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    K Number
    K120708
    Device Name
    ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    CILAG GMBH INTERNATIONAL
    Date Cleared
    2013-02-07

    (336 days)

    Product Code
    NBW,LFR
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K093745
    Why did this record match?
    Device Name :

    ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM

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

    The OneTouch Verio Sync Blood Glucose Monitoring System (BGMS) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The system is intended to be used by a single person and should not be shared.

    The OneTouch Verio Sync BGMS is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OneTouch Verio Sync BGMS should not be used for the diagnosis of or screening of diabetes or for neonatal use.

    The OneTouch Verio Test Strips are for use with the OneTouch Verio Sync Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

    Device Description

    The OneTouch® Verio™ Sync Blood Glucose Monitoring System consists of the OneTouch® Verio™ Sync Blood Glucose Meter, OneTouch® Verio™ Test Strips, OneTouch® Verio™ Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch® Verio™ Sync Blood Glucose Monitoring System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Acceptance Criteria and Device Performance for OneTouch Verio Sync Blood Glucose Monitoring System

    1. Table of Acceptance Criteria and Reported Device Performance

    The device's performance was evaluated against the requirements of ISO 15197:2003(E) for system accuracy. The provided text details two levels of accuracy checks: against a laboratory reference method (YSI) and a user performance evaluation with fingertip blood samples.

    System Accuracy (Against Laboratory Reference - YSI)

    Glucose Concentration RangeAcceptance Criteria (Implied by ISO 15197:2003(E) - General Guidance)Reported Device Performance (Number and Percent of Meter Results Matching Laboratory Test)
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