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510(k) Data Aggregation

    K Number
    K022580
    Device Name
    BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    BECTON DICKINSON & CO.
    Date Cleared
    2002-10-09

    (65 days)

    Product Code
    CGA,JJX,NBW
    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 Becton Dickinson Latitude™ Diabetes Management System is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

    The Becton Dickinson Latitude™ Diabetes Management System is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip.

    Device Description

    The Becton Dickinson Latitude™ Diabetes Management System is intended for use in the quantitative measurement of glucose in capillary blood collected from fingertips.

    The Becton Dickinson Latitude™ Diabetes Management System is designed to be simple and easy to use. It provides accurate blood glucose test results in 5 seconds using a small (0.4 L) sample volume. The system also offers the convenience of containing all of the daily needs for diabetes care in one place as the System includes the blood glucose meter and conveniently holds the test strip vial, lancing device, spare lancets, insulin pen and additional insulin pen needles.

    AI/ML Overview

    The provided text is a 510(k) summary for the BD Latitude™ Diabetes Management System. It states that "Laboratory and clinical studies demonstrate that the Becton Dickinson Latitude™ Diabetes Management System performed in an equivalent manner to the predicate and is suitable for its intended use." However, it does not include specific acceptance criteria, detailed study results, or the other requested information (sample sizes, expert details, adjudication methods, MRMC study results, standalone performance, ground truth types, or training set details).

    Therefore, I cannot populate the table or provide the requested study information based solely on the text provided. The document primarily focuses on the device's intended use, technological characteristics, and its "substantial equivalence" to a predicate device, rather than the detailed performance data asked for.

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