BEDFORD, Mass., Nov. 2, 2015 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced the full commercialization of their latest innovation, the ACL TOP Family 50 Series Hemostasis Testing Systems throughout Europe, Japan, South Korea, Australia and other selected international territories.* Designed for mid- to-high-volume clinical laboratories, including those using Lab Automation tracks, the ACL TOP Family 50 Series Systems represent a true breakthrough in Hemostasis Quality Management for routine and specialty testing.
Leaping past competitive offerings, the ACL TOP Family 50 Series offers unprecedented pre-analytical quality assurance, risk- management and laboratory accreditation benefits. Automated pre-analytical sample integrity checks identify under-filled sample tubes, abnormal sample aspiration potentially caused by clots, and assay-specific interference from hemolysis, lipemia and bilirubin. Additionally, the Systems offer enhanced laboratory accreditation tools to automate documentation for compliance with quality standards.
"Our ACL TOP Family 50 Series systems are designed to address the three core challenges healthcare systems around the world face today: improve patient care, improve patient satisfaction, and reduce costs," said Giovanni Russi, VP of Worldwide Marketing at IL. "New pre-analytical sample integrity checks provide greater confidence in test results, lower risk of clinical errors, reduce unnecessary patient sample redraws and ultimately, enhance efficiency. Coupled with new quality assurance features and all the benefits of our original ACL TOP platform, customers now have a flexible, standardized and efficient approach to directly address their most pressing challenges. "
The ACL TOP Family 50 Series is a true standardized platform comprised of five models: ACL TOP 750 and ACL TOP 750 CTS with closed-tube sampling (CTS) for high volume labs, ACL TOP 750 LAS for lab automation tracks, ACL TOP 550 CTS for mid-high volume labs, and ACL TOP 350 CTS for mid-sized labs. All models offer the same superior performance and usability throughout the entire testing process.
Upon receiving the European CE IVD Mark under the European Directive on in vitro Diagnostic Medical Devices in late 2014, IL initiated commercialization of the systems in the Western Europe. Now, commercialization will expand to other international territories, following a phased global process. The ACL TOP Family 50 Series is not yet 510(k)-cleared by the US FDA and is not currently available in North America.
Complementing the new ACL TOP Family 50 Series is the Company's comprehensive HemosIL® assay menu. In addition to tests for general screening, HemosIL D-Dimer assays for the exclusion of Venous Thromboembolism and HemosIL Liquid Anti-Xa assay for monitoring Heparin treatment, IL offers a complete line of Specialty testing assays for the diagnosis and management of bleeding and thrombotic disorders.
The ACL TOP Family remains the most advanced and successful Hemostasis testing platform in the world today. The addition of the new ACL TOP Family 50 Series systems to the IL portfolio will further strengthen their franchise and ensure the Company's leadership position in Hemostasis diagnostics in the future.
About Pre-analytical errors
Published studies estimate that pre-analytical variables may account for up to 75% of the laboratory test errors.1 Pre-analytical errors are often associated with undetected under-filled sample tubes, presence of clots, and of excessive levels of Hemolysis, Lipemia or Bilirubin. The automation of pre-analytical sample checks has the potential to enhance the efficiency and the accuracy in identifying affected samples and to reduce the rate of unnecessary sample rejections. This provides tremendous value in minimizing errors and enhancing quality.
*Not currently FDA 510(k) cleared. Not available in all countries.
1 S. Green. The cost of poor blood specimen quality and errors in preanalytical processes. Clinical Biochemistry. 2013;46:1175-9.
Instrumentation Laboratory (www.instrumentationlaboratory.com), founded in 1959, is a worldwide developer, manufacturer and distributor of in vitro diagnostic instruments, related reagents and controls for use primarily in hospitals and independent clinical laboratories. The Company's product lines include Critical Care systems, Hemostasis systems and Information Management systems. GEM® product offerings, part of the Critical Care line, include the GEM Premier™ 4000 analyzer with Intelligent Quality Management (iQM®), GEM Premier 3500 and GEMweb® Plus Custom Connectivity. The IL Hemostasis portfolio includes the ACL TOP® Family of Hemostasis Testing Systems, fully automated, high-productivity analyzers, comprised of the ACL TOP 700, ACL TOP 700 LAS, ACL TOP 700 CTS, ACL TOP 500 CTS and ACL TOP 300 CTS and new ACL TOP 750, ACL TOP 750 LAS, ACL TOP 750 CTS, ACL TOP 550 CTS and ACL TOP 350 CTS systems. IL also offers the ACL AcuStar®, ACL ELITE®, and other Hemostasis analyzers, along with the comprehensive HemosIL® line of reagents. IL is based in Bedford, Massachusetts.
The Instrumentation Laboratory logo, HemosIL, ACL, ACL TOP, ACL ELITE, ACL AcuStar and Premier are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies, and may be registered in the United States Patent and Trademark Office and in other jurisdictions. All other product names, company names, marks, logos, and symbols are trademarks of their respective owners.
SOURCE Instrumentation Laboratory