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510(k) Data Aggregation

    K Number
    K073231
    Device Name
    ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    LIFESCAN, INC.
    Date Cleared
    2008-04-18

    (155 days)

    Product Code
    NBW,CGA
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    K053529,K040603
    Why did this record match?
    Reference Devices :

    K053529, K040603

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

    The OneTouch® UltraLink™ Blood Glucose Monitoring System is intended to be used for self-testing outside the body (in vitro diagnostic use) for the quantitative measurement of glucose in fresh capillary whole blood obtained from the finger, forearm or palm. The OneTouch® UltraLink™ System is intended for use by people with diabetes in a home setting and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.

    The OneTouch® UltraLink™ Blood Glucose monitor may be used to transmit glucose values to appropriate MiniMed Paradigm® and Guardian® REAL Time devices using radio frequency communication.

    Device Description

    The OneTouch® UltraLink Blood Glucose Monitoring System is a modification to the OneTouch® Ultra® 2 Blood Glucose Monitoring System, retaining the features, functions, and user interface of the OneTouch® Ultra® 2 meter while introducing a feature allowing Radio-Frequency transmission of blood glucose results to compatible Medtronic MiniMed, Inc. devices. The OneTouch® UltraLink™ Blood Glucose Monitoring System is composed of the OneTouch® UltraLink™ Blood Glucose meter, OneTouch® Ultra® Test Strips, OneTouch® Ultra® Control Solution, OneTouch® Lancing device, OneTouch® UltraSoft® Lancets, and meter carrying case. System modifications were made only to the blood glucose meter, carrying case, and instructions for use.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information for the OneTouch® UltraLink™ Blood Glucose Monitoring System, based on the provided text:

    Acceptance Criteria and Device Performance

    Performance CharacteristicAcceptance Criteria (Test Method)Reported Device Performance
    AccuracyISO 15197:2003, Section 7.3 (7.4)95% of individual glucose results fell within ± 15 mg/dL of the reference method for glucose concentrations
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