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# T2 Biosystems Files 510(k) for Sepsis Panel
- URL: https://www.fdaweb.com/t2-biosystems-files-510-k-for-sepsis-panel/
- Published: 2017-09-15T12:00:00.000Z
- Updated: 2026-09-14T22:50:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139644

T2 Biosystems has filed a 510(k) for the T2Bacteria Panel that is designed to run on the company’s T2Dx Instrument as a rapid diagnostic solution to identify pathogens associated with sepsis within hours instead of days, potentially enabling 95% of patients with bloodstream infections to receive targeted therapy within eight hours of blood draw. The submission includes data from a pivotal clinical trial that evaluated the device’s performance compared to blood culture, the company says. “The combined results from the prospective and seeded arms of the study show an average sensitivity of 95.8% and an average specificity of 98.1%,” it adds.