PhenoMATRIX

PhenoMATRIX is an in vitro diagnostic software module for the WASPLab system that automatically sorts and classifies digital images of culture plates (blood-based agar, chocolate agar, MacConkey agar, and CHROMagar Orientation) based on microbial growth detection, colony counting, and phenotypic characteristics. The system combines image analysis results with patient demographic and clinical data using laboratory-defined rules to organize plate images into folders, with all images requiring final review and assessment by trained microbiologists.

PhenoMATRIX is installed on the WASPLab Control Unit and performs semi-quantitative and qualitative analysis of microbial colonies on solid culture media. Key technological similarities to predicates include: use of automated imaging and image analysis software, integration with LIS data, and classification of plates based on growth detection and morphological characteristics. A primary difference is that PhenoMATRIX requires review of all digital images by trained personnel, whereas predicate devices automatically manage negative results without mandatory review.

Not stated in this summary.

PhenoMATRIX is substantially equivalent to APAS Independence predicate devices (K183640, K200839) because both are Class II automated image assessment systems for microbial colonies on solid culture media with the same regulation (21 CFR 866.2190). Both devices perform semi-quantitative/qualitative analysis, detect microbial growth and morphology, integrate with LIS data, and require trained microbiologist review of positive/suspicious results. The differences in specimen types and review requirements do not change or expand the fundamental intended use, as all products support diagnosis of microbial infections through automated plate imaging and analysis.