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510(k) Data Aggregation

    K Number
    K991666
    Device Name
    TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-06-30

    (47 days)

    Product Code
    JMO
    Regulation Number
    862.1415
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Total Iron Binding Capacity (TIBC) reagents, product No. FE109-01, FE109-02 and The Total Iron Binding Capacity (TIDO) reagones processor seni-automated, quantitative determination of TIBC in serum, or plasma.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Total Iron Binding Capacity (TIBC) device. It confirms the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain the detailed study information required to answer your questions regarding acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment. The document is primarily an FDA regulatory approval letter and an "Indications For Use" statement.

    Therefore, I cannot provide the requested information based on the given input.

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