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The AcuSure System for Patient Self-Testing is intended for the quantitative prothombin time testing of fresh, capillary whole blood by selected and suitably trained patients or their caregivers on the prescription of the treating physician. The AcuSure System for Patient Self-Testing is for the monitoring of patients on oral anticoagulant therapy and not intended to be used for screening purposes. The AcuSure Pro System for Professional Use is intended for the quantitative prothrombin time testing of fresh, capillary whole blood by healthcare professionals. The AcuSure Pro System is for the monitoring of patients on oral anticoagulant therapy and not intended to be used for screening purposes.

The AcuSure and AcuSure Pro test strips and meter measure capillary blood PT levels. When the sample is applied to the target area on the test strip, the meter detects the electrical drop between two electrodes on the test strip and begins the test. Inside the membrane of the test strip the red blood cells are separated from the plasma. The membrane also contains the reagents necessary to cause the coagulation reaction (clot formation) to occur. The thrombin, formed as part of the coagulation reaction, reacts with a reagent, which causes a fluorescent molecule to be released The time from the initial resistance drop to the onset of fluorescence is proportional to the prothrombin time of the sample.

The Avoceter-Home is intended for quantitative prothrombin time testing of fresh, capillary whole blood for monitoring of oral anticoagulation therapy by trained patients or their caregivers, on the prescription or other order of a treating physician.

The AvocetpT-Home is a membrane-based, dry-reagent system for use with fresh capillary whole blood. The system uses a membrane to separate plasma from red cells. The membrane contains calcium and thromboplastin, and permits the reactions of the complete extrinsic pathway to occur with minimal distortion from membrane surface interactions. Thrombin generation is monitored optically using a rhodamine-110-based fluorescent thrombin substrate. Fluorescence kinetics are analyzed to produce a prothrombin-time-equivalent parameter that is converted to an international normalized ratio (INR) value. The AvocetpT-Home is the same device as the Avocetpт, except that it has the citrated whole blood and plasma sample modes deactivated in the meter software, a test strip CAL code is only given for capillary whole blood and the labeling has been modified for readability by the lay user.

The AvocetpT is an in vitro diagnostic system that provides a quantitative prothrombin time result, expressed as an International Normalized Ratio (INR). It is intended for use by health care professionals in monitoring patients who are on warfarin-type (coumarin) anticoagulation therapy.

The Avocetpr is a membrane-based, dry-reagent system for use with fresh capillary or venous whole blood, and citrated venous whole blood or citrated plasma. The system uses an membrane to separate plasma from red cells. The membrane contains calcium and thromboplastin, and permits the reactions of the complete extrinsic pathway to occur with minimal distortion from membrane surface interactions. Thrombin generation is monitored optically using a rhodamine-110-based fluorescent thrombin substrate. Fluorescence kinetics are analyzed to produce a prothrombin-time-equivalent parameter that is converted to an international normalized ratio (INR) value.

This product (The AvocetpT System Liquid Controls, Level 1 and Level 2) is used with the Avocetor in vitro diagnostic system to validate system performance. It is intended for use by health care professionals in assessing the functionality of the Avocetor System when monitoring patients who are on warfarin-type (coumarin) anticoagulation therapy.

AvocetpT System Liquid Controls, Level 1 and Level 2