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) → CIW — Starch-Dye Bound Polymer, Amylase

# CIW · Starch-Dye Bound Polymer, 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/CIW

## Overview

- **Product Code:** CIW
- **Device Name:** Starch-Dye Bound Polymer, 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 (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K931559](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIW/K931559.md) | DMA AMYLASE PROCEDURE | Data Medical Associates, Inc. | Oct 28, 1993 | SESE |
| [K924339](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIW/K924339.md) | OLYMPUS AMYLASE REAGENT | Olympus Corp. | Oct 19, 1992 | SESE |
| [K884382](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIW/K884382.md) | AMYLASE TEST (AMYL) ITEM NUMBER: 65653 | Em Diagnostic Systems, Inc. | Jan 11, 1989 | SESE |
| [K850639](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIW/K850639.md) | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | Bio-Analytics Laboratories, Inc. | Mar 5, 1985 | SESE |
| [K812027](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIW/K812027.md) | KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) | Eastman Kodak Company | Aug 3, 1981 | SESE |
| [K810584](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIW/K810584.md) | PHADEBAS ISOAMYLASE TEST | Pharmacia, Inc. | May 13, 1981 | SESE |
| [K810669](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIW/K810669.md) | PANTRAK E.K. | Calbiochem-Behring Corp. | Mar 31, 1981 | SESE |
| [K782032](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIW/K782032.md) | UNITEST AMYLASE | Boehringer Mannheim Corp. | Mar 2, 1979 | SESE |

## Top Applicants

- Bio-Analytics Laboratories, Inc. — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
- Calbiochem-Behring Corp. — 1 clearance
- Data Medical Associates, Inc. — 1 clearance
- Eastman Kodak Company — 1 clearance

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

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