KLT · Enzyme Immunoassay, Carbamazepine
Clinical Toxicology · 21 CFR 862.3645 · Class 2
Overview
| Product Code | KLT |
|---|---|
| Device Name | Enzyme Immunoassay, Carbamazepine |
| Regulation | 21 CFR 862.3645 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 56)
Showing 20 most recent of 56 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K151578 | Carbamazepine Gen 4 | Roche Diagnostics Operations (Rdo) | Oct 22, 2015 | SESE |
| K123518 | ABBOTT CARBAMAZEPINE ASSAY | Microgenics Corporation | Jun 5, 2013 | SESE |
| K103627 | ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS | Abbott Laboratories | Oct 14, 2011 | SESE |
| K063131 | CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS | Thermo Electron OY | Oct 5, 2007 | SESE |
| K042808 | ADVIA IMS CARBAMAZEPINE METHOD | Bayer Healthcare, LLC | Feb 8, 2005 | SESE |
| K031902 | ONLINE TDM CARBAMAZEPINE | Roche Diagnostics Corp. | Sep 17, 2003 | SESE |
| K011648 | RANDOX CARBAMAZEPINE | Randox Laboratories, Ltd. | Jan 15, 2002 | SESE |
| K010814 | EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 | Syva Co., Dade Behring, Inc. | Apr 13, 2001 | SESE |
| K000903 | ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM | Bayer Corp. | May 18, 2000 | SESE |
| K000007 | IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6 | Diagnostic Products Corp. | Feb 28, 2000 | SESE |
| K993987 | SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL | Syva Co. | Jan 27, 2000 | SESE |
| K993028 | ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90 | Syva Co. | Jan 27, 2000 | SESE |
| K980283 | VITROS CHEMISTRY PRODUCTS CRBM SLIDES | Johnson & Johnson Clinical Diagnostics, Inc. | Feb 25, 1998 | SESE |
| K973535 | ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS | Schiapparelli Biosystems, Inc. | Oct 20, 1997 | SESE |
| K964765 | CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY | Chiron Diagnostics Corp. | Feb 14, 1997 | SESE |
| K963673 | IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS | Beckman Instruments, Inc. | Feb 4, 1997 | SESE |
| K964068 | CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | Dec 13, 1996 | SESE |
| K962820 | CARBAMAZEPINE FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | Sep 13, 1996 | SESE |
| K955644 | SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM | Beckman Instruments, Inc. | Feb 16, 1996 | SESE |
| K955100 | CARBAMAZEPINE EIA TEST | Diagnostic Reagents, Inc. | Dec 13, 1995 | SESE |
Top Applicants
- Syva Co. — 12 clearances
- Abbott Laboratories — 5 clearances
- Beckman Instruments, Inc. — 3 clearances
- Miles Laboratories, Inc. — 3 clearances
- Bayer Corp. — 2 clearances
