Siemens Healthcare announces the FDA 510(k) clearance of the globally proven Sysmex CS-5100 System. This hemostasis system was the first to market with PSI technology globally and is now available to Siemens' US customers.

The first analyzer in the Sysmex CS System portfolio of hemostasis solutions in the United States, this system is equipped with simultaneous multi-wavelength Preanalytical Sample Integrity checks, or PSI technology, enabling high-volume laboratories to achieve first-run accuracy.

Leveraging globally proven PSI technology, the Sysmex CS-5100 System enables laboratories to automate and standardize sample management and detect unsuitable samples prior to analysis. This enhances the reliability of results while improving efficiency by minimizing the need for manual sample inspections. 

"This new technology provides a strong operational advantage to customers, as they no longer need to manually inspect patient samples to ensure the correct volume prior to analysis," said Mr Franz Walt, president, Laboratory Diagnostics, Siemens Healthcare. "Available both as a stand-alone or complete workflow solution with connectivity to automation, the Sysmex CS-5100 System has the flexibility to meet varying testing-volume requirements."

The Sysmex CS-5100 System also features third-generation cap-piercing technology, which contributes to reduced sample-processing time and maintains the analyzer's high-throughput capability.

Further, greater efficiency is gained via a wide optical spectrum, which allows clotting, chromogenic, immunologic, and aggregation testing capabilities on a single platform. With onboard capacity of up to 3000 tests and up to 40 reagents, the Sysmex CS-5100 System delivers extended walkway time to streamline workflow.

To better ensure consistency of results and simplify testing in multisite labs, test results from the Sysmex CS-5100 System correlate with all other Sysmex CS and CA hemostasis systems. Additionally, the Sysmex CS-5100 System uses the same reagents, controls, and calibrators as other coagulation analyzers offered by Siemens.