Copan Group announced that PhenoMATRIX®, its automated image assessment software used with WASPLab® full laboratory automation, received FDA 510(k) clearance as a Class II device in the United States.

PhenoMATRIX is an in vitro diagnostic software that uses artificial intelligence with laboratory-defined rules and clinical information to automatically sort images of bacterial culture plates, helping laboratory professionals streamline plate review while maintaining expert oversight.

The cleared intended use includes blood-based, chocolate and MacConkey agars, as well as CHROMagar orientation culture media plates, enabling semi-quantitative and qualitative image-based analysis through detection of microbial growth, estimation of colony counts, and differentiation of isolates based on phenotypic colony characteristics.

"This clearance represents a major milestone for Copan and microbiology laboratories in the United States," said Fabrizio Mazzocchi, CEO of Copan Diagnostics. "PhenoMATRIX builds on years of scientific development and real-world data to support laboratories and the critical work they do in patient care."

While PhenoMATRIX has been used globally for years as part of Copan's full laboratory automation solutions, including automated image review and auto-release workflows outside the United States, this clearance formally establishes its intended use in the U.S., where final image assessment and result decisions are performed by trained laboratory personnel.

Importantly, the FDA-cleared intended use represents an expansion beyond single-application algorithms, supporting multiple culture media plate types and integrating image analysis with patient data to assist laboratories in clinical microbiology review.

"This achievement is the result of an extraordinary collaborative effort," added Mario Savarese, CEO of Copan WASP, Copan's automation division. "Our Regulatory, R&D, Scientific Affairs, Quality, and Commercial teams worked tirelessly to support this submission. This clearance is a testament to their dedication and Copan's long-term vision."

Copan continues to invest in future submissions to expand the scope of PhenoMATRIX across additional applications and plate types, reinforcing its commitment to innovation and partnership with the clinical microbiology community.