Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MOB — Predicate Candidate Screening
74 FDA 510(k) clearances under this product code; the 50 most recent screened below.
123 daysmedian FDA review time
271 days90th percentile
74clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti | Zeus Scientific | 2025-05-07 | 149 | 0 |
| K172582 | EUROIMMUN IFA Granulocyte Mosaicâ„¢ EUROPattern and EUROIMMUN | Euroimmun Us, Inc. | 2018-05-24 | 269 | 0 |
| K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin | Aesku.Diagnostics GmbH & Co. KG | 2018-03-23 | 221 | 0 |
| K173792 | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immun | Phadia AB | 2018-03-13 | 89 | 1 |
| K161258 | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formali | Inova Diagnostics, Inc. | 2017-02-03 | 275 | 0 |
| K140225 | ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUN | Phadia US, Inc. | 2014-10-27 | 271 | 1 |
| K112545 | QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM | Inova Diagnostics, Inc. | 2012-07-31 | 334 | 0 |
| K100917 | FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM | Biomedical Diagnostics (Bmd) SA | 2010-11-03 | 215 | 0 |
| K092600 | IMMULISA PR3 ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-10-07 | 409 | 0 |
| K092601 | IMMULISA ANCA SCREEN ELISA | Immco Diagnostics, Inc. | 2010-10-07 | 409 | 0 |
| K092599 | IMMULISA MPO ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-10-07 | 409 | 0 |
| K091859 | AESKU PR3 | Aesku Diagnostics | 2010-06-03 | 349 | 0 |
| K091860 | AESKULISA MPO, MODEL 30-7303US | Aesku Diagnostics | 2010-02-23 | 249 | 0 |
| K083850 | EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST | Euroimmun Us, Inc. | 2009-05-20 | 147 | 0 |
| K082130 | EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) | Euroimmun Us, Inc. | 2009-04-07 | 252 | 0 |
| K070458 | MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 | Biomedical Diagnostics (Bmd) SA | 2007-12-21 | 308 | 0 |
| K060700 | EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. | Euroimmun Us, LLC | 2006-09-08 | 177 | 0 |
| K061376 | EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 | Theratest Laboratories, Inc. | 2006-07-20 | 64 | 0 |
| K053012 | FIDIS VASCULITIS, MODEL MX007 | Biomedical Diagnostics (Bmd) SA | 2006-03-02 | 127 | 0 |
| K051489 | EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY | Euroimmun Us, LLC | 2006-02-16 | 255 | 0 |
| K051455 | WIESLAB CAP MPO-ANCA | Eurodiagnostica | 2005-11-23 | 174 | 0 |
| K051458 | WIESLAB CAP PR-3 ANCA | Eurodiagnostica | 2005-11-22 | 173 | 0 |
| K050715 | QUANTA PLEX ANCA PROFILE | Inova Diagnostics, Inc. | 2005-05-12 | 55 | 0 |
| K041043 | VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 | Pharmacia Deutschland GmbH | 2004-07-02 | 71 | 0 |
| K041040 | VARELISA MPO ANCA, MODEL 17648/17696 | Sweden Diagnostics (Germany) GmbH | 2004-06-16 | 55 | 0 |
| K040111 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SY | Zeus Scientific, Inc. | 2004-04-05 | 76 | 0 |
| K040711 | MESACUP TEST PR-3 | Rhigene, Inc. | 2004-04-02 | 15 | 0 |
| K040586 | MESACUP TEST MPO, MODEL 11053 | Rhigene, Inc. | 2004-03-22 | 17 | 0 |
| K013285 | RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDAS | Immuno Concepts, Inc. | 2001-11-14 | 43 | 0 |
| K013283 | RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, | Immuno Concepts, Inc. | 2001-11-14 | 43 | 0 |
| K010287 | SCIMEDX PHASE II PR3 IGG ANTIBODY EIA | Scimedx Corp. | 2001-03-16 | 44 | 0 |
| K010289 | SCIMEDX PHASE II MPO IGG ANTIBODY EIA | Scimedx Corp. | 2001-03-07 | 35 | 0 |
| K002215 | AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA | Cogent Diagnotics , Ltd. | 2000-09-28 | 66 | 0 |
| K001127 | ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY | The Binding Site, Ltd. | 2000-08-30 | 149 | 0 |
| K990796 | AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANC | Cogent Diagnotics , Ltd. | 1999-04-28 | 49 | 0 |
| K984516 | THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYST | Zeus Scientific, Inc. | 1999-01-11 | 24 | 0 |
| K984315 | THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYS | Zeus Scientific, Inc. | 1998-12-17 | 14 | 0 |
| K982898 | IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYT | Immco Diagnostics, Inc. | 1998-11-30 | 105 | 0 |
| K984034 | THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA T | Zeus Scientific, Inc. | 1998-11-30 | 18 | 0 |
| K983740 | IS-ANTI-PR3 IGG ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1998-11-18 | 27 | 0 |
| K983390 | IS-ANTI-MPO IGG ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1998-11-18 | 54 | 0 |
| K981748 | WIELISA ANCA SCREENING KIT TEST SYSTEM | Wieslab AB | 1998-07-22 | 65 | 0 |
| K981750 | WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM | Wieslab AB | 1998-07-22 | 65 | 0 |
| K981030 | BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT | The Binding Site, Ltd. | 1998-07-20 | 123 | 0 |
| K981029 | BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT | The Binding Site, Ltd. | 1998-07-20 | 123 | 0 |
| K981330 | QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT | Inova Diagnostics, Inc. | 1998-06-19 | 67 | 0 |
| K981328 | QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT | Inova Diagnostics, Inc. | 1998-06-19 | 67 | 0 |
| K974166 | WIELISA MPO ANCA TEST SYSTEM | Wieslab AB | 1998-02-17 | 104 | 0 |
| K974701 | ORGENTEC ANTI-MPO (P-ANCA) ELISA | American Laboratory Products Co., Ltd. | 1998-02-17 | 71 | 0 |
| K974167 | WIELISA PR-3 ANCA TEST SYSTEM | Wieslab AB | 1998-02-17 | 104 | 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