Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3645](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3645) → KLT — Enzyme Immunoassay, Carbamazepine # KLT · Enzyme Immunoassay, Carbamazepine _Clinical Toxicology · 21 CFR 862.3645 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT ## Overview - **Product Code:** KLT - **Device Name:** Enzyme Immunoassay, Carbamazepine - **Regulation:** [21 CFR 862.3645](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3645) - **Device Class:** 2 - **Review Panel:** [Clinical Toxicology](/submissions/TX) - **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](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K151578.md) | Carbamazepine Gen 4 | Roche Diagnostics Operations (Rdo) | Oct 22, 2015 | SESE | | [K123518](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K123518.md) | ABBOTT CARBAMAZEPINE ASSAY | Microgenics Corporation | Jun 5, 2013 | SESE | | [K103627](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K103627.md) | ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS | Abbott Laboratories | Oct 14, 2011 | SESE | | [K063131](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K063131.md) | CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS | Thermo Electron OY | Oct 5, 2007 | SESE | | [K042808](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K042808.md) | ADVIA IMS CARBAMAZEPINE METHOD | Bayer Healthcare, LLC | Feb 8, 2005 | SESE | | [K031902](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K031902.md) | ONLINE TDM CARBAMAZEPINE | Roche Diagnostics Corp. | Sep 17, 2003 | SESE | | [K011648](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K011648.md) | RANDOX CARBAMAZEPINE | Randox Laboratories, Ltd. | Jan 15, 2002 | SESE | | [K010814](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K010814.md) | EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 | Syva Co., Dade Behring, Inc. | Apr 13, 2001 | SESE | | [K000903](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K000903.md) | ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM | Bayer Corp. | May 18, 2000 | SESE | | [K000007](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K000007.md) | IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6 | Diagnostic Products Corp. | Feb 28, 2000 | SESE | | [K993987](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K993987.md) | SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL | Syva Co. | Jan 27, 2000 | SESE | | [K993028](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K993028.md) | ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90 | Syva Co. | Jan 27, 2000 | SESE | | [K980283](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K980283.md) | VITROS CHEMISTRY PRODUCTS CRBM SLIDES | Johnson & Johnson Clinical Diagnostics, Inc. | Feb 25, 1998 | SESE | | [K973535](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K973535.md) | ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS | Schiapparelli Biosystems, Inc. | Oct 20, 1997 | SESE | | [K964765](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K964765.md) | CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY | Chiron Diagnostics Corp. | Feb 14, 1997 | SESE | | [K963673](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K963673.md) | IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS | Beckman Instruments, Inc. | Feb 4, 1997 | SESE | | [K964068](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K964068.md) | CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | Dec 13, 1996 | SESE | | [K962820](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K962820.md) | CARBAMAZEPINE FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | Sep 13, 1996 | SESE | | [K955644](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K955644.md) | SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM | Beckman Instruments, Inc. | Feb 16, 1996 | SESE | | [K955100](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K955100.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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