21 C.F.R. § 862.1185

Current through September 30, 2024
Section 862.1185 - Compound S (11-deoxycortisol) test system
(a)Identification. A compound S (11-dioxycortisol) test system is a device intended to measure the level of compound S (11-dioxycortisol) in plasma. Compound S is a steroid intermediate in the biosynthesis of the adrenal hormone cortisol. Measurements of compound S are used in the diagnosis and treatment of certain adrenal and pituitary gland disorders resulting in clinical symptoms of masculinization and hypertension.
(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 .

21 C.F.R. §862.1185

52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000