# Test, Propoxyphene, Over The Counter
> **Product code: QBF** · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3700
## Classification
- **FDA Product Code:** QBF
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 862.3700
- **Review panel:** TX
- **Medical specialty:** Clinical Toxicology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

The propoxyphene test is an in vitro diagnostic test for the qualitative detection of propoxyphene in human urine. The test is intended for over-the-counter use as the first step in a two step process to provide consumers with information concerning the presence or absence of propoxyphene in a urine sample.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 45
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QBF)
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