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The Xprecia Prime™ Coagulation System, which includes the INR Coagulation Analyzer (Meter) and PT/INR Test Strips, is for the determinational Normalized Ratio (INR) for the monitoring of oral anticoagulation therapy with Warfarin (a vitamin K antagonist) in fresh capillary whole blood from a fingerstick. The results are reported in INR as well as in seconds. It is intended to be used to monitor patients 18 years of age or older who are stable on vitamin K antagonist therapy for at least six weeks and is not intended for use in patients who are transitioning from heparin treatment to vitamin K antagonist therapy. The Xprecia Prime™ Coagulation System is an in-vitro diagnostic device intended for multi-patient use in professional healthcare settings including CLIA Waived and Point of care settings.

The Xprecia Prime™ Coagulation System has been specifically designed to monitor INR of patients undergoing anticoagulation therapy with warfarin (Vitamin K antagonist). It consists of the Xprecia Prime " Coagulation Analyzer, Xprecia Prime™ PT/INR Test Strips and Xprecia " Systems PT Controls. The Xprecia Prime™ Coagulation System analyses a blood sample taken from the patient by fingerstick. The sample is transferred from the patient's finger to a test strip that has been inserted in the Xprecia Prime™ Coagulation Analyzer. The blood is mixed with a reagent contained within the strip and the analyzer detects when clotting has occurred. The result is then displayed on the analyzer's screen in either units known as the International Normalized Ratio (INR) or in calibrated seconds.