Premier Biotech’s Oral Fluid Drug Testing Device Granted FDA Clearance

Published: Mar 07, 2018

MINNEAPOLIS--(BUSINESS WIRE)-- On February 2, 2018, Premier Biotech Inc. was granted a coveted 510(k) clearance for the following drugs Amphetamine, Cocaine, Marijuana, Methamphetamine, Opiates and Phencyclidine from the Food and Drug Administration (FDA) for OralTox®, 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.


OralTox FDA 510(k) Cleared (Photo: Premier Biotech Inc.)

OralTox FDA 510(k) Cleared (Photo: Premier Biotech Inc.)

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’s laboratory is uniquely positioned to offer LC-MS/MS confirmations of presumptive positive results as well as a comprehensive test panel.

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. OralTox also equips corporations throughout the United States to make immediate hiring decisions and facilitates expedited client interactions in the criminal justice industry.

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.”

Premier Biotech Inc. is a leading provider of rapid drug testing devices. The Chanhassen, MN, facility manufactures a comprehensive line of proprietary products. Premier Biotech Labs, LLC, located in Minneapolis, provides high complexity testing and customized laboratory services for toxicology testing in criminal justice/corrections, clinical medication monitoring; and corporate workforce clients. Premier Biotech Labs holds both CAP (College of American Pathologists) Forensic accreditation and Clinical Laboratory Improvement Amendments (CLIA) certification, each of which requires the highest level of quality control standards and rigorous protocol adherence, including complete chain of custody and frequent inspections.

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