FDA Cleared Blood Lead Testing System Displayed at AACC

US Food and Drug Administration (FDA) 510(k) clearance has been given for a new compact, relatively low cost analyzer to quantify lead levels in blood.

The “LeadCare Plus” clinical lead analyzer from Magellan Diagnostics (Billerica, MA, USA) offers simple-to-perform lead analysis with a compact footprint that makes blood lead testing accessible and practical for labs of any size. With dimensions smaller than a laptop, single-use consumables, and electronic calibration, the system is easy to implement even in space- and resource-constrained labs. The LeadCare Plus system is based on technology developed by Magellan Diagnostics that has been in clinical use for nearly two decades.

Blood lead testing is a critical preventative service: symptoms of lead exposure are nonspecific and subclinical, so a routine blood test is often the only way to identify exposure. According to the Centers for Disease Control and Prevention (CDC), there are over half a million children just in the USA still affected with elevated blood lead levels. Without early detection, elevated blood lead levels can impair cognition, reduce IQ, and cause attention-deficit disorders.

Amy Winslow, president, Magellan Diagnostics, said, "We are pleased that the FDA has cleared the LeadCare Plus System. Our mission is to help expand access to blood lead testing by offering a solution for every setting. With our other products CLIA-waived LeadCare II for point-of-care testing and LeadCare Ultra for high throughput lab analysis, LeadCare Plus completes this offering by providing a low capital cost system that gives even small labs the opportunity to bring this test in-house."

All three products will be on display during AACC 2015 (July 26–30; Atlanta, GA, USA) Clinical Lab Expo, Booth 3254.

Related Links:
Magellan Diagnostics
American Association for Clinical Chemistry (AACC)
AACC 2015 Annual Meeting & Clinical Lab Expo