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    K Number
    K964292
    Device Name
    N-ASSAY TIA APO A1 TEST KIT
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-08-01

    (276 days)

    Product Code
    DER
    Regulation Number
    866.5580
    Type
    Traditional
    Panel
    Immunology (IM)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    N-ASSAY TIA APO A1 TEST KIT

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

    The N-Assay TIA Apoprotein A-l Test Kit is intended to be used for the quantitative determination of human apoprotein a successor and in numan serum by immunoturòid assay. The measurement in numan serum by immunoturòid assay. The measurement in numan serum by immondtoldimetric assay. The meadershow. of apoprotein A-l is useful in the diagnosis of atherosclerosis.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the N-Assay TIA Apolipoprotein A-1 Test Kit. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the device's accuracy or effectiveness.

    Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them based on the provided input.

    The document mainly focuses on the regulatory aspects of the device's clearance for marketing.

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