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Copan Diagnostics Receives FDA 510(k) Clearance for Colibri Clinical Microbiology System

NEW YORK – Copan Diagnostics said Wednesday that it has received US Food and Drug Administration 510(k) clearance for its Colibri automated clinical microbiology system.

Part of Copan's larger WASPLab full laboratory automation system, the Colibri system is intended for use with the BioMérieux VITEK MS or Bruker MALDI Biotyper CA mass spectrometry microbiology systems for automating the identification of Gram-negative and Gram-positive bacteria.

The system automatically picks isolated bacterial colonies selected either manually or by Copan's AI-based PhenoMatrix tag system for further work-up. It can also seed colonies for antibiotic susceptibility testing.

"Clinical microbiology is facing tremendous challenges including labor shortages, dramatically increased workloads, pressure for on-demand testing, and rapid turnaround times for results," Copan Diagnostics CEO Norman Sharples said in a statement. "The FDA clearance of COPAN's Colibri will provide time and labor savings by automating a crucial step in diagnostic microbiology."