21 CFR § 862.1560 - Urinary phenylketones (nonquantitative) test system.

---
identifier: "/us/cfr/t21/s862.1560"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1560 - Urinary phenylketones (nonquantitative) test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1560"
section_name: "Urinary phenylketones (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"
---


# 862.1560 Urinary phenylketones (nonquantitative) test system.

(a) *Identification.* A urinary phenylketones (nonquantitative) test system is a device intended to identify phenylketones (such as phenylpyruvic acid) in urine. The identification of urinary phenylketones is used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.

(b) *Classification.* Class I (general controls). The device is exempt from the 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 2307, Jan. 14, 2000]