UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

The UniCel DxH 800 COULTER Cellular Analysis System is an automated hematology analyzer for in vitro diagnostic screening in clinical laboratories, providing comprehensive analysis of whole blood and body fluids. It utilizes the Coulter Principle for cell counting and sizing, and VCSn technology for advanced differential, nucleated red blood cell, and reticulocyte characterization based on volume, conductivity, and light scatter measurements.

The UniCel® DxH 800 COULTER® Cellular Analysis System, featuring software version 2.0, is an automated, quantitative multi-parameter hematology analyzer designed for in vitro diagnostic use in clinical laboratories. Its primary function is to perform comprehensive hematological analysis, including complete blood counts (CBC), leukocyte differentials, nucleated red blood cell (NRBC) enumeration, and reticulocyte analysis on various sample types such as whole blood (venous and capillary, including pre-diluted forms). The system also extends its capabilities to enumerate Total Nucleated Cells (TNC) and Red Blood Cells (RBC) in body fluids like cerebrospinal, serous, and synovial fluids. It is intended to assist clinicians by differentiating patients with normal hematological profiles from those who may require additional diagnostic studies. The DxH 800 employs established scientific principles for its analyses. It utilizes the Coulter Principle, an electrical impedance-based method, for counting and sizing cells, where particles passing through an aperture generate electrical pulses proportional to their volume. Hemoglobin concentration is determined photometrically at 525 nm following red blood cell lysis. For detailed analysis of white blood cell differentials, NRBCs, and reticulocytes, the system incorporates COULTER® VCSn technology. This technology measures cell volume (V), conductivity (C), and light scatter (Sn) characteristics using a diode laser as cells pass through a flow cell. The system architecture includes a Specimen Processing Module (SPM) for automated sample handling, mixing, and reagent incubation; a System Manager (a PC-based workstation) for operational control, data processing, and results management; a Pneumatic Supply Module; and a suite of dedicated reagents, controls, and calibrators. It offers flexibility through various test panels and sampling methods, including automated cassette loading and manual single tube (open or closed vial) options.

AI Regulatory Concerns

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• Q1. What are the specific performance characteristics (e.g., accuracy, precision, linearity) of the UniCel DxH 800 for each reported parameter, particularly for samples with very low or high cell counts?; How does the VCSn technology specifically differentiate between the five white blood cell types and identify NRBCs, and what are its limitations when analyzing samples with atypical or immature cell populations?; What are the daily, weekly, and monthly maintenance requirements for the UniCel DxH 800 system, and how does software version 2.0 specifically enhance usability or error handling compared to previous versions?; What is the effective throughput of the analyzer (samples per hour) when processing common test panel combinations, such as CBC with differential and reticulocytes, including any associated sample preparation time?; How does the system detect and flag potential interferences from common substances like lipemia, icterus, or hemolysis, and what is the impact of these interferences on the accuracy of reported parameters?