VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 16, 2017 BIOMERIEUX, INC. KAREN RUSSELL STAFF REGULATORY AFFAIRS SPECIALIST 595 ANGLUM ROAD HAZELWOOD MO 63042 Re: K161437 Trade/Device Name: VITEK®2 AST Gram Negative Cefotaxime (≤0.25 ->64 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system Regulatory Class: II Product Code: LON, LTT, LTW Dated: December 30, 2016 Received: January 3, 2017 Dear Ms. Russell: 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. 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. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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Sincerely yours, # Ribhi Shawar -A For Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K161437 #### Device Name VITEK® 2 AST Gram Negative Cefotaxime (<0.25 =>64 µg/mL) #### Indications for Use (Describe) VITEK® 2 Gram Negative Cefotaxime is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Gram Negative is a quantitative test. Cefotaxime 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 clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter spp. Escherichia.coli Klebsiella spp. (including Klebsiella pneumoniae) Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Serratia marcescens In vitro data available but clinical significance is unknown: Providencia spp. Salmonella spp. (including Salmonella typhi) The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., and clinically significant yeast. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # VITEK® 2 AST-GN Cefotaxime: Section 028. 510(k) Summary ## A. 510(k) Submission Information: | Submitter's Name: | bioMérieux, Inc. | |------------------------------|-------------------------------------------------------------------------------------------------------| | Address: | 595 Anglum Road<br>Hazelwood, MO 63042 | | Contact Person: | Karen Russell<br>Staff Regulatory Affairs Specialist | | Phone Number:<br>Fax Number: | 314-731-8639<br>314-731-8689 | | Date of Preparation: | May 23, 2016 | | B. Device Name: | Formal/Trade Name: VITEK® 2 Gram Negative Cefotaxime<br>(≤0.25 – ≥64 µg/mL) | | Classification Name: | 21 CFR 866.1645<br>Fully Automated Short-Term Incubation Cycle Antimicrobial<br>Susceptibility System | | Product Code: | LON | | Common Name: | VITEK® 2 AST-GN Cefotaxime | C. Predicate Device: VITEK® 2 AST-GN Ertapenem (K152075) ### D. 510(k) Summary: VITEK® 2 Gram Negative Cefotaxime 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 Cefotaxime is a quantitative test. Cefotaxime 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 Acinetobacter spp. Citrobacter spp. Enterobacter spp. Escherichia.coli {5}------------------------------------------------ Klebsiella spp. (including Klebsiella pneumoniae) Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Serratia marcescens In vitro data available but clinical significance is unknown Providencia spp. Salmonella spp. (including Salmonella typhi) 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. The antimicrobial presented in VITEK® 2 AST-GN Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology. The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors 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 Cefotaxime 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 Cefotaxime. {6}------------------------------------------------ # VITEK® 2 AST-GN Cefotaxime Traditional 510(k) Submission 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 Cefotaxime by comparing its performance with the CLSI broth microdilution reference method incubated at 16 - 20 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-GN Cefotaxime demonstrated acceptable performance of 97.5% overall Essential Agreement and 97.8% overall category agreement with the reference method. A limitation will be taken for P. vulgaris and Shigella spp. Reproducibility and Quality Control demonstrated acceptable results.