Instrumentation Laboratory in FDA Clearance

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."

Hemostasis Testing

Hemostasis testing is used to identify platelet disorders and diagnose bleeding problems. The tests include quantitative and functional methodologies.2 Common endpoints for platelet function testing include time to clot formation and time to cessation of bleeding. End values in some functional testing (e.g., bleeding time, prothrombin time) may be subject to variability based on alterations in the way tests are performed.3