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The Immedia System is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and INR units. It uses fresh capillary whole blood. It is intended for use by health care professional at the point of care to monitor patients who are on warfarin-type (coumarin) anticoagulation therapy. The device is not intended to be used for screening purposes.

The Immedia™ Prothrombin Time System measures the Prothrombin Time (PT) of fresh capillary whole blood. The test is performed by inserting a test strip into the meter and applying a drop of blood to the sample receptacle of the test strip. The meter automatically performs the PT test and the result is displayed as International Normalized Ratio (INR) and seconds (PT). The meter automatically stores all test results in memory. The device is powered by batteries and/or AC adapter. The disposable strip contains a rotating, spoked wheel that draws the sample into the reaction well after it is applied to the sample receptacle. The spokes rotate across the path of an infrared light beam and mix the liquid sample with the thromboplastin which is dried in the reaction well. When the sample clots, the clot is picked up by the spokes, interrupting the path of the infrared light beam that is detected by the meter. A separate Calibration Strip is used for inputting the calibration data. High Control and Low Control Strips are also provided for quality control purposes.