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510(k) Data Aggregation

    K Number
    K020234
    Device Name
    A1CNOW FOR RX HOME USE
    Manufacturer
    METRIKA, INC.
    Date Cleared
    2002-02-15

    (23 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Type
    Special
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    A1CNOW FOR RX HOME USE

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

    The AlcNow™ test provides quantitative measurement of the percent of glycated hemoglobin in fresh capillary or venous whole blood samples. The test is for prescription home use by people with diabetes to monitor glycemic control.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification for the A1cNow™ device, a glycosylated hemoglobin assay for prescription home use. There is no information in the provided text that describes the acceptance criteria, or a study that proves the device meets the acceptance criteria. The document is primarily a letter from the FDA confirming the device's substantial equivalence to legally marketed predicate devices.

    Therefore, I cannot provide the requested information in the format requested.

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