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    K Number
    K223481
    Device Name
    VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)
    Manufacturer
    bioMerieux, Inc
    Date Cleared
    2023-02-03

    (77 days)

    Product Code
    LON
    Regulation Number
    866.1645
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K111893
    Why did this record match?
    Device Name :

    VITEK**®** 2 Streptococcus Tetracycline (=16 µg/mL)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VITEK® 2 Streptococcus Tetracycline is designed for antimicrobial susceptibility testing of Streptococcus species 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 Streptococcus Tetracycline is a quantitative test. Tetracycline has been shown to be active against the microorganisms listed below, according to the FDA label for this antimicrobial.

    Active in vitro and in clinical infections: Streptococcus pneumoniae Streptococcus pyogenes*

    *The VITEK® 2 Streptococcus Susceptibility Card also reports the susceptibility of the following additional organisms as listed on the FDA Susceptibility Test Interpretative Criteria website (STIC): Streptococcus spp. B-Hemolytic Group (other than S. pyogenes).

    The VITEK® 2 Streptococcus Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Streptococcus pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.

    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(1) 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 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 Streptococcus Tetracycline has the following concentrations in the card: 0.125, 0.5, 1, and 4 ug/mL (equivalent standard method concentration by efficacy in ug/mL).

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study proving the device meets those criteria, based on the provided text:

    Device: VITEK® 2 Streptococcus Tetracycline (≤0.25 - ≥16 µg/mL)
    Intended Use: Antimicrobial susceptibility testing of Streptococcus species, as a laboratory aid in determining in vitro susceptibility to antimicrobial agents. Specifically for Streptococcus pneumoniae and Streptococcus pyogenes, with additional reporting for Beta-hemolytic Streptococcus (other than S. pyogenes).

    Acceptance Criteria and Reported Device Performance

    The study compared the VITEK® 2 Streptococcus Tetracycline performance against the CLSI broth microdilution reference method. The acceptance criteria are implicitly defined by the guidance document cited: "FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009)."

    Acceptance MetricRequirement (Implied by FDA Guidance and Overall Performance)Reported Device Performance
    Overall Essential Agreement (EA)Generally, >90% (industry standard for AST systems)98.3%
    Overall Category Agreement (CA)Generally, >90% (industry standard for AST systems)97.9%
    Very Major Errors (VME) for S. pneumoniaeN/A (Not Applicable - typically assessed for Resistant to Susceptible mismatches, but the table shows N/A)0.0%
    Major Errors (ME) for S. pneumoniaeN/A (Not Applicable - typically assessed for Susceptible to Resistant mismatches)0.0%
    Minor Errors (mE) for S. pneumoniaeLow (e.g.,
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