Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JZO — Predicate Candidate Screening
92 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
188 days90th percentile
92clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 | 262 | 0 |
| K240469 | Access TPO Antibody | Beckman Coulter, Inc. | 2024-08-09 | 171 | 0 |
| K213517 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2023-09-26 | 692 | 0 |
| K222610 | Elecsys Anti-Tg | Roche Diagnostics | 2023-09-15 | 382 | 0 |
| K193313 | Elecsys Anti-TSHR | Roche Diagnostics | 2020-02-27 | 90 | 1 |
| K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Th | Phadia AB | 2016-03-25 | 267 | 0 |
| K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verif | Siemens Healthcare Diagnostics, Inc. | 2016-03-03 | 223 | 1 |
| K092229 | THYRETAIN TM TSI REPORTER BIOASSAY | Diagnostic Hybrids, Inc. | 2010-05-18 | 299 | 0 |
| K090760 | THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, M | Theratest Laboratories, Inc. | 2009-09-03 | 164 | 0 |
| K083391 | THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY | Diagnostic Hybrids, Inc. | 2009-05-21 | 185 | 0 |
| K080092 | ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB | Roche Diagnostics Corp. | 2008-07-28 | 196 | 0 |
| K080159 | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT | Kronus Market Development Associates, Inc. | 2008-05-22 | 120 | 0 |
| K061794 | FIDIS TM THYRO, MODEL MX002 | Biomedical Diagnostics (Bmd) SA | 2006-11-21 | 148 | 0 |
| K052407 | ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS | Fisher Diagnostics | 2006-07-18 | 320 | 2 |
| K061382 | ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MO | Beckman Coulter, Inc. | 2006-07-06 | 49 | 0 |
| K052308 | ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROL | Fisher Diagnostics | 2006-05-10 | 259 | 0 |
| K053426 | ROCHE ELECSYS ANTI-TG | Roche Diagnostics Corp. | 2006-02-07 | 61 | 0 |
| K051890 | ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO | Roche Diagnostics Corp. | 2005-08-04 | 23 | 0 |
| K033977 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYS | Zeus Scientific, Inc. | 2004-03-22 | 90 | 0 |
| K033454 | BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN | Brahms Diagnostica, LLC | 2004-03-22 | 144 | 0 |
| K032134 | TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT | Kronus Market Development Associates, Inc. | 2003-09-10 | 61 | 0 |
| K023593 | SERAQUEST ANTI-THYROID PEROXIDASE (TPO) | Quest Intl., Inc. | 2003-02-06 | 104 | 0 |
| K020672 | ELECSYS ANTI-TG TEST SYSTEM | Roche Diagnostics Corp. | 2002-08-05 | 157 | 0 |
| K020687 | DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 | Axis-Shield Diagnostics, Ltd. | 2002-05-02 | 59 | 0 |
| K020349 | ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STAN | Axis-Shield Diagnostics, Ltd. | 2002-05-02 | 87 | 0 |
| K020348 | ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING | Axis-Shield Diagnostics, Ltd. | 2002-05-02 | 87 | 0 |
| K012777 | ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS | Bayer Corp. | 2001-10-22 | 63 | 0 |
| K011082 | TPO IGG ANTIBODY EIA TEST | Scimedx Corp. | 2001-06-06 | 57 | 0 |
| K011415 | ALPCO MILENIA ANTI-TG EIA | American Laboratory Products Co., Ltd. | 2001-05-30 | 22 | 0 |
| K011201 | ALPCO MILENIA ANTI-TPO ELISA | American Laboratory Products Co., Ltd. | 2001-05-24 | 35 | 0 |
| K003291 | BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY | Bayer Diagnostics Corp. | 2000-12-05 | 46 | 2 |
| K003414 | VARELISA TG (THYROGLOBULIN) ANTIBODIES, | Pharmacia & Upjohn Co. | 2000-11-27 | 25 | 0 |
| K000155 | ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM | Roche Diagnostics Corp. | 2000-05-17 | 119 | 0 |
| K000287 | BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO | Brahms Diagnostica, LLC | 2000-03-17 | 46 | 0 |
| K000286 | BRAHMS DIAGNOSTICA LUMITEST ANTI-TG | Brahms Diagnostica, LLC | 2000-03-17 | 46 | 0 |
| K000362 | MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SY | Zeus Scientific, Inc. | 2000-02-18 | 14 | 0 |
| K993585 | VARELISA TPO ANTIBODIES, MODEL 12348/12396 | Pharmacia & Upjohn Co. | 2000-01-05 | 75 | 0 |
| K992791 | BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO | Brahms Diagnostica, LLC | 1999-11-12 | 85 | 0 |
| K992790 | BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG | Brahms Diagnostica, LLC | 1999-11-12 | 85 | 0 |
| K991094 | IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6 | Diagnostic Products Corp. | 1999-05-13 | 42 | 2 |
| K991096 | IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 | Diagnostic Products Corp. | 1999-05-13 | 42 | 0 |
| K984165 | ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT | The Binding Site, Ltd. | 1999-02-02 | 74 | 0 |
| K984163 | ANTI-TPO EIA DIAGNOSTIC TEST KIT | The Binding Site, Ltd. | 1999-02-02 | 74 | 0 |
| K984228 | IS ANTI-TPO IGG ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1999-02-02 | 69 | 0 |
| K983992 | NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY | Nichols Institute Diagnostics | 1999-01-26 | 78 | 0 |
| K983553 | ANTI-TG IGG ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1998-12-07 | 59 | 0 |
| K982866 | NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOA | Nichols Institute Diagnostics | 1998-10-16 | 63 | 0 |
| K981521 | AIA-PACK TPOAB ASSAY | Tosoh Medics, Inc. | 1998-10-08 | 163 | 1 |
| K981522 | AIA-PACK TGAB ASSAY | Tosoh Medics, Inc. | 1998-10-08 | 163 | 1 |
| K981930 | UNICAP THYROID PEROXIDASE IGG | Pharmacia & Upjohn Co. | 1998-07-07 | 67 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda