ST. PAUL, Minn., Feb. 19, 2009 (GLOBE NEWSWIRE) -- MEDTOX Scientific, Inc. (Nasdaq:MTOX), announced today that on February 13, 2009, it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its PROFILE(r)-V MEDTOXScan(r) Drugs-of-Abuse Test System.
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The PROFILE(r)-V MEDTOXScan(r) Drugs-of-Abuse Test System consists of the PROFILE(r)-V MEDTOXScan(r) Test Devices and the MEDTOXScan(r) Reader. The Test Devices are one-step immunochromatographic tests for the rapid qualitative detection of one or more of the following drug classes and cutoff concentrations in human urine:
AMP Amphetamine 500 ng/mL BAR Barbiturates 200 ng/mL BZO Benzodiazepines 150 ng/mL COC Cocaine 150 ng/mL MAMP Methamphetamine 500 ng/mL MTD Methadone 200 ng/mL OPI Opiates 100 ng/mL PCP Phencyclidine 25 ng/mL THC Cannabinoids 50 ng/mL
The Reader provides accurate, easy-to-use and cost effective testing for drugs-of-abuse. Results are available in 10 minutes for improved turn around time. There is an optional attached bar-code scanner for accurate entry of user ID, patient ID and lot number of the device. Test results will remain on the digital display until cleared by the operator. A printer provides a paper copy of the results for a permanent record. The Reader also has network integration capabilities, enhanced record storage of 1,000 results with improved record management.
The MEDTOXScan(r) Reader includes a Positive QC Test Device, a Negative QC Test Device and a Cleaning Cassette. The Positive and Negative QC Test Devices are intended to detect potential errors associated with the Reader such as a contaminated contact imaging sensor (CIS) and to verify the CIS cleaning procedure using the approved Cleaning Cassette which effectively removed any contamination.
The Test System is intended for professional use in a hospital laboratory setting. Currently MEDTOX has between 300 and 400 hospital clients utilizing MEDTOX's PROFILE(r) visually read cassettes for drugs-of-abuse detection. The new Test System will be marketed not only to those clients, but to the broader hospital market which is estimated in excess of 2,500 hospitals.
MEDTOX Scientific, Inc., headquartered in St. Paul, Minn., is a provider of high quality specialized laboratory testing services and on-site/point-of-collection testing (POCT) devices. The company also supports customers with complete logistics, data and program management services. MEDTOX is a leader in providing esoteric laboratory testing services to hospitals and laboratories nationwide. This includes both central laboratory and bio-analytical testing for pharmaceutical clinical trials. MEDTOX develops and manufactures diagnostic devices for quick and economical on-site/point-of-collection analysis for drugs-of-abuse, therapeutic drugs and biological and agricultural toxins and provides employment drug screening and occupational health testing. For more information see www.medtox.com.
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