FDA product code OIF: Tyrosine Phosphatase (Ia-2) Autoantibody Assay
OIF is the FDA product code for tyrosine phosphatase (ia-2) autoantibody assay. 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 OIF, 1 in the last five years, from 2 different applicants. The average 510(k) review took 308 days (median 221).
Definition
The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).
Classification
| Field | Value |
|---|---|
| Device name | Tyrosine Phosphatase (Ia-2) Autoantibody Assay |
| 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 OIF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 221 |
| 2023 | 1 | 590 |
Compare with all 510(k) review times · Search every OIF clearance
Top OIF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kronus, Inc. | 2 | 2023-08-24 |
| Kronus Market Development Associates, Inc. | 1 | 2008-04-10 |
Most recent OIF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220085 | Kronus, Inc. | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | 2023-08-24 | 590 |
| K171731 | Kronus, Inc. | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | 2018-01-19 | 221 |
| K073590 | Kronus Market Development Associates, Inc. | KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT | 2008-04-10 | 112 |
Recalls for OIF devices
openFDA lists no recalls for product code OIF.
Frequently asked questions
What is FDA product code OIF?
OIF is the FDA product code for tyrosine phosphatase (ia-2) autoantibody assay. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is OIF?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code OIF?
Across 3 cleared submissions the average was 308 days from receipt to decision (median 221).
Which companies have the most OIF clearances?
Kronus, Inc. (2); Kronus Market Development Associates, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OIF
- Run a recall and safety report across every OIF manufacturer
- Watch product code OIF 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