Saliva Drug Testing Now FDA Insurance & Employment Approved

The FDA announced that new drug panels including Fentanyl, Tramadol, and Synthetic Cannabinoids (K2/Spice) are now FDA Approved for Employment & Insurance (E&I) Use in rapid urine devices. Additionally, many of the traditionally FDA approved drug classes are also FDA Employment & Insurance approved in Saliva devices. American Drug Test offers several E&I drug tests.

FDA E&I Approved Panels in Saliva:

- Alcohol
- THC 12 ng/mL
- COC 20 ng/mL
- OPI 40 ng/mL
- AMP 50 ng/mL
- MET 50 ng/mL
- BZO 10 ng/mL
- BAR 50 ng/mL
- BUP 5 ng/mL
- OXY 20 ng/mL
- MDMA 50 ng/mL
- MTD 30 ng/mL

FDA Summary:

On 11 July 2017, the Food and Drug Administration (FDA or Agency) announced a list of class II devices that the Agency has determined based on established factors to 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 that 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).

Link to Full FDA Employment & Insurance Premarket Letter