System, Test, Thyroid Autoantibody
FDA product code JZO · Class II (moderate risk) · 21 CFR 866.5870 · Immunology
92510(k) clearances
0PMA approvals
17recalls
Manufacturers
- American Laboratory Products Co., Ltd. 9
- Roche Diagnostics Corp. 7
- Brahms Diagnostica, LLC 5
- Elias U.S.A., Inc. 5
- Diagnostic Products Corp. 4
- Pharmacia & Upjohn Co. 4
- Kronus, Inc. 4
- Axis-Shield Diagnostics, Ltd. 3
- Beckman Coulter Inc. 3
- Zeus Scientific, Inc. 3
- Inova Diagnostics, Inc. 2
- Immco Diagnostics, Inc. 2
- Shield Diagnostics, Ltd. 2
- Joldon Diagnostics 2
- Tosoh Medics, Inc. 2
- Cogent Diagnotics , Ltd. 2
- Nichols Institute Diagnostics 2
- Cronus 2
- Columbia Bioscience, Inc. 2
- Kronus Market Development Associates, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase IIJZO · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/17/2025SE |
| K240469 | Access TPO AntibodyJZO · Traditional | Beckman Coulter, Inc. | 08/09/2024SE |
| K213517 | Access Thyroglobulin Antibody IIJZO · Traditional | Beckman Coulter, Inc. | 09/26/2023SE |
| K222610 | Elecsys Anti-TgJZO · Traditional | Roche Diagnostics | 09/15/2023SE |
| K193313 | Elecsys Anti-TSHRJZO · Traditional | Roche Diagnostics | 02/27/2020SE |
| K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250…JZO · Traditional | Phadia AB | 03/25/2016SE |
| K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialJZO · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/03/2016SE |
| K092229 | Thyretain TM Tsi Reporter BioassayJZO · Traditional | Diagnostic Hybrids, Inc. | 05/18/2010SE |
| K090760 | Theratest El-Anti-Tpo and Theratest El-Anti-Thyroglobulin, Model 104-119, 103-120JZO · Traditional | Theratest Laboratories, Inc. | 09/03/2009SE |
| K083391 | Thyroid Stimulating Immunoglobulin Reporter AssayJZO · Traditional | Diagnostic Hybrids, Inc. | 05/21/2009SE |
| K080092 | Elecsys Anti-Tshr Immunoassay, Elecsys Precicontrol ThyroabJZO · Traditional | Roche Diagnostics Corp. | 07/28/2008SE |
| K080159 | Kronus TSH Receptor Autoantibody (Trab) Elisa Assay KitJZO · Traditional | Kronus Market Development Associates, Inc. | 05/22/2008SE |
| K061794 | Fidis TM Thyro, Model MX002JZO · Traditional | Biomedical Diagnostics (Bmd) SA | 11/21/2006SE |
| K052407 | Architect Anti-Tpo Immunoassay, Calibrators & ControlsJZO · Traditional | Fisher Diagnostics | 07/18/2006SE |
| K061382 | Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models A12985 and A18227JZO · Traditional | Beckman Coulter, Inc. | 07/06/2006SE |
| K052308 | Architect Anti-Tg Immunoassay Reagents, Calibrators, Controls and System Assay Cd-RomJZO · Traditional | Fisher Diagnostics | 05/10/2006SE |
| K053426 | Roche Elecsys Anti-TgJZO · Special | Roche Diagnostics Corp. | 02/07/2006SE |
| K051890 | Roche Diagnostics Cobas Elecsys Anti-TpoJZO · Special | Roche Diagnostics Corp. | 08/04/2005SE |
| K033977 | Zeus Scientific, Inc., Athena Multi-Lyte Tpo/Tg Igg Test SystemJZO · Traditional | Zeus Scientific, Inc. | 03/22/2004SE |
| K033454 | Brahms Diagnostica Lumitest Trak HumanJZO · Traditional | Brahms Diagnostica, LLC | 03/22/2004SE |
| K032134 | TSH Receptor Antibody (Trab) Coated Tube (CT) Assay KitJZO · Traditional | Kronus Market Development Associates, Inc. | 09/10/2003SE |
| K023593 | Seraquest Anti-Thyroid Peroxidase (Tpo)JZO · Traditional | Quest Intl., Inc. | 02/06/2003SE |
| K020672 | Elecsys Anti-Tg Test SystemJZO · Traditional | Roche Diagnostics Corp. | 08/05/2002SE |
| K020687 | Diastat Anti-Thyroid Peroxidase Elisa Model #300JZO · Traditional | Axis-Shield Diagnostics, Ltd. | 05/02/2002SE |
