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510(k) Data Aggregation

    K Number
    K980603
    Device Name
    ETEST TROVAFLOXACIN
    Manufacturer
    AB BIODISK
    Date Cleared
    1998-05-13

    (85 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For in vitro diagnostic use:

    Etest is a quantitative technique for the determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneumococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

    This Etest 510(k) application is for MIC determination of Trovafloxacin in the range of 0.002 - 32 µg/ml with.non-fastidious Gram negative and Gram positive aerobic bacteria, S. pneumoniae, H. influenzae and anaerobic bacteria.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, the document is a letter from the FDA to AB Biodisk regarding the clearance of their device, Etest® Trovafloxacin, and an "Indications For Use" statement. It does not contain information on the acceptance criteria, device performance, study details, or ground truth establishment. Therefore, I cannot fulfill your request to describe these elements.

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