Silyl Amyl

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

510(k) Number

K931583 ↗

FDA Product Code

JFJ

Device Class

Class II

Regulation

21 CFR Part 862.1070

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Alanine Aminotransferase Test

  Class I

  FDA 510(k) K903198 Active Cleared 12 Sep 1990

• Emds Tm Phenobarbital(Phno) Testpack, #67677/95

  Class II

  FDA 510(k) K864926 Active Cleared 7 Jan 1987

• Olympus(Tm) Total Bilirubin

  Class II

  FDA 510(k) K897174 Active Cleared 10 May 1990

• Systamate Aspartate Aminotransferase Test Technico

  Class II

  FDA 510(k) K922857 Active Cleared 9 Sep 1992

• Systemate (Tm) Alanine Transferase (Alt)

  Class II

  FDA 510(k) K863094 Active Cleared 29 Aug 1986

• Systemate Ldh, 67210

  Class II

  FDA 510(k) K843269 Active Cleared 13 Sep 1984

See all devices from Em Diagnostic Systems, Inc. →

• What is the Silyl Amyl reagent kit used for?

  The Silyl Amyl is a catalytic method device designed for measuring alpha-amylase activity in serum or plasma samples. This measurement is essential for diagnosing conditions like pancreatitis, mumps, or other disorders affecting amylase levels, helping clinicians assess enzyme production or clearance accurately.

• How is the Silyl Amyl supplied and intended for use?

  The Silyl Amyl is supplied as a reagent kit for in vitro diagnostic use in clinical laboratories. It is intended exclusively for single-use applications, adhering to standard laboratory sterility practices. The device is not intended for reuse or alternative clinical settings beyond accredited clinical chemistry labs.

• Is sterility a special concern for this device?

  No additional sterility measures beyond standard laboratory practices are required for the Silyl Amyl. Since it is a single-use reagent kit, proper handling and storage in accordance with the manufacturer’s instructions ensure its integrity and usability in clinical settings.

• What regulatory pathway does the Silyl Amyl follow?

  The Silyl Amyl is classified as a Class II medical device under 21 CFR 862.1070 and has received FDA 510(k) clearance (K931583). This clearance confirms its substantial equivalence to a predicate device, ensuring compliance with regulatory standards for enzymatic assay reagents in clinical chemistry.

• Are there specific storage conditions for the Silyl Amyl?

  Storage conditions for the Silyl Amyl are outlined in the manufacturer’s instructions provided with the kit. Proper handling and storage are critical to maintaining the reagent’s stability and performance, particularly in accredited clinical chemistry labs where it is intended for use.