(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.

[45 FR 60625, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]