Radioimmunoassay, Free Thyroxine
FDA product code CEC · Class II (moderate risk) · 21 CFR 862.1695 · Clinical Chemistry
92510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Abbott Laboratories 8
- Bd Becton Dickinson Vacutainer Systems Preanalytic 8
- Amersham Corp. 5
- Siemens Healthcare Diagnostics, Inc. 5
- Corning Medical & Scientific 3
- Diagnostic Products Corp. 3
- Roche Diagnostics Corp. 3
- Eastman Kodak Company 2
- Roche Diagnostic Systems, Inc. 2
- Ciba Corning Diagnostics Corp. 2
- Boehringer Mannheim Corp. 2
- Nichols Institute Diagnostics 2
- Advanced Magnetics, Inc. 2
- Dade Behring, Inc. 2
- Bioclinical Group 2
- Boots-Celltech Diagnostics, Inc. 1
- Sclavo, Inc. 1
- American Dade 1
- Beckman Coulter Inc. 1
- Nuclear Diagnostics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240273 | Access Free T4CEC · Traditional | Beckman Coulter, Inc. | 03/06/2024SE |
| K220456 | Elecsys FT4 IVCEC · Traditional | Roche Diagnostics | 04/07/2023SE |
| K182423 | Maglumi 2000 FT4CEC · Traditional | Shenzhen New Industries Biomedical Engineering… | 10/04/2018SE |
| K181233 | Elecsys FT4 IIICEC · Traditional | Roche Diagnostics | 09/18/2018SE |
| K173122 | Abbott Architect Free T4CEC · Special | Abbott Laboratories | 10/27/2017SE |
| K152422 | FREND Free T4 Test SystemCEC · Traditional | Nanoentek USA, Inc. | 02/17/2016SE |
| K132058 | Vidas FT4CEC · Traditional | Biomerieux S.A. | 06/08/2015SE |
| K140859 | Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista Thyroid…CEC · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/26/2014SE |
| K140842 | Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid…CEC · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/26/2014SE |
| K131244 | Elecsys FT4 II Assay, Elecsys FT4 II CalsetCEC · Traditional | Roche Diagnostics | 01/27/2014SE |
| K132249 | Advia Centaur FT4, Advia Centaur T4CEC · Traditional | Siemens Healthcare Diagnostics, Inc. | 09/13/2013SE |
| K121951 | Liaison FT4 Liaison Control Thyroid 1 Liaison Control Thyroid 2 Liaison Control Thyroid 3CEC · Traditional | DiaSorin, Inc. | 04/04/2013SE |
| K123379 | Abbott Architect Free T4CEC · Special | Abbott Laboratories | 11/27/2012SE |
| K083373 | Immulite 2000 Free T4CEC · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/02/2009SE |
| K080167 | Acs 180 and Advia Centaur FT4 ImmunoassaysCEC · Traditional | Siemens Healthcare Diagnostics | 08/08/2008SE |
| K073604 | Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge…CEC · Traditional | Dade Behring, Inc. | 03/13/2008SE |
| K070708 | Olympus FT4-FREE Thyroxine, Olympus T4- Total Thyroxine, Model# OSR210102, OSR210104CEC · Traditional | Olympus Life & Material Science Europa GmbH (Irish | 08/21/2007SE |
| K053531 | Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1 CalibratorCEC · Traditional | Dade Behring, Inc. | 03/03/2006SE |
| K030329 | Fastpack Free T4 ImmunoassayCEC · Traditional | Qualigen, Inc. | 07/03/2003SE |
| K020548 | Free T4 (Thytoxine) Microplate Eia Test Models # 1225-300CEC · Traditional | Monobind | 04/05/2002SE |
| K983417 | Abbott Architect Free T4CEC · Traditional | Abbott Laboratories | 11/20/1998SE |
