# Enzyme Immunoassay, Oxcarbazepine Metabolite
> **Product code: POX** · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3645
## Classification
- **FDA Product Code:** POX
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 862.3645
- **Review panel:** TX
- **Medical specialty:** Clinical Toxicology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=POX)
---
*AI Analytics · CC0 1.0*