Selux Diagnostics’s PBC Separator obtains FDA 510(k) clearance 

The US Food and Drug Administration (FDA) has granted 510(k) clearance to biotech start-up Selux Diagnostics’ PBC Separator. 

The PBC Separator is a single-platform technology designed to deliver rapid antibiotic susceptibility testing (AST) results from positive blood cultures, as well as isolated colonies. 

It is a part of the company’s Next Generation Phenotyping (NGP) system, a rapid AST platform that delivers targeted therapeutic results significantly faster compared with the current standard of care. 

The Selux PBC Separator enables laboratories to conduct tests directly from positive blood cultures without the need for subculturing. It automates the sample preparation process for susceptibility testing.  

The FDA clearance approves the system’s ability to determine bacterial susceptibility to 17 specific antibiotic agents on the Selux Gram Negative Panel. 

Selux Diagnostics CEO Steve Lufkin said: “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.”  

Previously, the Selux PBC Separator received the FDA breakthrough designation, recognising its potential to meet the urgent need for performing AST directly from positive blood cultures and other sterile body fluids.  

Oregon Health and Science University antibiotic stewardship co-director and CLSI Antimicrobial Susceptibility Testing Subcommittee chair James Lewis II said: “The infectious disease community has eagerly awaited innovative technology to bolster our fight against difficult-to-treat infections.  

“This clearance, coupled with the Selux NGP System, marks a significant leap forward.” 

Last year, the FDA granted 510(k) clearance to Selux Diagnostics’s NGP System for rapid AST testing.  

The approval is for the company’s in vitro antimicrobial resistance test, which ascertains the susceptibility of a bacteria to 14 particular antimicrobial agents on the Selux Gram-Positive Panel. 

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• Source: https://www.medicaldevice-network.com/news/selux-pbc-fda-510k/