| K982954 | Free T4 Microwell Eia, Model #7019CEC · Traditional | Biomerica, Inc. | 09/24/1998SE |
| K982250 | Access Free T4 Reagents on the Access Immunoassay AnalyzerCEC · Traditional | Beckman Instruments, Inc. | 07/14/1998SE |
| K981243 | Biostride Free T4 Eia Test KitCEC · Traditional | Biostride Diagnostics, Inc. | 06/29/1998SE |
| K980819 | Biocircuits Ios Free Thyroxine (FT4) Test Cartridges Biocircuits Ios ControlsCEC · Traditional | Biocircuits Corp. | 04/03/1998SE |
| K974551 | Sealite Sciences, Inc. Aqualite Free T, AssayCEC · Traditional | Sealite Sciences, Inc. | 12/22/1997SE |
| K971792 | Immulite Free T4 (2-STEP)CEC · Traditional | Diagnostic Products Corp. | 07/25/1997SE |
| K971141 | FT4 Method for the Dimension RXL Clinical Chemistry SystemCEC · Traditional | Dade Chemistry Systems, Inc. | 04/28/1997SE |
| K965142 | Vitros Immunodiagnostics Products Free T4 Reagent Pack (GEM.1015) Free T4 Calibrators…CEC · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 03/18/1997SE |
| K962408 | Nichols Advantage Chemiluminescence Free T4- Estimate KitCEC · Traditional | Nichols Institute Diagnostics | 03/18/1997SE |
| K962602 | Aca Plus Free THYROXINE(FT4) MethodCEC · Traditional | Dade Intl., Inc. | 08/15/1996SE |
| K961489 | Elecsys FT4 AssayCEC · Traditional | Boehringer Mannheim Corp. | 06/11/1996SE |
| K955097 | Amerlite Mab FT4 AssayCEC · Traditional | Kodak Clinical Diagnostics, Ltd. | 12/20/1995SE |
| K942376 | Cobas Core Free T3 EiaCEC · Traditional | Roche Diagnostic Systems, Inc. | 04/21/1995SE |
| K944697 | Aura Flex FT4 200 Test Pack, FT4 Calibrator PackCEC · Traditional | Organon Teknika Corp. | 02/22/1995SE |
| K940507 | Opus FT4 Test SystemCEC · Traditional | Pb Diagnostic Systems, Inc. | 07/28/1994SE |
| K934544 | Axsym Free Thyroxine ( Free T4 )CEC · Traditional | Abbott Laboratories | 06/21/1994SE |
| K940482 | Ciba Corning Acs FT3 ImmunoassayCEC · Traditional | Ciba Corning Diagnostics Corp. | 04/26/1994SE |
| K932607 | Cobas(R) Core FT4 EiaCEC · Traditional | Roche Diagnostic Systems, Inc. | 01/24/1994SE |
| K934012 | FT4 RadioimmunoassayCEC · Traditional | Immunotech S.A. | 11/16/1993SE |
| K930322 | Free Thyroxine(F T4) Method/Technicon Immuno 1(R)CEC · Traditional | Heraeus Kulzer, Inc. | 11/10/1993SE |
| K932912 | Stratus Free Thyroxine (Free T4) FluorometricCEC · Traditional | Baxter Diagnostics, Inc. | 10/28/1993SE |
| K931704 | Immulite Free T4CEC · Traditional | Diagnostic Products Corp. | 08/16/1993SE |
| K931110 | Radias Free T4 Enzyme ImmunoassayCEC · Traditional | Bio-Rad | 05/20/1993SE |
| K925842 | Becton Dickinson Simultrac Component SystemCEC · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/20/1993SE |
| K925649 | Nat. Screening Institute Micro-Plate Free T4 AssayCEC · Traditional | Solarcare Technologies Corp,Inc. | 03/01/1993SE |
| K925913 | Access(R) Free T4 AssayCEC · Traditional | Bio-Rad Laboratories, Inc. | 01/27/1993SE |
| K925177 | Vidas Free THYROXINE(FT4) AssayCEC · Traditional | Biomerieux Vitek, Inc. | 11/30/1992SE |
| K923572 | Vista Free Thyroxine AssayCEC · Traditional | Syva Co. | 11/16/1992SE |
