In vitro diagnostic company LipoScience, Inc., has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the Vantera Clinical Analyzer. The analyzer combines nuclear magnetic resonance (NMR) spectroscopic detection and proprietary signal processing algorithms to identify and quantify concentrations of lipoproteins and, potentially, small molecule metabolites. It requires no previous knowledge of NMR technology to operate and has been designed to simplify complex technology. LipoScience representatives assert that its ease of use and walk-away automation provide efficient workflow to maximize laboratory resources while producing high-quality results.
The first assay cleared on this new diagnostic platform is low density lipoprotein particle number (LDL-P). LDL-P is a key component of LipoScience’s NMR LipoProfile test, which provides physicians and their patients with actionable information to personalize management of risk for heart disease from a single blood sample. To date, more than eight million NMR LipoProfile tests have been ordered to aid in the management of patients’ heart health.
“Historically, all NMR LipoProfile tests have been performed at LipoScience’s CLIA-certified laboratory in North Carolina,” says Tom Clement, Vice President of Regulatory and Quality Affairs. “The 510(k) clearance of the Vantera Clinical Analyzer will allow us to place Vantera systems in select high-volume national and regional clinical diagnostic laboratories across the U.S., as well as at leading medical centers and hospital outreach laboratories.” Learn more about solutions provided by LipoScience.
