FDA clears IL’s hemostasis testing systems
Bedford, Mass.-based Instrumentation Laboratory has received 510(k) clearance of their latest innovation, the ACL TOP Family 50 Series Hemostasis Testing Systems. The systems are designed for mid- to-high-volume clinical laboratories, including those using lab automation tracks. Commercialization in the U.S. will commence in 2016.
The ACL TOP Family 50 Series systems have automated preanalytical sample integrity checks to identify underfilled sample tubes, abnormal sample aspiration potentially caused by clots, and assay-specific interference from hemolysis, icterus and lipemia. Additionally, the new systems offer laboratory accreditation tools to automate documentation for compliance with quality standards.
The ACL TOP Family 50 Series is a standardized platform composed of five models: ACL TOP 750 and ACL TOP 750 CTS with closed-tube sampling 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 are designed to offer superior performance and usability throughout the entire testing process.
IL initiated commercialization of the 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, and Australia.