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510(k) Data Aggregation

    K Number
    K984336
    Device Name
    QUANTA LITE GBM ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1999-02-08

    (67 days)

    Product Code
    MVJ
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUANTA LITE GBM ELISA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A semiquantitative enzyme linked immunosorbant assay (ELISA) detecting IgG class autoantibody to glomerular basement membrane (GBM) in human serum. This test is an aid in the diagnosis of autoimmune renal disorders such as Goodpasture's syndrome.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called QUANTA Lite™ GBM ELISA. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain the acceptance criteria or the details of a study proving the device meets those criteria, nor does it provide information about the development and testing of a new AI/ML device.

    The letter is a regulatory approval, and while it references a 510(k) submission (K984336), the submission itself, which would contain the study details, is not provided in the input text. Therefore, I cannot extract the requested information.

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