Magellan Diagnostics Receives FDA Clearance for LeadCare Ultra Bench-top Clinical Lead Analyzer
, Aug. 26, 2013 /PRNewswire/ -- Magellan Diagnostics, Inc., the leader in clinical lead testing systems for both point-of-care and laboratory analysis, has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the LeadCare Ultra Blood Lead Testing System in the US for the quantification of lead levels in blood.
LeadCare Ultra is the first "plug-and-play" solution for laboratory lead analysis. It brings a significant improvement in the speed and cost of lead testing while providing labs the first bench-top lead testing system with an easy-to-use and flexible design.
"Our lab was impressed by how easy LeadCare Ultra was to set up and run," said Lindsay Gauthier, Chemistry Manager at Cambridge Hospital in Cambridge, Massachusetts, who participated in the system's clinical trial. "Compared to other systems, which can require significant maintenance and monitoring, Ultra really simplified our workflow."
According to the Centers for Disease Control and Prevention (CDC), there are over half a million US children affected with elevated blood lead levels, which can impair cognition, reduce IQ, and cause attention-deficit disorders. Because the symptoms of lead exposure are non-specific and often sub-clinical, a blood test is the only way to identify an exposed child.
Amy Winslow, president of Magellan Diagnostics, said, "We are pleased that the FDA has cleared the LeadCare Ultra System. Since there are still many children and adults at risk of lead exposure who don't get tested, we feel it is important to offer solutions that can help expand access to lead testing. LeadCare Ultra does this by offering a simple, cost effective solution for laboratories of all sizes."
The LeadCare Ultra System is based on technology developed by Magellan Diagnostics that has been in clinical use for nearly two decades and that is currently helping over 5,000 clinicians rapidly test and identify individuals who suffer from lead exposure. For more information on the LeadCare Ultra System, visit www.lcultra.com.
About Magellan Diagnostics
Magellan Diagnostics is a medical device company that provides point-of-care systems, clinical laboratory instruments, and analytical laboratory services focused on lead testing. Headquartered outside Boston in Billerica, Massachusetts, Magellan is dedicated to offering high-quality, reliable products that help identify children and adults at risk of harm due to lead exposure. We are committed to educating clinicians, policy makers, payers, families and communities about the permanent health damage caused by lead and how to detect and address lead exposure. For more information, visit www.magellandx.com.
SOURCE Magellan Diagnostics