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The Gmate® VOICE Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, hand, upper arm, forearm, calf or thigh as an aid in monitoring the effectiveness of diabetes management in the home by individuals with diabetes. The Gmate® VOICE Blood Glucose Monitoring System is intended to be used by a single user and should not be shared with any other person. The Gmate® VOICE Blood Glucose Monitoring System is for self-testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Gmate® VOICE Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The Gmate® VOICE Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users. The Gmate® Blood Glucose Test Strips are for use with the Gmate® VOICE Meter for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, hand, upper arm, forearm, calf or thigh. The Gmate® Control Solution is for use with the Gmate® VOICE Blood Glucose Monitoring System and is intended as a quality control measure to verify the accuracy of your blood glucose test results and to ensure that the Gmate® VOICE meter and Gmate® Test Strips are working properly. The Gmate® Control Solution is intended for use by people with diabetes at home.

The Gmate® VOICE Blood Glucose Monitoring System is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the Gmate® Blood Glucose Test Strips. The test principle is: This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the glucose oxidase that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.