Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
FDA product code KLI · Class II (moderate risk) · 21 CFR 862.1700 · Clinical Chemistry
86510(k) clearances
0PMA approvals
11recalls
Manufacturers
- Syva Co. 14
- Microgenics Corp. 6
- Abbott Laboratories 4
- Technicon Instruments Corp. 4
- Biotecx Laboratories, Inc. 2
- Medix Biotech, Inc. 2
- The DU Pont Co. 2
- Bio-Rad 2
- Biocircuits Corp. 2
- Ciba Corning Diagnostics Corp. 2
- Monobind 2
- Terumo Medical Corp. 1
- V-Tech, Inc. 1
- Collaborative Research, Inc. 1
- Immunotech Corp. 1
- American Dade 1
- Amersham Corp. 1
- Ortho-Clinical Diagnostics 1
- Diagnostic Products Corp. 1
- Icl Scientific 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K160495 | VITROS® Automation SolutionsKLI · Traditional | Ortho-Clinical Diagnostics, Inc. | 10/18/2016SE |
| K131515 | Ace -Gt Reagent; Ace Lipase Ragent; Ace T4 ReagentKLI · Traditional | Alfa Wassermann | 08/14/2013SE |
| K103484 | GSP Neonatal Thyroxine (T4)KLI · Traditional | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 04/22/2011SE |
| K082638 | Advia Centaur System with Streamlab Analytical WorkcellKLI · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/26/2009SE |
| K030860 | Accubind Neonatal T4 Microplate Eia, Model 2625-300KLI · Traditional | Monobind | 08/22/2003SE |
| K023369 | Access Total T4 AssayKLI · Traditional | Beckman Coulter, Inc. | 12/09/2002SE |
| K001603 | Reprobead T4 Enzyme Immunoassay Reagent Kit (Catalog# 105)KLI · Traditional | Repromedix Corp. | 10/05/2000SE |
| K000600 | Syva Emit 2000 Thyroxine Assay, CalibratorsKLI · Traditional | Syva Co., Dade Behring, Inc. | 03/27/2000SE |
| K991432 | Biocheck Total T4 Enzyme Immunoassay Test Kit, Model BC-1007KLI · Traditional | Biocheck, Inc. | 06/02/1999SE |
| K982298 | Opticoat T4 Eia KitKLI · Traditional | Biotecx Laboratories, Inc. | 02/03/1999SE |
| K983440 | Abbott Architect Total T4KLI · Traditional | Abbott Laboratories | 11/25/1998SE |
| K981377 | Ace T4 Reagent T4 CalibratorsKLI · Traditional | Schiapparelli Biosystems, Inc. | 06/10/1998SE |
| K972974 | Accuwell T4-EIAKLI · Traditional | Neometrics, Inc. | 10/06/1997SE |
| K971709 | Total Throxine Microplate EIA(225-300)KLI · Traditional | Monobind | 06/16/1997SE |
| K971269 | DSL Active T4 EiaKLI · Traditional | Diagnostic Systems Laboratories, Inc. | 05/22/1997SE |
| K971203 | Synchron Systems Thyroxine ReagentKLI · Traditional | Beckman Instruments, Inc. | 05/16/1997SE |
| K964721 | Vitros Immunodiagnostics Products Total T4 Reagent Pack (GEM.1005) Total T4 Calibrators…KLI · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 12/18/1996SE |
| K951014 | Isolab's T4 Test KitKLI · Traditional | Isolab, Inc. | 10/18/1996SE |
| K962211 | Ubi Magiwel Thyroxine (T4) QuantitativeKLI · Traditional | United Biotech, Inc. | 07/08/1996SE |
| K953837 | Biocircuits Ios T4 Test CartridgeKLI · Traditional | Biocircuits Corp. | 11/20/1995SE |
| K952751 | Biocircuits Ios T4/TU Test CartridgesKLI · Traditional | Biocircuits Corp. | 11/20/1995SE |
| K951321 | Radias Neonatal T4 Enzyme ImmunoassayKLI · Traditional | Bio-Rad | 08/24/1995SE |
| K950588 | T4 Microwell Eia (Enzyme IMMUNOASSAY0KLI · Traditional | Biomerica, Inc. | 06/29/1995SE |
| K946163 | Radias Total T4 Enzyme ImmunoassayKLI · Traditional | Bio-Rad | 02/22/1995SE |
| K944703 | Thyroxine Enzyme ImmunoassayKLI · Traditional | Diagnostic Reagents, Inc. | 12/09/1994SE |
| K943019 | Cedia T4 Mab AssayKLI · Traditional | Microgenics Corp. | 10/20/1994SE |
| K942575 | Cedia T4 Mab AssayKLI · Traditional | Microgenics Corp. | 07/28/1994SE |
| K941042 | Cedia T4 Mab AssayKLI · Traditional | Microgenics Corp. | 04/26/1994SE |
| K935880 | Cedia T4 Mab Assay ModificationKLI · Traditional | Microgenics Corp. | 03/03/1994SE |
