DeviceClearance

Product code QBF— Clinical Toxicology

First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup

Classification name
Test, Propoxyphene, Over The Counter
Device class
Class 2
Regulation
21 CFR 862.3700
Advisory panel
Clinical Toxicology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QBF under 21 CFR 862.3700, via openFDA

Market context for product code QBF

FDA has cleared 1 device under product code QBF, all in 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QBF

Recent clearances under product code QBF

Data sourced from openFDA. This site is unofficial and independent of the FDA.