Copan Diagnostics’ Colibrí Gains Second Clearance
Copan Diagnostics has received a second 510(k) clearance from the FDA for its Colibrí system, a pre-analytical processor that automates several steps of specimen preparation in diagnostic microbiology.
An addition to the company’s WASPLab laboratory automation system, Colibrí is an automated specimen workup platform that includes preparing mass spectrometry phenotyping targets and creating bacterial suspensions for antibiotic susceptibility testing.
The new clearance allows the system to be used in combination with bioMérieux’s VITEK 2 antimicrobial susceptibility testing. Colibrí first received FDA clearance in December 2021 for use with MALDI-TOF mass spectrometry analyzers.
Copan Diagnostics CEO Norman Sharples said the new clearance will help address challenges such as “labor shortages, dramatically increased workloads, pressure for on-demand testing and rapid turnaround times for results.”