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510(k) Data Aggregation

    K Number
    K981330
    Device Name
    QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1998-06-19

    (67 days)

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

    QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT

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

    An enzyme linked immunosorbant assay (ELISA) for the semiof autoantibodies to detection IgG quantitative myeloperoxidase(MPO). This test is to be used in conjunction with other clinical findings to aid in assessment of certain autoimmune vasculitides such as microscopic polyarteritis, and crescentic qlomerulonephritis.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the QUANTA Lite™ MPO IgG device. It indicates that the device has been found substantially equivalent to a predicate device but does not contain the acceptance criteria or a study description as requested.

    The letter is a regulatory document confirming clearance to market, not a scientific publication detailing performance studies. Therefore, I cannot extract the requested information from the provided text.

    To answer your request, I would need a different document, such as a summary of safety and effectiveness (SSE) from the 510(k) submission, a clinical study report, or a publication describing the device's performance.

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