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Last updated: June 14, 2026
Back to directoryCopan PhenoMATRIX medical AI product profile
FDA-cleared digital microbiology AI software that helps analyze and sort culture plate images with LIS-linked rules while preserving qualified-laboratory review.
Laboratory and hematology diagnostics
Best fit
Microbiology labs using or evaluating WASPLab workflows that need AI-assisted culture plate triage, standardized review queues, and documented technologist oversight.
- Primary use case
- AI-assisted digital microbiology plate image assessment, culture sorting, colony feature analysis, LIS-linked rules, and WASPLab workflow support
- Audience
- Clinical microbiology laboratories, hospital labs, reference labs, microbiology directors, medical laboratory scientists, and lab automation teams
- Risk level
- High
- Pricing signal
- Software, WASPLab, module, media, service, validation, distributor, and regulatory configuration pricing is not public; request current terms.
- Official sources
- 5 official sources
Compare within workflow: Laboratory and hematology diagnostics · comparison shortlist · source index
Regulatory snapshot
| Status | Copan reports FDA 510(k) K251511 clearance for PhenoMATRIX as a Class II device; verify exact cleared functions and local authorization. |
|---|---|
| Review route | FDA 510(k), module labeling, local IVD authorization, and laboratory validation |
| Intended use | AI-assisted assessment and sorting of digital microbiology culture plate images using laboratory-defined rules and professional oversight. |
| Verification note | Confirm package, media, module, auto-release status, TAG status, software version, and qualified-review requirements. |
| Source | www.copanusa.com / company-news / phenomatrix-receives-fda-510k-clearance-advancing-digital-microbiology-with-confidence |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Copan PhenoMATRIX as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Verify FDA K251511, exact package, media, organism workflow, auto-release status, TAG functionality, software version, and local authorization before using AI outputs for clinical culture reporting. |
|---|---|
| Privacy | Review WASPLab and PhenoMATRIX image storage, LIS-linked context, patient identifiers, access controls, audit logs, support access, retention, backups, exports, and data-processing terms. |
| Evidence | Validate against local plate media, incubation timing, specimen sources, organism prevalence, colony morphology, negative-rate assumptions, technologist review patterns, and downstream ID/AST workflow. |
| Workflow | Best governed as qualified-laboratory culture plate triage with lab-defined rules, documented validation, human review for consequential results, exception queues, and periodic performance monitoring. |
Where Copan PhenoMATRIX fits
Copan describes PhenoMATRIX as AI software for digital microbiology that combines image assessment, LIS-linked clinical context, and laboratory-defined rules to support standardized culture plate workflows. Copan's 2026 FDA-clearance materials state PhenoMATRIX received 510(k) clearance as a Class II device, while product materials note that some additional functions may not be FDA-cleared.
Not for: Autonomous microbiology diagnosis, assuming every PhenoMATRIX module is FDA-cleared, unvalidated auto-release, or use without laboratory-defined rules and qualified review.
What to verify before using Copan PhenoMATRIX
- Which PhenoMATRIX package and module are in scope: Essentials, Select, Plus, Auto-Release, TAG, media type, organism workflow, and FDA-cleared versus uncleared functionality.
- FDA 510(k), local authorization, intended culture media, plate type, LIS context, laboratory rules, and whether auto-release is permitted in the target market.
- How digital plate images, patient identifiers, LIS-linked clinical context, audit logs, user actions, support access, exports, retention, and cybersecurity are handled.
- Local validation for growth detection, colony counts, morphology, media, incubation timing, organism mix, negative-release rules, technologist review, and ID/AST handoff.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.copanusa.com / laboratory-automation / microbiology-laboratory-automation-ai
- www.copanusa.com / company-news / phenomatrix-receives-fda-510k-clearance-advancing-digital-microbiology-with-confidence
- www.copangroup.com / product-ranges / phenomatrix
- www.copanusa.com / laboratory-automation / microbiology-laboratory-automation-ai
- www.copanusa.com / laboratory-automation / microbiology-laboratory-automation-ai
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