Introduction

The VivaChek ™ Ino system is designed to quantitatively determine blood glucose levels in a fresh capillary whole blood sample. The test is based on measuring the electric current caused by the reaction of glucose and reagents at the electrode located on the test strip. The blood sample is pulled to the top of the test strip by capillary action. Glucose in the sample reacts with glucose enzyme and mediator. Electrons are created, creating a current that is positively correlated to the glucose level in the sample. After the reaction time, the glucose levels in the sample are displayed. The glucometer was calibrated to display plasma glucose levels. The system is intended for external use (in vitro diagnostic use) for diabetics at home and healthcare professionals in clinics; the system is used as a means of controlling diabetes. The system is not intended to diagnose diabetes.