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U.S. Department of Health and Human Services

Product Classification

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Device ecarin clotting time
Regulation Description Coagulation instrument.
Definition The tas ect test card is to be used with the tas analyzer and is intended to determine the anticoagulant effect of hirudin during cbp in patients who have hit.It is suited for professional use in decentralized areas of testing near the site of patient care as well as for use in the more traditional laboratory.Monitoring with the tas ect is indicated for persons who have been identified with and/or confirmed as a high risk for hit, and require high dose anticoagulant with hirudin for a scheduled or emergency cpb procedure.
Physical State The system requires pooled normmal human plasma to dilute the citrate whole blood usingpolypropylene plastic tube. The system's performance is monitored by two levels of quality control plasma avialble from Cardiovascular Diagnostics, Inc.
Technical Method The TAS ECT provides one stage test which measures the clotting time of a plasma diluted, citrate whole blood after combining it with the prothrombin activator, ecarin. It is composed of a thin plastic card in which a flat, shallow reaction chamber containing all reagents necessary for the ECT test. In the reaction chamber, it also contains paramagnetic iron peroxide particles (PIOP) which is impeded by a clot. The signal produced by the relative movement of the PIOP is interpreted by the TAS Analyzer and reported in seconds. The greater amount of recombinant hirudin in the patient blood, the longer the clotting time is generated by the TAS system.
Target Area Patient's citrated whole blood
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodePBA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type HDE - Humanitarian Device Exemption
Regulation Number 864.5400
Device Class HDE - Humanitarian Device Exemption
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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