Colibrí™ Receives FDA 510(k) Clearance for use with bioMérieux VITEK® 2 AST System
October 10, 2022
COPAN Diagnostics is proud to announce the second FDA clearance of Colibrí™, a semi-automated pre-analytical processor that is a complementary part of WASPLab®, COPAN’s full laboratory automation system.
Colibrí™ system is an in vitro fully automated specimen workup platform designed to prepare MALDI-TOF ID targets and create bacterial suspensions for antibiotic susceptibility testing (AST). It comprises of Colibrí™ Vision System and Colibrí™ Preparation Station. This new Colibrí™ 510(k) clearance announcement is exciting because it substantiates that fully automated culture workup for ID and AST is possible.
“COPAN is committed to continue to expand the capabilities of Colibrí™ to manage other AST platforms and the Company continues to innovate to remain at the leading edge of automation for clinical microbiology”
In December 2021, COPAN announced the FDA 510(k) clearance of Colibrí™ for use with MALDI-TOF MS analyzers. This same instrument has now received its second FDA 510(k) clearance for the preparation of microbial suspensions for AST with bioMérieux VITEK 2, making Colibrí™ the first instrument in its class to receive 510(k) clearance for simultaneous preparation of MALDI-TOF slides and McFarland AST suspensions.
“Clinical microbiology is facing tremendous challenges, including labor shortages, dramatically increased workloads, pressure for on-demand testing, and rapid turnaround times for results. The FDA clearance of COPAN’s Colibrí™ for MALDI and now Vitek 2 will save time and labor by automating crucial steps in diagnostic microbiology.
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. Complex tasks that occur tens of thousands of times per day in microbiology laboratories require great care and attention. Such tasks are now fully automated with unquestionable accuracy. With these critical processes in laboratory workup automated and interfaced with downstream mass spectrometry instruments and Vitek 2, experienced laboratory professionals may now use their time to perform other complex tasks requiring their unique skills and expertise.”
The Colibrí™ system, paired with Copan’s revolutionary artificial intelligence (AI) software, PhenoMATRIX®Elite with TAG, offers clinical Microbiology laboratories cutting-edge, intelligence-driven solutions for specimen workup to help streamline workflow and address the most challenging demands in the laboratory. “COPAN continues to develop robotic and AI-driven solutions for clinical laboratories as our commitment to innovating together is the heart of our Company,” concluded Sharples.
About Colibrí™
COPAN’s Colibrí™ automatically picks isolated colonies for further workup and investigations. Colonies are designated by the laboratory technologist or automatically by COPAN’s advanced AI, PhenoMATRIX® TAG. The precision robotics of full laboratory automation system WASPLab® combined with Colibrí™ help to eliminate any transposition errors.
Colibrí™ works with both bioMérieux VITEK® MS and Bruker Biotyper systems, seeding either manufacturers’ target plate formats, automatically applying matrix, and automatically sends instructions and coordinates identifying each culture workup spot.
Colibrí™ seeds colonies into various-size tubes to prepare McFarland suspensions for AST. The system is now FDA-cleared for the preparation of microbial suspensions for AST with bioMérieux VITEK 2.
Learn More About the Power of Colibrí™ and PhenoMATRIX® TAG
PhenoMATRIX® is an unparalleled AI-powered software which uses an advanced selection of highly sophisticated algorithms giving users of COPAN’s WASPLab® the power to automatically pre-assess and pre-sort culture plates and segregate bacterial cultures. PhenoMATRIX® allows laboratories to quickly view and discard the up to 80% of negative cultures which are processed in clinical Microbiology with the click of a button.
PhenoMATRIX® TAG is the latest evolution of COPAN’s advanced AI to detects and “tags” the best colonies to be picked by Colibrí™ for workup. The PhenoMATRIX® TAG software highlights isolated and aggregated colonies. After defining the optimal colonies for selection, PhenoMATRIX® TAG communicates the colony coordinates to the Colibrí™ for reliable and accurate picking.
WASPLab® is a highly efficient, modular, scalable, and customizable specimen processing and culture workup system for clinical microbiology. Samples move from front-end processing to smart incubation, digital microbiology, and artificial intelligence for plate reading.
COPAN Diagnostics is part of COPAN Group, a leading manufacturer of collection and transport systems and full laboratory automation in the world. With a reputation for innovation, COPAN’s collaborative approach to pre-analytics has resulted in FLOQSwabs®, ESwab™, UTM Universal Transport Medium®, laboratory automation including WASP® and WASPLab® and Microbiology laboratory artificial intelligence software PhenoMATRIX®. For more information, visit www.copanusa.com.