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510(k) Data Aggregation

    K Number
    K993456
    Device Name
    SAS STREP A TEST
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    2000-03-07

    (146 days)

    Product Code
    GTY
    Regulation Number
    866.3740
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SASTM Strep A is a visual test for the presumplive qualitative detection of group A streptococcal antigen from throat swab specimens. The test is for professional use.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the SAS™ Strep A Test. It establishes substantial equivalence to a predicate device and outlines regulatory responsibilities but does not contain the acceptance criteria or a study describing the device's performance against such criteria.

    Therefore, I cannot provide the requested information from the given text.

    To address your request, I would need access to the actual 510(k) summary or the pivotal study report that was submitted to the FDA for this device. These documents typically contain the detailed performance data and acceptance criteria.

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