21 CFR § 862.1695 - Free thyroxine test system.

---
identifier: "/us/cfr/t21/s862.1695"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1695 - Free thyroxine test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1695"
section_name: "Free thyroxine 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"
---


# 862.1695 Free thyroxine test system.

(a) *Identification.* A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

(b) *Classification.* Class II.