Vidas Kube

The U.S. Food and Drug Administration (FDA) is seeking information from potential sources capable of providing VIDAS KUBE systems to replace discontinued VIDAS systems currently used across the Office of Regulatory Testing and Surveillance (ORTS) laboratory network. The FDA requires a contractual vehicle to meet all needs over the next five years, beginning with an initial purchase of instruments for each ORTS laboratory location in FY26, with multiple option years for additional units as needed. The scope of the requirement includes the provision of VIDAS KUBE systems with specific technical and operational requirements. • The systems must have a modular, stackable benchtop design and support up to six modules operating simultaneously. • The systems must have an integrated PC capable of controlling up to two modules. • The systems must have a processing capacity of 12-72 samples per cycle for food testing and up to 36 tests/hour/module for clinical testing. • The systems must use Enzyme-Linked Fluorescent Immunoassay (ELFA) technology and be compatible with a minimum of 80 immunoassay tests, including pathogen detection for Salmonella spp. and Listeria spp. • The systems must have fully automated testing processes, an intuitive software interface, and 21 CFR Part 11 compliant data traceability with audit trail functionality. • The systems must have cybersecurity protections, bi-directional Laboratory Information Systems (LIS) connectivity, and quality control features, including on-board verification, optical sample detection, and automated alerts.