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510(k) Data Aggregation

    K Number
    K974001
    Device Name
    ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    1997-11-13

    (23 days)

    Product Code
    CIT
    Regulation Number
    862.1100
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For the quantitative determination of aspartate aminotransferase in serum. For IN VITRO diagnostic use.

    Elevated levels of aspartate aminotransferase result from a myocardial infarction, or hepatic disease. In cases of hepatic necrosis, elevations of AST levels occur prior to the onset of clinical symptoms such as jaundice. To a lesser extent elevated levels are indicative of diseases of some internal organs.

    Device Description

    Aspartate Aminotransferase-SL Assay

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Aspartate Aminotransferase-SL Assay. While it confirms the device's substantial equivalence to a predicate device and its indications for use, it does not contain the detailed study information needed to answer the questions about acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot provide the requested information from the given text. The letter primarily addresses regulatory approval and does not delve into the specifics of the performance study that would have underpinned the submission.

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