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510(k) Data Aggregation

    K Number
    K990297
    Device Name
    ETEST MINOCYCLINE
    Manufacturer
    AB BIODISK
    Date Cleared
    1999-03-22

    (52 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 µg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

    This Etest 510(k) application is for MIC determination of Minocycline in the range of 0.016 - 256 µg/ml with non-fastidious Gram negative and Gram positive aerobic bacteria.

    Device Description

    The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in µg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called Etest Minocycline, which is used for determining antimicrobial susceptibility. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Specifically, the document:

    • Identifies the device and its intended use.
    • States that the device is substantially equivalent to legally marketed predicate devices.
    • Outlines general controls provisions and other regulatory information.
    • Includes an "Indications For Use" section that describes what the device does (determines Minimum Inhibitory Concentration (MIC) of Minocycline for various bacteria).

    Therefore, I cannot provide the requested information as it is not present in the given text. The document focuses on regulatory clearance based on substantial equivalence, not on specific performance acceptance criteria or a detailed study report.

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