Point-of-care comparative study supports successful 510(k) clearance with CLIA waiver designation

Boca Biolistics supported a small biotech company in achieving FDA 510(k) clearance and CLIA waiver designation for a novel point-of-care diagnostic device targeting respiratory infections. Through a prospective comparative study conducted across six clinical sites, Boca managed both investigational product (IP) testing and predicate device validation within a unified workflow. The study enrolled 700 subjects in just four months, despite non-peak respiratory season conditions, and delivered rapid equivalency results within two days of sample receipt. By streamlining clinical operations, ensuring sample traceability, and accelerating data delivery, Boca enabled faster regulatory approval and successful market entry for a point-of-care diagnostic solution.