FDA product code QBK: Meprobamate Test System
QBK is the FDA product code for meprobamate test system. It is a Class II device, regulated under 21 CFR 862.3590 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under QBK. The average 510(k) review took 269 days (median 269). 1 De Novo request was granted under it.
Definition
A meprobamate test system is a device intended to measure meprobamate in human specimens. Measurements obtained by this device are used to detect the presence of meprobamate to diagnose the use or overdose of meprobamate or structurally-related drug compounds (e.g., prodrugs).
Classification
| Field | Value |
|---|---|
| Device name | Meprobamate Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.3590 |
| 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 QBK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 269 |
Compare with all 510(k) review times · Search every QBK clearance
Top QBK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immunalysis Corporation | 1 | 2019-11-15 |
Most recent QBK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190397 | Immunalysis Corporation | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA | 2019-11-15 | 269 |
Recalls for QBK devices
openFDA lists no recalls for product code QBK.
Frequently asked questions
What is FDA product code QBK?
QBK is the FDA product code for meprobamate test system. It is a Class II device, regulated under 21 CFR 862.3590 and reviewed by the Clinical Toxicology panel.
What device class is QBK?
Class II, regulation 21 CFR 862.3590. Typical premarket route: 510(k).
How long does a 510(k) take for product code QBK?
Across 1 cleared submissions the average was 269 days from receipt to decision (median 269).
Which companies have the most QBK clearances?
Immunalysis Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QBK
- Run a recall and safety report across every QBK manufacturer
- Watch product code QBK 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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