�Instrumentation Laboratory
(IL) announced that the US Food and Drug Administration (FDA) has
granted 510(k) clearance to expand the intended use of goods and services for the HemosIL D-Dimer
assay to exclude venous thromboembolism (VTE) in outpatients suspected of
deep venous thrombosis (DVT) and pulmonary embolism (PE), when put-upon in
junction with a clinical pretest probability (PTP) assessment model.
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.
As a part of the 510(k), IL performed a multi-center clinical report
involving more than six-hundred patients in four different 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(R) Hemostasis Testing System and 100% for DVT and 99.1% for
PE on the ACL ELITE(R) organisation.
In 2007, the FDA granted clearance for the same VTE exclusionary claims
with IL's second-generation HemosIL D-Dimer HS assay. Both assays at once have
proved clinical operation for the exclusion of DVT and PE when used with
a PTP assessment model and portion the same cut-off value.
"This expanded intended use for our D-Dimer check 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
founding or the throughput of their analyzers," said Giovanni Russi,
Director of Worldwide Marketing, Hemostasis Reagents at IL. "We are
passionate about development 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 is fully automated on ACL systems, with time to results
in less than seven-spot minutes. It was the first D-Dimer test machine-controlled on IL's
ACL systems and since its launch, a great deal has been published approximately its
excellent performance for the diagnosing of both DVT and PE.
About VTE
DVT occurs when a blood coagulate forms in a large vein, normally in a leg. A
potentially fateful PE happens if the blood clog breaks idle, migrates to
the lungs and blocks a pulmonic artery or one of its branches. These
weather can go on after whatever surgery, as well as in patients with spinal
fractures and spinal-cord injury, though it is most commonly seen in
patients who experience recently undergone orthopedic operating room. Two hundred
thousand new cases of DVT and PE occur in the US each year and 20% suffer
sudden death as a final result of PE. Learn more by visiting http://www.preventdvt.org
Instrumentation Laboratory ( http://www.ilus.com ), founded in 1959, is a
cosmopolitan developer, manufacturing business and distributor of in vitro diagnostic
instruments, related to 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(R) product offerings, part of the critical care line,
include the new GEM Premier 4000 analyzer with Intelligent Quality
Management (iQM(R)), GEM Premier(TM) 3000 analyser, GEM OPL(TM), a portable
whole blood CO-Oximeter and the GEM PCL Plus, a portable coagulation
analyser. IL's hemostasia portfolio includes the ACL TOP(R) Family of
Hemostasis Testing Systems, fully machine-controlled, high-productivity analyzers,
including the ACL TOP and the new ACL TOP D 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.
Instrumentation Laboratory (IL)
http://www.ilus.com
More info
