T2 Biosystems files 510(k) for T2Bacteria Panel

T2 Biosystems Inc. (NSDQ:TTOO) said today it filed a 510(k) appliation with the FDA for its T2Bateria Panel rapid diagnostic solution designed to identify pathogens assocaited with Sepsis. The T2Bacteria panel is designed to run on the FDA-cleared T2Dx instrument to provide diagnosis of sepsis pathogens within hours, reducing the time for patients with bloodstream infections to receive treatment, the Lexington, Mass.-based company said. The submission includes data from a pivotal clinical trial of the T2Bacteria Panel which compared it to blood culture, as well as the performance of the panel in known bacteria positive samples, the company said. Results from the trials indicated a 95.8% average sensitivity and 98.1% average specificity. “Bacterial infections are a major cause of poor health outcomes and a driver of costs in hospitals today. There is a great need for improved diagnostics to aid clinicians in providing faster treatment and the T2Bacteria Panel is the first product submitted for FDA clearance that detects bacteria species directly from whole blood, providing faster, actionable information,” Dr. Mitchell Cohen of the University of Colorado said in a prepared statement. The T2Bacteria Panel is designed to identify the human blood specimens Acinetobacter baumannii, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus, T2 said. “The filing of T2Bacteria brings us one step closer ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance T2 Biosystems Inc. Source Type: news