(a) Identification. An alpha -2-glycoproteins immunolgical test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha -2-glycoproteins (a group of plasma proteins found in the alpha- 2 group when subjected to electrophoresis) in serum and other body fluids. Measurement of alpha -2-glycoproteins aids in the diagnosis of some cancers and genetically inherited deficiencies of these plasma proteins.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.
[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]