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510(k) Data Aggregation

    K Number
    K023279
    Device Name
    GLUCOLEADER VALUE
    Manufacturer
    HMD BIOMEDICAL, INC.
    Date Cleared
    2003-08-04

    (307 days)

    Product Code
    NBW,CGA
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GLUCOLEADER VALUE

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

    For the quantitative measurement of glucose levels in human whole blood by people with diabetes at home and by health care workers in a professional setting.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information needed to answer your request about the acceptance criteria, study details, and performance of the HMD Biomedical GlucoLeader™ Blood Glucose Test System. The document is a 510(k) clearance letter from the FDA, which confirms the device's substantial equivalence to a predicate device but does not include the specifics of the performance study or clinical trial results.

    To answer your request, I would need a document such as a clinical study report, a detailed summary of safety and effectiveness, or the full 510(k) submission which would typically contain such information. This current document only states that the device is cleared for marketing based on substantial equivalence.

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