Easy-Test Amylase (Amyl), #67521/93

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

Full name

Easy-Test Amlase (Amyl), #67521/93

510(k) Number

K860918 ↗

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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See all devices from Em Diagnostic Systems, Inc. →

• What is the Easy-Test Amylase (Amyl) used for in a clinical setting?

  The Easy-Test Amylase (Amyl) is designed to measure amylase levels in patient samples through an enzymatic catalytic method. This helps clinicians diagnose conditions like pancreatitis or other pancreatic disorders by quantifying amylase activity in clinical chemistry laboratories.

• Is the Easy-Test Amylase (Amyl) intended for single-use or repeated use?

  The Easy-Test Amylase (Amyl) is supplied as a single-use reagent kit, meaning each kit is intended for one-time use in testing patient samples. This ensures accuracy and sterility for each procedure.

• How is the Easy-Test Amylase (Amyl) regulated by the FDA?

  The device holds a traditional FDA 510(k) clearance (K860918) and is classified as a Class II medical device under 21 CFR 862.1070. It was determined to be substantially equivalent to a predicate device, allowing it to be marketed in the U.S. for its intended use in clinical chemistry.

• Where can the Easy-Test Amylase (Amyl) be used, and what training is required?

  This device is intended for use in approved clinical chemistry laboratories. Proper training and adherence to the manufacturer’s instructions are required to ensure accurate and safe operation, as outlined in the device’s regulatory submission.

• What type of samples can the Easy-Test Amylase (Amyl) analyze?

  The Easy-Test Amylase (Amyl) is specifically designed for in vitro diagnostic use to quantify amylase activity in patient samples, aiding in the evaluation of conditions related to the pancreas, such as pancreatitis.