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510(k) Data Aggregation

    K Number
    K052656
    Device Name
    VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN
    Manufacturer
    BIOMERIEUX, INC.
    Date Cleared
    2005-11-07

    (42 days)

    Product Code
    LON
    Regulation Number
    866.1645
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K022045
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VITEK® Gram Positive Daptomycin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Staphylococcus epidermidis and Stapylococcus haemolyticus. VITEK Gram Positive Daptomycin is a qualitative test. It is intended for use with the VITEK System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

    The VITEK® Gram Positive Susceptibility Test is intended to be used with the VITEK® System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinicant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

    Device Description

    VITEK® Gram Positive Daptomcyin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphyloccocus aureus, Steptococcus agalactiae, Staphylococcus epidermidis and Staphylococcous haemolyticus. It is intended for use with the VITEK® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK GPS Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK GPS Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

    After the card is inoculated with a standardized organism suspension, it is placed in the Reader/Incubator of the VITEK System. Organism growth inside the card is optically monitored throughout the 6-15 hour incubation cycle. MIC results are automatically calculated once a predetermined growth threshold is reached, and a report is generated that contains the MIC result and the interpretive category result.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the VITEK® Gram Positive Daptomycin, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implied)Reported Device Performance
    Substantial equivalence to the NCCLS reference agar dilution methodVITEK Gram Positive Ertapenem (Note: text error, should be Daptomycin) demonstrated substantially equivalent performance
    Acceptable overall Category Agreement99.5% overall Category Agreement when compared to the broth microdilution reference method
    Acceptable ReproducibilityDemonstrated acceptable results
    Acceptable Quality ControlDemonstrated acceptable results

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: Explicitly stated as "fresh and stock clinical isolates and stock challenge strains." The exact number of isolates is not provided in the summary, but it implies a diverse set of samples.
    • Data Provenance: The isolates included "fresh and stock clinical isolates" (implying retrospective clinical samples, potentially from various geographic regions where bioMérieux operates, though not specified) and "stock challenge strains" (likely well-characterized laboratory strains). The study was an "external evaluation," suggesting it was conducted at sites other than just the manufacturer's lab.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

    This information is not provided in the given text. The ground truth method is specified, but not the number or qualifications of experts involved in the reference method.

    4. Adjudication Method for the Test Set

    This information is not provided in the given text.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    This section is not applicable to this device. The VITEK® Gram Positive Daptomycin is an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. It directly measures Minimum Inhibitory Concentration (MIC) and interpretive categories.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

    Yes, this study represents a standalone performance evaluation of the VITEK® device. The device itself performs the testing and generates the results automatically without human intervention for interpretation beyond initial setup and reading the final report.

    7. The Type of Ground Truth Used

    The ground truth used was the CLSI (formerly NCCLS) broth microdilution reference method.

    8. The Sample Size for the Training Set

    This information is not provided in the given text, as the summary focuses on the external validation study rather than the development or training of the device.

    9. How the Ground Truth for the Training Set Was Established

    This information is not provided in the given text.

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