Amyloclastic, Amylase
The Amyloclastic, Amylase test system (product code CJA) is an in-vitro diagnostic device used in clinical chemistry to measure amylase activity in serum or urine by the amyloclastic method, which monitors the decrease in starch substrate absorbance as amylase degrades it, supporting the diagnosis of pancreatitis and related conditions. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1070 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- CJA
- Device Class
- FDA class 2
- Regulation Number
- 862.1070
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K895555 | MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) | Dec 22, 1989 | Substantially Equivalent | Hichem Diagnostics |
| K884226 | AMYLASE REAGENT KIT FOR ASTRA SYSTEMS | Dec 09, 1988 | Substantially Equivalent | A-Kem, Inc. |
| K883059 | WAKO(TM) AUTOKIT AMYLASE | Aug 30, 1988 | Substantially Equivalent | Wako Chemicals USA, Inc. |
| K873520 | PARAMAX AMYLASE REAGENT | Nov 23, 1987 | Substantially Equivalent | Baxter Healthcare Corp |
| K863052 | ALPHA AMYLASE | Sep 09, 1986 | Substantially Equivalent | J. D. Assoc. |
| K862640 | AMYLASE LTS | Sep 09, 1986 | Substantially Equivalent | Electro-Nucleonics Laboratories, Inc. |
| K860530 | AMYLASE REAGENT SET (MODIFIED CARAWAY) | Feb 28, 1986 | Substantially Equivalent | Sterling Diagnostics, Inc. |
| K844168 | AMYLASE REAGENT CS-726 | Nov 20, 1984 | Substantially Equivalent | Fisher Scientific Co., LLC |
| K843529 | ASTRA SYSTEMS AMYLASE REAGENT KIT | Oct 11, 1984 | Substantially Equivalent | Beckman Instruments, Inc. |
| K833864 | AMYLASE REAGENT SET-MODIFIED CARAWAY | Jan 13, 1984 | Substantially Equivalent | Sterling Biochemical, Inc. |