Last updated: June 14, 2026
Back to directoryFDA-cleared automated culture plate reader from Clever Culture Systems, distributed by Thermo Fisher in the U.S. and Europe, using AI algorithms for microbiology plate triage.
Microbiology labs that want a focused AI culture plate reader for urine or other authorized modules with documented validation and qualified review.
Compare within workflow: Laboratory and hematology diagnostics · comparison shortlist · source index
| Status | FDA K183648 source describes APAS Independence and urine analysis module; Clever Culture Systems also cites CE and TGA clearances for applicable markets. |
|---|---|
| Review route | FDA 510(k), CE/TGA/local authorization, module labeling, and laboratory validation |
| Intended use | Automated imaging and interpretation of microbial colonies on solid culture media for authorized modules and qualified laboratory workflows. |
| Verification note | Confirm module, media, specimen type, software version, distributor, clinical or pharma use, and auto-release boundaries. |
| Source | www.accessdata.fda.gov / cdrh_docs / pdf18 |
Product-specific review. These product-specific signals summarize what the cited sources imply before treating APAS Independence as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Verify FDA K183648 or relevant local authorization, module, media, specimen type, clinical versus environmental-monitoring use, and distributor labeling before relying on APAS outputs. |
|---|---|
| Privacy | Review plate image retention, patient or sample identifiers, APAS Web User Interface, LIMS/LIS integration, audit logs, user roles, remote review, backup options, service access, and data-transfer terms. |
| Evidence | Validate APAS performance with local media, specimen mix, incubation protocols, organism prevalence, colony counts, negative-release rules, microbiologist review, and quality or clinical reporting requirements. |
| Workflow | Best governed as AI culture plate triage with qualified laboratory review, documented validation, controlled auto-release rules where authorized, data-integrity controls, and ongoing performance monitoring. |
Thermo Fisher describes APAS Independence as an in-vitro diagnostic instrument for automated imaging, analysis, and interpretation of agar culture plates using APAS imaging technology and AI algorithms; Clever Culture Systems describes APAS as AI-powered microbiology automation with FDA, CE, and TGA regulatory clearances and scientific validation materials.
Not for: Unsupported culture media, autonomous release outside validated rules, replacing microbiologists, or assuming all clinical and pharma modules carry the same regulatory authorization.
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
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