The On Call® Smart Pro Blood Glucose/Ketone/Uric Acid Analyzer is intended for quantitative measurement of glucose with On Call® Sure Blood Glucose Test Strips in fresh capillary whole blood from the fingertip, forearm and palm, venous, arterial and neonatal blood samples to monitor blood glucose for individuals who have diabetes or are potentially at risk for diabetes.
It is also intended for quantitative measurement of β-ketone (β-hydroxybutyrate) with On Call® Blood Ketone Test Strips in fresh capillary whole blood from the fingertip and venous blood sample to monitor blood β-ketone for individuals who have diabetic ketoacidosis (DKA), or are potentially at risk for diabetic ketoacidosis (DKA).
It is also intended for quantitative measurement of uric acid with On Call® Blood Uric Acid Test Strips in fresh capillary whole blood from the fingertip to monitor blood uric acid for individuals who have hyperuricemia or gout, or are potentially at risk for hyperuricemia or gout.
The analyzer is intended for near-patient testing by healthcare professionals in professional point-of-care (PoC) settings and for professional use in laboratories.
The analyzer is not automated and only for use outside the body (in vitro diagnostic use). It is not used for the diagnosis of diabetes mellitus, nor for diabetic ketoacidosis (DKA), nor for hyperuricemia or gout.