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510(k) Data Aggregation

    K Number
    K991244
    Device Name
    TOTAL IRON, MODELS FE 109-01, FE 109-02
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-05-25

    (43 days)

    Product Code
    JMO
    Regulation Number
    862.1415
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TOTAL IRON, MODELS FE 109-01, FE 109-02

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

    The total iron reagents: Buffer, pH 4.5 (R1), product No. FE109-01 and Color reagent, product No. FE109-02 are intended for use in the automated, quantitative determination of Total Iron in serum, or plasma.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the "TOTAL IRON" device. It acknowledges that the device is substantially equivalent to legally marketed predicate devices for the "automated, quantitative determination of Total Iron in serum, or plasma."

    However, this letter does not contain any information regarding specific acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment. It is a regulatory approval document based on substantial equivalence, not a detailed scientific study report.

    Therefore, I cannot fulfill your request to create a table of acceptance criteria and device performance, or describe the study details using the provided input. This document only states the intended use and regulatory classification.

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