Sequenom Files Premarket 510(k) Notification with FDA for IMPACT Dx System
Sequenom (NASDAQ: SQNM) today announced that it has submitted Premarket 510(k) Notifications to the United States Food and Drug Administration (FDA) for its IMPACT Dx™ System and its IMPACT Dx™ Factor V Leiden and Factor II Genotyping Test. The system and test are intended for use in the clinical laboratory setting.
"The submission of our premarket notifications is a tremendous achievement that we believe contributes significant value to our Genetic Analysis business segment and represents the transition of our proven research-use-only MassARRAY® System into the clinical diagnostics arena," said Michael Monko, Senior Vice President, Genetic Analysis at Sequenom, Inc.
In anticipation of applying the CE mark for the IMPACT Dx System, the Company also received ISO 13485:2003 and EN ISO 13485:2012 certification for its quality management system. The ISO 13485 certification confirms that the Company's medical device manufacturing quality management system is compliant with globally recognized standards set forth by the International Organization for Standardization (ISO). The Company is finalizing plans to commercialize the IMPACT Dx System in a number of European countries that require CE marking.