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510(k) Data Aggregation

    K Number
    K973006
    Device Name
    QUANTA LITE B2 GPI IGA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1997-10-20

    (68 days)

    Product Code
    MSV
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    K982434
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    semiquantitative enzyme linked immunoassay for detecting IgA A class autoantibody to f2 glycoprotein I (B2 GPI) for use as an aid diagnosis of certain autoimmune disease thrombotic in the disorders, such as those secondary to systemic lupus erythematosus (SLE) or other lupus-like disorders.

    Device Description

    Not Found

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for the QUANTA Lite™ B2 GPI IgA ELISA device (K973006). It does not contain any information about acceptance criteria or a study proving the device meets those criteria.

    The letter primarily states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It also mentions general regulatory requirements and where to get further information.

    Therefore, I cannot provide the requested information based on the provided text.

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