Code of Federal Regulations Title 21. Food and Drugs § 21.866.5420 Alpha–1–glycoproteins immunological test system

(a) Identification. An alpha–1–glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques alpha–1–glycoproteins (a group of plasma proteins found in the alpha–1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specific alpha–1–glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

(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.