PhenoMATRIX sorted culture plate images with few missed growths

In clinical studies at three US laboratories that FDA reviewed, PhenoMATRIX had false positive rates of 1.0-1.3% and false negative rates of 0.1-0.5% against technicians.

  • Not rated an organization

    The study measured agreement with technicians' reads, and the summary reports no time saved or result changed at any laboratory.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Intended benefit.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

Experienced technicians reading the same digital plate images. Measured.

The system’s part
Not isolated. The study compared the software's reads with experienced technicians' reads of the same images. It did not compare laboratory work with and without the software. The summary describes image analysis software but does not say whether it learned from data.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

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Benefit type
Repetitive Task Automation
System
PhenoMATRIX
Made by
Copan WASP S.r.l.
Used by
Three US clinical microbiology laboratories in the clinical study
Where
Three clinical laboratories, United States
Stage
Tested in a laboratory
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Identifying Objects, Actions, and Events, Processing Information
Collections
Scrutiny and findings, Cross-border records
Last revised
31 October 2026

Sources

  1. Regulatory document, by authors with no tie to the system.

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. 510(k) substantial equivalence determination decision summary for PhenoMATRIX (K251511). Cleared 2026-01-22.

    In the clinical studies, growth detection and morphological interpretation false positive rates ranged from 1.0-1.3% and false negative rates ranged from 0.1-0.5%. These data demonstrate that the PhenoMATRIX can accurately identify colony growth and morphology across the range of colony sizes and morphologies expected during routine clinical use.

Details

AI system

Workflow

Plates were incubated and imaged inside the WASPLab system. Expert rules defined by the laboratory combined the image analysis results with patient data to sort the images.

Follow-up

Conditions for replication

Trained personnel evaluate every plate image before a result is reported. The plates use blood-based, chocolate, MacConkey or CHROMagar Orientation media.

Entry details

Sector

Healthcare.

Purpose

Copan WASP built PhenoMATRIX to analyze culture plate images on the WASPLab system and sort them by growth and colony type for review by trained personnel.

Not yet checked: model, release, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.

Cite this record

Peter H. Vartanian. (2026). PhenoMATRIX sorted culture plate images with few missed growths (AIBD-0800). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0800.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

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