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U.S. DRUG TESTING RECEIVES FDA MARKETING APPROVAL FOR AMPHETAMINE ASSAY

 RANCHO CUCAMONGA, Calif., Nov. 29 /PRNewswire/ -- U.S. Drug Testing Inc. announced today that it has received notice from the Food and Drug Administration (FDA) that its 510(k) application, submitted on Sept. 30, 1993, has been determined to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments.
 The application submitted is for the assay which detects amphetamines in urine utilizing the Flow Immunosensor Technology. The company had previously received FDA marketing approvals for the Flow Immunoassay System, Model 9000; for the assay which detects cocaine and its metabolite benzoylecgonine; and for the assay which detects opiates, including heroin and morphine.
 The notification from the FDA permits the company to begin marketing the device subject to the general control provisions of the Medical Device Amendments Act including requirements for registration, listing of the device, good manufacturing practice, and labeling. With this approval the company will begin negotiating with companies to license on an exclusive basis the marketing rights for the Flow Immunoassay System and its five drugs of abuse assays.
 The company has recently submitted a 510(k) application to the FDA for the assay which detects phencyclidine (PCP) and expects to submit an application for marijuana by year-end.
 The FDA notification of marketing approval came just 56 days after the application was submitted, far ahead of the average clearance time.
 The Flow Immunosensor Technology provides a more sensitive method for testing for drugs of abuse while significantly decreasing the assay time and cost. This technology, developed by scientists at the Naval Research Laboratory, was licensed to the company in January 1992 from the United States government through the Technology Transfer Act. A subsequent one-year Cooperative Research and Development Agreement was signed in April 1992 and was recently extended until April 1994.
 U.S. Drug Testing is a 67 percent owned subsidiary of U.S. Alcohol Testing of America Inc. (AMEX: AAA) and is engaged in the research and development of devices which detect drugs of abuse from urine and saliva samples.
 -0- 11/29/93
 /CONTACT: Gary S. Wolff, 909-466-8378/


CO: U.S. Drug Testing of America Inc. ST: California IN: HEA SU:

LM-LS -- LA034 -- 8417 11/29/93 16:09 EST
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Publication:PR Newswire
Date:Nov 29, 1993
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