21 CFR § 862.1377 - Urinary homocystine (nonquantitative) test system.

---
identifier: "/us/cfr/t21/s862.1377"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1377 - Urinary homocystine (nonquantitative) test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1377"
section_name: "Urinary homocystine (nonquantitative) 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"
---


# 862.1377 Urinary homocystine (nonquantitative) test system.

(a) *Identification.* A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.

(b) *Classification.* Class II.