San Diego, CA February 28, 2018 –Alfa Scientific Designs, Inc. (ALFA), as an innovative pioneer of rapid, point-of-care (POC) medical devices, has received US FDA 510(k) clearance for Instant-view-plus multi-drug of abuse urine test. This Simple Cup DOA urine test features ALFA’s Driven Flow Technology. The Simple Cup is FDA 510(k) cleared for professional/over-the-counter (OTC) and CLIA-waived use. The urine immunoassay identifies thirteen (13) drugs or drug metabolites and offers competitive differentiation: The Simple Cup yields results at two (2) minutes and maintains line integrity for at least two (2) hours with 98.88% accuracy. These features are significant improvements to existing lateral flow immunoassay drug testing devices on the market.
“It is with a tremendous sense of accomplishment that we announce the news of US FDA 510(k) clearances for ALFA Driven Flow™ products,” says ALFA’s founder and chairman of the board, Dr. Naishu Wang, MD, PhD. “With the FDA 510(k) clearances, ALFA’s new Simple Cup urine multi-drug test is available for use in professional/OTC and CLIA settings.”
About Alfa Scientific Designs, Inc.:
ALFA, an innovator and leader in the development and manufacture of rapid, immunoassay, point-of-care medical devices, is a minority, woman-owned, small business. ALFA, a US manufacturer, offers a broad range of services including contract product development, technology transfer, OEM services, custom assembly, and packaging with private labeling. With more than 50 FDA 510(k) cleared (for professional/OTC use), CLIA-waived and CE Mark products, ALFA’s innovation in research and development has resulted in more than 27 granted patents and numerous partnerships. To learn more about ALFA’s services, development capabilities and partnership opportunities, visit the company’s website at www.alfascientific.com for more information.
Alfa Scientific Designs, Inc.
Cathy Parsons, Marketing Director