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510(k) Data Aggregation

    K Number
    K982121
    Device Name
    ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
    Manufacturer
    TRACE SCIENTIFIC LTD.
    Date Cleared
    1998-09-17

    (93 days)

    Product Code
    DBM
    Regulation Number
    866.5090
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT

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

    Intended for the in vitro determination of mitochondrial (M2) antibody in human serum. Anti-M2 assays are used as an aid in the diagnosis of Primary Biliary Cirrhosis - CFR 866.5090

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) approval letter from the FDA for a device called "TRACE Enzymatic Mitochondria (M2) Antibody Reagent." This document does not contain the detailed information required to answer your questions about acceptance criteria and the study proving device performance.

    Specifically, the letter is a regulatory filing indicating substantial equivalence to a previously marketed device, allowing it to be sold. It does not include:

    • Details of a performance study.
    • Acceptance criteria for such a study.
    • Sample sizes for test or training sets.
    • Information on expert ground truth, adjudication methods, or MRMC studies.

    Therefore, I cannot provide the requested table or answer the specific questions based on the input text.

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