FDA product code PDA: Investigational Use Only - Clinical Chemistry
PDA is the FDA product code for investigational use only - clinical chemistry. It is a Not classified device, reviewed by the Clinical Chemistry panel. Devices under PDA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Investigational use only and for products imported into the US only.
Classification
| Field | Value |
|---|---|
| Device name | Investigational Use Only - Clinical Chemistry |
| Device class | Not classified |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for PDA devices
openFDA lists no recalls for product code PDA.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- Q4240 — Corecyte, for topical use only, per 0.5 cc
- Q4241 — Polycyte, for topical use only, per 0.5 cc
Frequently asked questions
What is FDA product code PDA?
PDA is the FDA product code for investigational use only - clinical chemistry. It is a Not classified device, reviewed by the Clinical Chemistry panel.
What device class is PDA?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PDA
- Run a recall and safety report across every PDA manufacturer
- Watch product code PDA 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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