| K020349 | Abbott Axsym Anti-Thyroglobulin, Models 5F5B Comprising Standard/CalibratorsJZO · Traditional | Axis-Shield Diagnostics, Ltd. | 05/02/2002SE |
| K020348 | Abbott Axsym Anti-Thyroid-Peroxidase, MODELS5F57 Comprising Standards/CalibratorsJZO · Traditional | Axis-Shield Diagnostics, Ltd. | 05/02/2002SE |
| K012777 | Acs: 180 and Advia Centaur Anti-Thyroglobulin ImmunoassaysJZO · Traditional | Bayer Corp. | 10/22/2001SE |
| K011082 | Tpo Igg Antibody Eia TestJZO · Traditional | Scimedx Corp. | 06/06/2001SE |
| K011415 | Alpco Milenia Anti-Tg EiaJZO · Traditional | American Laboratory Products Co., Ltd. | 05/30/2001SE |
| K011201 | Alpco Milenia Anti-Tpo ElisaJZO · Traditional | American Laboratory Products Co., Ltd. | 05/24/2001SE |
| K003291 | Bayer Diagnostics ACS:180 and Advia Centaur Anti-Tpo AssayJZO · Traditional | Bayer Diagnostics Corp. | 12/05/2000SE |
| K003414 | Varelisa TG (Thyroglobulin) Antibodies,JZO · Traditional | Pharmacia & Upjohn Co. | 11/27/2000SE |
| K000155 | Elecsys Anti-Thyroid Peroxidase Antibody Test SystemJZO · Traditional | Roche Diagnostics Corp. | 05/17/2000SE |
| K000287 | Brahms Diagnostica Lumitest Anti-TpoJZO · Traditional | Brahms Diagnostica, LLC | 03/17/2000SE |
| K000286 | Brahms Diagnostica Lumitest Anti-TgJZO · Traditional | Brahms Diagnostica, LLC | 03/17/2000SE |
| K000362 | Modification to Zeus Scientific, Inc., Tpo Igg Elisa Test SystemJZO · Special | Zeus Scientific, Inc. | 02/18/2000SE |
| K993585 | Varelisa Tpo Antibodies, Model 12348/12396JZO · Traditional | Pharmacia & Upjohn Co. | 01/05/2000SE |
| K992791 | Brahms Diagnostica Dynotest Anti-TpoJZO · Traditional | Brahms Diagnostica, LLC | 11/12/1999SE |
| K992790 | Brahms Diagnostica Dynotest Anti-TgJZO · Traditional | Brahms Diagnostica, LLC | 11/12/1999SE |
| K991096 | Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06JZO · Special | Diagnostic Products Corp. | 05/13/1999SE |
| K991094 | Immulite 2000 Anti-Tg AB, Model L2KTG2, L2KTG6JZO · Special | Diagnostic Products Corp. | 05/13/1999SE |
| K984228 | Is Anti-Tpo Igg Elisa Test SystemJZO · Traditional | Columbia Bioscience, Inc. | 02/02/1999SE |
| K984165 | Anti-Thyroglobulin Eia Diagnostic Test KitJZO · Traditional | The Binding Site, Ltd. | 02/02/1999SE |
| K984163 | Anti-Tpo Eia Diagnostic Test KitJZO · Traditional | The Binding Site, Ltd. | 02/02/1999SE |
| K983992 | Nichols Advantage Thyroglobulin Autoantibodies (Tgab) AssayJZO · Traditional | Nichols Institute Diagnostics | 01/26/1999SE |
| K983553 | Anti-Tg Igg Elisa Test SystemJZO · Traditional | Columbia Bioscience, Inc. | 12/07/1998SE |
| K982866 | Nichols Advantage Chemiluminescence Thyroid Peroxidase Autoantibodies Immunoassay, Model…JZO · Traditional | Nichols Institute Diagnostics | 10/16/1998SE |
| K981522 | Aia-Pack Tgab AssayJZO · Traditional | Tosoh Medics, Inc. | 10/08/1998SE |
| K981521 | Aia-Pack Tpoab AssayJZO · Traditional | Tosoh Medics, Inc. | 10/08/1998SE |
| K981930 | Unicap Thyroid Peroxidase IggJZO · Traditional | Pharmacia & Upjohn Co. | 07/07/1998SE |
| K981559 | Unicap Thyroglobulin Igg Assay, Unicap Thyroid Peroxidase Igg AssayJZO · Traditional | Pharmacia & Upjohn Co. | 07/07/1998SE |
| K980206 | Immulite Anti-Tg ABJZO · Traditional | Diagnostic Products Corp. | 05/01/1998SE |
| K972190 | Thyroglobulin Assay SystemJZO · Traditional | American Laboratory Products Co., Ltd. | 07/14/1997SE |
| K963695 | Immulite ANTI-TPO-AB(LKTOI,LKT05,LKTOZJZO · Traditional | Diagnostic Products Corp. | 01/17/1997SE |
