>to determine the susceptibility of<br>clinically significant aerobic Gram-<br>negative bacilli to antimicrobial<br>agents when used as instructed. | The VITEK® 2 Antimicrobial<br>Susceptibility Test (AST) is intended<br>to be used with the VITEK® 2 Systems<br>for the automated quantitative or<br>qualitative susceptibility testing of<br>isolated colonies for the most<br>clinically significant aerobic gram-<br>negative bacilli, <i>Staphylococcus</i> spp.,<br><i>Enterococcus</i> spp., <i>Streptococcus</i> spp.<br>and clinically significant yeast. | | Test Methodology | Automated quantitative antimicrobial<br>susceptibility test for use with the<br>VITEK® 2 and VITEK® 2 Compact<br>Systems to determine the <i>in vitro</i><br>susceptibility of microorganisms | Same | | Inoculum | Saline suspension of organism | Same | | Test Card | Gram-Negative (AST-GN) | Same | | New Device and Predicate Device: | New Device:<br>VITEK® 2 AST-Gram Negative<br>Plazomicin (≤0.5 - ≥16 µg/mL) | Predicate Device:<br>VITEK® 2 AST-GN Gentamicin<br>(≤1–≥16 µg/mL) (K163563) | | | Susceptibility Card | | | Analysis Algorithms | Growth Pattern Analysis (GPA) | Same | | Instrument | VITEK® 2 and VITEK® 2 Compact Systems | Same | | General Device Characteristic Differences | | | | Indications for Use | VITEK® 2 AST-Gram Negative<br>Plazomicin is designed for<br>antimicrobial susceptibility testing of<br>Gram negative bacilli and is intended<br>for use with the VITEK® 2 and<br>VITEK® 2 Compact Systems as a<br>laboratory aid in the determination of<br><i>in vitro</i> susceptibility to antimicrobial<br>agents. VITEK® 2 AST-Gram<br>Negative Plazomicin is a quantitative<br>test. Plazomicin has been shown to<br>be active against most strains of the<br>microorganisms listed below,<br>according to the FDA label for this<br>antimicrobial. | VITEK® 2 Gram Negative Gentamicin<br>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 <i>in vitro</i> susceptibility<br>to antimicrobial agents. VITEK® 2<br>Gram Negative Gentamicin is a<br>quantitative test. Gentamicin has been<br>shown to be active against most strains<br>of the microorganisms listed below,<br>according to the FDA label for this<br>antimicrobial. | | | Active both <i>in vitro</i> and in clinical<br>infections:<br><i>Escherichia coli</i><br><i>Klebsiella pneumoniae</i><br><i>Enterobacter cloacae</i> | Active <i>in vitro</i> and in clinical<br>infections<br><i>Citrobacter</i> species<br><i>Enterobacter</i> species<br><i>Escherichia coli</i><br><i>Klebsiella</i> species<br><i>Proteus</i> species<br><i>Serratia</i> species<br><i>Pseudomonas aeruginosa</i> | | | <i>In vitro</i> data are available, but their<br>clinical significance is unknown:<br><i>Citrobacter freundii</i><br><i>Citrobacter koseri</i><br><i>Klebsiella (Enterobacter) aerogenes</i><br><i>Klebsiella oxytoca</i><br><i>Proteus vulgaris</i><br><i>Serratia marcescens</i> | | | | The VITEK® 2 Gram-Negative<br>Susceptibility Card is intended for<br>use with the VITEK® 2 Systems in<br>clinical laboratories as an <i>in vitro</i> test<br>to determine the susceptibility of<br>clinically significant aerobic Gram-<br>negative bacilli to antimicrobial | The VITEK® 2 Antimicrobial<br>Susceptibility Test (AST) is intended<br>to be used with the VITEK® 2 Systems<br>for the automated quantitative or<br>qualitative susceptibility testing of<br>isolated colonies for the most<br>clinically significant aerobic gram-<br>negative bacilli, <i>Staphylococcus</i> spp.,<br><i>Enterococcus</i> spp., <i>Streptococcus</i> spp.<br>and clinically significant yeast. | #### Table 1: Substantial Equivalence {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle divided into two halves. The top half is a dark blue color, and the bottom half is a gradient of yellow and green. The word "BIOMÉRIEUX" is written in white letters in the center of the blue half of the circle. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a yellow-green bottom half. The word "BIOMÉRIEUX" is written in white, sans-serif font in the center of the blue half of the circle. | New Device and<br>Predicate Device: | New Device:<br>VITEK® 2 AST-Gram Negative<br>Plazomicin (≤0.5 - ≥16 µg/mL) | Predicate Device:<br>VITEK® 2 AST-GN Gentamicin<br>(≤ 1 –≥16 µg/mL) (K163563) | |-------------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------| | | agents when used as instructed. | | | Antimicrobial Agent | Plazomicin | Gentamicin | | Concentrations | 2, 4, 8 µg/mL | 4, 8, 32 µg/mL | ## F. Intended Use: 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. ## G. Performance Overview and Conclusion: VITEK® 2 AST-GN Plazomicin (≤0.5 - ≥16 µg/mL) 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 Plazomicin (≤0.5 - >16 ug/mL). 