Menlo Park, Calif. – December 1, 2007 – Pria Diagnostics announces that their first product, the Element male fertility test kit for home-use, has received Medical Device Class I clearance from the Japanese Ministry of Health, Labour and Welfare. The product is scheduled to begin production at UL-Tech Electronics Sdn Bhd (ULTE) in Malaysia at the beginning of next year, and will be available for sale in Japan shortly thereafter.
The regulatory approval process started one year ago, and has involved a thorough review of Element’s product design, accuracy, usability, and final packaging, as well as an investigation of UL-Tech’s manufacturing facilities in Malaysia. Results from a pre-clinical study were key to the successful demonstration of the product’s ability to diagnose male fertility with high accuracy. On November 15, 2007, Pria’s contract manufacturing partner, UL-Tech Electronics, obtained ISO 13485:2003 QMS Certification, based upon an extensive audit of their assembly capabilities, equipment, and implementation of quality processes.
As stated by Dan Morrow, President and Chief Executive Officer of Pria Diagnostics, “We consider approval from the Japanese Ministry of Health, Labour and Welfare pivotal to achieving regulatory acceptance across Asia, Europe, and the United States.”
For more information, please contact:
Doug Erwin, Chairman and Chief Business Officer, Pria Diagnostics