BEDFORD, Mass., May 5 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced that it has received FDA clearance 510(k) for the ACL AcuStar Hemostasis Testing System. This clearance allows IL to market the ACL AcuStar Hemostasis Testing System, which will commence in Europe.
The ACL AcuStar is the first specialty-test analyzer that offers full automation of highly sensitive immunoassays for the hemostasis lab. Labor-intensive specialty tests that previously required specialized training and up to two hours to perform, can now be performed in as little as 25 minutes, with no special training required.
Additionally, the ACL AcuStar is the first hemostasis analyzer to incorporate chemiluminescence technology, broadly considered the most accurate and sensitive method for routine immunoassay testing. And, all of the reagents necessary for testing are packaged in a proprietary ready-to-use cartridge, greatly simplifying operations.
“In today’s busy hemostasis lab, saving staff time is key. The ACL AcuStar offers full automation of specialty tests, that, until now, required highly trained lab personnel and a significant investment of time,” said Remo Tazzi, Director of Marketing, Hemostasis Instruments at Instrumentation Laboratory. “At IL, we are constantly striving to develop new innovations that improve laboratory testing -- the ACL AcuStar is an outstanding result of this objective.”
The new HemosIL AcuStar D-Dimer assay also received FDA clearance, in conjunction with the ACL AcuStar system, as an aid in the diagnosis of venous thromboembolism. It offers high analytical sensitivity and a broad working range, providing more accurate test results than conventional reagents.
“This assay marks the beginning of a very robust line of ACL AcuStar reagents we look forward to introducing over the next several months,” said Giovanni Russi, Director of Marketing, Hemostasis Reagents at IL. “The ACL AcuStar assays will be a perfect complement to our existing comprehensive line of automated tests, which together, will provide healthcare providers with an integrated diagnostic assessment, enhancing the quality of patient care.”
Following the HemosIL AcuStar D-Dimer assay, the Company anticipates introducing a panel of assays for the diagnosis of Antiphospholipid Syndrome, and other tests for complex disease states, all aimed at enhancing accuracy and efficiency in hemostasis testing.
Instrumentation Laboratory (www.ilus.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. IL’s GEM® product offerings, part of the critical care line, include the GEM Premier(TM) 4000 analyzer with Intelligent Quality Management (iQM®), the new GEM Premier 3500 analyzer with iQM and the GEM PCL Plus, a portable coagulation analyzer. IL’s hemostasis portfolio includes the ACL TOP® Family of Hemostasis Testing Systems, fully automated, high-productivity analyzers, including the ACL TOP and the new ACL TOP 500 CTS. IL also offers the new ACL AcuStar Hemostasis Testing System, the ACL ELITE® and ELITE PRO, other hemostasis analyzers and the HemosIL® line of reagents. IL is based in Bedford, Massachusetts.
The Instrumentation Laboratory logo, GEM, iQM, HemosIL, ACL, ACL TOP, ACL ELITE, ACL AcuStar, Premier and GEM OPL 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.
