FDA product code QAW: Test, Tricyclic Antidepressants, Over The Counter
QAW is the FDA product code for test, tricyclic antidepressants, over the counter. It is a Class II device, regulated under 21 CFR 862.3910 and reviewed by the Clinical Toxicology panel. Devices under QAW reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Intended to measure any of the tricyclic antidepressant drugs in serum or urine.
Classification
| Field | Value |
|---|---|
| Device name | Test, Tricyclic Antidepressants, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 862.3910 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for QAW devices
openFDA lists no recalls for product code QAW.
Frequently asked questions
What is FDA product code QAW?
QAW is the FDA product code for test, tricyclic antidepressants, over the counter. It is a Class II device, regulated under 21 CFR 862.3910 and reviewed by the Clinical Toxicology panel.
What device class is QAW?
Class II, regulation 21 CFR 862.3910. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QAW
- Run a recall and safety report across every QAW manufacturer
- Watch product code QAW 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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