Amylase Test (Amyl) Item Number 65653

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K884382 ↗

FDA Product Code

CIW

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 Amylase Test (Amyl) Item Number 65653 used for in a clinical setting?

  The Amylase Test (Amyl) Item Number 65653 is designed to measure amylase levels in biological samples, helping diagnose conditions affecting the pancreas or salivary glands. It works by quantifying enzyme activity through a colorimetric reaction with a starch-dye substrate, providing quantitative results for clinical chemistry analysis.

• Is this test kit intended for single-use or repeated use, and does it require sterilization?

  The Amylase Test (Amyl) Item Number 65653 is explicitly supplied for single-use only and does not require additional sterilization beyond the manufacturer’s sealed packaging. It is intended for in vitro use in clinical laboratories, where reagent stability is maintained under standard laboratory protocols.

• How should this diagnostic reagent kit be stored, and what are the key handling considerations?

  Storage and handling follow standard laboratory protocols for reagent stability, as outlined by the manufacturer. Since it is a diagnostic reagent kit, it should be kept in its original packaging, protected from moisture, extreme temperatures, and direct light. Always refer to the manufacturer’s instructions for precise storage conditions, as improper handling could compromise test accuracy.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Amylase Test (Amyl) Item Number 65653 received FDA 510(k) clearance under the Clinical Chemistry advisory committee (CH) via a traditional review process. It is classified as a Class II device with the product code CIW, indicating it is substantially equivalent to a predicate device and subject to general controls plus special controls for clinical chemistry tests.