21 CFR 862.1615
§ 862.1615 Pregnenolone test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1615, § 862.1615 Pregnenolone test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89170
- Permanent ID
ys:prov:89170@1- SHA-256
2720b922de432be1889dfef88b5754c5553958c7173dde76ce0cfe033ca0e86e
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Full text
(a) Identification. A pregnenolone test system is a device intended to measure pregnenolone (a precursor in the biosynthesis of the adrenal hormone cortisol and adrenal androgen) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diseases of the adrenal cortex or the gonads.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.