Hemostasis Testing System has FDA clearance.
Press Release Summary:
Featuring FDA clearance 510(k) for ACL TOP® software v3.0.0, ACL TOP 500 CTS is designed to meet testing needs of mid- to high-volume hemostasis laboratories. It combines speed, simplicity, and intelligence to meet varied needs of routine and specialty labs, while enabling true standardization across ACL TOP product line by using same reagents and consumables as other models.
Original Press Release:
Instrumentation Laboratory Launches ACL Top® 500 CTS Hemostasis Testing System
- New Member of the ACL TOP Family -
LEXINGTON, Mass., June 25 -- Instrumentation Laboratory (IL) today announced that it has received FDA clearance 510(k) for the ACL TOP software V3.0.0. This clearance allows IL to market the ACL TOP 500 CTS Hemostasis Testing System in the United States as a member of the ACL TOP Family of analyzers.
Featuring the same advanced technology as the other members of the ACL TOP Family, including the highly successful ACL TOP and ACL TOP CTS systems, the ACL TOP 500 CTS is designed to meet the testing needs of the mid-to-high volume hemostasis laboratories. Like its predecessors, the ACL TOP 500 CTS combines speed, simplicity and intelligence to meet the varied needs of routine and specialty labs and enable true standardization across the ACL TOP product line. All three analyzers provide the same accurate results, use the same reagents and consumables, feature the same broad test menu and usability, and share the same intuitive software.
"The ACL TOP 500 CTS rounds out our product offering and allows us to provide Hemostasis laboratories with a complete testing solution. Now, we can offer the same user-friendly, high throughput of the ACL TOP to medium-sized routine and specialty labs," said Remo Tazzi, Director of Marketing, Hemostasis Instruments at IL. "The ACL TOP 500 CTS was introduced very successfully in Europe several months ago and customers have been extremely satisfied. We are looking forward to sharing our new analyzer with customers in the US."
Instrumentation Laboratory (http://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 new GEM Premier 4000 analyzer with Intelligent Quality Management (iQM(R)), GEM Premier 3000 analyzer, GEM OPL(TM), a portable whole blood CO-Oximeter and the GEM PCL Plus, a portable coagulation analyzer. IL's hemostasis portfolio includes the ACL TOP(R) 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 ACL ELITE(R) and ELITE PRO, other hemostasis analyzers and the HemosIL(R) line of reagents. IL is based in Lexington, Massachusetts.
CONTACT: Sally McCraven of Instrumentation Laboratory, +1-781-861-4577
