DeviceClearance

Product code OTF— Clinical Toxicology

ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0

Classification name
Gabapentin Assay
Device class
Class 2
Regulation
21 CFR 862.3350
Advisory panel
Clinical Toxicology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Test for the quantitative determination of gabapentin in human serum or plasma. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.”

— U.S. Food and Drug Administration, device classification record for product code OTF under 21 CFR 862.3350, via openFDA

Market context for product code OTF

FDA has cleared 1 device under product code OTF, all in 2010, 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 OTF

Recent clearances under product code OTF

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