StacksVerified U.S. regulatory reference

21 CFR §862.1080

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  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 § 862.9.