Microbiology · 510(k) · 2026
PhenoMATRIX
Copan Wasp Srl. Cleared by FDA on 22 January 2026 under submission K251511, product code PPU (microbial colony image assessment system). What FDA's record says, in FDA's words.
Device record · K251511
- Device. PhenoMATRIXDEVICE
- Company. Copan Wasp Srl (IT)COMPANY
- Decision. 22 January 2026, 510(k), substantially equivalent (traditional review); received 16 May 2025DECISION
- Panel. MicrobiologyPANEL
- Product code. PPU, Microbial Colony Image Assessment SystemCODE
- Regulation. 21 CFR 866.2190, Class IIREG
- Source. FDA database entry · decision document (17 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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.
The product code's definition, from FDA's classification record. A microbial colony image assessment system is an instrument that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, phenotypic and morphologic characteristics. This device type provides a semi-quantitative assessment of colony counts that are used as an aid in the diagnosis of urinary tract infection. All urine culture plates that are identified as positive for growth by the APAS Compact, when using its urine analysis module, must be reviewed by a trained microbiologist.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code PPU. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code PPU, in Microbiology, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.