Applied BioCode won expanded FDA 510(k) clearance for its BioCode Respiratory Pathogen Panel (RPP), adding automated extraction using Thermo Fisher Scientific’s KingFisher Flex platform. The cleared workflow pairs the RPP with the company’s BioCode MDx-3000 automated detection system and is intended to help labs streamline specimen processing. Applied BioCode said the expanded offering targets detection of 17 prevalent respiratory pathogens and is built to support timely results for clinical decision-making. The company previously secured similar KingFisher Flex pairing clearance for its gastrointestinal pathogen panel. For clinical labs, the update matters most for reducing manual steps and improving throughput while keeping sensitivity coverage aligned with existing FDA-cleared performance claims.