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    K Number
    K080641
    Device Name
    TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81
    Manufacturer
    HOME DIAGNOSTICS, INC.
    Date Cleared
    2008-08-19

    (166 days)

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

    TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81

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

    The TRUEresult Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and Healthcare Professional in the management of diabetes. Healthcare Professionals may use the device to test venous whole blood; home-use is limited to capillary whole blood testing. Not for neonatal use.

    Device Description

    TRUEresult Blood Glucose Monitoring System

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the TRUEresult Blood Glucose Monitoring System. It does not contain the acceptance criteria, reported device performance, or details of the study used to establish substantial equivalence.

    Therefore, I cannot fulfill the request for information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications based on this document. This letter only states that the device is substantially equivalent to a predicate device for its stated indications for use.

    To answer your questions, I would need access to the actual 510(k) submission, which would include the study reports and validation data.

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