General coagulation IVDs

Intended purpose

Xprecia Prime System: The Xprecia Prime™ System, which includes the automated INR Coagulation Analyzer (Meter) and PT/INR Test Strips, is for the quantitative determination of International Normalized Ratio (INR) for the monitoring of vitamin K antagonist oral anticoagulation therapy in fresh capillary whole blood from a fingerstick or non-anticoagulated venous whole blood. It is an in vitro diagnostic device intended for use by professional healthcare providers in multi-patient use settings including point of care. Same test strips are also used for patient self-testing device. Xprecia Prime 4U System: The Xprecia Prime™ 4U System, which includes the automated INR Coagulation Analyzer (Meter) and PT/INR Test Strips, is for the quantitative determination of International Normalized Ratio (INR) based on a prothrombin time (PT) response for the monitoring of vitamin K antagonist oral anticoagulation therapy in fresh capillary whole blood from a fingerstick. It is an in vitro diagnostic device intended for use by patients and their respective caregivers at in home setting. The Xprecia Prime 4U System is intended for single patient self-testing only. The Xprecia Prime™ 4U system is intended for single patient self-testing only in a range of settings, including the patient’s home. Xprecia Systems PT Controls: Xprecia Systems PT Controls is a combination package containing lyophilized normal and abnormal plasma controls to be reconstituted with Cacl2 diluent for use with Xprecia Coagulation systems for PT/INR determinations by professional healthcare providers.