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    K Number
    K140325
    Device Name
    Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System
    Manufacturer
    JOINSOON MEDICAL TECHNOLOGY CO, LTD.
    Date Cleared
    2015-10-13

    (610 days)

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

    JOINSOON MEDICAL TECHNOLOGY CO, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Joinsoon® EON L Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The Joinsoon® EON L Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes in a home setting as an aid to monitor the effectiveness of diabetes control. The Joinson® EON L Glucose Monitoring System should not be used for the diagnosis of circening of diabetes or for neonatal use. The Joinsoon® EON L Glucose Monitoring System is intended to be used by a single person and should not be shared. The Joinsoon® Single Strips are for use with the Joinsoon® EON L Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips. The Joinsoon® Control Solution is for use with the Joinsoon® HON L Glucose Meter and Joinsoon® Single Strips as a quality control check to verify that the meter and test strips are working together properly, and that the test is performing correctly. The Joinsoon® EON LS Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The Joinsoon® EON LS Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes in a home setting as an aid to monitor the effectiveness of diabetes control. The Joinsoon® EON LS Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The Joinsoon® EON LS Glucose Monitoring System is intended to be used by a single person and should not be shared. The Joinsoon® Snap Strips are for use with the Joinsoon® EON LS Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips. The Joinsoon® Control Solution is for use with the Joinsoon® EON LS Glucose Meter and Joinsoon® Snap Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.
    Device Description
    The Joinsoon® EON LS Glucose Monitoring system consists of: a Joinsoon® EON LS Glucose Meter and Joinsoon® Snap Strips. The Joinsoon® EON L Glucose Monitoring system consists of: a Joinsoon® EON L Glucose Meter and Joinsoon® Single Strips. Both systems utilize an electrochemical – method based meter and dry reagent biosensor (test strip) for blood glucose testing. The electron accumulates on the electrode when glucose reacts with the reagent on the electrode. A current can be detected by the Joinsoon® EON LS and EON L glucose meters when a constant voltage is applied across the electrodes. The current will be converted into glucose concentration by an embedded transfer function in the meter. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions. The Joinsoon® Snap Strips utilize the enzyme glucose oxidase. There is no-coding needed for use of the meter and test strips. The Joinsoon® Snap Strip has 10 individual test sections which can be used one at a time with the Joinsoon® EON LS Glucose Meter. Each test section has its own Reaction Zone with the Enzyme at one end, and contact pads at the other end. The Single Strips utilize the enzyme glucose oxidase. There is no-coding needed for use of the meter and test strips. The Joinsoon® EON L Glucose Monitoring system is sold with the following components: Joinsoon® EON L Glucose Meter, Joinsoon® Single Strips, control solution, lancet, lancing device, quick start user guide, user manual, warranty card and a carrying case. The Joinsoon® EON LS Glucose Monitoring system is sold with the following components: Joinsoon® EON LS Glucose Meter, Joinsoon® Snap Strips, control solution, lancet, lancing device, quick start user guide, user manual, warranty card and a carrying case.
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