| K922713 | Kodak Amerlite Mab FT3 AssayCEC · Traditional | Eastman Kodak Company | 10/26/1992SE |
| K922284 | Elegance FT4 ElisaCEC · Traditional | Bioclone Australia Pty , Ltd. | 07/10/1992SE |
| K920247 | Amerlite Mab FT4 AssayCEC · Traditional | Eastman Kodak Company | 03/02/1992SE |
| K914835 | Lumatag Free T4 Chemiluminescence AssayCEC · Traditional | London Diagnostics, Inc. | 12/17/1991SE |
| K912937 | SR1 Free T4 Enzyme ImmunoassayCEC · Traditional | Serono-Baker Diagnostics, Inc. | 11/19/1991SE |
| K912698 | Affinity Free T4 Test SystemCEC · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/07/1991SE |
| K913493 | Aia-Pack FT4CEC · Traditional | Tosoh Corp. | 09/10/1991SE |
| K911634 | Microzyme(Tm) Free T4 Enzyme Immunoassay TestCEC · Traditional | Immunotech Corp. | 06/24/1991SE |
| K910684 | Ciba Corning Acs FT4 ImmunoassayCEC · Traditional | Ciba Corning Diagnostics Corp. | 05/01/1991SE |
| K904539 | Flagen TM Free T4CEC · Traditional | Cyberfluor, Inc. | 11/30/1990SE |
| K903384 | Imx Free T4 CalculationCEC · Traditional | Abbott Laboratories | 09/10/1990SE |
| K903383 | TDX Free T4 CalculationCEC · Traditional | Abbott Laboratories | 09/10/1990SE |
| K902834 | Abbott Imx Free T4CEC · Traditional | Abbott Laboratories | 09/07/1990SE |
| K900883 | Enzymun Test(R) FT4 (Free Thyroxine)CEC · Traditional | Boehringer Mannheim Corp. | 05/15/1990SE |
| K900060 | Free T4 Immunoassay KitCEC · Traditional | Advanced Magnetics, Inc. | 03/29/1990SE |
| K896222 | Free Thyroxine (FT4) Radioimmunoassay KitCEC · Traditional | Nichols Institute Diagnostics | 11/17/1989SE |
| K894605 | Delfia Free Thyroxine (FT4) KitCEC · Traditional | Pharmacia, Inc. | 09/18/1989SE |
| K894091 | Amerlex-Mab FT4 KitCEC · Traditional | Amersham Corp. | 08/03/1989SE |
| K884753 | Modified Free T4 Radioimmunoassay KitCEC · Traditional | Advanced Magnetics, Inc. | 02/27/1989SE |
| K883123 | Amerliite FT4 Assay LAN.0006/2006 240/144 Test KitCEC · Traditional | Amersham Corp. | 12/22/1988SE |
| K883971 | Qlia T Uptake AssayCEC · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/25/1988SE |
| K874875 | Chemelia Free THYROXINE(FT4)/ENZYME Immuno. (Eia)CEC · Traditional | Boots-Celltech Diagnostics, Inc. | 03/24/1988SE |
| K870268 | Diagnostic Kit Free T3 and Free T4CEC · Traditional | Sclavo, Inc. | 09/14/1987SE |
| K870158 | Stratus Free Thyroxine (FT4) Fluor. Enzyme Immuno.CEC · Traditional | American Dade | 03/19/1987SE |
| K865104 | Iq Fti ImmunoassayCEC · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/16/1987SE |
| K864658 | Iq Free T4 ImmunoassayCEC · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/12/1987SE |
| K864838 | Simultrac Free T4[57CO]/TSH MAB[125I]CEC · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/18/1987SE |
| K860251 | Amerlex-M T4 Ria Kit for Serum and PlasmaCEC · Traditional | Amersham Corp. | 02/11/1986SE |
| K853628 | Simultrac Free T4(57CO)/TSH[125I] RadioimmunoassayCEC · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/18/1985SE |
| K842482 | Amerlex-M Free T-4 Radioimmunoassay KitCEC · Traditional | Amersham Corp. | 08/10/1984SE |
| K840901 | Phase II Free T4 KitCEC · Traditional | Medical & Scientific Designs, Inc. | 04/25/1984SE |
