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 Code | PDY |
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 |