Announcing FDA 510(k) Clearance of our Oral Fluid Drugs of Abuse Test – OralTox®


We are pleased to announce our OralTox (rapid oral fluid drug test) has received FDA 510(k) clearance for the following drugs Amphetamine, Cocaine, Marijuana, Methamphetamine, Opiates and Phencyclidine from the U.S. Food and Drug Administration. This clearance will further expand our ability to offer our patented oral fluid drug testing device to customers in the clinical market.

Healthcare professionals including treatment providers, behavioral healthcare clinics, addiction medicine specialists, psychiatrists, pain physicians, and primary care clinicians may look for the presence of prescribed medications as evidence of patient use. Finding no presence of the prescribed drug, or finding illicit drugs merits further discussion with the patient.

OralTox provides an immediate result and acts as a first line of defense helping to make sure that patients are complying with prescriptions and identifying the absence/presence of illicit drugs. Additionally, OralTox can be sent to a laboratory for extensive LC-MS/MS confirmatory testing.

Clinical Oral Fluid Testing Benefits:


  • Ideal for treatment providers, behavioral health, pain clinics and primary care drug testing programs
  • Assists with medication monitoring and adherence
  • Rapid results help to prevent dangerous drug interactions resulting in better care for patients
  • A less invasive means of collection that can be done anywhere, anytime and by anyone
  • Resistant to adulteration

Learn More About Our FDA 510(k) Cleared OralTox Device

Premier Biotech, Inc.
Product: 888-686-9909

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Minneapolis, MN 55414

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