MOB · Class II · 21 CFR 866.5660

FDA Product Code MOB: Test System, Antineutrophil Cytoplasmic Antibodies (anca)

Leading manufacturers include Inova Diagnostics, Inc., Zeus Scientific, Inc. and Scimedx Corp..

75
Total
75
Cleared
139d
Avg days
1995
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 129d avg (recent)

FDA 510(k) Cleared Test System, Antineutrophil Cytoplasmic Antibodies (anca) Devices (Product Code MOB)

75 devices
1–24 of 75
Cleared Aug 21, 2026
Alegria Flash MPO
K261466
Zeus Scientific
Immunology · 109d
Cleared May 07, 2025
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed)
K243776
Zeus Scientific
Immunology · 149d
Cleared May 24, 2018
EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern
K172582
Euroimmun Us, Inc.
Immunology · 269d
Cleared Mar 23, 2018
AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
K172461
Aesku.Diagnostics GmbH & Co. KG
Immunology · 221d
Cleared Mar 13, 2018
EliA PR3s Immunoassay
K173792
Phadia AB
Immunology · 89d
Cleared Feb 03, 2017
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
K161258
Inova Diagnostics, Inc.
Immunology · 275d
Cleared Oct 27, 2014
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
K140225
Phadia US, Inc.
Immunology · 271d
Cleared Jul 31, 2012
QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
K112545
Inova Diagnostics, Inc.
Immunology · 334d
Cleared Nov 03, 2010
FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM
K100917
Biomedical Diagnostics (Bmd) SA
Immunology · 215d
Cleared Oct 07, 2010
IMMULISA MPO ANTIBODY ELISA
K092599
Immco Diagnostics, Inc.
Immunology · 409d
Cleared Oct 07, 2010
IMMULISA PR3 ANTIBODY ELISA
K092600
Immco Diagnostics, Inc.
Immunology · 409d
Cleared Oct 07, 2010
IMMULISA ANCA SCREEN ELISA
K092601
Immco Diagnostics, Inc.
Immunology · 409d
Cleared Jun 03, 2010
AESKU PR3
K091859
Aesku Diagnostics
Immunology · 349d
Cleared Feb 23, 2010
AESKULISA MPO, MODEL 30-7303US
K091860
Aesku Diagnostics
Immunology · 249d
Cleared May 20, 2009
EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS
K083850
Euroimmun Us, Inc.
Immunology · 147d
Cleared Apr 07, 2009
EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)
K082130
Euroimmun Us, Inc.
Immunology · 252d
Cleared Dec 21, 2007
MODIFICATION TO FIDIS VASCULITIS, MODEL MX007
K070458
Biomedical Diagnostics (Bmd) SA
Immunology · 308d
Cleared Sep 08, 2006
EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.
K060700
Euroimmun Us, LLC
Immunology · 177d
Cleared Jul 20, 2006
EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
K061376
Theratest Laboratories, Inc.
Immunology · 64d
Cleared Mar 02, 2006
FIDIS VASCULITIS, MODEL MX007
K053012
Biomedical Diagnostics (Bmd) SA
Immunology · 127d
Cleared Feb 16, 2006
EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM
K051489
Euroimmun Us, LLC
Immunology · 255d
Cleared Nov 23, 2005
WIESLAB CAP MPO-ANCA
K051455
Eurodiagnostica
Immunology · 174d
Cleared Nov 22, 2005
WIESLAB CAP PR-3 ANCA
K051458
Eurodiagnostica
Immunology · 173d
Cleared May 12, 2005
QUANTA PLEX ANCA PROFILE
K050715
Inova Diagnostics, Inc.
Immunology · 55d

About Product Code MOB - Regulatory Context

510(k) Submission Activity

75 total 510(k) submissions under product code MOB since 1995, with 75 receiving FDA clearance (average review time: 139 days).

Submission volume has increased in recent years - 2 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 129 days recently vs 139 days historically.

MOB devices are reviewed by the Immunology panel. Browse all Immunology devices →