Sysmex XR-Series (XR-10) Automated Hematology Analyzer

The Sysmex XR-Series (XR-10) is a quantitative multi-parameter automated hematology analyzer for in vitro diagnostic use in clinical laboratories. It analyzes whole blood and body fluid samples (cerebrospinal fluid, peritoneal, pleural, and synovial fluids) to measure and classify blood cells and various hematologic parameters.

The XR-10 uses RF/DC detection, sheath flow DC detection, and flow cytometry with a semiconductor laser for cell analysis. Key differences from the predicate (XN-20): the XR-10 lacks the WPC measuring channel and WPC reagents, uses Lysercell WDF II instead of Lysercell WDF and WPC lyse reagents, and achieves 110 samples/hour throughput versus the XN-20's 100 samples/hour. All other reagents, controls, calibrators, analysis modes, and software specifications remain identical.

CLSI EP05-A3 (precision/repeatability), CLSI EP06-ED2:2020 (linearity), CLSI H26-A2 (carryover), and CLSI EP09-A3 (matrix/bridging studies). Testing followed these approved guidelines for analytical validation.

The XR-10 and predicate XN-20 share identical intended use, measurement principles (Hydro Dynamic Focusing and flow cytometry with SLS-hemoglobin), parameters, reagents, controls, analysis modes, and sample aspiration pathways. Method comparison studies on 865 whole blood and 397 body fluid samples demonstrated excellent correlation (r ≥0.93 for most parameters) and minimal bias with the XN-20. The removal of the WPC channel and reagents does not impact the claimed parameters or safety/effectiveness. Precision, linearity, interference, stability, and clinical sensitivity/specificity testing all met predefined acceptance criteria, with performance comparable to the predicate.