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510(k) Data Aggregation

    K Number
    K163087
    Device Name
    PixoTest Blood Glucose Monitoring System
    Date Cleared
    2017-11-02

    (364 days)

    Product Code
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    iXensor Company Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PixoTest Blood Glucose Monitoring System is comprised of PixoTest Glucose Test Strip, PixoTest Uni-Clip, and the PixoHealth App as the display component of the system. The PixoTest Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. The PixoTest 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 system is intended for single person use only and should not be shared. It is not in the diagnosis of or screening for diabetes and is not intended for use on neonates.
    Device Description
    PixoTest BGMS consists of the following devices: - PixoTest Glucose Test Strip (single-use) abbreviated as Glucose Test Strip 1) - PixoTest Control Solutions (2 levels 1 and 2) optional 2) - 3) PixoTest Standard Card - PixoTest Uni-Clip 4) - ર) PixoHealth App - Requires compatible smartphone (iPhone 5/5S/6/6S) not provided by iXensor 6) iXensor provides the following kits: - Starter (5 Pcs) Kit- includes PixoTest Standard Card, PixoTest Uni-Clip, and 5 Pcs 1) Glucose Test Strip - 2) 10 Pcs Kit - includes PixoTest Standard Card and 10 Pcs PixoTest Glucose Test Strip The PixoTest BGMS uses glucose oxidase test methodology to measure capillary whole blood glucose levels from 40 to 500 mg/dL. The system will display "Hi" when the results are above 500 mg/dL and "Lo" when the results are below 40mg/dL.
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