| K960370 | Thyroglobulin Antibody ElisaJZO · Traditional | Immco Diagnostics, Inc. | 06/20/1996SE |
| K960369 | Thyroid Peroxidase Antibody ElisaJZO · Traditional | Immco Diagnostics, Inc. | 06/20/1996SE |
| K952183 | Diastat Anti-Thyroglobulin KitJZO · Traditional | Shield Diagnostics, Ltd. | 06/30/1995SE |
| K951487 | Diastat Anti-Thyroid Peroxidase KitJZO · Traditional | Shield Diagnostics, Ltd. | 06/30/1995SE |
| K952130 | Orgentec Anti-Tg ElisaJZO · Traditional | American Laboratory Products Co., Ltd. | 06/20/1995SE |
| K952129 | Orgentec Anti-Tpo ElisaJZO · Traditional | American Laboratory Products Co., Ltd. | 06/20/1995SE |
| K950217 | Orgentec Thyroglobulin Pia (Pin Immuno Assay)JZO · Traditional | American Laboratory Products Co., Ltd. | 04/24/1995SE |
| K950090 | Orgentec Anti-Tpo Pia (Pin Immuno Assay)JZO · Traditional | American Laboratory Products Co., Ltd. | 04/21/1995SE |
| K950089 | Orgentec Anti-Tg Pia (Pin Immuno Assay)JZO · Traditional | American Laboratory Products Co., Ltd. | 04/21/1995SE |
| K950088 | Orgentec Anti-Tg/Anti-Tpo Pia (Pin Immuno Assay)JZO · Traditional | American Laboratory Products Co., Ltd. | 04/21/1995SE |
| K931311 | Thyroid Peroxidase Auto Antibodies(Tpo) Immun KitJZO · Traditional | Nichols Institute | 05/14/1993SE |
| K930485 | Quanta Lite(Tm) Thyroid M ElisaJZO · Traditional | Inova Diagnostics, Inc. | 03/16/1993SE |
| K930274 | Thyroid Microsomal Antigen Auto-Antibody EnzymeJZO · Traditional | Joldon Diagnostics | 02/23/1993SE |
| K925194 | Thyroglobulin Auto-Antibody Eia Test KitJZO · Traditional | Joldon Diagnostics | 02/05/1993SE |
| K925826 | Encore Thyroglobulin Ige, Iga and Igm EiaJZO · Traditional | Clark Laboratories, Inc. | 01/26/1993SE |
| K925785 | Autostat Anti-Thyroid Microsomal KitJZO · Traditional | Cogent Diagnotics , Ltd. | 01/21/1993SE |
| K925784 | Autostat AntithyroglobinJZO · Traditional | Cogent Diagnotics , Ltd. | 01/21/1993SE |
| K925923 | Elias TmabJZO · Traditional | Elias U.S.A., Inc. | 01/14/1993SE |
| K925922 | Elias TgabJZO · Traditional | Elias U.S.A., Inc. | 01/14/1993SE |
| K915135 | Synelisa Tgab/TmabJZO · Traditional | Elias U.S.A., Inc. | 04/08/1992SE |
| K915134 | Synelisa TgabJZO · Traditional | Elias U.S.A., Inc. | 04/08/1992SE |
| K915133 | Synelisa TmabJZO · Traditional | Elias U.S.A., Inc. | 04/08/1992SE |
| K915429 | Kronus Kalibre Thyroid Peroxidase Antibody Eia KitJZO · Traditional | Kronus | 03/30/1992SE |
| K915428 | Kronus Kalibre Thyroglobulin Antibody Eia KitJZO · Traditional | Kronus | 03/30/1992SE |
| K905485 | Immunowell Thyroglobulin TestJZO · Traditional | General Biometrics, Inc. | 01/25/1991SE |
| K904224 | Nova Lite TM ThyroidJZO · Traditional | Inova Diagnostics, Inc. | 10/15/1990SE |
| K894364 | Modified Kronus Test Kit for Antibodies to (Tpo)JZO · Traditional | Kronus | 07/25/1989SE |
| K894203 | Anti-Thyroglobulin Test KitJZO · Traditional | Kronus | 07/25/1989SE |
| K881933 | Kallestad Quantafluor Antithyroid Antibody TestJZO · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 06/06/1988SE |
| K871193 | I-125 Anti-Thyroglobulin Antibody Irma Test KitJZO · Traditional | Cronus | 05/15/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | Miles Laboratories, Inc. | 02/18/1987SE |
| K863006 | 125-I TSH Receptor Antibody KitJZO · Traditional | Cronus | 09/08/1986SE |
| K843343 | Medica Iif-Anti-Thyroid Antibody TestJZO · Traditional | Medical Diagnostics, Ca. | 10/22/1984SE |
