PCR.AI supports all major real-time PCR instruments including Applied Biosystems, Bio-Rad, Qiagen, and Roche systems. The platform works with most commercial and laboratory-developed assays, including hydrolysis probe (TaqMan), intercalating dye (SYBR Green), and multiplexed assays. For specific compatibility questions, please contact our technical team.

The AI Analysis Engine component within PCR.AI is CE-IVDR & MHRA registered as a Class A medical device software. This component provides the automated interpretation of PCR results. The user interface and visualization components are non-medical device workflow components. This split architecture gives laboratories flexibility in how they implement PCR.AI within their quality systems.

PCR.AI's AI Analysis Engine has demonstrated >99.9% interpretation accuracy in clinical validation studies conducted with major reference laboratories. This performance has been validated across multiple assay types, instruments, and laboratory settings. The system's neural networks have been trained on millions of PCR curves representing diverse real-world scenarios.

PCR.AI supports laboratory accreditation by providing comprehensive documentation of analysis methods, automated quality controls, complete audit trails, and standardized reporting. The system reduces subjective interpretation, ensures consistent application of acceptance criteria, and provides evidence of compliance with defined procedures—all key factors in meeting ISO 15189, CAP, and CLIA requirements.

PCR.AI provides validation support appropriate to each tier. All customers receive access to our Validation Guide and standard IQ/OQ/PQ protocols. Enterprise customers receive additional validation assistance including custom protocol development and on-site validation support. OEM Partners receive comprehensive regulatory documentation designed to support manufacturer validation activities.

Yes, PCR.AI is designed to be included within a laboratory's accreditation scope. We provide the necessary documentation to support method validation, including technical specifications, performance characteristics, and quality control procedures. Many accredited laboratories have successfully included PCR.AI in their ISO 15189, CAP, and CLIA accreditations.

All customers can submit feature requests through our support portal where they are reviewed by our product team. Enterprise customers have additional channels through their Technical Account Managers, with priority enhancement requests incorporated into our development roadmap. OEM Partners can discuss custom development needs through their partnership manager.