Clinical chemistry substrate IVDs

Intended purpose

The KETOSURE POC Blood Ketone Test Strip and associated control are to be used with the KETOSURE POC meter to quantitatively measure blood ketone in venous whole blood or capillary whole blood. They are intended for use by healthcare professionals as an aid in monitoring blood ketone level. The KETOSURE POC Blood Ketone Test Strip is not intended for neonatal use or for diagnosis of ketone related illness such as diabetic ketoacidosis (DKA).