Enzyme Immunoassay, Carbamazepine
FDA product code KLT · Class II (moderate risk) · 21 CFR 862.3645 · Clinical Toxicology
56510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Syva Co. 12
- Abbott Laboratories 5
- Miles Laboratories, Inc. 3
- Beckman Instruments, Inc. 3
- Bayer Corp. 2
- Instrumentation Laboratory CO 2
- Roche Diagnostic Systems, Inc. 2
- Microgenics Corp. 2
- Em Diagnostic Systems, Inc. 1
- Roche Diagnostics Operations (Rdo) 1
- Biotrack, Inc. 1
- Boehringer Mannheim Corp. 1
- Pb Diagnostic Systems, Inc. 1
- Colony Laboratories, Inc. 1
- Innotron of Oregon, Inc. 1
- Windsor Laboratories, Inc. 1
- Environmental Diagnostics, Inc. 1
- Clinical Data, Inc. 1
- American Dade 1
- American Diagnostic Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K151578 | Carbamazepine Gen 4KLT · Traditional | Roche Diagnostics Operations (Rdo) | 10/22/2015SE |
| K123518 | Abbott Carbamazepine AssayKLT · Traditional | Microgenics Corporation | 06/05/2013SE |
| K103627 | Architect Icarbamazepine Icarbamazepine Reagents; Architect Icarbamazepine CalibratorsKLT · Traditional | Abbott Laboratories | 10/14/2011SE |
| K063131 | Carbamazepine, Valproic Acid, TDM Calibration Set B and Abtrol, Nortrol ControlsKLT · Traditional | Thermo Electron OY | 10/05/2007SE |
| K042808 | Advia Ims Carbamazepine MethodKLT · Traditional | Bayer Healthcare, LLC | 02/08/2005SE |
| K031902 | Online TDM CarbamazepineKLT · Traditional | Roche Diagnostics Corp. | 09/17/2003SE |
| K011648 | Randox CarbamazepineKLT · Traditional | Randox Laboratories, Ltd. | 01/15/2002SE |
| K010814 | Emit 2000 Carbamazepine Assay, Model OSR4F229KLT · Special | Syva Co., Dade Behring, Inc. | 04/13/2001SE |
| K000903 | Additional Assays for Bayer Advia Ims SystemKLT · Traditional | Bayer Corp. | 05/18/2000SE |
| K000007 | Immulite Carbamazepine, Immulite 2000 Carbamazepine, Catalog # LKCB1, LKCB5 & L2KCB2…KLT · Traditional | Diagnostic Products Corp. | 02/28/2000SE |
| K993987 | Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129ULKLT · Traditional | Syva Co. | 01/27/2000SE |
| K993028 | Abbott Aeroset Carbamazepine Assay and Calibrators; Models 1E12 and 6E90KLT · Traditional | Syva Co. | 01/27/2000SE |
| K980283 | Vitros Chemistry Products CRBM SlidesKLT · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 02/25/1998SE |
| K973535 | Ace Carbamazepine Reagent/Aed CalibratorsKLT · Traditional | Schiapparelli Biosystems, Inc. | 10/20/1997SE |
| K964765 | Chiron Diagnostics Acs: 180 Carbamazepine AssayKLT · Traditional | Chiron Diagnostics Corp. | 02/14/1997SE |
| K963673 | Immage Immunochemistry System TDM (Car,Phe,Phy, & the) ReagentsKLT · Traditional | Beckman Instruments, Inc. | 02/04/1997SE |
| K964068 | Carbamazepine Assay for the Technicon Immuno 1 SystemKLT · Traditional | Bayer Corp. | 12/13/1996SE |
| K962820 | Carbamazepine Flex Reagent CartridgeKLT · Traditional | Dade Intl., Inc. | 09/13/1996SE |
| K955644 | Synchron Systems Carbamazepine Test SystemKLT · Traditional | Beckman Instruments, Inc. | 02/16/1996SE |
| K955100 | Carbamazepine Eia TestKLT · Traditional | Diagnostic Reagents, Inc. | 12/13/1995SE |
| K942687 | Il Test Carbamazepine, PN 181754-00; Il Test Carbamazepine Calibrators, PN 181762-00KLT · Traditional | Instrumentation Laboratory CO | 01/25/1995SE |
| K935374 | Axsym CarbamazephineKLT · Traditional | Abbott Laboratories | 06/21/1994SE |
| K940374 | QMS Carbamazepine AssayKLT · Traditional | Seradyn, Inc. | 06/02/1994SE |
| K933684 | Il Test CarbamazephineKLT · Traditional | Instrumentation Laboratory CO | 10/01/1993SE |
