Enzyme Immunoassay, Diphenylhydantoin
FDA product code DIP · Class II (moderate risk) · 21 CFR 862.3350 · Clinical Toxicology
44510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Syva Co. 10
- Abbott Laboratories 4
- E.I. Dupont DE Nemours & Co., Inc. 3
- Em Diagnostic Systems, Inc. 3
- Schiapparelli Biosystems, Inc. 2
- Instrumentation Laboratory CO 2
- Thermo Electron OY 1
- Eastman Kodak Company 1
- Baxter Diagnostics, Inc. 1
- Biotrack, Inc. 1
- Microgenics Corp. 1
- Seradyn, Inc. 1
- Immunotech Corp. 1
- Sigma Diagnostics, Inc. 1
- Technicon Instruments Corp. 1
- Syva / A Syntex Co. 1
- Allied Instrumentation Laboratory 1
- Clinical Data, Inc. 1
- Miles Laboratories, Inc. 1
- Ventrex Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080696 | Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models 1P34, and…DIP · Traditional | Abbott Laboratories | 09/11/2008SE |
| K063145 | Phenobarbital, Phenytoin, TDM Calibration Set B and Abtrol/Nortrol ControlsDIP · Traditional | Thermo Electron OY | 10/17/2007SE |
| K030428 | Roche Online TDM PhenytoinDIP · Traditional | Roche Diagnostics Corp. | 04/28/2003SE |
| K011393 | Randox PhenytoinDIP · Traditional | Randox Laboratories, Ltd. | 12/04/2001SE |
| K011347 | Emit 2000 Phenytoin Assay, Model 0SR4A229DIP · Special | Syva Co. | 05/17/2001SE |
| K000006 | Immulite Phenytoin, Immulite 2000 Phenytoin, Catalog # LKPN1, LKPN5 & L2KPN2, L2KPN6DIP · Traditional | Diagnostic Products Corp. | 02/28/2000SE |
| K993026 | Abbot Aeroset Phenytoin Assay & Abbot Aeroset Phenytoin CalibratorsDIP · Traditional | Syva Co. | 01/27/2000SE |
| K973414 | Ace Phenytoin Reagent, AED CalibratorsDIP · Traditional | Schiapparelli Biosystems, Inc. | 11/04/1997SE |
| K963840 | Cedia Phenytoin II AssayDIP · Traditional | Boehringer Mannheim Corp. | 11/20/1996SE |
| K943980 | Il Test Phenytion CalibratorsDIP · Traditional | Instrumentation Laboratory CO | 05/01/1995SE |
| K945725 | Phenytion Eia TestDIP · Traditional | Diagnostic Reagents, Inc. | 02/03/1995SE |
| K944085 | Ace(Tm) Cedia(R) Phenytoin AssayDIP · Traditional | Schiapparelli Biosystems, Inc. | 12/28/1994SE |
| K941142 | Kodak Ektachem Clinical Chemistry Slide PhenytoinDIP · Traditional | Eastman Kodak Company | 06/13/1994SE |
| K932686 | Paramax(R) Phenytoin ReagentDIP · Traditional | Baxter Diagnostics, Inc. | 11/26/1993SE |
| K915755 | Biotrack Phenytoin Test CartridgeDIP · Traditional | Biotrack, Inc. | 07/23/1992SE |
| K913429 | Emit(R) 2000 Phenytoin Assay/CalibratorsDIP · Traditional | Syva Co. | 08/26/1991SE |
| K911056 | Du Pont Dimension(R) Phenytoin (PTN) MethodDIP · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 04/03/1991SE |
| K905689 | Cedia Phenytoin AssayDIP · Traditional | Microgenics Corp. | 01/17/1991SE |
| K904815 | QMS Tm- PhenytoinDIP · Traditional | Seradyn, Inc. | 11/06/1990SE |
| K902952 | Il Phenytoin Assay SystemDIP · Traditional | Instrumentation Laboratory CO | 08/22/1990SE |
| K901080 | Ez-Bead Phenytoin Enzyme Immunoassay KitDIP · Traditional | Immunotech Corp. | 05/17/1990SE |
| K896074 | Vision PhenytoinDIP · Traditional | Abbott Laboratories | 11/17/1989SE |
| K874856 | Emit Convenience Pack: Phenytoin AssayDIP · Traditional | Syva Co. | 01/05/1988SE |
| K870953 | Phenytoin Fpia Reagent SetDIP · Traditional | Sigma Diagnostics, Inc. | 03/31/1987SE |
| K864925 | Emds TM Phenytoin (PTN) Testpack, Item #67676/95DIP · Traditional | Em Diagnostic Systems, Inc. | 01/07/1987SE |
| K864554 | Easy-Test Primidone Item No. 67---/95DIP · Traditional | Em Diagnostic Systems, Inc. | 01/07/1987SE |
| K863403 | Phenytoin, AS Performed on Technicon Ra SystemsDIP · Traditional | Technicon Instruments Corp. | 09/29/1986SE |
