FDA product code OYA: P2psa
OYA is the FDA product code for p2psa. It is a Class III device, reviewed by the Immunology panel. Devices under OYA reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for OYA devices, 1 initiated in the last five years.
Definition
Quantitative determination of [-2]proPSA antigen in human serum to be used in combination with total PSA and free PSA to calculate the Prostate Health Index (phi)
Classification
| Field | Value |
|---|---|
| Device name | P2psa |
| Device class | Class III |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for OYA devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-05-17.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code OYA?
OYA is the FDA product code for p2psa. It is a Class III device, reviewed by the Immunology panel.
What device class is OYA?
Class III. Typical premarket route: PMA.
Have OYA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-05-17.
Next steps
- Run an FDA pathway report with predicate devices for product code OYA
- Run a recall and safety report across every OYA manufacturer
- Watch product code OYA 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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