The clearance includes a Predetermined Change Control Plan to streamline future updates for the Concentriq AP-Dx system.
Proscia received a new 510(k) clearance from the Food and Drug Administration (FDA) for its Concentriq AP-Dx digital pathology platform. The clearance includes compatibility with the Leica Aperio GT 450 DX slide scanner, cloud deployment, and a Predetermined Change Control Plan (PCCP), according to a company release.
The PCCP provides the company with a pathway to expand the platform’s interoperability while maintaining regulatory oversight. This plan enables Proscia to validate and implement support for additional FDA-cleared scanners, image formats, and displays without requiring further 510(k) submissions, according to the company.
Concentriq AP-Dx is a digital pathology platform used for primary diagnosis in laboratories of all sizes. It initially received FDA 510(k) clearance for primary diagnosis with the Hamamatsu NanoZoomer S360MD slide scanner in February 2024 and is also CE-marked under In Vitro Diagnostic Regulation, according to the release.
“Laboratories choose a digital pathology platform with the expectation that it will sit at the center of their practice for years to come,” says Ian Cadieux, head of quality and regulatory at Proscia, in a release. “The PCCP helps us to protect that investment, giving customers confidence that Concentriq AP-Dx will continue to be an interoperable foundation as their needs evolve.”
Meeting Rising Diagnostic Needs
The American Cancer Society projects more than 2.1 million Americans will be diagnosed with cancer this year, which may increase pressure on a declining pathologist workforce, according to the source material. Laboratories are increasingly using digital pathology to keep pace with diagnostic demand and require flexibility to adopt technologies outside of proprietary ecosystems, according to Proscia.
The company earned the top score for supporting customer integration goals and the highest overall performance score in the KLAS Research Digital Pathology 2026 report on the US market, according to the company. Proscia currently serves diagnostic laboratories that manage 12 million patient cases annually, as well as 16 of the top 20 pharmaceutical companies.
Photo caption: Concentriq AP-Dx digital pathology platform
Photo provided; Proscia
