Bedford, Mass., Dec. 21, 2015 /PRNewswire/ — Instrumentation Laboratory (IL) today announced the 510(k) clearance of their latest innovation, the ACL TOP Family 50 Series Hemostasis Testing Systems, by the US Food and Drug Administration (FDA). 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. Commercialization in the US will commence in 2016.
The ACL TOP Family 50 Series systems offer 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, icterus and lipemia. Additionally, the new systems offer enhanced laboratory accreditation tools to automate documentation for compliance with quality standards.
“This is a major milestone for Hemostasis laboratory testing. New ACL TOP Family 50 Series systems are designed to address the key challenges healthcare providers face today: improve patient care, improve patient satisfaction, and reduce total cost of care,” said Giovanni Russi, VP of Worldwide Marketing at IL. “Now, IL can offer laboratories a complete and standardized hemostasis testing solution that automates pre-analytical sample checks, and provides greater confidence in test results, lowers risk of clinical errors, and reduces unnecessary patient sample redraws.”
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.
Instrumentation Laboratory Receives Clearance from US FDA for New ACL TOP Family 50 Series Hemostasis Systems in Selected Territories
IL initiated commercialization of the new ACL TOP Family 50 Series systems in Europe upon receiving the European CE IVD Mark, in late 2014. Since then, the systems have been introduced in Japan, South Korea, Australia and other international territories.
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.
Complementing the new ACL TOP Family 50 Series is the Company’s comprehensive HemosIL® assay menu. IL offers a complete line of general screening and specialty testing assays for the diagnosis and management of bleeding and thrombotic disorders.
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, Icterus or Lipemia. 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.
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, MA, USA.
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 StatesPatent 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
Instrumentation Laboratory Receives US FDA Clearance For New ACL TOP® Family 50 Series Hemostasis Testing Systems