T2 Biosystems Submits 510(k) Application for Bacteria Panel

NEW YORK (360Dx) – T2 Biosystems announced today that its has filed a 510(k) premarket submission for its T2Bacteria Panel with the US Food and Drug Administration.

The panel runs on the FDA-cleared T2Dx instrument and is designed to be a comprehensive rapid diagnostic test that identifies pathogens associated with sepsis within hours instead of days, T2 Biosystems said.