Product code MOB
- Device name
- Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5660
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) | Zeus Scientific | 2025-05-07 |
| K172582 | EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern | Euroimmun Us, Inc. | 2018-05-24 |
| K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin | Aesku.Diagnostics GmbH & Co. KG | 2018-03-23 |
| K173792 | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay | Phadia AB | 2018-03-13 |
| K161258 | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit | Inova Diagnostics, Inc. | 2017-02-03 |
| K140225 | ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO | Phadia US, Inc. | 2014-10-27 |
| K112545 | QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM | Inova Diagnostics, Inc. | 2012-07-31 |
| K100917 | FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM | Biomedical Diagnostics (Bmd) SA | 2010-11-03 |
| K092600 | IMMULISA PR3 ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-10-07 |
| K092599 | IMMULISA MPO ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-10-07 |
| K092601 | IMMULISA ANCA SCREEN ELISA | Immco Diagnostics, Inc. | 2010-10-07 |
| K091859 | AESKU PR3 | Aesku Diagnostics | 2010-06-03 |
| K091860 | AESKULISA MPO, MODEL 30-7303US | Aesku Diagnostics | 2010-02-23 |
| K083850 | EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS | Euroimmun Us, Inc. | 2009-05-20 |
| K082130 | EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) | Euroimmun Us, Inc. | 2009-04-07 |
| K070458 | MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 | Biomedical Diagnostics (Bmd) SA | 2007-12-21 |
| K060700 | EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. | Euroimmun Us, LLC | 2006-09-08 |
| K061376 | EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 | Theratest Laboratories, Inc. | 2006-07-20 |
| K053012 | FIDIS VASCULITIS, MODEL MX007 | Biomedical Diagnostics (Bmd) SA | 2006-03-02 |
| K051489 | EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM | Euroimmun Us, LLC | 2006-02-16 |
| K051455 | WIESLAB CAP MPO-ANCA | Eurodiagnostica | 2005-11-23 |
| K051458 | WIESLAB CAP PR-3 ANCA | Eurodiagnostica | 2005-11-22 |
| K050715 | QUANTA PLEX ANCA PROFILE | Inova Diagnostics, Inc. | 2005-05-12 |
| K041043 | VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 | Pharmacia Deutschland GmbH | 2004-07-02 |
| K041040 | VARELISA MPO ANCA, MODEL 17648/17696 | Sweden Diagnostics (Germany) GmbH | 2004-06-16 |
| K040111 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM | Zeus Scientific, Inc. | 2004-04-05 |
| K040711 | MESACUP TEST PR-3 | Rhigene, Inc. | 2004-04-02 |
| K040586 | MESACUP TEST MPO, MODEL 11053 | Rhigene, Inc. | 2004-03-22 |
| K013285 | RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 | Immuno Concepts, Inc. | 2001-11-14 |
| K013283 | RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 | Immuno Concepts, Inc. | 2001-11-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08059304340239 | dIFine ANCA Classifier | VISIA LAB SRL | 2025-06-27 |
| 08426950767053 | NOVA Lite® DAPI ANCA (Ethanol) Kit | INOVA DIAGNOSTICS, INC. | 2017-06-12 |
| 08426950767046 | NOVA Lite® DAPI ANCA (Formalin) Kit | INOVA DIAGNOSTICS, INC. | 2017-06-12 |
| 00845714004247 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714004179 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714004162 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714002922 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714002786 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714004186 | IMMCO DIAGNOSTIC | IMMCO DIAGNOSTICS, INC. | 2016-10-27 |
| 00845714003462 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-10-27 |
| 00845714004315 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-09-23 |
| 00845714004308 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-09-23 |
| 00845714003318 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-09-23 |
| 00847865002387 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 08426950602118 | NOVA Lite® ANCA (Formalin) Kit with DAPI | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950602125 | NOVA Lite® ANCA (Ethanol) Kit with DAPI | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594550 | QUANTA Lite® PR3 SC ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594512 | QUANTA Lite® MPO SC ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594109 | NOVA Lite® ANCA Formalin Kit | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594055 | NOVA Lite® ANCA Kit | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950554103 | NOVA Lite® ANCA Formalin Kit | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950544258 | QUANTA Flash® PR3 Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950544241 | QUANTA Lite® PR3 SC ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950544197 | QUANTA Flash® MPO Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950544180 | QUANTA Lite® MPO SC ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950513995 | NOVA Lite® ANCA Kit | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950512912 | NOVA Lite® ANCA Kit | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950456216 | NOVA Lite® ANCA Kit | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950448303 | QUANTA Lite® PR-3 IgG ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950448280 | QUANTA Lite® MPO IgG ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |