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510(k) Data Aggregation

    K Number
    K971635
    Device Name
    AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    Manufacturer
    OXOID, LTD.
    Date Cleared
    1997-07-03

    (62 days)

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

    Antimicrobial Susceptibility Test Discs are indicated for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Staphylococcus spp., modified by procedures, Haemophilus influenzae, Streptococcus pneumoniae.

    Device Description

    Oxoid Azithromycin Susceptibility Test Disc

    AI/ML Overview

    This document is a 510(k) submission for an antimicrobial susceptibility test disc. It does not contain the detailed information required to answer your specific questions about acceptance criteria, study design, or performance metrics.

    The document primarily states that the FDA has found the Azithromycin Antimicrobial Susceptibility Test Disc to be "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It mentions the "Indication for Use" and "Quality Control organisms" but does not delve into the specifics of a study conducted to prove the device meets acceptance criteria.

    Therefore, I cannot provide the requested information from this document. To answer your questions, I would need a different type of document, such as a full clinical study report, a detailed performance evaluation, or a more comprehensive summary of the 510(k) submission that includes performance data.

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