21 CFR § 862.1680 - Testosterone test system.

---
identifier: "/us/cfr/t21/s862.1680"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1680 - Testosterone test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1680"
section_name: "Testosterone 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"
---


# 862.1680 Testosterone test system.

(a) *Identification.* A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

(b) *Classification.* Class I.

[52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, 1988]