FDA product code QBF: Test, Propoxyphene, Over The Counter
QBF is the FDA product code for test, propoxyphene, over the counter. It is a Class II device, regulated under 21 CFR 862.3700 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under QBF. The average 510(k) review took 189 days (median 189).
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.
Classification
| Field | Value |
|---|---|
| Device name | Test, Propoxyphene, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 862.3700 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for QBF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 189 |
Compare with all 510(k) review times · Search every QBF clearance
Top QBF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| W.H.P.M., Inc. | 1 | 2021-08-12 |
Most recent QBF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K210327 | W.H.P.M., Inc. | 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 | 2021-08-12 | 189 |
Recalls for QBF devices
openFDA lists no recalls for product code QBF.
Frequently asked questions
What is FDA product code QBF?
QBF is the FDA product code for test, propoxyphene, over the counter. It is a Class II device, regulated under 21 CFR 862.3700 and reviewed by the Clinical Toxicology panel.
What device class is QBF?
Class II, regulation 21 CFR 862.3700. Typical premarket route: 510(k).
How long does a 510(k) take for product code QBF?
Across 1 cleared submissions the average was 189 days from receipt to decision (median 189).
Which companies have the most QBF clearances?
W.H.P.M., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QBF
- Run a recall and safety report across every QBF manufacturer
- Watch product code QBF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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