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510(k) Data Aggregation

    K Number
    K972288
    Device Name
    FACTOR DEFICIENT PLASMAS - FACTOR IX (9)
    Manufacturer
    UNIVERSAL REAGENTS, INC.
    Date Cleared
    1997-07-14

    (25 days)

    Product Code
    GGP,GJT
    Regulation Number
    864.7290
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This product is intended for use in the quantitative determination of factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, IX.

    Device Description

    Factor Deficient Coagulation Plasma Factor - IX (nine) is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

    The document is a 510(k) clearance letter from the FDA for a device called "URI Factor IX Regulatory Class: II Product Code: GJT, GGP". It states that the device is "substantially equivalent" to previously marketed devices.

    However, it does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about a study that proves the device meets specific acceptance criteria.
    • Information on sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, types of ground truth, or training set details.

    The document mainly focuses on the regulatory clearance of the device based on substantial equivalence, rather than providing a detailed performance study report.

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