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U.S. ALCOHOL TESTING OF AMERICA RECEIVES FDA MARKETING APPROVAL FOR RECENTLY SUBMITTED OPIATE ASSAY

 RANCHO CUCAMONGA, Calif., June 21 /PRNewswire/ -- Gary S. Wolff, chief financial officer, announced today that U.S. Drug Testing, Inc. (USDT), a wholly owned subsidiary of U.S. Alcohol Testing of America, Inc. (USAT) has received notice from the Food and Drug Administration (FDA) that its 510(k) application, submitted on May 6, 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 opiates, including heroine and morphine utilizing the Flow Immunosensor technology. The company had previously received FDA marketing approvals for the Flow Immunoassay System, Model 9000, and for the assay which detects cocaine and its metabolite benzoylecgonine.
 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. The company, however, does not intend to begin marketing the technology until it has proven equivalency of additional assays being developed, including those for marijuana, amphetamines, and PCP. Submissions to the FDA of these remaining assays are expected over the next several months.
 The FDA notification of marketing approval came just 40 days after the application was submitted, far ahead of the average clearance time. According to the Jan. 8, 1993, edition of "Devices and Diagnostics Letter," "The average 510(k) clearance time rose from 102 to 126 days in fiscal 1992, and has risen to over 130 days since then and is expected to continue lengthening." A recent Wall Street Journal article reported that 510(k) approval time has increased to an average of 170 days.
 The Flow Immunosenor 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.
 U.S. Alcohol Testing of America, Inc. manufactures evidential and screening equipment for alcohol breath testing analysis used by law enforcement agencies and industry.
 -0- 6/21/93
 /CONTACT: Gary S. Wolff of U.S. Alcohol Testing of America, 909-466-8378/


CO: U.S. Alcohol Testing of America, Inc. ST: California IN: SU:

TS-PS -- NY021 -- 3901 06/21/93 08:10 EDT
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Date:Jun 21, 1993
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