DeviceClearance

Product code PDY— Clinical Toxicology

QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS

Classification name
Organophosphate Test System
Device class
Class 2
Regulation
21 CFR 862.3652
Advisory panel
Clinical Toxicology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PDY under 21 CFR 862.3652, via openFDA

Market context for product code PDY

FDA has cleared 1 device under product code PDY, all in 2013, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PDY

Recent clearances under product code PDY

Data sourced from openFDA. This site is unofficial and independent of the FDA.