21 CFR § 862.1070 - Amylase test system.

---
identifier: "/us/cfr/t21/s862.1070"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1070 - Amylase test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1070"
section_name: "Amylase 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"
---


# 862.1070 Amylase test system.

(a) *Identification.* An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

(b) *Classification.* Class II.