General coagulation IVDs

Intended purpose

The i-STAT PTplus cartridge is intended for use in the in vitro quantitative measurement of the clot time of the extrinsic coagulation pathway when activated by thromboplastin in non-anticoagulated whole blood (venous or capillary), using the i-STAT 1 System. Measurements of prothrombin time are used to aid in the monitoring of patients receiving anticoagulant therapy with coumarin derivatives. The i-STAT PTplus Prothrombin Time test result is reported in seconds and as an International Normalised Ratio (INR). The test is intended for point of care use. The i-STAT PTplus Controls are used for the quality control of the i-STAT PTplus cartridge.