Amylase Reagent Kit For Astra Systems
by A-Kem, Inc. 510(k)
Active
510(k) K884226
Overview
The Amylase Reagent Kit for Astra Systems is an amylase test system designed to measure the activity of the enzyme amylase in serum and urine. These measurements are used primarily for the diagnosis and treatment of pancreatitis, which is an inflammation of the pancreas.
This device is classified as a class 2 medical device under regulation number 862.1070. It has received FDA 510(k) clearance under the number K884226.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884226 | Date9 Dec 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CJA
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1070
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from A-Kem, Inc.
Questions
What is the primary clinical use of the Amylase Reagent Kit?
This reagent kit is designed to measure the activity of the enzyme amylase within serum and urine samples. These measurements are primarily utilized by clinicians to assist in the diagnosis and treatment of pancreatitis, which is characterized by inflammation of the pancreas.
What is the regulatory status of this amylase test system?
The Amylase Reagent Kit for Astra Systems is a class 2 medical device under regulation number 862.1070. It has received FDA 510(k) clearance under the number K884226, indicating it has been found substantially equivalent to other legally marketed devices.
Which systems is this reagent kit compatible with?
This specific reagent kit is formulated for use with Astra Systems. It is manufactured by A-Kem, Inc. and is categorized under the clinical chemistry advisory committee.