Gabapentin Assay
The Gabapentin Assay (product code OTF) is an in vitro diagnostic test for the quantitative determination of gabapentin concentrations in human serum or plasma. Gabapentin is used to treat epilepsy and neuropathic pain, and this assay supports therapeutic drug monitoring to aid in patient management. As an FDA Class 2 device under regulation 862.3350, it requires 510(k) premarket clearance and falls within the Clinical Toxicology specialty. The device is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- OTF
- Device Class
- FDA class 2
- Regulation Number
- 862.3350
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K101574 | ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 | Nov 23, 2010 | Substantially Equivalent | Ark Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.