21 CFR § 862.1025 - Adrenocorticotropic hormone (ACTH) test system.

---
identifier: "/us/cfr/t21/s862.1025"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1025 - Adrenocorticotropic hormone (ACTH) test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1025"
section_name: "Adrenocorticotropic hormone (ACTH) test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 862.1025 Adrenocorticotropic hormone (ACTH) test system.

(a) *Identification.* An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.

(b) *Classification.* Class II.