FDA product code PDY: Organophosphate Test System
PDY is the FDA product code for organophosphate test system. It is a Class II device, regulated under 21 CFR 862.3652 and reviewed by the Clinical Toxicology panel. Devices under PDY reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
For the quantitation of specific organophosphate metabolites in human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning. The data obtained by this device is intended to aid in the confirmation and investigation of organophosphate exposure.
Classification
| Field | Value |
|---|---|
| Device name | Organophosphate Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.3652 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
Recalls for PDY devices
openFDA lists no recalls for product code PDY.
Frequently asked questions
What is FDA product code PDY?
PDY is the FDA product code for organophosphate test system. It is a Class II device, regulated under 21 CFR 862.3652 and reviewed by the Clinical Toxicology panel.
What device class is PDY?
Class II, regulation 21 CFR 862.3652. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PDY
- Run a recall and safety report across every PDY manufacturer
- Watch product code PDY 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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