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510(k) Data Aggregation

    K Number
    K980773
    Device Name
    ETEST GREPAFLOXACIN
    Manufacturer
    AB BIODISK
    Date Cleared
    1998-05-18

    (77 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 Grepafloxacin in the range of 0.002 - 32 ug/ml with non-fastidious Gram negative and Gram positive aerobic bacteria, S. pneumoniae, H. influenzae and N. gonorrhoeae.

    Device Description

    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.

    AI/ML Overview

    This document is a 510(k) clearance letter for the Etest Grepafloxacin device, which determines the Minimum Inhibitory Concentration (MIC) of grepafloxacin against various bacteria. It does not contain specific details about acceptance criteria, a study that proves the device meets those criteria, or the methodology of such a study.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding the study design, sample sizes, ground truth establishment, or expert involvement. The document primarily focuses on the regulatory approval of the device.

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