| K855026 | Acculevel Phenytoin TestDIP · Traditional | Syva / A Syntex Co. | 08/25/1986SE |
| K862349 | Easy-Test Emit Phenytoin(Phtn) Item # 67535/93DIP · Traditional | Em Diagnostic Systems, Inc. | 07/07/1986SE |
| K860286 | Il Test PhenytoinDIP · Traditional | Allied Instrumentation Laboratory | 03/05/1986SE |
| K860048 | Determination of Phenytoin (Diphenylhydantoin)DIP · Traditional | Clinical Data, Inc. | 01/22/1986SE |
| K850712 | Emit QST Phenytoin Assay -Monoclonal AntibodyDIP · Traditional | Syva Co. | 03/20/1985SE |
| K842092 | Seralyzer Aris Phenytoin Reagent StripsDIP · Traditional | Miles Laboratories, Inc. | 03/19/1985SE |
| K844991 | Emit Phenytoin AssayDIP · Traditional | Syva Co. | 01/23/1985SE |
| K843209 | Phenytoin Aca Analytical Test PackDIP · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 10/11/1984SE |
| K842161 | Ventrezyme Phenytoin Kit ImmunoassayDIP · Traditional | Ventrex Laboratories, Inc. | 07/09/1984SE |
| K834406 | Emit QST Phenytoin AssayDIP · Traditional | Syva Co. | 02/03/1984SE |
| K833806 | Chemkit Phenytoin Diag. KitDIP · Traditional | Abbott Laboratories | 01/30/1984SE |
| K832419 | A-Gent PherytoinDIP · Traditional | Abbott Laboratories | 09/01/1983SE |
| K832033 | Emit AED Phenytoin AssayDIP · Traditional | Syva Co. | 08/01/1983SE |
| K811745 | Virgo Ipa for Detection of PhenytoinDIP · Traditional | Electro-Nucleonics Laboratories, Inc. | 07/10/1981SE |
| K780218 | Analyzer, Emit AED Assays to CentrificheDIP · Traditional | Syva Co. | 03/03/1978SE |
| K772179 | Emit Antiepileptic Drug AssaysDIP · Traditional | Syva Co. | 12/20/1977SE |
| K771233 | Phenytoin Analytical Test PacksDIP · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 07/15/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1136-2021 Class II | VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to…A deformity affecting a specific lot of VITROS Chemistry Products VersaTips. Deformed VersaTips results may… | Ortho-Clinical Diagnostics, Inc. | 01/14/2021Terminated |
| Z-2344-2018 Class II | VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnosticThere is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT… | Ortho-Clinical Diagnostics | 05/09/2018Terminated |
| Z-0273-2018 Class II | VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD…The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide… | Ortho-Clinical Diagnostics | 06/12/2017Terminated |
| Z-0148-2015 Class II | siemens Dimension Phenytoin Flex Reagent Cartridge The PTN method used on the Dimension…Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot… | Siemens Healthcare Diagnostics, Inc. | 09/24/2014Terminated |
| Z-0007-2015 Class II | VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For…Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT… | Ortho-Clinical Diagnostics | 08/20/2014Terminated |
| Z-0930-2014 Class II | ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro…ADVIA Centaur Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the… | Siemens Healthcare Diagnostics, Inc | 12/18/2013Terminated |
| Z-0929-2014 Class II | ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro…ADVIA Centaur Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the… | Siemens Healthcare Diagnostics, Inc | 12/18/2013Terminated |
| Z-0321-2014 Class II | VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |
| Z-2059-2008 | ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation…An Abbott investigation has determined that the phenytoin reagent does not maintain an onboard stability of… | Abbott Laboratories Inc. | 02/15/2008Terminated |