# K251511: PhenoMATRIX

- Pathway: 510(k) (Traditional)
- Applicant: Copan Wasp Srl
- Decided: Jan 22, 2026 after 251 days
- Product code: PPU (Microbial Colony Image Assessment System)
- Device class: 2
- Regulation: 21 CFR 866.2190
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN150059 (2016). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183648: APAS Independence with Urine Analysis Module, Clever Culture Systems AG (2019). Our reading of the summary gave K183640, FDA’s number for Cellvizio 100 Series Confocal laser Imaging systems and… (Mauna Kea Technologies). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “APAS Indipendence with Urine Analysis Module”. Summary page 8.
- K200839: APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module, Clever Culture Systems (2021) Summary page 6.

## Indications for 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.

Source page: https://510kreport.com/device/K251511
Methodology: https://510kreport.com/methodology