(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.