DLI · Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
Clinical Toxicology · 21 CFR 862.3240 · Class 1
Overview
| Product Code | DLI |
|---|---|
| Device Name | Acetylcholine Chloride, Specific Reagent For Pseudo 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950180 | DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD | E.I. Dupont DE Nemours & Co., Inc. | Mar 15, 1995 | SESE |
| K930208 | CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO | Heraeus Kulzer, Inc. | Apr 20, 1993 | SESE |
| K860350 | SERUM CHOLINESTERASE REAGENT SET | Sterling Diagnostics, Inc. | Apr 24, 1986 | SESE |
| K860641 | EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93 | Em Diagnostic Systems, Inc. | Apr 3, 1986 | SESE |
| K833062 | SERUM CHOLINESTERASE REAGENT SET | Sterling Biochemical, Inc. | Nov 25, 1983 | SESE |
| K771024 | CHOLINESTERASE REAGENT SYSTEM | American Monitor Corp. | Jul 15, 1977 | SESE |
Top Applicants
- American Monitor Corp. — 1 clearance
- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance
- Em Diagnostic Systems, Inc. — 1 clearance
- Heraeus Kulzer, Inc. — 1 clearance
- Sterling Biochemical, Inc. — 1 clearance
