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510(k) Data Aggregation

    K Number
    K974701
    Device Name
    ORGENTEC ANTI-MPO (P-ANCA) ELISA
    Manufacturer
    AMERICAN LABORATORY PRODUCTS CO., LTD.
    Date Cleared
    1998-02-17

    (71 days)

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

    ORGENTEC ANTI-MPO (P-ANCA) ELISA

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

    The anti-MPO indirect solid phase enzyme immunometric assay (ELISA) is designed for the semiquantitative measurement of IgG class autoantibodies directed against myeloperoxidase (MPO) and to aid in the diagnosis of microscopic polyangiitis and progressive glomerulonephritis.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for a device called "Orgentec Anti-MPO(P-ANCA) ELISA". It announces that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain information about acceptance criteria, the study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

    The text only provides:

    • Device Name: Orgentec Anti-MPO(P-ANCA) ELISA
    • Intended Use: "The anti-MPO indirect solid phase enzyme immunometric assay (ELISA) is designed for the semiquantitative measurement of IgG class autoantibodies directed against myeloperoxidase (MPO) and to aid in the diagnosis of microscopic polyangiitis and progressive glomerulonephritis."

    Therefore, based solely on the provided text, I cannot answer the requested questions regarding study details. This document is a regulatory approval letter, not a scientific study report.

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