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    K Number
    K150214
    Device Name
    OneTouch Verio Flex Blood Glucose Monitoring System
    Manufacturer
    LIFESCAN EUROPE
    Date Cleared
    2015-07-31

    (182 days)

    Product Code
    NBW,LFR
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K131363
    Why did this record match?
    Device Name :

    OneTouch Verio Flex Blood Glucose Monitoring System

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

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

    OneTouch Verio Flex™ Blood Glucose Monitoring System 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 Flex™ Blood Glucose Monitoring System is not to 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 Flex™ Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.

    Device Description

    The OneTouch Verio Flex Blood Glucose Monitoring System consists of the OneTouch Verio Flex Blood Glucose Meter, OneTouch® Verio® Test Strips, OneTouch® Verio® Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch Verio Flex 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

    OneTouch Verio Flex™ Blood Glucose Monitoring System Acceptance Criteria and Study Details

    1. Acceptance Criteria and Reported Device Performance

    The OneTouch Verio Flex™ Blood Glucose Monitoring System was designed and tested in accordance with ISO 15197:2013(E) guidelines for system accuracy. The key acceptance criteria and reported performance from the device's system accuracy study are summarized below.

    Acceptance Criteria per ISO 15197:2013(E) Clause 6.3 - System Accuracy (Healthcare Professional Use):

    Glucose Concentration RangeAcceptance Criterion (Percentage of samples within range)
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