Sequenom, a US-based manufacturer of DNA massarrays, has announced the submission of premarket 510(k) notifications to the US Food and Drug Administration (FDA) for its IMPACT Dx system and the IMPACT Dx Factor V Leiden and Factor II genotyping test.
Designed for use with the company’s IMPACT Dx Factor V Leiden and Factor II genotyping test and other genotyping tests, the IMPACT Dx system detects multiple analytes in a DNA sample using matrix-assisted desorption ionization time-of-flight mass spectrometry.
The IMPACT Dx Factor V Leiden and Factor II genotyping test is intended as an aid in the diagnosis of patients with suspected thrombophilia.
The company also obtained ISO 13485:2003 and EN ISO 13485:2012 certification, confirming that its medical device manufacturing quality management system is compliant with the International Organization for Standardization (ISO) standards.
Sequenom genetic analysis senior vice president Michael Monko said: "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."
The company anticipates applying the CE Mark for the IMPACT Dx system and it is also finalizing its plan to commercialize the system in a number of European countries.