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.