Copan’s PhenoMatrix software gets FDA 510(k) clearance

Feb. 23, 2026—Copan Group’s PhenoMatrix, an automated image assessment software used with the company’s WASPLab laboratory automation platform, received FDA 510(k) clearance as a class II device. 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. The cleared intended use includes blood-based, chocolate, and MacConkey agars, as well as ChroMagar orientation culture media plates. The system performs semiquantitative and qualitative image analysis to detect microbial growth, estimate colony counts, and differentiate isolates based on phenotypic colony characteristics.