FDA clearance granted to Premier Biotech’s Oral Fluid Drug Testing Device, OralTox

Premier Biotech was awarded a 510 (k) clearance for the following drugs Amphetamine, Cocaine, Marijuana, Methamphetamine, Opiates and Phencyclidine from the Food and Drug Administration (FDA) for OralTox which is its flagship, patented rapid oral fluid drug screen device.

A FDA 510(k) clearance is a significant achievement as it paves the way for distribution and utilization in clinical markets and allows for further expansion in the employment sector. The Minnesota-based manufacturer of rapid drug testing devices designed, developed and manufactures the OralTox screening device. OralTox can simultaneously detect up to 12 drugs. The use of oral fluid as a testing matrix offers numerous benefits over urine testing: the process is less invasive, the collection can be fully observed without privacy concerns, tests can be administered without the need for specialized collection facilities and, most significantly, is resistant to adulteration.

Premier Biotech has extensive experience working with corporate workplace customers and government agencies to expedite their drug screening processes with fast, accurate drug tests. After rigorous precision, safety, and efficacy review, the FDA’s 510(k) clearance of OralTox enables the implementation of a rapid oral fluid drug test in the clinical market. OralTox is the only FDA-cleared, rapid oral fluid drug test capable of being sent to a lab for confirmation. OralTox can help medical professionals including treatment providers, behavioral health centers, and pain clinics test for illicit substance use and medication compliance.

Todd Bailey, CEO, states, “Premier Biotech was founded with the goal of designing, developing and commercializing drug testing devices that represent the highest quality and most reliable results. With the clearance of OralTox, we can offer expertise in oral fluid drug testing, giving corporations and clinical groups alike an effective way to quickly screen and identify illicit substance use or monitoring the utilization of prescribed medications.”