# Test, Tricyclic Antidepressants, Over The Counter
> **Product code: QAW** · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3910
## Classification
- **FDA Product Code:** QAW
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 862.3910
- **Review panel:** TX
- **Medical specialty:** Clinical Toxicology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

Intended to measure any of the tricyclic antidepressant drugs in serum or urine.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 47
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QAW)
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