FDA product code OCN: Insulin Autoantibody Kit
OCN is the FDA product code for insulin autoantibody kit. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under OCN. The average 510(k) review took 175 days (median 175).
Definition
The device is used for the semi-quantitative determination of insulin autoantibodies in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.
Classification
| Field | Value |
|---|---|
| Device name | Insulin Autoantibody Kit |
| 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 |
Compare with all 510(k) review times · Search every OCN clearance
Top OCN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kronus Market Development Associates, Inc. | 1 | 2007-07-13 |
Most recent OCN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070183 | Kronus Market Development Associates, Inc. | KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT | 2007-07-13 | 175 |
Recalls for OCN devices
openFDA lists no recalls for product code OCN.
Frequently asked questions
What is FDA product code OCN?
OCN is the FDA product code for insulin autoantibody kit. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is OCN?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code OCN?
Across 1 cleared submissions the average was 175 days from receipt to decision (median 175).
Which companies have the most OCN clearances?
Kronus Market Development Associates, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OCN
- Run a recall and safety report across every OCN manufacturer
- Watch product code OCN 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.
All Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times