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

NEW YORK — Copan Diagnostics said Monday that it has received 510(k) clearance from the US Food and Drug Administration for the use of its Colibri automated clinical microbiology system with Beckman Coulter's MicroScan Walkaway instruments and panels for microbial identification and antibiotic susceptibility testing (ID/AST).

The Colibri system, which comprises the Colibri Vision System and Colibri Preparation Station, automatically selects isolated microbial colonies for further work-up and investigations.

In early 2022, the sample prep system was 510(k) cleared for use with BioMérieux's Vitek MS or Bruker MALDI Biotyper CA mass spec microbiology systems for automating the identification of Gram-negative and Gram-positive bacteria. Later that year, Murrieta, California-based Copan received 510(k) clearance for the system's use with BioMérieux's Vitek 2 platform.

"This third FDA clearance for Copan's Colibri opens the door to automated AST work-up with another leading system, offering significant time and labor savings by automating a vital step in diagnostic microbiology," Copan CEO Fabrizio Mazzocchi said in a statement.