FDA product code OTF: Gabapentin Assay
OTF is the FDA product code for gabapentin assay. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under OTF. The average 510(k) review took 169 days (median 169).
Definition
Test for the quantitative determination of gabapentin in human serum or plasma. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.
Classification
| Field | Value |
|---|---|
| Device name | Gabapentin Assay |
| Device class | Class II |
| Regulation | 21 CFR 862.3350 |
| 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 OTF clearance
Top OTF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ark Diagnostics, Inc. | 1 | 2010-11-23 |
Most recent OTF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101574 | Ark Diagnostics, Inc. | ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 | 2010-11-23 | 169 |
Recalls for OTF devices
openFDA lists no recalls for product code OTF.
Frequently asked questions
What is FDA product code OTF?
OTF is the FDA product code for gabapentin assay. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel.
What device class is OTF?
Class II, regulation 21 CFR 862.3350. Typical premarket route: 510(k).
How long does a 510(k) take for product code OTF?
Across 1 cleared submissions the average was 169 days from receipt to decision (median 169).
Which companies have the most OTF clearances?
Ark Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OTF
- Run a recall and safety report across every OTF manufacturer
- Watch product code OTF 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.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times