1. Intended Use

The Blood Glucose Monitoring system is intended for use in the quantitative measurement of glucose in human whole blood taken from the fingertip (capillary) or from the vein (venous) or from the artery (arterial). It is intended to be used by people with diabetes at home or clinical site as an aid in monitoring the effectiveness of their diabetes control programs.

2. Test Principle

A glucose test is based on the measurement of electrical current caused by the reaction of glucose with the FAD glucose dehydrogenase on the electrode of the strip. The blood or control solution sample is drawn into the tip of the test strip through capillary action. Glucose in the sample reacts with the FAD glucose dehydrogenase and generates electrons, which produce an electrical current. The Gold AQ Plus blood glucose meter measures the electrical current and calculates the glucose result. The glucose result is displayed by the meter in the unit of mg/dL or mmol/L.

3. About the Gold AQ Plus Blood Glucose Test Strip

The Gold AQ Plus blood glucose test strip is intended to be used with the Gold AQ Plus blood glucose meter to measure the amount of blood glucose in fresh capillary whole blood or venous blood or arterial blood. The Gold AQ Plus blood glucose test strip used with the Gold AQ Plus blood glucose meter provides a complete test system that is intended for in vitro diagnostic use by people with diabetes.