Clinical chemistry substrate IVDs

Intended purpose

Self-testing blood glucose and multi-functional monitoring systems, which may include measurement of glucose, ß-Ketone, lactate, total cholesterol, triglycerides, and uric acid for the monitoring and management of blood levels of one or more reportable parameters, not intended to be used for diagnosis or screening of diseases. The devices may also be used for testing by Health Professionals, including use of fingertip capillary blood (all parameters), arterial blood samples (glucose only), venous blood samples (glucose and ketone) and neonatal blood samples (glucose only)