Magellan Diagnostics’ Blood Lead Testing System Secures FDA Clearance

Magellan Diagnostics has won FDA 510(k) clearance for its LeadCare Plus blood lead testing system, the Billerica, Mass., devicemaker said Thursday.

Symptoms for children with lead exposure are non-specific and sub-clinical, making blood lead testing the only way to identify exposure, the company says. If elevated blood lead levels aren’t detected early with routine tests, children can suffer from impaired cognition, reduced IQ and attention-deficit disorders.

The Center for Disease Control and Prevention estimates there are more than half a million U.S. children afflicted with elevated blood lead levels, the devicemaker adds. — Jason Scott