# Organophosphate Test System
> **Product code: PDY** · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3652
## Classification
- **FDA Product Code:** PDY
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 862.3652
- **Review panel:** TX
- **Medical specialty:** Clinical Toxicology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

For the quantitation of specific organophosphate metabolites in human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning.  The data obtained by this device is intended to aid in the confirmation and investigation of organophosphate exposure.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PDY)
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