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510(k) Data Aggregation

    K Number
    K033847
    Device Name
    A1CNOW FOR HOME AND PROFESSIONAL USE
    Manufacturer
    METRIKA, INC.
    Date Cleared
    2003-12-23

    (12 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    K042212,K051321
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AlcNow® test provides quantitative measurement of glycated hemoglobin (%HbA1c, %A1C) levels in whole blood samples. The test is for home use and professional use for monitoring glycemic control in people with diabetes.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Metrika, Inc A1cNow® device, a glycated hemoglobin assay. It states that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, and study design.

    Therefore, I cannot provide the requested information based on the provided text.

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