Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1070](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1070) → CJA — Amyloclastic, Amylase

# CJA · Amyloclastic, Amylase

_Clinical Chemistry · 21 CFR 862.1070 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJA

## Overview

- **Product Code:** CJA
- **Device Name:** Amyloclastic, Amylase
- **Regulation:** [21 CFR 862.1070](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1070)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

## Classification Rationale

Class II.

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K895555](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJA/K895555.md) | MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) | Hichem Diagnostics | Dec 22, 1989 | SESE |
| [K884226](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJA/K884226.md) | AMYLASE REAGENT KIT FOR ASTRA SYSTEMS | A-Kem, Inc. | Dec 9, 1988 | SESE |
| [K883059](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJA/K883059.md) | WAKO(TM) AUTOKIT AMYLASE | Wako Chemicals USA, Inc. | Aug 30, 1988 | SESE |
| [K873520](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJA/K873520.md) | PARAMAX AMYLASE REAGENT | Baxter Healthcare Corp | Nov 23, 1987 | SESE |
| [K863052](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJA/K863052.md) | ALPHA AMYLASE | J. D. Assoc. | Sep 9, 1986 | SESE |
| [K862640](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJA/K862640.md) | AMYLASE LTS | Electro-Nucleonics Laboratories, Inc. | Sep 9, 1986 | SESE |
| [K860530](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJA/K860530.md) | AMYLASE REAGENT SET (MODIFIED CARAWAY) | Sterling Diagnostics, Inc. | Feb 28, 1986 | SESE |
| [K844168](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJA/K844168.md) | AMYLASE REAGENT CS-726 | Fisher Scientific Co., LLC | Nov 20, 1984 | SESE |
| [K843529](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJA/K843529.md) | ASTRA SYSTEMS AMYLASE REAGENT KIT | Beckman Instruments, Inc. | Oct 11, 1984 | SESE |
| [K833864](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJA/K833864.md) | AMYLASE REAGENT SET-MODIFIED CARAWAY | Sterling Biochemical, Inc. | Jan 13, 1984 | SESE |

## Top Applicants

- A-Kem, Inc. — 1 clearance
- Baxter Healthcare Corp — 1 clearance
- Beckman Instruments, Inc. — 1 clearance
- Electro-Nucleonics Laboratories, Inc. — 1 clearance
- Fisher Scientific Co., LLC — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJA](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJA)

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