| K926441 | Roche Cobas(R)-Fp Reagent for Total T4 Thyrox/CaliKLT · Traditional | Roche Diagnostic Systems, Inc. | 05/26/1993SE |
| K915756 | Biotrack Carbamazepine Test CartridgeKLT · Traditional | Biotrack, Inc. | 07/23/1992SE |
| K914857 | Cedia(R) Carbamazepine AssayKLT · Traditional | Microgenics Corp. | 01/15/1992SE |
| K913066 | Emit(R) 2000 Carbamazepine Assay/CalibratorsKLT · Traditional | Syva Co. | 07/30/1991SE |
| K901086 | Enzymun Test(R) T4 (Total Thyroxine)KLT · Traditional | Boehringer Mannheim Corp. | 03/30/1990SE |
| K897114 | Emit Convenience Pack: Carbamazepine AssayKLT · Traditional | Syva Co. | 01/18/1990SE |
| K896860 | Opus Carbamazepine Test SystemKLT · Traditional | Pb Diagnostic Systems, Inc. | 01/02/1990SE |
| K894519 | FPR Carbamazepine KitKLT · Traditional | Colony Laboratories, Inc. | 08/28/1989SE |
| K893507 | Innofluor Carbamazepine Reagent SetKLT · Traditional | Innotron of Oregon, Inc. | 08/11/1989SE |
| K882961 | Emit QST Carbamazepine AssayKLT · Traditional | Syva Co. | 08/29/1988SE |
| K873282 | Carbamazepine Fpia Fluores. Polariza. ImmunoassayKLT · Traditional | Windsor Laboratories, Inc. | 09/22/1987SE |
| K871254 | Acculevel Carbamazepine TestKLT · Traditional | Syva Co. | 06/17/1987SE |
| K871306 | Emit Carbamazepine AssayKLT · Traditional | Syva Co. | 04/14/1987SE |
| K863842 | Seralyzer Aris Carbamazepine Strips/Modu/Cali/ContKLT · Traditional | Miles Laboratories, Inc. | 01/14/1987SE |
| K864553 | Easy-Test Carbamazepine Item No. 67---/95KLT · Traditional | Em Diagnostic Systems, Inc. | 01/08/1987SE |
| K862916 | Ez-Screen: CannabinoidKLT · Traditional | Environmental Diagnostics, Inc. | 01/07/1987SE |
| K860047 | Determination of CarbamazepineKLT · Traditional | Clinical Data, Inc. | 01/22/1986SE |
| K853835 | Emit QST Carbamazepine AssayKLT · Traditional | Syva Co. | 10/01/1985SE |
| K850807 | Cobas FP Reagents for CarbamazepineKLT · Traditional | Roche Diagnostic Systems, Inc. | 03/22/1985SE |
| K834052 | Chemkit Carbamazepine Diagnostic KitKLT · Traditional | Abbott Laboratories | 01/24/1984SE |
| K832720 | Emit AED Carbamazepine AssayKLT · Traditional | Syva Co. | 10/04/1983SE |
| K832766 | Ames Tda Disopyramide TestKLT · Traditional | Miles Laboratories, Inc. | 09/29/1983SE |
| K832631 | A-Gent CarbamazepineKLT · Traditional | Abbott Laboratories | 09/12/1983SE |
| K832447 | Stratus Carbamazepine FlurometricKLT · Traditional | American Dade | 09/12/1983SE |
| K831222 | Carbamezepine Reagent Test KitKLT · Traditional | Beckman Instruments, Inc. | 05/09/1983SE |
| K821945 | Carbamazepine Flourescent ImmunoassayKLT · Traditional | American Diagnostic Corp. | 07/16/1982SE |
| K820189 | Carbamazepine AssayKLT · Traditional | Syva Co. | 02/12/1982SE |
| K811952 | Ames Tda Carbamazepine TestKLT · Traditional | Miles Laboratories, Inc. | 07/15/1981SE |
| K802902 | Cybrex CarbamazepineKLT · Traditional | Abbott Laboratories | 12/19/1980SE |
| K790255 | Emit AED Assays 3500 Computer DirectedKLT · Traditional | Syva Co. | 03/02/1979SE |
| K781958 | Analytical Test Pack, CarbamazepineKLT · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 01/10/1979SE |
| K780466 | Emit Carbamazepine AssayKLT · Traditional | Syva Co. | 04/24/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1470-2014 Class II | VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics…The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS… | Ortho-Clinical Diagnostics | 03/05/2014Terminated |
| Z-0307-2014 Class II | VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |