Clinical lab instruments developer Magellan Diagnostics has received the US Food and Drug Administration (FDA) 510(k) approval to market its LeadCare Ultra blood lead testing system in the US.
Claimed to be the first plug-and-play solution for laboratory lead analysis, the bench-top lead testing system is used to measure lead levels in blood.
Increase of lead levels in blood can impair cognition, reduce IQ, and cause attention-deficit disorders in children, according to the Centers for Disease Control and Prevention (CDC).
Magellan Diagnostics president Amy Winslow said that LeadCare Ultra offers a simple, cost effective solution for laboratories of all sizes.
"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," Winslow added.
Based on technology developed by Magellan, the easy-to-use system which features flexible design improves the speed and cost of lead testing.
Commenting on the system, Cambridge Hospital chemistry manager Lindsay Gauthier said: "Compared to other systems, which can require significant maintenance and monitoring, Ultra really simplified our workflow."
