DeviceClearance

Product code POX— Clinical Toxicology

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control

Classification name
Enzyme Immunoassay, Oxcarbazepine Metabolite
Device class
Class 2
Regulation
21 CFR 862.3645
Advisory panel
Clinical Toxicology
Total cleared
1
First cleared
Most recent

FDA classification definition

“An Oxcarbazepine Metabolite Assay is an enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy.”

— U.S. Food and Drug Administration, device classification record for product code POX under 21 CFR 862.3645, via openFDA

Market context for product code POX

FDA has cleared 1 device under product code POX, all in 2016, 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 POX

Recent clearances under product code POX

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