Enzyme Immunoassay, Phenobarbital
FDA product code DLZ · Class II (moderate risk) · 21 CFR 862.3660 · Clinical Toxicology
35510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Syva Co. 8
- Abbott Laboratories 3
- Ortho-Clinical Diagnostics 2
- Em Diagnostic Systems, Inc. 2
- Instrumentation Laboratory CO 2
- Microgenics Corp. 1
- E.I. Dupont DE Nemours & Co., Inc. 1
- Diagnostic Products Corp. 1
- Diagnostic Reagents, Inc. 1
- Dupont Medical Products 1
- Schiapparelli Biosystems, Inc. 1
- Baxter Diagnostics, Inc. 1
- Pb Diagnostic Systems, Inc. 1
- Technicon Instruments Corp. 1
- Allied Instrumentation Laboratory 1
- Clinical Data, Inc. 1
- Miles Laboratories, Inc. 1
- Immunotech Corp. 1
- Ventrex Laboratories, Inc. 1
- Kallestad Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210858 | VITROS Chemistry Products PHBR SlidesDLZ · Traditional | Ortho-Clinical Diagnostics, Inc. | 08/13/2021SE |
| K123271 | Abbott Phenobarbital AssayDLZ · Traditional | Microgenics Corp. | 04/26/2013SE |
| K081231 | Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33…DLZ · Traditional | Abbott Laboratories | 09/26/2008SE |
| K071644 | Online Phenobarbital, Model 03016757190 & 03510620DLZ · Traditional | Roche Diagnostics Corp. | 09/12/2007SE |
| K011303 | Randox PhenobarbitalDLZ · Traditional | Randox Laboratories, Ltd. | 07/02/2001SE |
| K011528 | Emit 2000 Phenobarbital Assay, Model OSR4D229DLZ · Special | Syva Co. | 06/06/2001SE |
| K000012 | Immulite Phenobarbital, Models LKPB1, LKPB5DLZ · Traditional | Diagnostic Products Corp. | 03/03/2000SE |
| K993031 | Abbott Aeroset Phenobarbital Assey and Calibrators;Models 1E08 and 5F54DLZ · Traditional | Syva Co. | 01/27/2000SE |
| K984288 | Vitros Chemistry Products PHBR SlidesDLZ · Traditional | Ortho-Clinical Diagnostics, Inc. | 01/26/1999SE |
| K946210 | Phenobarbital Enzyme ImmunoassayDLZ · Traditional | Diagnostic Reagents, Inc. | 02/10/1995SE |
| K943981 | Il Test Phenobarbital CalibratorsDLZ · Traditional | Instrumentation Laboratory CO | 01/18/1995SE |
| K944932 | Phenobarbital Flex Reagent CartridgeDLZ · Traditional | Dupont Medical Products | 12/28/1994SE |
| K942501 | Ace Cedia Phenobarbital AssayDLZ · Traditional | Schiapparelli Biosystems, Inc. | 10/06/1994SE |
| K935568 | Paramax Phenobarbital Reagent and CalibratorsDLZ · Traditional | Baxter Diagnostics, Inc. | 03/11/1994SE |
| K913190 | Emit(R) 2000 Phenobarbital Assay/CalibratorsDLZ · Traditional | Syva Co. | 08/26/1991SE |
| K910355 | Il Phenobarbital Assay SystemDLZ · Traditional | Instrumentation Laboratory CO | 04/03/1991SE |
| K896861 | Opus Phenobarbital Test SystemDLZ · Traditional | Pb Diagnostic Systems, Inc. | 01/11/1990SE |
| K884419 | Technicon Ra-PhenobarbitalDLZ · Traditional | Technicon Instruments Corp. | 11/22/1988SE |
| K874625 | Emit Convenience Pack: Phenobarbital AssayDLZ · Traditional | Syva Co. | 12/22/1987SE |
| K864926 | Emds TM Phenobarbital(Phno) Testpack, #67677/95DLZ · Traditional | Em Diagnostic Systems, Inc. | 01/07/1987SE |
| K854607 | Acculevel Phenobarbital TestDLZ · Traditional | Syva Co. | 08/25/1986SE |
| K862308 | Easy-Test (TM) Emit* Phenobarbital (PHNO)/67534/93DLZ · Traditional | Em Diagnostic Systems, Inc. | 07/07/1986SE |
| K860365 | Phenobarbital Test SystemDLZ · Traditional | Allied Instrumentation Laboratory | 03/17/1986SE |
| K860046 | Determination of PhenobarbitalDLZ · Traditional | Clinical Data, Inc. | 01/22/1986SE |
| K852946 | Sera Aris Pheno Reag Strip, Test Mod Cal & CLTDLZ · Traditional | Miles Laboratories, Inc. | 09/30/1985SE |
| K852995 | Endab PhenobarbitalDLZ · Traditional | Immunotech Corp. | 08/12/1985SE |
| K842264 | Ventrezyme Phenobarbital Kit ImmunoDLZ · Traditional | Ventrex Laboratories, Inc. | 08/14/1984SE |
| K833796 | Chem Kit PhenobarbitalDLZ · Traditional | Abbott Laboratories | 01/30/1984SE |
| K834216 | Emit QST Phenobarbital AssayDLZ · Traditional | Syva Co. | 01/24/1984SE |
| K832457 | A-Gent PhenobarbitalDLZ · Traditional | Abbott Laboratories | 09/12/1983SE |
| K832097 | Phenobartial Assay Use on Cobas-BioDLZ · Traditional | Syva Co. | 08/11/1983SE |
| K811621 | Emit-St Serum Phenobarbital AssayDLZ · Traditional | Syva Co. | 06/25/1981SE |
| K811367 | Kallestad Antisera to PhenobarbitalDLZ · Traditional | Kallestad Laboratories, Inc. | 05/29/1981SE |
| K802039 | Phenobarbital Reagent Test KitDLZ · Traditional | Beckman Instruments, Inc. | 10/23/1980SE |
| K770919 | Phenobarbital Analytical Test PacksDLZ · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 06/22/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0181-2014 Class II | Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital AssayImprecision with certain lots | Siemens Healthcare Diagnostics, Inc. | 08/30/2013Terminated |
| Z-0319-2014 Class II | VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |
| Z-1152-2013 Class II | VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the…Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or… | Ortho-Clinical Diagnostics | 03/14/2013Terminated |
| Z-0664-2013 Class II | Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay…Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the… | Siemens Healthcare Diagnostics, Inc. | 12/10/2012Terminated |
| Z-1118-2013 Class II | Clinical Chemistry Phenobarbital, list number 1E08Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to… | Abbott Laboratories, Inc | 11/16/2012Terminated |
| Z-0030-2013 Class II | Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay…Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. Also, if the… | Siemens Healthcare Diagnostics, Inc. | 07/30/2012Terminated |
| Z-1117-2012 | VITROS Chemistry Products PHBR Slides, REF 822 1384 --- COMMON/USUAL NAME: VITROS PHBR…Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or… | Ortho-Clinical Diagnostics | 06/23/2011Terminated |
| Z-1173-2012 | Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, Classification Product Code:…The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the… | Beckman Coulter Inc. | 08/11/2009Terminated |
| Z-0454-2007 | Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics…Erratic elevated results and or the inability to calibrate due to imprecision. | Abbott Laboratories Inc. | 09/26/2006Terminated |