FDA Clears Siemens’ New High-volume Coagulation Analyzer
Jan 13, 2016
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’ U.S. customers. The Sysmex CS-5100 System enables automated, standardized sample management as well as automated detection of unsuitable samples. 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.
Preanalytical errors and unsuitable samples account for up to 70% of mistakes in laboratory diagnostics.1 For example, in coagulation testing, under-filling sample tubes may cause significant sample dilution and provide falsely prolonged clotting times.2 The effect of laboratory diagnostic errors on patient care is potentially significant, since information provided by clinical laboratories impacts up to 60–70% of clinical decisions.3
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.
To date, the system has been well-received in laboratories outside the U.S. Dr. Lee-Ann Lambert of Brant Community Healthcare System (BCHS) in Brantford, Ontario, Canada, reports that the Sysmex CS-5100 System began paying dividends from the moment the analyzer went into service. According to Dr. Lambert, “The system validated itself right out of the gate” by detecting insufficient volumes on its first day in the BCHS lab.
The Sysmex CS-5100 System also helps labs streamline workflows with its ability to connect to Siemens’ automation and data-management offerings, including the flexible, track-based Aptio Automation and ADVIA LabCell automation solutions. Siemens is the only single-source provider of complete automation solutions in all four core laboratory disciplines: hemostasis, hematology, chemistry, and immunoassay.
“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 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 aggregation4 testing capabilities on a single platform. With onboard capacity of up to 3000 tests5 and up to 40 reagents, the Sysmex CS-5100 System delivers extended walkway time to streamline workflow.
“U.S. healthcare providers have experienced seismic shifts due to the implementation of the Affordable Care Act and reimbursement cuts. In response, laboratories must be more cost-effective in delivering timely, accurate results for a steadily increasing volume of patient tests,” said Jack Kenny, Senior Vice President, Laboratory Diagnostics, Siemens Healthcare, North America. “The Sysmex CS-5100 System enables customers to confidently achieve higher throughput while improving accuracy.”
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.
For more information about the Sysmex CS-5100 System, please visit http://usa.healthcare.siemens.com/hemostasis/systems/sysmex-cs-5100-system.
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The products/features mentioned here are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Further details are available from the local Siemens organizations.
Siemens AG (Berlin and Munich) is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. The company is active in more than 200 countries, focusing on the areas of electrification, automation and digitalization. One of the world's largest producers of energy-efficient, resource-saving technologies, Siemens is No. 1 in offshore wind turbine construction, a leading supplier of combined cycle turbines for power generation, a major provider of power transmission solutions and a pioneer in infrastructure solutions as well as automation, drive and software solutions for industry. The company is also a leading provider of medical imaging equipment – such as computed tomography and magnetic resonance imaging systems – and a leader in laboratory diagnostics as well as clinical IT. In fiscal 2014, which ended on September 30, 2014, Siemens generated revenue from continuing operations of €71.9 billion and net income of €5.5 billion. At the end of September 2014, the company had around 343,000 employees worldwide on a continuing basis. Further information is available on the Internet at http://www.siemens.com.
1Lippi G, Banfi G, Buttarello M, et al. Recommendations for detection and management of unsuitable samples in clinical laboratories. Clin Chem Lab Med. 2007;45(6):728-736.
2Favaloro E, Lippi G, Adcock D. Preanalytical and postanalytical variables: the leading causes of diagnostic error in hemostasis? Semin Thromb Hemost. 2008;34:612-634.
3LLopis MA, Alvarez V, Martínez-Brú C, Gómez R, Barba N, Ibarz M, Cortés M, Ventura M, M. Alsina MJ. Applications and experiences of quality control. Ognyan Ivanov (Ed.): InTech; 2011. Chapter 9, Quality assurance in the preanalytical phase. Available from: http://www.intechopen.com/books/applications-and-experiences-of-qualitycontrol/quality-assurance-in-the-preanalytical-phase
4This product feature is still under development and not yet commercially available. Its future availability cannot be ensured.
5Based on internal validation data from Sysmex Corporation.