Clinical chemistry substrate IVDs

Intended purpose

The blood glucose test strips or ketone test strips are intended to be used together with the meters by the patient at home or by healthcare professionals for quantitative measurement of glucose (sugar) with capillary blood from the fingertip or alternate site and venous and arterial blood (professional use only) and Beta-Hydroxybutyrate (Ketone) in fresh whole blood samples from the finger. It should not be used for the diagnosis of diabetes, or screening for diabetes mellitus.