LEG · Enzyme Immunoassay, Valproic Acid
Clinical Toxicology · 21 CFR 862.3645 · Class 2
Overview
| Product Code | LEG |
|---|---|
| Device Name | Enzyme Immunoassay, Valproic Acid |
| 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 35)
Showing 20 most recent of 35 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K090358 | ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 | Abbott Laboratories, Inc. | Aug 6, 2009 | SESE |
| K060690 | ONLINE VALPROIC ACID | Roche Diagnostics Corp. | Aug 8, 2006 | SESE |
| K042807 | ADVIA IMS VALPROIC ACID METHOD | Bayer Healthcare, LLC | Feb 8, 2005 | SESE |
| K042476 | 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 | ROCHE ONLINE TDM VALPROIC ACID | Roche Diagnostics Corp. | Aug 22, 2003 | SESE |
| K031870 | SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT | Beckman Coulter, Inc. | Jul 15, 2003 | SESE |
| K030405 | QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 | Seradyn | Apr 28, 2003 | SESE |
| K011649 | RANDOX VALPROIC ACID | Randox Laboratories, Ltd. | Jan 15, 2002 | SESE |
| K011947 | EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL | Syva Co. | Jul 2, 2001 | SESE |
| K002551 | EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL | Dade Behring, Inc. | Oct 11, 2000 | SESE |
| K000005 | IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6 | Diagnostic Products Corp. | Mar 3, 2000 | SESE |
| K982880 | DIMENSION(R) VALPROIC (VALP) ACID METHOD | Dade Behring, Inc. | Aug 25, 1998 | SESE |
| K973581 | ACE VALPROIC ACID REAGENT, AED CALIBRATORS | Schiapparelli Biosystems, Inc. | Nov 12, 1997 | SESE |
| K972132 | SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS | Sigma Diagnostics, Inc. | Jul 30, 1997 | SESE |
| K964442 | VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | Dec 18, 1996 | SESE |
| K961988 | VALPROIC ACID EIA TEST | Diagnostic Reagents, Inc. | Jul 16, 1996 | SESE |
| K961256 | SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT | Beckman Instruments, Inc. | May 15, 1996 | SESE |
| K953224 | COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID | Roche Diagnostic Systems, Inc. | Oct 30, 1995 | SESE |
| K943866 | VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS | Sigma Diagnostics, Inc. | Nov 10, 1994 | SESE |
| K941615 | 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
