Code of Federal Regulations Title 21. Food and Drugs § 21.866.5425 Alpha–2–glycoproteins immunological test system

(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.