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510(k) Data Aggregation

    K Number
    K984138
    Device Name
    APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    1999-03-23

    (125 days)

    Product Code
    LSR
    Regulation Number
    866.3830
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This test system is designed for the manual or automated, qualitative, for the presumptive (first-step) detection of IgG and/or IgM antibody to Borrelia burgdorferi in human serum from patients with history, signs, or symptoms suggestive of infection with B. burgdorferi. The test system is intended to by used as an aid in the diagnosis of Lyme disease, and is for in vitro diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the "Aptus (Automated) Application for the B. burgdorferi Antibody ELISA Test System." This document grants market clearance based on substantial equivalence to a predicate device.

    The letter itself does not contain the acceptance criteria or the study details that prove the device meets these criteria. Such information would typically be found in the 510(k) submission summary or a separate technical document, which are not provided here.

    Therefore, I cannot extract the requested information from the given text. The document only confirms that the device has been reviewed and found substantially equivalent for its stated indications for use.

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