| K841580 | TSH Receptor Antibody Kit 125I TSHJZO · Traditional | Clinetics Corp. | 10/22/1984SE |
| K821489 | Cordia TGJZO · Traditional | Cordis Corp. | 06/09/1982SE |
| K810982 | Antithyroid Antibody ImmunofluorescentJZO · Traditional | Immuno-Products Industries | 05/01/1981SE |
| K791458 | Agglutinotest-ThyroglobulinJZO · Traditional | Volu Sol Medical Industries | 12/31/1979SE |
| K760154 | Test, (Ivdp) Thyroid AntibodyJZO · Traditional | Zeus Scientific, Inc. | 07/20/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1009-2026 Class II | The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with…Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may… | Roche Diagnostics Operations, Inc. | 11/21/2025Open, Classified |
| Z-1844-2025 Class II | ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | Mckesson Medical-Surgical Inc. Corporate… | 04/24/2025Open, Classified |
| Z-1843-2025 Class II | ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | Mckesson Medical-Surgical Inc. Corporate… | 04/24/2025Open, Classified |
| Z-3305-2024 Class II | Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below… | Siemens Healthcare Diagnostics, Inc. | 08/21/2024Open, Classified |
| Z-3304-2024 Class II | ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below… | Siemens Healthcare Diagnostics, Inc. | 08/21/2024Open, Classified |
| Z-1887-2024 Class II | IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test…The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793)… | Siemens Healthcare Diagnostics, Inc. | 04/23/2024Open, Classified |
| Z-1886-2024 Class II | IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test…The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787… | Siemens Healthcare Diagnostics, Inc. | 04/23/2024Open, Classified |
| Z-1696-2023 Class III | Alinity i Anti-TPO Reagent Kit, List Number 09P3521Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume… | Abbott Ireland Limited | 04/24/2023Open, Classified |
| Z-1820-2022 Class II | IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens…An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins… | Siemens Healthcare Diagnostics, Inc. | 08/11/2022Open, Classified |
| Z-2981-2020 Class II | Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190Recent internal verification studies found the current RF interference claim to no longer be met for the… | Roche Diagnostics Operations, Inc. | 08/20/2020Terminated |
| Z-1236-2019 Class II | Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG… | Siemens Healthcare Diagnostics, Inc | 12/07/2018Terminated |
| Z-1235-2019 Class II | Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG… | Siemens Healthcare Diagnostics, Inc | 12/07/2018Terminated |
| Z-1234-2019 Class II | SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG… | Siemens Healthcare Diagnostics, Inc | 12/07/2018Terminated |
| Z-1233-2019 Class II | Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG… | Siemens Healthcare Diagnostics, Inc | 12/07/2018Terminated |
| Z-2169-2017 Class III | AIA-PACK TgAb CONTROL SETThe label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL)… | Tosoh Bioscience, Inc. | 02/08/2017Terminated |
| Z-2168-2017 Class III | AIA-PACK TPOAb CONTROL SETThe label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL)… | Tosoh Bioscience, Inc. | 02/08/2017Terminated |
| Z-1187-2021 Class II | Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO…Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the… | Tosoh Bioscience Inc | 02/23/2012Terminated |