Flow Cytometer Cleared for Diagnostic Use

The US Food and Drug Administration (FDA) has cleared a flow cytometry system for in vitro diagnostic use by immunophenotyping. With superior detection capabilities, it provides accurate measurements, including for rare events critical to clinical diagnosis and monitoring.

The “Navios” flow cytometry system from Beckman Coulter Life Sciences (Brea, CA, USA) has received 510(k) clearance from the US FDA for in vitro diagnostic use. It has also received an Import Medical Device Registration Certificate from the China FDA. This clinical system provides analytical excellence by coupling extraordinary sensitivity, resolution, and dynamic range with high-speed data collection.

Ready to use, preoptimized CYTO-STAT tetraCHROME reagents make sample preparation easy. A no-wash protocol reduces sample handling and increases laboratory safety. The Navios Tetra system, for simultaneous identification and enumeration of T, B, and NK lymphocytes in whole blood, provides an easy-to-use solution for multicolor flow cytometric analysis of lymphocyte subsets as well as CD4+ and CD8+ T cell subsets ratios.

Navios software reports cellular characteristics such as size, granularity, and phenotype, and combines data in one automated, customized report with plots and formulas. A variety of reporting options are available. Easy integration with a variety of automated preparation devices and LIS-readiness offers secure, high-throughput results, even at high volumes.

Navios is optimized for signal to noise resolution and its quick and easy setup of automated walk-away processing improves workflow while its remote diagnostics reduces downtime and increases lab productivity. Patented electronics provide accurate and efficient digital signal processing at high event rates over a wide dynamic range of fluorescence intensities. These benefits are packaged in a compact analyzer that delivers stable performance over long periods of time and across a wide range of operating temperatures.

In the USA, the Navios flow cytometer is currently cleared for clinical immunophenotyping in conjunction with proprietary Navios Tetra software and CYTO-STAT tetraCHROME reagents. In the USA, all other uses are currently for research only. The Navios has additional capabilities to meet expanded (e.g., research) needs. It incorporates 12 detectors—10 fluorescence detectors and 2 light scattering detectors. Simultaneous measurements of integral, peak, and width are available for all scatter measurements and up to 10 fluorescent parameters.

According to Mario Koksch, vice president of Beckman Coulter Life Sciences’ Flow Cytometry Business Unit, “Every aspect of the optics design of Navios increases application performance, sensitivity, and resolution. These systems enhance flow laboratory efficiency by increasing productivity and improving the reliability and reproducibility of results, thus reducing the cost of flow cytometry testing.”

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Beckman Coulter Life Sciences