bioMérieux receives FDA 510(k) Clearance for its VITEK COMPACT PRO

April 8, 2025

bioMérieux announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for VITEK COMPACT PRO.

This system for microorganism identification (ID) and antibiotic susceptibility testing (AST) will benefit clinical laboratories to help diagnose infectious diseases and combat antimicrobial resistance, and industrial laboratories to identify contaminants for ensuring consumer safety.

VITEK COMPACT PRO combines the latest diagnostic technology with the advantages of its predecessor: VITEK 2 COMPACT. With an ergonomically advanced design and a simplified workflow, it further enhances the user experience and improves overall efficiency as the laboratory technician has to spend less time for sample loading and processing.

Ideally suited for small and medium-sized laboratories, VITEK COMPACT PRO will also enable laboratories transitioning from manual workflows to benefit from automation efficiencies.

For industrial applications, VITEK COMPACT PRO will be used for routine identification of pathogens to ensure the quality and safety of food, pharmaceutical, and cosmetic products.

The commercial launch of VITEK COMPACT PRO is initially planned in select countries, followed by global launch starting in the second quarter of 2025.

bioMérieux release