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) → LEG — Enzyme Immunoassay, Valproic Acid # LEG · Enzyme Immunoassay, Valproic Acid _Clinical Toxicology · 21 CFR 862.3645 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG ## Overview - **Product Code:** LEG - **Device Name:** Enzyme Immunoassay, Valproic Acid - **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 35) Showing 20 most recent of 35 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K090358](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K090358.md) | ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 | Abbott Laboratories, Inc. | Aug 6, 2009 | SESE | | [K060690](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K060690.md) | ONLINE VALPROIC ACID | Roche Diagnostics Corp. | Aug 8, 2006 | SESE | | [K042807](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K042807.md) | ADVIA IMS VALPROIC ACID METHOD | Bayer Healthcare, LLC | Feb 8, 2005 | SESE | | [K042476](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K042476.md) | VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS | Ortho-Clinical Diagnostics, Inc. | Dec 1, 2004 | SESE | | [K032049](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K032049.md) | ROCHE ONLINE TDM VALPROIC ACID | Roche Diagnostics Corp. | Aug 22, 2003 | SESE | | [K031870](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K031870.md) | SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT | Beckman Coulter, Inc. | Jul 15, 2003 | SESE | | [K030405](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K030405.md) | QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 | Seradyn | Apr 28, 2003 | SESE | | [K011649](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K011649.md) | RANDOX VALPROIC ACID | Randox Laboratories, Ltd. | Jan 15, 2002 | SESE | | [K011947](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K011947.md) | EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL | Syva Co. | Jul 2, 2001 | SESE | | [K002551](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K002551.md) | EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL | Dade Behring, Inc. | Oct 11, 2000 | SESE | | [K000005](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K000005.md) | IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6 | Diagnostic Products Corp. | Mar 3, 2000 | SESE | | [K982880](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K982880.md) | DIMENSION(R) VALPROIC (VALP) ACID METHOD | Dade Behring, Inc. | Aug 25, 1998 | SESE | | [K973581](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K973581.md) | ACE VALPROIC ACID REAGENT, AED CALIBRATORS | Schiapparelli Biosystems, Inc. | Nov 12, 1997 | SESE | | [K972132](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K972132.md) | SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS | Sigma Diagnostics, Inc. | Jul 30, 1997 | SESE | | [K964442](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K964442.md) | VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | Dec 18, 1996 | SESE | | [K961988](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K961988.md) | VALPROIC ACID EIA TEST | Diagnostic Reagents, Inc. | Jul 16, 1996 | SESE | | [K961256](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K961256.md) | SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT | Beckman Instruments, Inc. | May 15, 1996 | SESE | | [K953224](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K953224.md) | COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID | Roche Diagnostic Systems, Inc. | Oct 30, 1995 | SESE | | [K943866](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K943866.md) | VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS | Sigma Diagnostics, Inc. | Nov 10, 1994 | SESE | | [K941615](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K941615.md) | AXSYM VALPROIC ACID | Abbott Laboratories | Aug 16, 1994 | SESE | ## Top Applicants - Syva Co. — 5 clearances - Roche Diagnostic Systems, Inc. — 3 clearances - Abbott Laboratories — 2 clearances - Beckman Instruments, Inc. — 2 clearances - Dade Behring, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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