Copan Diagnostics, a provider of clinical microbiology automation solutions, has received its third US Food and Drug Administration (FDA) clearance for the Colibrí pre-analytical processor.
The Colibrí system is a fully automated platform for specimen preparation. It is intended to produce bacterial suspensions for antibiotic susceptibility testing (AST) and to prepare matrix-assisted laser desorption/ionisation time-of-flight identification (MALDI-TOF ID) targets.
The system includes the Colibrí Vision System and the Colibrí Preparation Station.
Colibrí is part of Copan Diagnostics’ full line of laboratory automation products which are designed to transform microbiology lab workflow and productivity.
The latest FDA clearance acknowledges that the system can be integrated easily with Beckman Coulter MicroScan Walkaway Instruments & Panels for ID/AST.
Additionally, the pre-analytical processor automates the preparation of microbial suspensions at a known concentration for the MicroScan system, which is frequently used in clinical labs for AST analyses.
According to Copan Diagnostics, Colibrí is the first tool in its class to be cleared under 510(k) for simultaneously preparing AST suspensions and MALDI-TOF slides.
The company’s portfolio of artificial intelligence (AI) and laboratory automation is distributed by US-based Beckman Coulter.
Copan Diagnostics CEO Fabrizio Mazzocchi said: “At Copan, we are unwavering in our commitment to support clinical microbiology laboratory professionals. They face unprecedented challenges today, including labour shortages, skyrocketing workloads, and the demand for rapid testing and result delivery.
“This third FDA clearance for Copan’s Colibrí opens the door to automated AST workup with another leading system, offering significant time and labour savings by automating a vital step in diagnostic Microbiology.”
Copan Diagnostics announced the FDA 510(k) clearance for use with MALDI-TOF Mass Spectrometry Analyzers in 2022.
In the same year, the American health regulator granted the Colibrí technology 510(k) clearance to be used with the bioMérieux VITEK 2 Antimicrobial Susceptibility Testing System.
Furthermore, the system can be combined with Copan Diagnostics’ advanced AI software, PhenoMATRIX, to empower clinical microbiology laboratories with AI-driven solutions for specimen workup.
