Section 866.5430 - Beta-2-glycoprotein I immunological test system(a)Identification. A beta-2-glycoprotein I immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the beta-2-glycoprotein I (a serum protein) in serum and other body fluids. Measurement of beta-2-glycoprotein I aids in the diagnosis of an inherited deficiency of this serum protein.(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