Product code JZO
- Device name
- System, Test, Thyroid Autoantibody
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5870
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| K240469 | Access TPO Antibody | Beckman Coulter, Inc. | 2024-08-09 |
| K213517 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2023-09-26 |
| K222610 | Elecsys Anti-Tg | Roche Diagnostics | 2023-09-15 |
| K193313 | Elecsys Anti-TSHR | Roche Diagnostics | 2020-02-27 |
| K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 | Phadia AB | 2016-03-25 |
| K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2016-03-03 |
| K092229 | THYRETAIN TM TSI REPORTER BIOASSAY | Diagnostic Hybrids, Inc. | 2010-05-18 |
| K090760 | THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 | Theratest Laboratories, Inc. | 2009-09-03 |
| K083391 | THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY | Diagnostic Hybrids, Inc. | 2009-05-21 |
| K080092 | ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB | Roche Diagnostics Corp. | 2008-07-28 |
| K080159 | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT | Kronus Market Development Associates, Inc. | 2008-05-22 |
| K061794 | FIDIS TM THYRO, MODEL MX002 | Biomedical Diagnostics (Bmd) SA | 2006-11-21 |
| K052407 | ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS | Fisher Diagnostics | 2006-07-18 |
| K061382 | ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 | Beckman Coulter, Inc. | 2006-07-06 |
| K052308 | ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM | Fisher Diagnostics | 2006-05-10 |
| K053426 | ROCHE ELECSYS ANTI-TG | Roche Diagnostics Corp. | 2006-02-07 |
| K051890 | ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO | Roche Diagnostics Corp. | 2005-08-04 |
| K033454 | BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN | Brahms Diagnostica, LLC | 2004-03-22 |
| K033977 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM | Zeus Scientific, Inc. | 2004-03-22 |
| K032134 | TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT | Kronus Market Development Associates, Inc. | 2003-09-10 |
| K023593 | SERAQUEST ANTI-THYROID PEROXIDASE (TPO) | Quest Intl., Inc. | 2003-02-06 |
| K020672 | ELECSYS ANTI-TG TEST SYSTEM | Roche Diagnostics Corp. | 2002-08-05 |
| K020687 | DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 | Axis-Shield Diagnostics, Ltd. | 2002-05-02 |
| K020349 | ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS | Axis-Shield Diagnostics, Ltd. | 2002-05-02 |
| K020348 | ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS | Axis-Shield Diagnostics, Ltd. | 2002-05-02 |
| K012777 | ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS | Bayer Corp. | 2001-10-22 |
| K011082 | TPO IGG ANTIBODY EIA TEST | Scimedx Corp. | 2001-06-06 |
| K011415 | ALPCO MILENIA ANTI-TG EIA | American Laboratory Products Co., Ltd. | 2001-05-30 |
| K011201 | ALPCO MILENIA ANTI-TPO ELISA | American Laboratory Products Co., Ltd. | 2001-05-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336217641 | Elecsys Anti-TSHR | Roche Diagnostics GmbH | 2026-06-01 |
| 00630414245362 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2026-02-04 |
| 00630414245355 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2026-02-04 |
| 00630414245324 | Atellica IM Anti-Thyroglobulin II (aTgII) | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2026-02-04 |
| 00630414245317 | Atellica IM Anti-Thyroglobulin II (aTgII) | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2026-02-04 |
| 00630414608754 | Atellica IM aTPOII | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2026-01-26 |
| 00630414608761 | Atellica IM aTPOII | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2026-01-26 |
| 00630414609492 | Atellica IM aTPOII Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2026-01-26 |
| 00630414608747 | ADVIA Centaur aTPOII | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2025-11-21 |
| 00630414608570 | ADVIA Centaur aTPOII | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2025-11-21 |
| 00630414609409 | ADVIA Centaur aTPOII Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2025-11-21 |
| 15099590763527 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2023-12-01 |
| 07613336171479 | Elecsys Anti-Tg | Roche Diagnostics GmbH | 2023-10-31 |
| 07613336203521 | Elecsys Anti-Tg | Roche Diagnostics GmbH | 2023-10-31 |
| 04048474033694 | TSH Receptor Autoantibody ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 00840239037084 | Anti TG Ab ELISA | DRG International Inc | 2023-08-25 |
| 00840239033697 | TSH Receptor Autoantibody ELISA | DRG International Inc | 2023-08-24 |
| 04015630939954 | Elecsys Anti-TSHR | Roche Diagnostics GmbH | 2017-04-21 |
| 04015630939619 | Elecsys Anti-Tg | Roche Diagnostics GmbH | 2017-04-14 |
| 04015630939626 | Elecsys Anti-TPO | Roche Diagnostics GmbH | 2017-04-14 |
| 07333066015736 | EliA anti-TG Well | Phadia AB | 2016-09-23 |
| 07333066015729 | EliA anti-TPO Well | Phadia AB | 2016-09-23 |
| 07333066004013 | ImmunoCAP Specific IgG, Antigen tp, Thyroid Peroxidase | Phadia AB | 2016-09-23 |
| 04015630929702 | cobas Elecsys AntiTPO | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630929726 | Elecsys AntiTg Assay | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630929719 | Elecsys AntiTg Calset | Roche Diagnostics GmbH | 2016-09-20 |
| 00380740003463 | ARCHITECT | Abbott Ireland Diagnostics | 2016-06-06 |
| 00380740003449 | ARCHITECT | Abbott Ireland Diagnostics | 2016-06-06 |
| 00380740003425 | ARCHITECT | Abbott Ireland Diagnostics | 2016-06-06 |
| 00380740003418 | ARCHITECT | Abbott Ireland Diagnostics | 2016-06-06 |