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San Diego, CA
October 14, 2005 ACON Laboratories, Inc. (ACON, San Diego, CA) recently received CLIA waived status for its patent pending E-Z Split Key Cup and its multi-line drugs of abuse device tests. Both products, which have been 510(k)-cleared by the U.S. Food and Drug Administration (FDA) , are simple enough to be used by non-laboratory trained personnel. CLIA waived tests are the most widely used tests in physician's office laboratories and are in-demand for occupational health and criminal justice applications. ACON's proprietary E-Z Split Key Cup, designed to virtually eliminate exposure to urine, has a 24-month shelf life at room temperature. Results are ready in 5 minutes and are stable for 60 minutes. The cup can be custom-configured to detect any combination of amphetamine, cannabinoids, methamphetamine, MDMA, opiates, phencyclidine, and cocaine metabolites with cut-off levels matching the screening requirement for specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA) when applicable. The E-Z Split Key Cup is also available with built in adulteration strips to help determine specimen validity.
The multi-line device, which requires a smaller sample volume than traditional cup or dip card tests, can be custom-configured to detect any combination of amphetamines, cannabinoids, methamphetamines, opiates, phencyclidine, and cocaine metabolites at cut-off levels matching the screening requirement for specimens set by SAMHSA when applicable. Results, available within 5 minutes of the simple procedure, are stable for 4 hours.
Achieving CLIA waived status for our drug tests represents another major step for ACON in our relentless pursuit to set the standard in the point-of-care drug testing industry, commented Lorraine Cogan , Senior Director of Global Drugs of Abuse Products. ?Combining the inherent features and benefits of the E-Z Split Key Cup and the multi-line drug device with proven ease-of-use by untrained personnel, will allow our partners to expand distribution into the physician's office laboratory and other markets.
CLIA (Clinical Laboratory Improvement Amendment) was enacted in 1988 to regulate diagnostic testing on human specimens to ensure the reliability of test results. Waived tests, the least regulated category, are simple and accurate and therefore most widely used in doctor's offices at point of patient care. Over 100,000 doctor's offices in the United States are capable of performing CLIA waived tests. - Source ACON
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