Magellan Diagnostics receives FDA clearance for its LeadCare Ultra bench-top clinical lead analyzer

Magellen Diagnostics, Inc., has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the LeadCare Ultra Blood Lead Testing System in the United States for the quantification of lead levels in blood. LeadCare Ultra is a “plug-and-play” solution for laboratory lead analysis that provides labs with a bench-top lead testing system. The LeadCare Ultra System is based on technology developed by Magellan Diagnostics that has been in clinical use for nearly two decades.

According to the Centers for Disease Control and Prevention (CDC), more than half a million children in the United States have elevated blood lead levels, which can impair cognition and cause attention-deficit disorders. Because the symptoms of lead exposure are nonspecific and are often subclinical, a blood lead test is the only way to identify an exposed child.

Amy Winslow, president of Magellan Diagnostics, says, “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.” Learn more about the LeadCare Ultra System.