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510(k) Data Aggregation

    K Number
    K024194
    Device Name
    ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS
    Manufacturer
    LIFESCAN, INC.
    Date Cleared
    2003-02-07

    (49 days)

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

    ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS

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

    The One Touch® Ultra® System is intended to be used for quantitative measurement of glucose in fresh capillary whole blood. The One Touch® Ultra® System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control.

    The One Touch® InDuo™ Blood Glucose Meter is intended to be used for quantitative measurement of glucose in fresh capillary whole blood. The InDuo™ Blood Glucose Meter is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control.

    The One Touch® InDuo™ Blood Glucose Meter also functions as the cap for the InDuo™ Insulin Doser. The two devices fit together to form a single unit for user convenience.

    Device Description

    The One Touch Ultra System consists of the One Touch Ultra Meter. One Touch Ultra Test Strips. One Touch Ultra Control Solution, UltraSoft Lancing Device, UltraClear Cap and UltraSoft lancets. The One Touch Ultra meter, when used with the One Touch Ultra Blood Glucose Test Strips, quantitatively measures glucose in capillary whole blood. The One Touch Ultra Control Solution verifies the performance of the One Touch Ultra Blood Glucose Test Strips.

    The One Touch InDuo System consists of the One Touch InDuo Meter (which also functions as a cap for the InDuo Insulin Doser), One Touch Ultra Test Strips, One Touch Ultra Control Solution, UltraSoft Lancing Device, UltraClear Cap and UltraSoft lancets. The One Touch InDuo meter, when used with the One Touch Ultra Blood Glucose Test Strips, quantitatively measures glucose in capillary whole blood. The One Touch Ultra Control Solution verifies the performance of the One Touch Ultra Blood Glucose Test Strips.

    AI/ML Overview

    The provided documents do not contain information about acceptance criteria or a study that specifically proves the device meets those criteria.

    The 510(k) summaries for both the One Touch Ultra and One Touch InDuo Blood Glucose Monitoring Systems state that "There has been no change to the performance characteristics of the device system" and "The modifications to the device system encompass meter software and labeling changes." This implies that the performance characteristics were already established and accepted for the predicate devices, and the current submissions are for minor changes that do not affect those established characteristics.

    Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, and training set details are not present in these documents as they are not new device submissions requiring such detailed performance studies. The 510(k) is based on substantial equivalence to a predicate device, and the changes are described as minor (software and labeling).

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