QBF — Test, Propoxyphene, Over The Counter Class II
FDA product code QBF covers "Test, Propoxyphene, Over The Counter", a Class II medical device regulated under 21 CFR 862.3700. Submissions are reviewed by the Clinical Toxicology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QBF
- Device Class
- Class II
- Regulation Number
- 862.3700
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K210327 | w.h.p.m | First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign | August 12, 2021 |