FDA product code POX: Enzyme Immunoassay, Oxcarbazepine Metabolite
POX is the FDA product code for enzyme immunoassay, oxcarbazepine metabolite. It is a Class II device, regulated under 21 CFR 862.3645 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under POX. The average 510(k) review took 237 days (median 237).
Definition
An Oxcarbazepine Metabolite Assay is an enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Oxcarbazepine Metabolite |
| Device class | Class II |
| Regulation | 21 CFR 862.3645 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every POX clearance
Top POX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ark Diagnostics, Inc. | 1 | 2016-08-09 |
Most recent POX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K153596 | Ark Diagnostics, Inc. | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control | 2016-08-09 | 237 |
Recalls for POX devices
openFDA lists no recalls for product code POX.
Frequently asked questions
What is FDA product code POX?
POX is the FDA product code for enzyme immunoassay, oxcarbazepine metabolite. It is a Class II device, regulated under 21 CFR 862.3645 and reviewed by the Clinical Toxicology panel.
What device class is POX?
Class II, regulation 21 CFR 862.3645. Typical premarket route: 510(k).
How long does a 510(k) take for product code POX?
Across 1 cleared submissions the average was 237 days from receipt to decision (median 237).
Which companies have the most POX clearances?
Ark Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code POX
- Run a recall and safety report across every POX manufacturer
- Watch product code POX 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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