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510(k) Data Aggregation

    K Number
    K021943
    Device Name
    ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    LIFESCAN, INC.
    Date Cleared
    2002-06-28

    (31 days)

    Product Code
    CGA
    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 ONETOUCH® Profile Meter is used for the quantitative measurement of glucose in whole blood by lay persons in the home and by medical professionals in clinical settings as an aid in monitoring effectiveness of diabetes management.

    Device Description

    The labeling of this device was modified to enhance instructions for use advising users to insure the display is operating properly each time they perform a test.

    AI/ML Overview

    The provided document is a 510(k) summary for the ONETOUCH® Profile Meter, specifically regarding a change in labeling. It confirms the device's substantial equivalence to previously marketed devices but does not contain information regarding new acceptance criteria or a study proving that the device meets such criteria.

    The document focuses on:

    • Identifying the device and applicant.
    • Stating its intended use.
    • Describing a minor labeling change ("The labeling of this device was modified to enhance instructions for use advising users to insure the display is operating properly each time they perform a test.").
    • Confirming substantial equivalence based on this labeling change.

    Therefore, I cannot provide the requested information as it is not present in the given text.

    Summary of missing information:

    1. A table of acceptance criteria and the reported device performance: Not available. The document discusses a labeling change, not performance criteria.
    2. Sample size used for the test set and the data provenance: Not available. No new testing is mentioned.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
    4. Adjudication method for the test set: Not available.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a glucose meter, not an AI-assisted diagnostic imaging device.
    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
    7. The type of ground truth used: Not available.
    8. The sample size for the training set: Not applicable, as this is a glucose meter, not a device that typically involves a "training set" in the context of AI/machine learning.
    9. How the ground truth for the training set was established: Not applicable.
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