NEW YORK – Accelerate Diagnostics said Monday that it has secured US Food and Drug Administration 510(k) clearance for a blood culture sample preparation platform to aid pathogen identification and the treatment of sepsis.
The Tucson, Arizona-based firm said that it got the green light from the agency for its Accelerate Arc System, comprising its Arc Module and BC kit, for automated positive blood culture sample preparation. The clearance allows the use of the system with Bruker's MALDI Biotyper CA (MBT-CA) System and MBT-CA Sepsityper software for direct microbial identification.
Accelerate said that the Arc system eliminates the need for overnight culture and laborious laboratory-developed test-related sample preparation methods, and it shortens the time to result for microbial identification tests. The company said that it is also conducting clinical trials in preparation of an FDA 510(k) submission for its Accelerate Wave antimicrobial susceptibility testing platform. The systems will be used together to deliver same-shift antimicrobial susceptibility test results so that patients can start optimal antibiotic therapies hours sooner.
"Together with the Accelerate Wave system, we are positioned to empower laboratories to deliver faster, more actionable results to clinicians, ultimately enhancing patient care and outcomes," Accelerate President and CEO Jack Phillips said in a statement.