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510(k) Data Aggregation

    K Number
    K251511

    Validate with FDA (Live)

    Device Name
    PhenoMATRIX
    Manufacturer
    Date Cleared
    2026-01-22

    (251 days)

    Product Code
    Regulation Number
    866.2190
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PhenoMATRIX is a WASPLab optional module intended for the automatic sorting of images of blood-based agar, chocolate agar, MacConkey agar, and CHROMagar Orientation culture media plates according to classification parameters based on Image Analysis Software results and clinical and demographic data.

    Image Analysis Software performs semi-quantitative and/or qualitative analysis of culture media plates by detecting microbial growth, estimating colony counts and differentiating isolates based on phenotypic colony characteristics.

    The system determines how the images should be sorted based on image analysis results in addition to patient data according to expert rules defined by the laboratory.

    All images shall be evaluated by trained personnel for final assessment and result definition.

    Device Description

    The PhenoMATRIX is an in vitro diagnostic software for automated classification of images of solid culture media plates streaked with microbiological samples derived from the human body.

    The PhenoMATRIX comprises software modules intended for image analysis and automatic classification of high-resolution digital images captured by WASPLab device for semi-quantitative and qualitative assessment of microbial growth.

    WLPostProcessing, its plugin and the Imaging Product SET perform microbial growth detection, colony counts estimations and isolates differentiation basing on phenotypic colony characteristics. The image analysis result is combined with LIS data (such as demographic data, clinical data and / or sample data) according to customizable logic rules defined by the laboratory, for image classification. The classification is used for image sorting into dedicated digital folders associated to suggested results.

    The PhenoMATRIX requires the WASPLab in order to operate. WASPLab is an in vitro diagnostic device for handling, incubation, digital imaging and sorting of agar culture plates.

    After PhenoMATRIX processing, the physical plates are left inside the WASPLab and images are available for digital inspection by the trained microbiologist through the WASPLab User Interface. The trained microbiologist shall assess the plate images in each digital classification folder. To each digital image a suggested result is assigned according to rules previously defined by the laboratory. The trained microbiologist reviews the plate images, folder by folder, and confirms (or changes) the assigned folder and result. After that, the plates follow the workflow that has been defined by the laboratory according to the assigned result.

    The main functionalities of PhenoMATRIX are:

    • Assignment of classification parameters to media plate images based on criteria defined by the user (e.g., LIS information, Image Analysis).
    • Result assignment according to the classification folder.
    • Visualization of media plate images in the WASPLab User Interface for digital inspection.

    All plate images shall be reviewed by trained microbiologist before any result definition.

    AI/ML Overview

    N/A

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