FDA product code OEG: Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
OEG is the FDA product code for autoantibodies, skin (bullous pemphigoid 180 and bullous pemphigoid 230. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under OEG, from 2 different applicants. The average 510(k) review took 271 days (median 310).
Definition
The device is intended as an aid in the diagnosis of bullous pemphigoid.
Classification
| Field | Value |
|---|---|
| Device name | Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 |
| 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 OEG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 310 |
Compare with all 510(k) review times · Search every OEG clearance
Top OEG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Euroimmun Us, Inc. | 2 | 2020-09-17 |
| Mbl International Corporation | 1 | 2008-08-25 |
Most recent OEG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K193115 | Euroimmun Us, Inc. | EUROIMMUN Anti-BP230-CF ELISA (IgG) | 2020-09-17 | 310 |
| K083615 | Euroimmun Us, Inc. | EUROIMMUN ANTI BP 180-4X ELISA (IGG) | 2009-03-16 | 98 |
| K071961 | Mbl International Corporation | MESACUP MODELS BP180 AND BP230 ELISA KITS | 2008-08-25 | 406 |
Recalls for OEG devices
openFDA lists no recalls for product code OEG.
Frequently asked questions
What is FDA product code OEG?
OEG is the FDA product code for autoantibodies, skin (bullous pemphigoid 180 and bullous pemphigoid 230. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is OEG?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code OEG?
Across 3 cleared submissions the average was 271 days from receipt to decision (median 310).
Which companies have the most OEG clearances?
Euroimmun Us, Inc. (2); Mbl International Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OEG
- Run a recall and safety report across every OEG manufacturer
- Watch product code OEG 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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