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The Confidence Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The Confidence Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Confidence 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 Confidence Blood Glucose Monitoring System should not be used for the diagnosis of or diabetes or for neonatal use. The Confidence Blood Glucose Test Strips are for use with the Confidence Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.

The Confidence™ BGMS consists of test strips stored in a vial with desiccant lining, a hand held blood qlucose meter and a control solution. To perform blood glucose test a test strip is removed from the vial and inserted into Confidence™ meter. On inserting the strip meter gets activated and displays a code, user must select a code corresponding to their strip vial using meter's interface, after selecting correct code, meter will be ready to apply sample by showing a droplet on the LCD display. On applying blood on the end of the test strip a countdown starts and meter LCD displays the plasma equivalent value in the blood sample within 10 seconds in mg/dL unit. The user can validate the operation of the system by using provided control solution. The system uses an electrochemical method based on the GDH-FAD enzyme and a known algorithm, where generated current is directly proportional to glucose concentration.