MOB · Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Immunology · 21 CFR 866.5660 · Class 2
Overview
| Product Code | MOB |
|---|---|
| Device Name | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) |
| Regulation | 21 CFR 866.5660 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 74)
Showing 20 most recent of 74 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) | Zeus Scientific | May 7, 2025 | SESE |
| K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern | Euroimmun Us, Inc. | May 24, 2018 | SESE |
| K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin | Aesku.Diagnostics GmbH & Co. KG | Mar 23, 2018 | SESE |
| K173792 | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay | Phadia AB | Mar 13, 2018 | SESE |
| K161258 | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit | Inova Diagnostics, Inc. | Feb 3, 2017 | SESE |
| K140225 | ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO | Phadia US, Inc. | Oct 27, 2014 | SESE |
| K112545 | QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM | Inova Diagnostics, Inc. | Jul 31, 2012 | SESE |
| K100917 | FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM | Biomedical Diagnostics (Bmd) SA | Nov 3, 2010 | SESE |
| K092601 | IMMULISA ANCA SCREEN ELISA | Immco Diagnostics, Inc. | Oct 7, 2010 | SESE |
| K092600 | IMMULISA PR3 ANTIBODY ELISA | Immco Diagnostics, Inc. | Oct 7, 2010 | SESE |
| K092599 | IMMULISA MPO ANTIBODY ELISA | Immco Diagnostics, Inc. | Oct 7, 2010 | SESE |
| K091859 | AESKU PR3 | Aesku Diagnostics | Jun 3, 2010 | SESE |
| K091860 | AESKULISA MPO, MODEL 30-7303US | Aesku Diagnostics | Feb 23, 2010 | SESE |
| K083850 | EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS | Euroimmun Us, Inc. | May 20, 2009 | SESE |
| K082130 | EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) | Euroimmun Us, Inc. | Apr 7, 2009 | SESE |
| K070458 | MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 | Biomedical Diagnostics (Bmd) SA | Dec 21, 2007 | SESE |
| K060700 | EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. | Euroimmun Us, LLC | Sep 8, 2006 | SESE |
| K061376 | EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 | Theratest Laboratories, Inc. | Jul 20, 2006 | SESE |
| K053012 | FIDIS VASCULITIS, MODEL MX007 | Biomedical Diagnostics (Bmd) SA | Mar 2, 2006 | SESE |
| K051489 | EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM | Euroimmun Us, LLC | Feb 16, 2006 | SESE |
Top Applicants
- Inova Diagnostics, Inc. — 8 clearances
- Zeus Scientific, Inc. — 7 clearances
- Scimedx Corp. — 5 clearances
- Immco Diagnostics, Inc. — 4 clearances
- Immuno Concepts, Inc. — 4 clearances
