FDA recently granted premarket notification (510(k)) clearance to bioMérieux, Marcy l’Etoile, France, for its new generation Vidas immunoassay system.

Vidas 3 features enhanced automation of the analytical process, improved traceability, and new software capabilities with full connectivity to internal and external networks. The low-throughput immunoassay system can perform up to 36 tests per hour, on-demand, individually, or in series.

The latest release uses the same reagents as other instruments in the Vidas product line. Users have access to more than 100 tests, each in a single-test format, for the diagnosis of allergies, cancers, cardiovascular diseases, infectious diseases, infertility, pregnancy, and thyroiditis. The instrument’s new features and single-test format make the system particularly suited to meet the needs of labs supporting emergency and critical care departments.

The system is also CE marked and registered at the Chinese Food and Drug Administration (CFDA).

“This regulatory clearance will allow us to offer to our US customers the reliability and robustness experience, which has already been demonstrated with our European and Asian customers,” says François Lacoste, bioMérieux corporate vice president of the business’ clinical unit. “It is a major step forward in the continuous development of Vidas 3 worldwide, and an opportunity to fulfill our ambition to make our innovative diagnostic solutions available to as many laboratories as possible.”

For more information, visit bioMérieux.