Section 862.1080 - Androsterone test system(a)Identification. An androsterone test system is a device intended to measure the hormone adrosterone in serum, plasma, and urine. Androsterone measurements are used in the diagnosis and treatment of gonadal and adrenal diseases.(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 § 862.9 .52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000