The FDA has granted 510(k) clearance for the LeadCare® Ultra™ Blood Lead Testing System from Magellan Diagnostics Inc, Billerica, Mass, for the quantification of lead levels in blood.
LeadCare Ultra, a plug-and-play solution for lab lead analysis, is a user-friendly bench-top lead testing system for labs of all sizes.
According to the Centers for Disease Control and Prevention (CDC), more than half a million US children are affected with elevated blood lead levels, which can impair cognition, reduce IQ, and cause attention-deficit disorders. Because the symptoms of lead exposure are nonspecific and often subclinical, a blood test is the only way to identify an exposed child.
The system is based on technology developed by the company that has been in clinical use for nearly 2 decades and is currently helping more than 5,000 clinicians rapidly test and identify individuals who suffer from lead exposure.
[Source: Magellan Diagnostics]
