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510(k) Data Aggregation

    K Number
    K053312
    Device Name
    EASYMATE BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    BIOPTIK TECHNOLOGY, INC.
    Date Cleared
    2006-03-01

    (93 days)

    Product Code
    NBW,JJY
    Regulation Number
    862.1345
    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 self-testing EasyMate Blood Glucose Monitoring System is indicated for use by healthcare professionals and persons with diabetes to measure glucose values in capillary, finger stick whole blood. Frequent monitoring of whole blood glucose is an adjunct to the care of persons with diabetes.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the EasyMate Blood Glucose Monitoring System, not a study report. Therefore, it does not contain the detailed information required to answer your questions about acceptance criteria and the study proving the device meets them.

    The letter confirms that the device has been found substantially equivalent to a legally marketed predicate device, indicating it has met the regulatory requirements for market clearance. However, it does not describe the specific performance studies, acceptance criteria, or their results in detail.

    To provide the information you requested, an FDA submission document (e.g., the 510(k) application itself) or a separate clinical study report would be necessary.

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