www.fdanews.com/articles/210900-selux-phenotyping-system-cleared-for-antibiotic-susceptibility-testing
Selux Phenotyping System Cleared for Antibiotic Susceptibility Testing
January 24, 2023
The FDA has granted 510(k) clearance to Selux Diagnostics for its next-generation phenotyping (NGP) system, a rapid antibiotic susceptibility testing platform for gram-positive bacteria.
The NGP system has the potential to decrease overreliance on broad-spectrum antibiotics since results provide specific susceptibility, enabling clinicians to prescribe a targeted antibiotic for gram-positive bacteria such as Staphylococcus aureus.
The FDA is currently reviewing the company’s NGP system for assessing the antibiotic susceptibility of gram-negative bacteria.