FDA product code PIL: Test For Periprosthetic Joint Infection
PIL is the FDA product code for test for periprosthetic joint infection. It is a Not classified device, reviewed by the Immunology panel. Devices under PIL reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
A qualitative in vitro diagnostic device intended as an adjunct for the detection of periprosthetic joint infection (PJI) in synovial fluid of patients experiencing pain and/or inflammation in a replacement joint.
Classification
| Field | Value |
|---|---|
| Device name | Test For Periprosthetic Joint Infection |
| Device class | Not classified |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for PIL devices
openFDA lists no recalls for product code PIL.
Frequently asked questions
What is FDA product code PIL?
PIL is the FDA product code for test for periprosthetic joint infection. It is a Not classified device, reviewed by the Immunology panel.
What device class is PIL?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PIL
- Run a recall and safety report across every PIL manufacturer
- Watch product code PIL 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.