Search Results
Found 1 results
510(k) Data Aggregation
K Number
DEN130005Device Name
QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS
Manufacturer
Date Cleared
2013-08-08
(72 days)
Product Code
Regulation Number
862.3652Why did this record match?
Product Code :
PDY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is intended for the quantitation of specific organophosphate metabolites by LC/MS/MS. The device system includes organophosphate metabolite calibrators to calibrate the system and organophosphate metabolite controls for quality control monitoring of the system. This device is intended for use in a single laboratory to detect and measure the concentration of specific organophosphate metabolites in human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning. The data obtained by this device will be used following an exposure or suspected exposure event to confirm exposure, identify the causative agent, and distinguish exposed from the unexposed patients.
Device Description
The device comprises internal standards which serve as the basis for the calibrators and quality control materials. A solid phase extraction cartridge is initially used to extract the metabolites for further separation and analysis on a tandem mass spectrometer and HPLC system.
Ask a Question
Ask a specific question about this device
Page 1 of 1