FDA product code MOB: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
MOB is the FDA product code for test system, antineutrophil cytoplasmic antibodies (anca). It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel. FDA has cleared 75 510(k) submissions under MOB, 2 in the last five years, from 28 different applicants. The average 510(k) review took 139 days (median 109); 129 days on average over the last three years. FDA has posted 1 recall for MOB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) |
| Device class | Class II |
| Regulation | 21 CFR 866.5660 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MOB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 275 |
| 2018 | 3 | 193 |
| 2025 | 1 | 149 |
| 2026 | 1 | 109 |
Compare with all 510(k) review times · Search every MOB clearance
Top MOB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inova Diagnostics, Inc. | 8 | 2017-02-03 |
| Zeus Scientific, Inc. | 7 | 2004-04-05 |
| Scimedx Corp. | 5 | 2001-03-16 |
| Immco Diagnostics, Inc. | 4 | 2010-10-07 |
| Immuno Concepts, Inc. | 4 | 2001-11-14 |
23 more applicants have MOB clearances. See the full list in Caduvo.
Most recent MOB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261466 | Zeus Scientific | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM | 2026-08-21 | 109 |
| K243776 | Zeus Scientific | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) | 2025-05-07 | 149 |
| K172582 | Euroimmun Us, Inc. | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern | 2018-05-24 | 269 |
| K172461 | Aesku.Diagnostics GmbH & Co. KG | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin | 2018-03-23 | 221 |
| K173792 | Phadia AB | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay | 2018-03-13 | 89 |
Recalls for MOB devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-05-24.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code MOB?
MOB is the FDA product code for test system, antineutrophil cytoplasmic antibodies (anca). It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is MOB?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code MOB?
Across 75 cleared submissions the average was 139 days from receipt to decision (median 109).
Which companies have the most MOB clearances?
Inova Diagnostics, Inc. (8); Zeus Scientific, Inc. (7); Scimedx Corp. (5); Immco Diagnostics, Inc. (4); Immuno Concepts, Inc. (4).
Have MOB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-05-24.
Next steps
- Run an FDA pathway report with predicate devices for product code MOB
- Run a recall and safety report across every MOB manufacturer
- Watch product code MOB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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