Clinical chemistry substrate IVDs

Intended purpose

Blood glucose test strips and Blood glucose monitoring system intended for in-vitro (outside the body) diagnostic use for self-testing and used for the quantitative measurement of the glucose level as an aid in monitoring diabetes management. The Blood Glucose Monitoring System cannot be used for the diagnosis of diabetes. The coding of the test strips is automatically detected. The test result is plasma equivalent and achieved by using (a) fresh capillary whole blood that may be drawn from the fingertip (b) and venous whole blood samples if drawn by healthcare professionals.