OTF

Gabapentin Assay

Product code

OTF

Device name

Gabapentin Assay

Device class

Class 2

21 CFR

21 CFR 862.3350

Medical specialty

Clinical Toxicology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).