(71 days)
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 provided text is a 510(k) summary for the Avocet AcuSure System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any AI-related information.
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§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).