21 CFR § 862.1060 - Delta-aminolevulinic acid test system.

---
identifier: "/us/cfr/t21/s862.1060"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1060 - Delta-aminolevulinic acid test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1060"
section_name: "Delta-aminolevulinic acid 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"
---


# 862.1060 Delta-aminolevulinic acid test system.

(a) *Identification.* A *delta*-aminolevulinic acid test system is a device intended to measure the level of *delta*-aminolevulinic acid (a precursor of porphyrin) in urine. *Delta*-aminolevulinic acid measurements are used in the diagnosis and treatment of lead poisoning and certain porphyrias (diseases affecting the liver, gastrointestinal, and nervous systems that are accompanied by increased urinary excretion of various heme compounds including *delta*-aminolevulinic acid).

(b) *Classification.* Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]