Copan Diagnostics on Monday announced it has received a second 510 (k) clearance from the U.S. Food and Drug Administration (FDA) for Colibri, a semiautomated preanalytical processor that is a complementary part of its laboratory automation system, WaspLab.
The system had received its first FDA 510k clearance in December 2021, allowing it to be used with MALDI-TOF MS analyzers, Copan said.
With this second clearance, Colibri can prepare microbial suspensions for antibiotic susceptibility testing (AST) with the BioMérieux Vitek 2 system, the company added.
“The FDA clearance of Copan's Colibri for MALDI and now Vitek 2 will save time and labor by automating crucial steps in diagnostic microbiology,” Norman Sharples, CEO and cofounder of Copan, said in a statement. “When used with Copan's advanced AI software, the laboratory has total traceability and precision regarding colony selection and transfer to MALDI-TOF target slides and now AST tube preparation.”
Colibri can also be paired with its artificial intelligence (AI) software, PhenoMatrix Tag, to optimize the detection and isolation of bacterial cultures that would be used in microbial suspensions, Copan said.