| K832381 | Corning Magic Single Step Free T4CEC · Traditional | Corning Medical & Scientific | 09/01/1983SE |
| K823264 | Thyroxine Analysis Products/Radio-FreeCEC · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/12/1983SE |
| K823005 | Bio Mag Free T4 Radioimmunoassay KitCEC · Traditional | Bioclinical Group | 12/15/1982SE |
| K823144 | Single Step FREE-T4 125I Radioimmuno-CEC · Traditional | Corning Medical & Scientific | 11/29/1982SE |
| K822882 | Coat-A-Count Free Thyroxine Kit/ComponenCEC · Traditional | Diagnostic Products Corp. | 11/05/1982SE |
| K821241 | Free T4 Radioimmunoassay KitCEC · Traditional | Bioclinical Group | 06/01/1982SE |
| K813465 | Free T4 Ria Test SetCEC · Traditional | Ventrex Laboratories, Inc. | 12/31/1981SE |
| K810231 | Code Im 2050 Amerlex Free T4 Ria KitCEC · Traditional | Amersham Corp. | 02/10/1981SE |
| K781560 | Ria Diag. Test Kit for Indexing Thyrox.CEC · Traditional | Nuclear Diagnostics, Inc. | 10/17/1978SE |
| K781012 | Ria Test Kit Sys. Damon Kiquisol FreeCEC · Traditional | Damon Corp. | 07/27/1978SE |
| K772194 | Immo Phase FT4 AssayCEC · Traditional | Corning Medical & Scientific | 01/06/1978SE |
| K771236 | TRIOBEAD-125 Diagnostic KitCEC · Traditional | Abbott Laboratories | 08/03/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2237-2020 Class II | Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880…The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all… | Beckman Coulter Inc. | 04/30/2019Terminated |
| Z-0665-2019 Class II | Alinity i Free T4 Reagent Kit, List Number 07P7030Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the… | Abbott Ireland Diagnostics Division | 11/21/2018Terminated |
| Z-2081-2018 Class II | ST-AIA PACK FT4; Part Number: 025268 Assay, ThyroidAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-1669-2018 Class II | Dimension Free Thyroxine (FT4L) Flex reagent cartridgeThe concentrations for biotin listed in the non-interfering substances section of the instructions for use… | Siemens Healthcare Diagnostics, Inc. | 01/02/2018Terminated |
| Z-2637-2017 Class II | Access System-Free T4 Assay, B01902E, Catalog No. 33880The Access immunoassays are susceptible to biotin interference. | Beckman Coulter Inc. | 05/09/2017Terminated |
| Z-0549-2014 Class II | FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The…Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a… | Qualigen Inc | 11/08/2013Terminated |
| Z-1945-2011 | Access Free T4 Calibrator, Part Number: 33885, Lot Numbers: 014769 The Access Free T4…The recall was initiated because the stability claim for Access Free T4 calibrator lot 014769 is not met.… | Beckman Coulter Inc. | 11/11/2010Terminated |
| Z-0458-2011 | The Dimension FT4L Flex reagent cartridge( Free Thyroxine) manufactured by Siemens…Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high… | Siemens Healthcare Diagnostics, Inc. | 04/12/2010Terminated |
| Z-2658-2010 | Access Immunoassay Systems Free T4, Part Number: 33880The recall was initiated after Beckman Coulter determined that kit boxes for Access Free T4 reagent (REF… | Beckman Coulter Inc. | 03/24/2010Terminated |