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510(k) Data Aggregation

    K Number
    K964296
    Device Name
    N-ASSAY TIA APO B TEST KIT
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-08-01

    (276 days)

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

    N-ASSAY TIA APO B TEST KIT

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

    The N-Assay TIA APO B Test Kit is intended to be used for the quantitative determination of human apolipoprotein B in human serum by immunoturbidimetric assay. The measurement of Apolipoproteinbis useful in the diagnosis of atherosclerosis.

    Device Description

    Not Found

    AI/ML Overview

    This letter from the FDA is an approval for a medical device (N-Assay® TIA Apolipoprotein B Test Kit) and does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

    The letter explicitly states that the FDA "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This indicates a substantial equivalence (510(k)) pathway, which means the device was found to be as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical studies and acceptance criteria as would be needed for a Premarket Approval Application (PMA) for a novel device.

    Therefore, I cannot fulfill your request using the provided text.

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