FDA Product Code MOB: Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Leading manufacturers include Inova Diagnostics, Inc., Zeus Scientific, Inc. and The Binding Site, Ltd..
74
Total
74
Cleared
139d
Avg days
1995
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Consistent review times:
149d avg (recent)
FDA 510(k) Cleared Test System, Antineutrophil Cytoplasmic Antibodies (anca) Devices (Product Code MOB)
74 devices
Cleared
May 07, 2025
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed)
Zeus Scientific
Immunology
149d
Cleared
May 24, 2018
EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern
Euroimmun Us, Inc.
Immunology
269d
Cleared
Mar 23, 2018
AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
Aesku.Diagnostics GmbH & Co. KG
Immunology
221d
Cleared
Mar 13, 2018
EliA PR3s Immunoassay
Phadia AB
Immunology
89d
Cleared
Feb 03, 2017
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
Inova Diagnostics, Inc.
Immunology
275d
Cleared
Jul 31, 2012
QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
Inova Diagnostics, Inc.
Immunology
334d
Cleared
Oct 07, 2010
IMMULISA MPO ANTIBODY ELISA
Immco Diagnostics, Inc.
Immunology
409d
Cleared
Oct 07, 2010
IMMULISA PR3 ANTIBODY ELISA
Immco Diagnostics, Inc.
Immunology
409d
Cleared
Oct 07, 2010
IMMULISA ANCA SCREEN ELISA
Immco Diagnostics, Inc.
Immunology
409d
Cleared
May 12, 2005
QUANTA PLEX ANCA PROFILE
Inova Diagnostics, Inc.
Immunology
55d
Cleared
Apr 05, 2004
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
Zeus Scientific, Inc.
Immunology
76d
Cleared
Nov 14, 2001
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
Immuno Concepts, Inc.
Immunology
43d
Cleared
Nov 14, 2001
RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
Immuno Concepts, Inc.
Immunology
43d
Cleared
Aug 30, 2000
ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY
The Binding Site, Ltd.
Immunology
149d
Cleared
Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET
Zeus Scientific, Inc.
Immunology
24d
Cleared
Dec 17, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE
Zeus Scientific, Inc.
Immunology
14d
Cleared
Nov 30, 1998
IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM
Immco Diagnostics, Inc.
Immunology
105d
Cleared
Nov 30, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
Zeus Scientific, Inc.
Immunology
18d
Cleared
Jul 20, 1998
BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT
The Binding Site, Ltd.
Immunology
123d
Cleared
Jul 20, 1998
BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT
The Binding Site, Ltd.
Immunology
123d
Cleared
Jun 19, 1998
QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT
Inova Diagnostics, Inc.
Immunology
67d
Cleared
Jun 19, 1998
QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT
Inova Diagnostics, Inc.
Immunology
67d
Cleared
Feb 09, 1998
IMMUNO CONCEPTS ANCA TEST SYSTEM
Immuno Concepts, Inc.
Immunology
75d
Cleared
Feb 09, 1998
IMMUNO CONCEPTS ANCA TEST SYSTEMS
Immuno Concepts, Inc.
Immunology
75d
About Product Code MOB - Regulatory Context
510(k) Submission Activity
74 total 510(k) submissions under product code MOB since 1995, with 74 receiving FDA clearance (average review time: 139 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - MOB Product Code
FDA review times for MOB submissions have been consistent, averaging 149 days recently vs 139 days historically.
MOB devices are reviewed by the Immunology panel. Browse all Immunology devices →