DIH · Colorimetry, Cholinesterase
Clinical Toxicology · 21 CFR 862.3240 · Class 1
Overview
| Product Code | DIH |
|---|---|
| Device Name | Colorimetry, Cholinesterase |
| Regulation | 21 CFR 862.3240 |
| Device Class | Class 1 |
| Review Panel | Clinical Toxicology |
Identification
A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (20 of 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K103373 | SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 | Beckman Coulter, Inc. | Feb 7, 2011 | SESE |
| K061093 | CHOLINESTERASE GEN.2 TEST SYSTEM | Roche Diagnostics Corp. | Jul 3, 2006 | SESE |
| K051444 | SENTINEL CHOLINESTERASE LIQUID | Sentinel Ch. Srl | Jun 20, 2005 | SESE |
| K030045 | OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) | Olympus America, Inc. | Feb 21, 2003 | SESE |
| K023992 | WIENER LAB COLINESTERASA AA | Wiener Laboratories Saic | Feb 12, 2003 | SESE |
| K013750 | ADVIA 1650 CHOLINESTERASE ASSAY | Bayer Diagnostics Corp. | Jan 18, 2002 | SESE |
| K002792 | CARESIDE CHOLINESTERASE | Careside, Inc. | Nov 8, 2000 | SESE |
| K001344 | ADVIA IMS | Bayer Corp. | Jun 26, 2000 | SESE |
| K961656 | TEST-MATE CHE CHOLINESTERASE TEST SYSTEM | Eqm Research, Inc. | Nov 26, 1996 | SESE |
| K943367 | IL TEST CHOLINESTERASE | Instrumentation Laboratory CO | Feb 5, 1996 | SESE |
| K955498 | CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05 | Diagnostic Chemicals , Ltd. | Jan 24, 1996 | SESE |
| K914171 | IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE | Tech Intl. Co. | Dec 18, 1991 | SESE |
| K913198 | KODAK EKTACHEM DT SLIDES (CHE) | Eastman Kodak Company | Aug 26, 1991 | SESE |
| K912148 | CHOLINESTERASE TEST KIT | Crestat Diagnostics, Inc. | Aug 12, 1991 | SESE |
| K912217 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES | Eastman Kodak Company | Jul 1, 1991 | SESE |
| K893583 | BECKMAN CHOLINESTERASE REAGENT KIT | Beckman | Aug 15, 1989 | SESE |
| K885272 | CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE | Sigma Chemical Co. | Mar 28, 1989 | SESE |
| K880199 | CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE | Sclavo, Inc. | Jan 27, 1989 | SESE |
| K880049 | CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE | Sclavo, Inc. | Jan 27, 1989 | SESE |
| K873496 | ATYPICAL CHOLINESTERASE | Sclavo, Inc. | Jan 27, 1989 | SESE |
Top Applicants
- Sclavo, Inc. — 3 clearances
- Eastman Kodak Company — 2 clearances
- Sigma Diagnostics, Inc. — 2 clearances
- Bayer Corp. — 1 clearance
- Bayer Diagnostics Corp. — 1 clearance
