Can the T-Cube be used in Employment and Insurance Testing?

On July 11th 2017, the Food and Drug Administration (FDA or Agency) announced a list of class II devices that they determined, based on established factors, no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations.

FDA exemption is limited to test systems intended for Employment and Insurance testing, that include a statement in their labeling saying the device is intended solely for use in Employment and Insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Please refer to the Package Insert/Inner Carton Label to determine whether the T-Cube can be used in Employment and Insurance Testing.