21 CFR § 862.1050 - Alkaline phosphatase or isoenzymes test system.

---
identifier: "/us/cfr/t21/s862.1050"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1050 - Alkaline phosphatase or isoenzymes test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1050"
section_name: "Alkaline phosphatase or isoenzymes 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"
---


# 862.1050 Alkaline phosphatase or isoenzymes test system.

(a) *Identification.* An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

(b) *Classification.* Class II.