PDY · Organophosphate Test System
Clinical Toxicology · 21 CFR 862.3652 · Class 2
Overview
| Product Code | PDY |
|---|---|
| Device Name | Organophosphate Test System |
| Regulation | 21 CFR 862.3652 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
Identification
An organophosphate test system is a device intended to measure organophosphate metabolites quantitatively 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.
Classification Rationale
Class II (special controls). The special controls for this device are:
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) The distribution of these devices is limited to laboratories with experienced personnel who are trained to measure and evaluate organophosphate exposure and guide public health response. (2) Analytical testing must demonstrate the device has appropriate performance characteristics, including adequate precision and accuracy across the measuring range and near medical decision points.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN130005 | QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS | Centers for Disease Control and Prevention | Aug 8, 2013 | DENG |
Top Applicants
- Centers for Disease Control and Prevention — 1 clearance
