# Gabapentin Assay
> **Product code: OTF** · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3350
## Classification
- **FDA Product Code:** OTF
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 862.3350
- **Review panel:** TX
- **Medical specialty:** Clinical Toxicology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OTF)
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