| K932605 | Cobas (R) Core T4 EiaKLI · Traditional | Roche Diagnostic Systems, Inc. | 01/24/1994SE |
| K926475 | Access(R) Thyroxine AssayKLI · Traditional | Bio-Rad Laboratories, Inc. | 06/15/1993SE |
| K926393 | Vidas Thyroxine (T4) Assay (T4)KLI · Traditional | Biomerieux Vitek, Inc. | 05/13/1993SE |
| K922433 | Vista Thyroxine (T-4) Assay -- ModificationKLI · Traditional | Syva Co. | 09/18/1992SE |
| K921904 | Thyroxine (Fpia) KitKLI · Traditional | Tudor Laboratories, Inc. | 06/24/1992SE |
| K920712 | Medix Biotech Throxine Enzyme Immunoassay Test KitKLI · Traditional | Medix Biotech, Inc. | 03/27/1992SE |
| K915194 | Cedia T4KLI · Traditional | Boehringer Mannheim Corp. | 12/09/1991SE |
| K912616 | Technicon Immuno 1 TM System Additional AnalytesKLI · Traditional | Technicon Instruments Corp. | 09/25/1991SE |
| K911217 | SR1 T4 Enzyme Immunoassay (Magnetic Solid-Phase)KLI · Traditional | Serono-Baker Diagnostics, Inc. | 08/16/1991SE |
| K910261 | Immulite(Tm) Total T4KLI · Traditional | Cirrus Diagnostics, Inc. | 04/16/1991SE |
| K903095 | Il Thyroxine (T4) Assay SystemKLI · Traditional | Instrumentation Laboratory CO | 08/23/1990SE |
| K897072 | NDS Thyroxine Test Kit & NDS Thyroxine CalibratorKLI · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 03/29/1990SE |
| K897193 | Opus T4 Test SystemKLI · Traditional | Pb Diagnostic Systems, Inc. | 03/19/1990SE |
| K897144 | THYROXIN(T4) Enzyme Immunoassay Test KitKLI · Traditional | Medix Biotech, Inc. | 03/15/1990SE |
| K896982 | Aia-Pack T4KLI · Traditional | Tosoh Corp. | 03/09/1990SE |
| K896865 | Vitro T4-EIA-XTKLI · Traditional | In Vitro Diagnostics, Inc. | 01/30/1990SE |
| K896329 | D-Chem Total T4 Test Kit for Thyroxine Quantita.KLI · Traditional | Photec Diagnostics, Inc. | 12/12/1989SE |
| K892853 | T4 Clasp-Bead Eia KitKLI · Traditional | Biotecx Laboratories, Inc. | 05/22/1989SE |
| K890831 | Emit Convenience Pack: Thyroxine AssayKLI · Traditional | Syva Co. | 04/14/1989SE |
| K884260 | Thyroxine MicroassayKLI · Traditional | Diamedix Corp. | 02/23/1989SE |
| K885258 | Aca Thyroxine (T4 E) MethodKLI · Traditional | The DU Pont Co. | 02/17/1989SE |
| K885141 | Emit Thyroxine AssayKLI · Traditional | Syva Co. | 02/17/1989SE |
| K884700 | Analyst Thyroxine (T4) RotorKLI · Traditional | The DU Pont Co. | 01/27/1989SE |
| K884634 | Modified Cedia Total T4 AssayKLI · Traditional | Microgenics Corp. | 12/09/1988SE |
| K881357 | Emit Convenience Pack: Thyroxine AssayKLI · Traditional | Syva Co. | 05/27/1988SE |
| K880620 | Emit Thyroxine AssayKLI · Traditional | Syva Co. | 03/24/1988SE |
| K880662 | Vision(R) Thyroxine (T4)KLI · Traditional | Abbott Laboratories | 03/16/1988SE |
| K874866 | T4 Serozyme Enzymeimmunoassay Kit/Mag. Solid PhaseKLI · Traditional | Serono Diagnostics, Inc. | 02/11/1988SE |
| K874603 | Ciba Corning T4 Lipia (Liposome Immunoassay)KLI · Traditional | Ciba Corning Diagnostics Corp. | 12/18/1987SE |
| K873976 | Amerlite TT4 Assay (240/480/144 Test Kits)KLI · Traditional | Amersham Corp. | 11/05/1987SE |
| K873518 | Affinity Total Thyroxine ImmunitKLI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/29/1987SE |
| K872192 | Immubead T4 Enzyme Immunoassay KitKLI · Traditional | Immunotech Corp. | 08/13/1987SE |
| K862233 | Ciba Corning Prisma T4 Lipia (Liposome)KLI · Traditional | Ciba Corning Diagnostics Corp. | 10/14/1986SE |
| K854971 | V-Trend Eia T4 Enzyme Immunoassay Test KitKLI · Traditional | V-Tech, Inc. | 02/06/1986SE |
| K852164 | Cedia Total T4 AssayKLI · Traditional | Microgenics Corp. | 07/22/1985SE |
| K841601 | Terumo Sensibead Thyroxine Eia KitKLI · Traditional | Terumo Medical Corp. | 05/22/1984SE |
| K841576 | Technicon RA-1000 Sys T4-THYROXINEKLI · Traditional | Technicon Instruments Corp. | 05/22/1984SE |
| K840473 | Ventrezyme T4 Immunoassay T4KLI · Traditional | Vxr, Inc. | 04/04/1984SE |
