We are thrilled to announce our [Premier Biotech] patented rapid oral fluid device, OralTox, has received a coveted 510(k) clearance from the Food and Drug Administration (FDA) for two additional oral fluid assays, Oxycodone and Methadone. In total, OralTox has 510(k) clearance for the following 8 drugs: Amphetamine, Cocaine, Marijuana, Methadone, Methamphetamine, Opiates, Oxycodone and Phencyclidine. This clearance represents another landmark achievement that demonstrates our continued commitment to invest in the design, development and commercialization of near-donor solutions for the toxicology market.
By design, the OralTox format can scale to simultaneously detect up to 12 drugs, so this clearance marks the beginning of the next phase where more assays will be validated and submitted to the FDA in an effort to fully utilize the capacity of the device. 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.
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. Now with the clearance of Oxycodone and Methadone for OralTox, we are directly responding to the opioid crisis in the United States by enabling corporations and clinical groups alike to promptly screen and identify these illicit substances in a non-invasive manner.”
To purchase, contact Preston Clewis at firstname.lastname@example.org or 817-332-3341.