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    K Number
    K251337

    Validate with FDA (Live)

    Device Name
    Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
    Manufacturer
    Thermo Fisher Scientific (Oxoid Ltd.)
    Date Cleared
    2025-12-05

    (219 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro.

    The Thermo Scientific Oxoid Gepotidacin Disc (10 microgram) GEP10 is intended to determine susceptibility of Enterobacterales, Staphylococcus saprophyticus, and Enterococcus faecalis to gepotidacin, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The Thermo Scientific Oxoid Gepotidacin Disc (10 microgram) GEP10 demonstrated acceptable performance to determine susceptibility to gepotidacin against the following microorganisms:

    • Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Morganella morganii, Proteus mirabilis, and Providencia rettgeri)
    • Staphylococcus saprophyticus
    • Enterococcus faecalis
    Device Description

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