Enzyme Immunoassay, Theophylline
FDA product code KLS · Class II (moderate risk) · 21 CFR 862.3880 · Clinical Toxicology
71510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Syva Co. 11
- Abbott Laboratories 7
- E.I. Dupont DE Nemours & Co., Inc. 3
- Immunotech Corp. 2
- Em Diagnostic Systems, Inc. 2
- Diagnostic Products Corp. 2
- Instrumentation Laboratory CO 2
- Technicon Instruments Corp. 2
- Electro-Nucleonics Laboratories, Inc. 2
- Miles Laboratories, Inc. 2
- Beckman Instruments, Inc. 2
- Jay Rau, Technical Suppprt 1
- Clinical Assays, Inc. 1
- American Dade 1
- Allergenetics 1
- Vxr, Inc. 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- Ortho-Clinical Diagnostics 1
- Clinical Data, Inc. 1
- Accra Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042520 | Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and IIIKLS · Traditional | Ortho-Clinical Diagnostics, Inc. | 11/30/2004SE |
| K042407 | Emit Caffeine AssayKLS · Traditional | Dade Behring, Inc. | 10/28/2004SE |
| K020740 | Roche Online TheophyllineKLS · Traditional | Roche Diagnostics Corp. | 04/16/2002SE |
| K011771 | Randox TheophyllineKLS · Traditional | Randox Laboratories, Ltd. | 01/17/2002SE |
| K013272 | Acs: 180 and Advia Centaur Theophylline 2 AssayKLS · Special | Bayer Corp. | 10/25/2001SE |
| K011166 | Modification to Emit 2000 Theophylline Assay, Model Osr 4P229KLS · Special | Syva Co., Dade Behring, Inc. | 05/10/2001SE |
| K993029 | Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and 6E89KLS · Traditional | Syva Co. | 01/27/2000SE |
| K973583 | Ace Theophylline Reagent, Theo CalibratorsKLS · Traditional | Schiapparelli Biosystems, Inc. | 11/12/1997SE |
| K972495 | Accumeter Theophylline TestKLS · Traditional | Chemtrak, Inc. | 10/10/1997SE |
| K961462 | Cedia Theophylline AssayKLS · Traditional | Boehringer Mannheim Corp. | 06/27/1996SE |
| K954569 | Immulite TheophyllineKLS · Traditional | Diagnostic Products Corp. | 11/13/1995SE |
| K952596 | Theophylline Enzyme ImmunoassayKLS · Traditional | Diagnostic Reagents, Inc. | 08/11/1995SE |
| K943979 | Il Test TheophyllineKLS · Traditional | Instrumentation Laboratory CO | 01/18/1995SE |
| K935373 | Axsym TheophyllineKLS · Traditional | Abbott Laboratories | 06/21/1994SE |
| K932685 | Paramax(R) Theophylline Reagent and CalibratorsKLS · Traditional | Baxter Diagnostics, Inc. | 09/24/1993SE |
| K933258 | Vidas Theophylline(Theo)KLS · Traditional | Biomerieux Vitek, Inc. | 08/16/1993SE |
| K926245 | Abbott Vision Theophylline IiaKLS · Traditional | Abbott Laboratories | 05/06/1993SE |
| K913123 | Emit(R) 2000 Theophylline Assay/CalibratorsKLS · Traditional | Syva Co. | 09/19/1991SE |
| K911060 | Immunomatrix Theophyline Assay SystemKLS · Traditional | Immunomatrix | 05/08/1991SE |
| K910697 | Il Theophylline Assay SystemKLS · Traditional | Instrumentation Laboratory CO | 04/03/1991SE |
| K902243 | Technicon Immuno I(Tm) System and AnalytesKLS · Traditional | Technicon Instruments Corp. | 07/05/1990SE |
| K901510 | Enzymatic Theophylline Reagent, #500-82KLS · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 06/12/1990SE |
| K900373 | Biotrack Theophylline Test CartridgeKLS · Traditional | Biotrack, Inc. | 05/30/1990SE |
| K900009 | NDS Theophylline Test Kit & NDS TDM Calibrator SetKLS · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 03/29/1990SE |
| K896927 | Vision Theophylline IIKLS · Traditional | Abbott Laboratories | 01/18/1990SE |
| K885253 | Acculevel One-Step Theophylline TestKLS · Traditional | Syva Co. | 03/31/1989SE |
| K884358 | Cedia Theophylline AssayKLS · Traditional | Microgenics Corp. | 02/07/1989SE |
| K890002 | Coat-A-Count (TM) TheophyllineKLS · Traditional | Diagnostic Products Corp. | 01/23/1989SE |
| K885044 | Behring Polaroid Opus TheophyllineKLS · Traditional | Pb Diagnostic Systems, Inc. | 12/29/1988SE |
| K884002 | Analyst Theophylline RotorKLS · Traditional | The DU Pont Co. | 10/31/1988SE |
| K881257 | Ez-Bead Theophylline Enzyme Immunoassay KitKLS · Traditional | Immunotech Corp. | 05/27/1988SE |
| K874578 | Emit Convenience Pack: Theophylline AssayKLS · Traditional | Syva Co. | 11/24/1987SE |
| K873596 | Baker TDM Theophylline AssayKLS · Traditional | Baker Instructions Corp. | 10/20/1987SE |
| K870736 | Dart Theophylline Reagent SystemKLS · Traditional | Coulter Electronics, Inc. | 04/14/1987SE |
| K870952 | Theophylline Fpia Reagent SetKLS · Traditional | Sigma Diagnostics, Inc. | 03/31/1987SE |
| K864041 | Emds Theophylline Testpacks Item #67662/95KLS · Traditional | Em Diagnostic Systems, Inc. | 11/25/1986SE |
| K862955 | Methods for the Dimension Clinical Chem. SystemKLS · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/25/1986SE |
| K862350 | Easy-Test Emit* Theophylline(Theo) Item 67533/93KLS · Traditional | Em Diagnostic Systems, Inc. | 07/07/1986SE |
