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

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a stacked formation. The profiles are rendered in a dark color, creating a sense of depth and unity. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 12, 2017 BIOMERIEUX, INC. KAREN RUSSELL STAFF REGULATORY AFFAIRS SPECIALIST 595 ANGLUM ROAD HAZELWOOD MO 63042 Re: K161217 Trade/Device Name: VITEK 2 Gram Negative Ceftriaxone (<0.25 ->64 u/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: II Product Code: LON Dated: December 22, 2016 Received: December 23, 2016 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. 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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}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | | |-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | VITEK® 2 AST-GN Ceftriaxone<br>Traditional 510(k) Submission<br>K161217.AINN<br><br>Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. | | 510(k) Number (if known) | K161217 | | Device Name | VITEK® 2 Gram Negative Ceftriaxone<br>(≤0.25-≥64 µg/mL) | | Indications for Use (Describe) | VITEK® 2 Gram Negative Ceftriaxone is designed for antimicrobial susceptibility testing of Gram-negative bacilli.<br>VITEK® 2 Gram Negative Ceftriaxone is a quantitative test intended for use with the VITEK® 2 and VITEK® 2<br>Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Ceftriaxone<br>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: | | | | Escherichia coli | | | Enterobacter aerogenes | | | Klebsiella pneumoniae | | | Proteus mirabilis | | | Klebsiella oxytoca | | | Serratia marcescens | | In vitro data available but clinical significance is unknown: | | | | Citrobacter freundii | | | Citrobacter koseri (formerly Citrobacter diversus) | | | Providencia species (including Providencia rettgeri) | | | Shigella species | | | Salmonella species (including Salmonella typhi) | | | The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the<br>automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic<br>gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp., S. pneumoniae, and clinically<br>significant yeast. | | Type of Use (Select one or both, as applicable) | | | | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | | | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (8/14) ස 这 ုး ၂၀၂ ခုစုများ ၂၀၇ ဦး၊ လူဦးရေ {3}------------------------------------------------ # VITEK® 2 AST-GN Ceftriaxone: 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: | 314-731-8639 | | Fax Number: | 314-731-8689 | | Date of Preparation: | December 2, 2016 | ## B. Device Name: | Formal/Trade Name: | VITEK® 2 Gram Negative Ceftriaxone<br>(≤0.25 – ≥64 µg/mL) | |----------------------|-------------------------------------------------------------------------------------------------------| | Classification Name: | 21 CFR 866.1645<br>Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility System | | Product Code | LON | | Common Name: | VITEK® 2 AST-GN Ceftriaxone | C. Predicate Device: VITEK®2 AST-GN Doxycycline (K121546) ## D. 510(k) Summary: VITEK® 2 Gram Negative Ceftriaxone is designed for antimicrobial susceptibility testing of Gram-negative bacilli. VITEK® 2 Gram Negative Ceftriaxone is a quantitative test 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. Ceftriaxone 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: Enterobacter aerogenes Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis {4}------------------------------------------------ Serratia marcescens In vitro data available but clinical significance is unknown: Citrobacter koseri (formerly Citrobacter diversus) Citrobacter freundii Shigella species Providencia species (including Providencia rettgeri) Salmonella species (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., Streptococcus spp., S. pneumoniae, 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 Ceftriaxone 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 Ceftriaxone. 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 Ceftriaxone 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 Ceftriaxone demonstrated acceptable performance of 97.5% overall Essential Agreement and 99.0% overall Category Agreement with the reference method. A performance limitation will be taken for Proteus vulgaris. Reproducibility and Quality Control demonstrated acceptable results.