FDA product code PTG: Test, Methadone, Over The Counter
PTG is the FDA product code for test, methadone, over the counter. It is a Class II device, regulated under 21 CFR 862.3620 and reviewed by the Clinical Toxicology panel. Devices under PTG reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
The methadone test is an in vitro diagnostic test for the qualitative analysis of methadone in human urine.
Classification
| Field | Value |
|---|---|
| Device name | Test, Methadone, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 862.3620 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for PTG devices
openFDA lists no recalls for product code PTG.
Frequently asked questions
What is FDA product code PTG?
PTG is the FDA product code for test, methadone, over the counter. It is a Class II device, regulated under 21 CFR 862.3620 and reviewed by the Clinical Toxicology panel.
What device class is PTG?
Class II, regulation 21 CFR 862.3620. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PTG
- Run a recall and safety report across every PTG manufacturer
- Watch product code PTG 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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