FDA 510(k) Applications for Medical Device Product Code "MOB"
(Test System, Antineutrophil Cytoplasmic Antibodies (Anca))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K091859 | AESKU.DIAGNOSTICS | AESKU PR3 | 06/03/2010 |
| K091860 | AESKU.DIAGNOSTICS | AESKULISA MPO, MODEL 30-7303US | 02/23/2010 |
| K172461 | Aesku.Diagnostics GmbH & Co. KG | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin | 03/23/2018 |
| K974701 | AMERICAN LABORATORY PRODUCTS CO., LTD. | ORGENTEC ANTI-MPO (P-ANCA) ELISA | 02/17/1998 |
| K974702 | AMERICAN LABORATORY PRODUCTS CO., LTD. | ORGENTEC ANTI-PR3 (C-ANCA) ELISA | 02/17/1998 |
| K100917 | BIOMEDICAL DIAGNOSTICS (BMD) SA | FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM | 11/03/2010 |
| K053012 | BIOMEDICAL DIAGNOSTICS (BMD) SA | FIDIS VASCULITIS, MODEL MX007 | 03/02/2006 |
| K070458 | BIOMEDICAL DIAGNOSTICS (BMD) SA | MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 | 12/21/2007 |
| K002215 | COGENT DIAGNOTICS LTD. | AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA | 09/28/2000 |
| K990796 | COGENT DIAGNOTICS LTD. | AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA | 04/28/1999 |
| K983390 | COLUMBIA BIOSCIENCE, INC. | IS-ANTI-MPO IGG ELISA TEST SYSTEM | 11/18/1998 |
| K983740 | COLUMBIA BIOSCIENCE, INC. | IS-ANTI-PR3 IGG ELISA TEST SYSTEM | 11/18/1998 |
| K953587 | ELIAS U.S.A., INC. | VARELISA MPO-ANCA | 01/26/1996 |
| K953586 | ELIAS U.S.A., INC. | VARELISA PR3-ANCA | 01/26/1996 |
| K971689 | EURO-DIAGNOSTICA AB | IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT | 10/29/1997 |
| K971690 | EURO-DIAGNOSTICA AB | IMMUNOSCAN PR3-ANCA | 10/29/1997 |
| K051455 | EURODIAGNOSTICA | WIESLAB CAP MPO-ANCA | 11/23/2005 |
| K051458 | EURODIAGNOSTICA | WIESLAB CAP PR-3 ANCA | 11/22/2005 |
| K083850 | EUROIMMUN US INC | EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS | 05/20/2009 |
| K082130 | EUROIMMUN US INC | EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) | 04/07/2009 |
| K051489 | EUROIMMUN US LLC | EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM | 02/16/2006 |
| K060700 | EUROIMMUN US LLC | EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. | 09/08/2006 |
| K172582 | Euroimmun US, Inc. | EUROIMMUN IFA Granulocyte MosaicÖ EUROPattern and EUROIMMUN EUROPLUS Granulocyte MosaicÖ EUROPattern | 05/24/2018 |
| K973823 | HEMAGEN DIAGNOSTICS, INC. | PR 3 ANTIBODY KIT | 11/13/1997 |
| K973822 | HEMAGEN DIAGNOSTICS, INC. | VIRGO ANCA SCREEN KIT | 11/13/1997 |
| K973824 | HEMAGEN DIAGNOSTICS, INC. | VIRGO PANCO KIT | 11/13/1997 |
| K982898 | IMMCO DIAGNOSTICS, INC. | IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM | 11/30/1998 |
| K092601 | IMMCO DIAGNOSTICS, INC. | IMMULISA ANCA SCREEN ELISA | 10/07/2010 |
| K092599 | IMMCO DIAGNOSTICS, INC. | IMMULISA MPO ANTIBODY ELISA | 10/07/2010 |
| K092600 | IMMCO DIAGNOSTICS, INC. | IMMULISA PR3 ANTIBODY ELISA | 10/07/2010 |
| K974463 | IMMUNO CONCEPTS, INC. | IMMUNO CONCEPTS ANCA TEST SYSTEM | 02/09/1998 |
| K974478 | IMMUNO CONCEPTS, INC. | IMMUNO CONCEPTS ANCA TEST SYSTEMS | 02/09/1998 |
| K013285 | IMMUNO CONCEPTS, INC. | RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 | 11/14/2001 |
| K013283 | IMMUNO CONCEPTS, INC. | RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 | 11/14/2001 |
| K961765 | IMMUNO PROBE, INC. | MPO ELISA TEST SYSTEM | 08/19/1996 |
