FDA Clears Copan's PhenoMATRIX for Expanded Microbiology Uses

Automated image assessment software receives 510(k) clearance to support digital microbiology review across multiple culture media types.

Published on Feb. 20, 2026

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Copan Group announced that its PhenoMATRIX automated image assessment software, used with the company's WASPLab full laboratory automation system, has received FDA 510(k) clearance as a Class II medical device in the United States. The clearance expands the intended use of PhenoMATRIX to support digital microbiology review across multiple culture media types, including blood-based, chocolate and MacConkey agars, as well as CHROMagar orientation plates.

Why it matters

This FDA clearance represents a significant milestone for Copan and clinical microbiology laboratories in the U.S., as it formally establishes the intended use of PhenoMATRIX to assist laboratory professionals in streamlining plate review and maintaining expert oversight through the integration of image analysis and laboratory-defined rules.

The details

PhenoMATRIX uses artificial intelligence and laboratory-defined rules, along with clinical information, to automatically sort images of bacterial culture plates. The cleared intended use includes supporting semi-quantitative and qualitative image-based analysis through the detection of microbial growth, estimation of colony counts, and differentiation of isolates based on phenotypic colony characteristics. While PhenoMATRIX has been used globally as part of Copan's full laboratory automation solutions, this clearance formally establishes its intended use in the U.S., where final image assessment and result decisions are performed by trained laboratory personnel.

  • Copan Group announced the FDA 510(k) clearance on February 17, 2026.

The players

Copan Group

A leading manufacturer of collection and transport systems, including breakthrough technologies such as FLOQSwabs, ESwab, UTM Universal Transport Medium, and WASPLab full laboratory automation with artificial intelligence.

Fabrizio Mazzocchi

CEO of Copan Diagnostics.

Mario Savarese

CEO of Copan WASP, Copan's automation division.

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What they’re saying

“This clearance represents a major milestone for Copan and microbiology laboratories in the United States. PhenoMATRIX builds on years of scientific development and real-world data to support laboratories and the critical work they do in patient care.”

— Fabrizio Mazzocchi, CEO of Copan Diagnostics (PRNewswire)

“This achievement is the result of an extraordinary collaborative effort. 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.”

— Mario Savarese, CEO of Copan WASP (PRNewswire)

What’s next

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.

The takeaway

This FDA clearance for Copan's PhenoMATRIX software represents a significant advancement in digital microbiology review, enabling clinical laboratories in the U.S. to streamline plate assessment and maintain expert oversight through the integration of artificial intelligence and laboratory-defined rules.