X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application

The X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application is a digital cell morphology system that automatically locates and displays high-resolution images of white blood cells, red blood cells, and platelets from fixed and stained blood smears. It assists qualified technologists in conducting WBC differentials, RBC morphology evaluation, and platelet estimates for in vitro diagnostic use.

The device uses fully automated scanning and image acquisition to capture multiple images under varying illumination conditions, reconstructing 100X magnification images without immersion oil. The modification adds decision support system (DSS) features: system-suggested RBC morphological pre-gradings shown with dotted lines around selection boxes, and system-suggested platelet clump detection indicators. Critically, users must actively confirm or adjust all suggestions; the system does not auto-populate final results.

CLSI EP05-A3 (Evaluation of Precision of Quantitative Measurement Procedures) was used for repeatability and reproducibility studies. FDA's Guidance for the Content of Premarket Submission for Software Contained in Medical Devices (June 14, 2023) was applied for software verification and validation testing at the Basic Documentation Level.

The modified device is substantially equivalent because it retains identical intended use, intended user population, sample type, and core analysis techniques as the predicate (K201301, K220013). The sole technological difference—addition of DSS suggestions for RBC morphology and platelet clumping—does not change safety or effectiveness since users retain full manual control and must actively confirm all grading decisions, preserving the cleared workflow. Method comparison testing on 1200 slides and precision studies demonstrated performance meeting pre-defined acceptance criteria across all RBC and platelet parameters.