FDA product code OPN: Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex
OPN is the FDA product code for auto-antibodies; phosphatidylserine, prothrombin, phosphatidylserine/prothrombin complex. 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 OPN. The average 510(k) review took 318 days (median 318).
Definition
For the detection of autoantibodies to phosphatidylserine (PS), prothrombin (PT), or phosphatidylserine/prothrombin (PS/PT) complex in human serum or plasma. To aid in the diagnosis of certain autoimmune thrombotic disorders such as anti-phospholipid syndrome and those secondary to systemic lupus erythematosus or other lupus-like diseases
Classification
| Field | Value |
|---|---|
| Device name | Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex |
| 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 OPN clearance
Top OPN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inova Diagnostics, Inc. | 1 | 2010-02-01 |
Most recent OPN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K090755 | Inova Diagnostics, Inc. | QUANTA LITE APS/PT IGG AND IGM ELISA | 2010-02-01 | 318 |
Recalls for OPN devices
openFDA lists no recalls for product code OPN.
Frequently asked questions
What is FDA product code OPN?
OPN is the FDA product code for auto-antibodies; phosphatidylserine, prothrombin, phosphatidylserine/prothrombin complex. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is OPN?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code OPN?
Across 1 cleared submissions the average was 318 days from receipt to decision (median 318).
Which companies have the most OPN clearances?
Inova Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OPN
- Run a recall and safety report across every OPN manufacturer
- Watch product code OPN 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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