Instrumentation Laboratory (IL; Lexington, Massachusetts) reported FDA clearance to expand the intended use of its HemosIL D-Dimer assay to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE), when used in conjunction with a clinical pretest probability (PTP) assessment model.

The company's second-generation HemosIL D-Dimer HS assay was granted FDA clearance last year for the same exclusionary claims (Medical Device Daily, Oct. 15, 2007). Both assays now have proven clinical performance for the exclusion of DVT and PE when used with PTP assessment model and share the same cut-off value, the company said.

As a part of the 510(k), IL said it performed a multi-center clinical study involving more than 600 patients in four hospitals, according to a strict protocol reviewed through the FDA. Using a cut-off value of 230 ng/mL, the Negative Predicative Value was 100% for DVT and PE on the ACL TOP hemostasis testing system and 100% for DVT and 99.1% for PE on the ACL ELITE system.

"This expanded intended use for our D-Dimer assay allows IL to provide the tools healthcare professionals need to more accurately and efficiently rule out patients suspected of DVT and PE, regardless of the size of their institution or the throughput of their analyzers," said Giovanni Russi, director of worldwide marketing of hemostasis reagents at IL. "We are passionate about developing innovative products and offering all of our customers a full range of solutions through our comprehensive portfolio of hemostasis reagents and instruments."

HemosIL D-Dimer was originally released in 1998 for the quantitative determination of D-Dimer in human citrated plasma and in 2005 was FDA-cleared for use as an aid in the diagnosis of VTE (MDD, July 8, 2005).

HemosIL D-Dimer is fully automated on ACL systems, with time to results in less than seven minutes. It was the first D-Dimer test automated on IL's ACL systems, the company noted.

DVT occurs when a blood clot forms in a large vein, usually in a leg. A potentially fatal PE happens if the blood clot breaks loose, migrates to the lungs and blocks a pulmonary artery or one of its branches. These conditions can occur after any surgery, as well as in patients with spinal fractures and spinal-cord injury, though it is most commonly seen in patients who have recently undergone orthopedic surgery, according to IL. The company said that 200,000 new cases of DVT and PE occur in the U.S. annually and 20% suffer sudden death as a result of PE.

IL develops 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 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 ACL Elite and Elite Pro, other hemostasis analyzers and the HemosIL line of reagents.

No Comments