| K860464 | Vision Theophylline - Addit. of Whole Blood ClaimKLS · Traditional | Abbott Laboratories | 06/17/1986SE |
| K853872 | Emit Caffeine AssayKLS · Traditional | Syva Co. | 06/13/1986SE |
| K861367 | Kodak Ektachem Clinical Chemistry Slides (Theo)KLS · Traditional | Eastman Kodak Company | 05/29/1986SE |
| K855227 | Micro-Eia Theophylline Test Kit MonoclonalKLS · Traditional | Bioclinical Systems, Inc. | 04/11/1986SE |
| K854183 | In Vitro Test Determination of TheophyllineKLS · Traditional | Clinical Data, Inc. | 12/19/1985SE |
| K853858 | Il Test Theophylline AssayKLS · Traditional | Allied Instrumentation Laboratory | 10/15/1985SE |
| K853834 | Vision TheophyllineKLS · Traditional | Abbott Laboratories | 10/15/1985SE |
| K853372 | Gemstar Ipa Theophylline Test KitKLS · Traditional | Electro-Nucleonics Laboratories, Inc. | 09/04/1985SE |
| K852573 | Technicon RA-1000 System Analyte TheophyllineKLS · Traditional | Technicon Instruments Corp. | 07/12/1985SE |
| K851741 | Acculevel Theophylline Test(Modification)KLS · Traditional | Syva Co. | 06/06/1985SE |
| K850856 | Ics Theophylline ReagentsKLS · Traditional | Beckman Instruments, Inc. | 03/29/1985SE |
| K844642 | Acculevel Theophylline TestKLS · Traditional | Syva Co. | 03/19/1985SE |
| K844170 | Theophylline Radioimmunoassay Aria HT SystemKLS · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/11/1984SE |
| K841656 | Dupont Theophylline Assay KitKLS · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 05/22/1984SE |
| K832825 | Seralyzer Theophylline Reagent StripsKLS · Traditional | Miles Laboratories, Inc. | 03/19/1984SE |
| K833989 | Ventrezyme Theophylline ImmunoassayKLS · Traditional | Vxr, Inc. | 01/30/1984SE |
| K834244 | Theofast Test Kit for Quantitative TheoKLS · Traditional | Allergenetics | 01/24/1984SE |
| K832965 | Stratus Theophylline AssayKLS · Traditional | American Dade | 12/30/1983SE |
| K833683 | Chem Kit Theophylline Diag. KitKLS · Traditional | Abbott Laboratories | 12/27/1983SE |
| K831934 | Theophylline Test Pack AcaKLS · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/12/1983SE |
| K832034 | Emit Aad Theophylline AssayKLS · Traditional | Syva Co. | 08/01/1983SE |
| K831272 | Emit QST Theophylline AssayKLS · Traditional | Syva Co. | 05/27/1983SE |
| K821544 | Detection of TheophyllineKLS · Traditional | Electro-Nucleonics Laboratories, Inc. | 06/10/1982SE |
| K821154 | Kallestad Quantizyme Theophylline EnzymeKLS · Traditional | Jay Rau, Technical Suppprt | 05/13/1982SE |
| K812003 | A-Gent TheophyllineKLS · Traditional | Abbott Laboratories | 07/27/1981SE |
| K810578 | Beckman Theophylline Reagent Test KitKLS · Traditional | Beckman Instruments, Inc. | 03/13/1981SE |
| K803094 | Copper Sulfate Solution Sp. GR.1.053KLS · Traditional | Accra Laboratories, Inc. | 03/06/1981SE |
| K802066 | Endab Theophylline Enzyme ImmunoassayKLS · Traditional | Immunotech Corp. | 10/23/1980SE |
| K801642 | Fiax Test Kit for Theophylline Quant.KLS · Traditional | Intl. Diagnostic Technology | 08/27/1980SE |
| K801476 | Application of Emit Theophylline AssayKLS · Traditional | Syva Co. | 07/08/1980SE |
| K800646 | Ames Tda Theophyl-Line TestKLS · Traditional | Miles Laboratories, Inc. | 04/10/1980SE |
| K790256 | Emit Theophylline AssayKLS · Traditional | Syva Co. | 03/02/1979SE |
| K772017 | In Vitro Theophylline Ria TestKLS · Traditional | Clinical Assays, Inc. | 03/27/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1946-2018 Class II | Syva EMIT 2000 Theophylline Product Usage: The Syva Emit 2000 Theophylline Assay is a…Lot J1 of the Syva EMIT 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may… | Siemens Healthcare Diagnostics, Inc. | 11/27/2017Terminated |
| Z-2299-2016 Class II | ADVIA Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro…Siemens Healthcare Diagnostics has confirmed the Syva EMIT 2000 Theophylline reagent lot G3, when run on a… | Siemens Healthcare Diagnostics, Inc. | 06/17/2016Terminated |
| Z-2298-2016 Class II | Syva EMIT 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme…Siemens Healthcare Diagnostics has confirmed the Syva EMIT 2000 Theophylline reagent lot G3, when run on a… | Siemens Healthcare Diagnostics, Inc. | 06/17/2016Terminated |
| Z-0326-2014 Class II | VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |
| Z-0325-2014 Class II | VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |
| Z-0512-2013 Class II | Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test…Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature… | Siemens Healthcare Diagnostics, Inc | 11/14/2012Terminated |
| Z-0408-2013 Class II | Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071)…Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibrations, QC and… | Siemens Healthcare Diagnostics, Inc. | 08/09/2012Terminated |