Amylase Test

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K923677 ↗

FDA Product Code

JFJ

Device Class

Class II

Regulation

21 CFR Part 862.1070

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the primary clinical purpose of the Amylase Test?

  This device is designed to measure the activity of the enzyme amylase within serum and urine samples. These measurements are used by clinicians primarily to aid in the diagnosis and management of pancreatitis, which is an inflammation of the pancreas.

• How is this device classified for regulatory purposes?

  The Amylase Test is classified as a Class II catalytic method for amylase under regulation number 862.1070. It received FDA 510(k) clearance on September 9, 1992, under submission number K923677.

• Which medical specialty oversees this diagnostic test?

  The device falls under the Clinical Chemistry medical specialty. This classification is based on its function as a catalytic method for measuring enzyme activity in biological fluids.