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510(k) Data Aggregation

    K Number
    K020532
    Device Name
    POLYMEDCO HBA1C TEST
    Manufacturer
    POLYMEDCO, INC.
    Date Cleared
    2002-04-24

    (64 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K993077
    Why did this record match?
    Device Name :

    POLYMEDCO HBA1C TEST

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

    The Polymedco HbA1c assay used on the Cobas Mira, Poly-Chem, Olympus, Hitachi and Dimension analyzers is an in vitro diagnostic assay for the quantitative determination of percent HbA1c in anticoagulated whole blood. Measurements of percent HbA1c are effective in monitoring long-texm glucose control in individuals with diabetes mellitus.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Polymedco HbA1c Test, an in vitro diagnostic device. It does not contain any information about acceptance criteria for device performance, nor does it describe a study that proves the device meets such criteria.

    The letter primarily focuses on the substantial equivalence determination of the device to legally marketed predicate devices, which allows it to proceed to market. It outlines regulatory requirements and provides contact information for further inquiries.

    Therefore, I cannot extract the requested information from the provided input. The document is a regulatory approval notice, not a performance study report.

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