FDA product code OKM: Antibodies, Outer-Membrane Proteins
OKM is the FDA product code for antibodies, outer-membrane proteins. It is a Class II device, regulated under 21 CFR 866.5785 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under OKM. The average 510(k) review took 178 days (median 178).
Definition
For the detection of anti-outer membrane protein (anti-OMP) antibodies in human serum. To aid in the diagnosis of Crohn's Disease.
Classification
| Field | Value |
|---|---|
| Device name | Antibodies, Outer-Membrane Proteins |
| Device class | Class II |
| Regulation | 21 CFR 866.5785 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OKM clearance
Top OKM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inova Diagnostics, Inc. | 1 | 2008-10-27 |
Most recent OKM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K081248 | Inova Diagnostics, Inc. | QUANTA LITE OMP PLUS ELISA | 2008-10-27 | 178 |
Recalls for OKM devices
openFDA lists no recalls for product code OKM.
Frequently asked questions
What is FDA product code OKM?
OKM is the FDA product code for antibodies, outer-membrane proteins. It is a Class II device, regulated under 21 CFR 866.5785 and reviewed by the Immunology panel.
What device class is OKM?
Class II, regulation 21 CFR 866.5785. Typical premarket route: 510(k).
How long does a 510(k) take for product code OKM?
Across 1 cleared submissions the average was 178 days from receipt to decision (median 178).
Which companies have the most OKM clearances?
Inova Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OKM
- Run a recall and safety report across every OKM manufacturer
- Watch product code OKM 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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