21 CFR §866.5160

1. (a)Identification. A beta-globulin immunological test system is a device that consists of reagents used to measure by immunochemical techniques beta globulins (serum protein) in serum and other body fluids. Beta-globulin proteins include beta-lipoprotein, transferrin, glycoproteins, and complement, and are rarely associated with specific pathologic disorders.
2. (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.