Title 21: Food and Drugs
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/ PART 864 - HEMATOLOGY AND PATHOLOGY DEVICES
/ Subpart H - Hematology Kits and Packages / § 864.7720 Prothrombin consumption test.
§ 864.7720 Prothrombin consumption test.
(a) Identification. A prothrombin consumption tests is a device that measures the patient's capacity to generate thromboplastin in the coagulation process. The test also is an indirect indicator of qualitative or quantitative platelet abnormalities. It is a screening test for thrombocytopenia (decreased number of blood platelets) and hemophilia A and B.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.