Product Code: KLT FDA class 2 21 CFR 862.3645

Enzyme Immunoassay, Carbamazepine

Clinical Toxicology

The Carbamazepine Enzyme Immunoassay is an in vitro diagnostic test used in clinical toxicology laboratories to quantitatively measure carbamazepine serum levels, supporting therapeutic drug monitoring for patients receiving this antiepileptic and mood-stabilizing medication. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KLT and it is regulated under 21 CFR 862.3645 in the Clinical Toxicology specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: KLT
Device Class: FDA class 2
Regulation Number: 862.3645
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 56 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K151578	Carbamazepine Gen 4	Oct 22, 2015	Substantially Equivalent	Roche Diagnostics Operations (Rdo)
K123518	ABBOTT CARBAMAZEPINE ASSAY	Jun 05, 2013	Substantially Equivalent	Microgenics Corporation
K103627	ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS	Oct 14, 2011	Substantially Equivalent	Abbott Laboratories
K063131	CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS	Oct 05, 2007	Substantially Equivalent	Thermo Electron OY
K042808	ADVIA IMS CARBAMAZEPINE METHOD	Feb 08, 2005	Substantially Equivalent	Bayer Healthcare, LLC
K031902	ONLINE TDM CARBAMAZEPINE	Sep 17, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K011648	RANDOX CARBAMAZEPINE	Jan 15, 2002	Substantially Equivalent	Randox Laboratories, Ltd.
K010814	EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229	Apr 13, 2001	Substantially Equivalent	Syva Co., Dade Behring, Inc.
K000903	ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM	May 18, 2000	Substantially Equivalent	Bayer Corp.
K000007	IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6	Feb 28, 2000	Substantially Equivalent	Diagnostic Products Corp.
K993987	SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL	Jan 27, 2000	Substantially Equivalent	Syva Co.
K993028	ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90	Jan 27, 2000	Substantially Equivalent	Syva Co.
K980283	VITROS CHEMISTRY PRODUCTS CRBM SLIDES	Feb 25, 1998	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K973535	ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS	Oct 20, 1997	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K964765	CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY	Feb 14, 1997	Substantially Equivalent	Chiron Diagnostics Corp.
K963673	IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS	Feb 04, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K964068	CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM	Dec 13, 1996	Substantially Equivalent	Bayer Corp.
K962820	CARBAMAZEPINE FLEX REAGENT CARTRIDGE	Sep 13, 1996	Substantially Equivalent	Dade Intl., Inc.
K955644	SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM	Feb 16, 1996	Substantially Equivalent	Beckman Instruments, Inc.
K955100	CARBAMAZEPINE EIA TEST	Dec 13, 1995	Substantially Equivalent	Diagnostic Reagents, Inc.
K942687	IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00	Jan 25, 1995	Substantially Equivalent	Instrumentation Laboratory CO
K935374	AXSYM CARBAMAZEPHINE	Jun 21, 1994	Substantially Equivalent	Abbott Laboratories
K940374	QMS CARBAMAZEPINE ASSAY	Jun 02, 1994	Substantially Equivalent	Seradyn, Inc.
K933684	IL TEST CARBAMAZEPHINE	Oct 01, 1993	Substantially Equivalent	Instrumentation Laboratory CO
K926441	ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI	May 26, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K915756	BIOTRACK CARBAMAZEPINE TEST CARTRIDGE	Jul 23, 1992	Substantially Equivalent	Biotrack, Inc.
K914857	CEDIA(R) CARBAMAZEPINE ASSAY	Jan 15, 1992	Substantially Equivalent	Microgenics Corp.
K913066	EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS	Jul 30, 1991	Substantially Equivalent	Syva Co.
K901086	ENZYMUN TEST(R) T4 (TOTAL THYROXINE)	Mar 30, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K897114	EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY	Jan 18, 1990	Substantially Equivalent	Syva Co.
K896860	OPUS CARBAMAZEPINE TEST SYSTEM	Jan 02, 1990	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K894519	FPR CARBAMAZEPINE KIT	Aug 28, 1989	Substantially Equivalent	Colony Laboratories, Inc.
K893507	INNOFLUOR CARBAMAZEPINE REAGENT SET	Aug 11, 1989	Substantially Equivalent	Innotron of Oregon, Inc.
K882961	EMIT QST CARBAMAZEPINE ASSAY	Aug 29, 1988	Substantially Equivalent	Syva Co.
K873282	CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY	Sep 22, 1987	Substantially Equivalent	Windsor Laboratories, Inc.
K871254	ACCULEVEL CARBAMAZEPINE TEST	Jun 17, 1987	Substantially Equivalent	Syva Co.
K871306	EMIT CARBAMAZEPINE ASSAY	Apr 14, 1987	Substantially Equivalent	Syva Co.
K863842	SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT	Jan 14, 1987	Substantially Equivalent	Miles Laboratories, Inc.
K864553	EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95	Jan 08, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K862916	EZ-SCREEN: CANNABINOID	Jan 07, 1987	Substantially Equivalent	Environmental Diagnostics, Inc.
K860047	DETERMINATION OF CARBAMAZEPINE	Jan 22, 1986	Substantially Equivalent	Clinical Data, Inc.
K853835	EMIT QST CARBAMAZEPINE ASSAY	Oct 01, 1985	Substantially Equivalent	Syva Co.
K850807	COBAS FP REAGENTS FOR CARBAMAZEPINE	Mar 22, 1985	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K834052	CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT	Jan 24, 1984	Substantially Equivalent	Abbott Laboratories
K832720	EMIT AED CARBAMAZEPINE ASSAY	Oct 04, 1983	Substantially Equivalent	Syva Co.
K832766	AMES TDA DISOPYRAMIDE TEST	Sep 29, 1983	Substantially Equivalent	Miles Laboratories, Inc.
K832631	A-GENT CARBAMAZEPINE	Sep 12, 1983	Substantially Equivalent	Abbott Laboratories
K832447	STRATUS CARBAMAZEPINE FLUROMETRIC	Sep 12, 1983	Substantially Equivalent	American Dade
K831222	CARBAMEZEPINE REAGENT TEST KIT	May 09, 1983	Substantially Equivalent	Beckman Instruments, Inc.
K821945	CARBAMAZEPINE FLOURESCENT IMMUNOASSAY	Jul 16, 1982	Substantially Equivalent	American Diagnostic Corp.
K820189	CARBAMAZEPINE ASSAY	Feb 12, 1982	Substantially Equivalent	Syva Co.
K811952	AMES TDA CARBAMAZEPINE TEST	Jul 15, 1981	Substantially Equivalent	Miles Laboratories, Inc.
K802902	CYBREX CARBAMAZEPINE	Dec 19, 1980	Substantially Equivalent	Abbott Laboratories
K790255	EMIT AED ASSAYS 3500 COMPUTER DIRECTED	Mar 02, 1979	Substantially Equivalent	Syva Co.
K781958	ANALYTICAL TEST PACK, CARBAMAZEPINE	Jan 10, 1979	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K780466	EMIT CARBAMAZEPINE ASSAY	Apr 24, 1978	Substantially Equivalent	Syva Co.