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 AST-GN Plazomicin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-24 hours. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. The VITEK® 2 AST-GN Plazomicin (<0.5 - >16 µg/mL) demonstrated acceptable performance as presented in Table 2 below: {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a green bottom half. The word "BIOMÉRIEUX" is written in white letters in the center of the blue half of the circle. # Table 2: VITEK® 2 AST-GN Plazomicin Performance | Antimicrobi<br>al | Antimicrobial<br>Code | Antibiotic<br>Version | Bp1 | Comment | Essential Agreement Category<br>% Error | | | | Category Agreement<br>% Error | | | | %<br>Reprodu<br>cibility | |-------------------|-----------------------|-----------------------|---------------|----------------------------|-----------------------------------------|-----|-----|-----|-------------------------------|---------------|----------------|----------------|--------------------------| | | | | | | %EA | VME | ME | mE | %CA | VME | ME | mE | | | Plazomicin | PLZ | (plz01n) | FDA<br>(CLSI) | #, E<br>Enterobacteriaceae | (847/858)<br>98.7 | N/A | N/A | N/A | (853/858)<br>99.4 | (0/57)<br>0.0 | (1/797)<br>0.1 | (4/858)<br>0.5 | 97.0 | The VITEK® 2 AST-GN Plazomicin MIC values tended to be in exact agreement or at least one doubling dilution lower when testing E. coli, and S. marcescens compared to the CLSI reference broth microdilution. The VITEK® 2 AST-GN Plazomicin MIC values tended to be one doubling dilution higher when testing K. pneumoniae compared to the CLSI reference broth microdilution. 1 Abbreviations - Bp = breakpoint committee; EA = essential agreement; CA = category agreement; VME = Very Major Error (susceptible result with resistant reference result); ME = Major Error (resistant with susceptible reference result); mE = minor Error (susceptible or resistant result with an intermediate reference result, or an intermediate result with a susceptible or resistant reference result). Key: # = US Food and Drug Administration 510(k) cleared E = External performance data # H. Quality Control: | CLSI® Quality Control Organisms VITEK® 2 Results | | | | |--------------------------------------------------|--------|--------------------------------------------------------------------------------|--------------------------------------| | Antimicrobic | Code | <i>E. coli</i><br>ATCC® 25922™ | <i>P. aeruginosa</i><br>ATCC® 27853™ | | Plazomicin | plz01n | ≤0.5 - 2*◊<br>(*FDA/CLSI broth dilution expected<br>QC range = 0.25 – 2 μg/mL) | 1 - 4 | Numerical values are expressed in ug/mL · Does not include the full CLSI/FDA-recommended dilution range for QC testing with this organism. Results for the VITEK® 2 AST-GN Plazomicin (≤0.5 - ≥16 µg/mL) were within the expected QC results range >95% of the time for both dilution options of the VITEK® 2 and manual dilution on the VITEK® 2 Compact. #### I. Limitations: Perform an alternative method of testing prior to reporting of results for the following antibiotic/organism combination(s): {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo is a circle with a blue upper half and a yellow-green lower half. The company name, "BIOMÉRIEUX", is written in white, sans-serif font in the blue portion of the circle. - Plazomicin (plz01n): Morganella morganii, Proteus mirabilis, Providencia stuartii ● The ability of the AST card to detect resistance with the following combination(s) is unknown because resistant strains were not available at the time of comparative testing: - Plazomicin (plz01n): Citrobacter freundii, Citrobacter koseri, Klebsiella (Enterobacter) aerogenes, Klebsiella oxytoca, Proteus vulgaris, and Serratia marcescens #### J. 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. - Gerlach, E.H., Microdilution 1: A Comparative Study, p. 63-76. Current Techniques for 2. Antibiotic Susceptibility Testing. A. Balows (ed.), Charles C. Thomas, Springfield, IL, 1974. - Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, 3. Philadelphia, PA, 1976.