Roche Digital Pathology Dx

Roche Digital Pathology Dx is an automated whole slide imaging system that creates, views, and manages digital images of pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue. It is intended as an aid to pathologists in reviewing and interpreting scanned surgical pathology slides by conventional light microscopy, and is not intended for frozen sections, cytology, or non-FFPE hematopathology specimens.

The candidate device adds a new VENTANA DP 600 slide scanner (240-slide capacity via 40 trays) alongside the existing VENTANA DP 200 scanner (6-slide single tray). Both scanners share an identical Image Acquisition Unit (IAU) and use the same Roche uPath enterprise software and ASUS PA248QV display. Both scanners support 20x and 40x magnification, automated barcode reading, and output in BIF format with embedded ICC color profiles.

EN 61326-1:2013, IEC 61010-1, IEC 62368-1, EN 61000-4, EN 55011:2016 for electromagnetic compatibility testing. The submission also references the FDA's Technical Performance Assessment (TPA) guidance document 'Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices' (April 20, 2016).

The VENTANA DP 600 and DP 200 scanners are substantially equivalent because they share an identical Image Acquisition Unit (IAU)—the hardware and software components that directly affect pixel values and image quality. The DP 600 differs only in slide capacity and workflow-support components (tray storage, slide loading mechanism, frames), which do not impact image acquisition. Performance data collected on the DP 200 predicate device therefore applies directly to the DP 600. Human factors analysis showed no new risks or high-level workflow differences despite minor UI terminology and appearance changes. Clinical performance does not require additional testing since the image output and intended use remain unchanged.