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510(k) Data Aggregation

    K Number
    K023654
    Device Name
    GLYCA-DIRECT FRUCTOSAMINE
    Manufacturer
    POLYMEDCO, INC.
    Date Cleared
    2003-05-02

    (184 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    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 Polymedco Glyca-Direct™ Fructosamine Test is used for the quantitative determination of glycated proteins in serum and plasma. The measurement of glycated serum proteins (Fructosamine) is useful for monitoring long-term control of diabetes. This application was developed for the Polymedco Poly-Chem analyzer.

    Device Description

    The Polymedco Glyca-Direct™ Fructosamine Test is used for the quantitative determination of glycated proteins in serum and plasma.

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for "The Polymedco Glyca-Direct™ Fructosamine Test". It confirms the device's substantial equivalence to a predicate device but does not contain detailed information about acceptance criteria or the study that proves the device meets those criteria.

    Therefore, I cannot provide the requested information based solely on the provided text. The document primarily focuses on regulatory approval rather than technical performance data.

    To answer your questions, I would need access to the actual 510(k) submission document or a summary of its contents, which would typically include the study design, acceptance criteria, and performance data.

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