| K840241 | Thyroxine EmiaKLI · Traditional | Collaborative Research, Inc. | 03/30/1984SE |
| K834102 | RA-1000 SYS-T4(THYROXINE)SERUM AnalKLI · Traditional | Technicon Instruments Corp. | 03/15/1984SE |
| K834210 | Stratus Total Thyroxine FluorometricKLI · Traditional | American Dade | 03/05/1984SE |
| K830683 | TDX ThyroxineKLI · Traditional | Abbott Laboratories | 04/06/1983SE |
| K830769 | Fekal Con-Trate SystemKLI · Traditional | Trend Scientific, Inc. | 04/05/1983SE |
| K830136 | Paramount Thyroxine AssayKLI · Traditional | Syva Co. | 02/07/1983SE |
| K823751 | Sopheia Thyroxine Eia KitKLI · Traditional | Diagnostic Products Corp. | 01/12/1983SE |
| K823034 | Syva Advance Thyroxine AssayKLI · Traditional | Syva Co. | 11/08/1982SE |
| K820750 | Enzymune-Test T4KLI · Traditional | Icl Scientific | 04/06/1982SE |
| K810586 | Emit-Tfg Prisma Thyroxine AssayKLI · Traditional | Syva Co. | 03/17/1981SE |
| K802693 | Oreia-Q-Ty, Enzyme ImmunoassayKLI · Traditional | Organon, Inc. | 12/10/1980SE |
| K801475 | Application of Emit AED AssaysKLI · Traditional | Syva Co. | 07/08/1980SE |
| K801288 | Emit Aaii Thyroxine AssayKLI · Traditional | Syva Co. | 06/30/1980SE |
| K800384 | Smac System, T4 MethodKLI · Traditional | Technicon Instruments Corp. | 03/19/1980SE |
| K790848 | A-Gent Quantichrom T4 11AKLI · Traditional | Abbott Laboratories | 08/10/1979SE |
| K790686 | Emit Cfa Thyroxine AssayKLI · Traditional | Syva Co. | 05/25/1979SE |
| K782085 | Emit Thyroxine AssayKLI · Traditional | Syva Co. | 02/01/1979SE |
| K781828 | Computer, 3500, Gilford SystemKLI · Traditional | Syva Co. | 12/04/1978SE |
| K770070 | Enit Aba Thyroxine AssayKLI · Traditional | Syva Co. | 01/21/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1922-2026 Class II | Access Total T4 Calibrator, Catalog No. 33805Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on… | Beckman Coulter, Inc. | 03/16/2026Open, Classified |
| Z-1303-2024 Class II | Access Total T4, REF 33800, IVD, thyroxine reagent assay.Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which… | Beckman Coulter, Inc. | 02/08/2024Open, Classified |
| Z-0310-2022 Class II | Total Thyroxine (T4) ELISA; REF EIA-1781Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls.… | DRG International, Inc. | 10/18/2021Open, Classified |
| Z-0214-2022 Class II | T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This…Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls. | BioCheck, Inc. | 10/14/2021Terminated |
| Z-1834-2020 Class III | VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations. | Ortho Clinical Diagnostics | 03/10/2020Terminated |
| Z-2079-2018 Class II | ST-AIA PACK T4; Part Number: 025258 Assay, ThyroidAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-1660-2018 Class II | Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | Siemens Healthcare Diagnostics, Inc. | 06/29/2017Terminated |
| Z-2302-2016 Class II | VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468…Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products… | Ortho-Clinical Diagnostics | 06/02/2016Terminated |
| Z-1648-2014 Class II | VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human…Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results. | Ortho-Clinical Diagnostics | 02/20/2014Terminated |
| Z-1949-2011 | Access Total T4 Reagent Kit, Part Number: 33800, Lot Numbers (s): All reagent pack lots…The recall was initiated because the concentration of total T4 in samples from pregnant women is erroneously… | Beckman Coulter Inc. | 03/10/2011Terminated |
| Z-3027-2011 | Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805, Subsequent Product…The recall was initiated because Beckman Coulter has confirmed that the stability claims for the Access… | Beckman Coulter Inc. | 08/26/2010Terminated |