| K961764 | IMMUNO PROBE, INC. | PR-3 ELISA TEST SYSTEM | 08/19/1996 |
| K961340 | INOVA DIAGNOSTICS, INC. | NOVA LITE ANCA | 07/10/1996 |
| K161258 | INOVA DIAGNOSTICS, INC. | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit | 02/03/2017 |
| K112545 | INOVA DIAGNOSTICS, INC. | QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM | 07/31/2012 |
| K955022 | INOVA DIAGNOSTICS, INC. | QUANTA LITE MPO | 03/19/1996 |
| K981330 | INOVA DIAGNOSTICS, INC. | QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT | 06/19/1998 |
| K955021 | INOVA DIAGNOSTICS, INC. | QUANTA LITE PR3 | 03/19/1996 |
| K981328 | INOVA DIAGNOSTICS, INC. | QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT | 06/19/1998 |
| K050715 | INOVA DIAGNOSTICS, INC. | QUANTA PLEX ANCA PROFILE | 05/12/2005 |
| K173792 | Phadia AB | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay | 03/13/2018 |
| K140225 | PHADIA US INC. | ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO | 10/27/2014 |
| K041043 | PHARMACIA DEUTSCHLAND GMBH | VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 | 07/02/2004 |
| K040586 | RHIGENE, INC. | MESACUP TEST MPO, MODEL 11053 | 03/22/2004 |
| K040711 | RHIGENE, INC. | MESACUP TEST PR-3 | 04/02/2004 |
| K954105 | SCIMEDX CORP. | EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES | 03/19/1996 |
| K954062 | SCIMEDX CORP. | EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES | 03/19/1996 |
| K962360 | SCIMEDX CORP. | IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES | 09/30/1996 |
| K010289 | SCIMEDX CORP. | SCIMEDX PHASE II MPO IGG ANTIBODY EIA | 03/07/2001 |
| K010287 | SCIMEDX CORP. | SCIMEDX PHASE II PR3 IGG ANTIBODY EIA | 03/16/2001 |
| K041040 | SWEDEN DIAGNOSTICS (GERMANY) GMBH | VARELISA MPO ANCA, MODEL 17648/17696 | 06/16/2004 |
| K001127 | THE BINDING SITE, LTD. | ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY | 08/30/2000 |
| K965133 | THE BINDING SITE, LTD. | ANCA COMBI DIAGNOSTIC TEST KIT | 05/21/1997 |
| K981030 | THE BINDING SITE, LTD. | BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT | 07/20/1998 |
| K981029 | THE BINDING SITE, LTD. | BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT | 07/20/1998 |
| K061376 | THERATEST LABORATORIES, INC. | EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 | 07/20/2006 |
| K981748 | WIESLAB AB | WIELISA ANCA SCREENING KIT TEST SYSTEM | 07/22/1998 |
| K981750 | WIESLAB AB | WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM | 07/22/1998 |
| K974166 | WIESLAB AB | WIELISA MPO ANCA TEST SYSTEM | 02/17/1998 |
| K974167 | WIESLAB AB | WIELISA PR-3 ANCA TEST SYSTEM | 02/17/1998 |
| K964449 | ZEUS SCIENTIFIC, INC. | ANCA SCREEN ELISA TEST SYSTEM | 04/10/1997 |
| K964446 | ZEUS SCIENTIFIC, INC. | MYELOPEROXIDASE ELISA TEST SYSTEM | 04/10/1997 |
| K964448 | ZEUS SCIENTIFIC, INC. | PROTEINASE-3 IGG ELISA TEST SYSTEM | 04/10/1997 |
| K984034 | ZEUS SCIENTIFIC, INC. | THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | 11/30/1998 |
| K984516 | ZEUS SCIENTIFIC, INC. | THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET | 01/11/1999 |
| K984315 | ZEUS SCIENTIFIC, INC. | THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE | 12/17/1998 |
| K040111 | ZEUS SCIENTIFIC, INC. | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM | 04/05/2004 |
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