Selux PBC Separator with Selux AST System receives FDA 510(k) clearance
The Selux PBC Separator, part of the Next Generation Phenotyping (NGP) System, makes this the only FDA cleared, single-platform technology capable of delivering rapid AST results for both positive blood culture and isolated colonies
12 Mar 2024
Selux Diagnostics, a biotech startup whose mission is to combat superbug infections and preserve the lifesaving power of antibiotics for future generations, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its proprietary Positive Blood Culture (PBC) Separator. The addition of positive blood culture sample type expands the Selux NGP System, a rapid AST platform that can provide targeted therapeutic results days faster than the current standard of care.
The Selux PBC Separator allows labs to test directly from positive blood culture without the need to subculture by automatically preparing the sample for susceptibility testing. This latest FDA clearance determines a bacteria's susceptibility to 17 specific antibiotic agents on the Selux Gram Negative Panel.
The Selux PBC Separator has already garnered FDA Breakthrough Designation, acknowledging its potential to address the critical need for performing AST directly from positive blood culture and other sterile body fluids. The FDA's Breakthrough Devices Program aims to provide timely access to medical devices that improve the treatment or diagnosis of life-threatening or debilitating human diseases or conditions.
Steve Lufkin, CEO of Selux Diagnostics, commented, "This third 510(k) clearance for Selux marks a significant advancement in infectious disease care. The Selux NGP System is the only AST platform able to deliver rapid AST results direct from positive blood culture and isolated colonies. We extend our gratitude to our employees, partners, and advisors whose contributions were instrumental in achieving this breakthrough designated accomplishment."