Organophosphate Test System
The Organophosphate Test System is a clinical toxicology in vitro diagnostic device used for the quantitation of specific organophosphate metabolites in human urine from individuals who present with signs and symptoms of organophosphate poisoning, such as from pesticide exposure or nerve agent contact. It falls under the Clinical Toxicology medical specialty and is classified as a Class 2 device under regulation 862.3652, requiring 510(k) premarket notification. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PDY
- Device Class
- FDA class 2
- Regulation Number
- 862.3652
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
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.
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 |
|---|---|---|---|---|
| DEN130005 | QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS | Aug 08, 2013 | Unknown | Centers for Disease Control and Prevention |