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U.S. Department of Health and Human Services

Product Classification
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Device organophosphate test system
Regulation Description Organophosphate test system.
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.
Physical State solid-phase extraction cartridge, mass spectrometer, HPLC
Technical Method Urine is diluted in acetonitrile and separated using normal phase solid-phase extraction which is further concentrated so that the analytes can be ionized via mass spectrometry.
Target Area Not applicable
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodePDY
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3652
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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