June 2024—Affinity Biosensors announced that its LifeScale AST system received FDA 510(k) clearance. The multiplex in vitro diagnostic test uses a microfluidic sensor and resonant frequency to calculate organism concentration and/or mass distribution for quantitative antimicrobial susceptibility testing. Testing is performed directly on blood cultures signaled as positive by a continuous monitoring blood culture system and confirmed by Gram stain. Results are available in less than five hours.
Affinity Biosensors, 805-960-5100
