FDA Clears Drugs-of-Abuse Panel

Two devices that perform on-site screening for multiple drugs of abuse have been cleared by the U.S. Food and Drug Administration (FDA).

One device, called the Profile-ER, is targeted at hospital laboratories for emergency response (ER) screening in drugs-of-abuse overdose situations. The device simultaneously detects multiple drugs of abuse and allows the end user to perform an on-site screen for the presence of nine commonly abused drugs: cocaine, amphetamines, cannabinoids, opiates, phencyclidine (PCP), benzodiazapine, barbiturates, tricyclic antidepressants, and methadone. The screen is a one-step process that produces qualitative results in seven minutes.

The second device, called Verdict-II, was developed for the prison, probation, parole, and rehabilitation markets. The Verdict consists of 13 different configurations to detect from one to five drugs of abuse. Verdict and Profile-ER are the products of Medtox Diagnostics, Inc. (St. Paul, MN, USA).

"As part of a reorganization, we are emphasizing the marketing, sales, and operations of our diagnostic device business rather than laboratory drugs-of-abuse screening. This includes converting as rapidly as possible our drugs-of-abuse laboratory clients to our Profile system for on-site screening,” noted Richard Braun, CEO of Medtox Scientific, Inc., the parent of Medtox Diagnostics.



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