Abbott Earns FDA OK for Handheld Concussion Blood Test

Abbott Laboratories has received the FDA’s 510(k) marketing clearance for a test that helps evaluate mild traumatic brain injuries, also known as concussions, using a handheld device.

The blood test is run on the company’s handheld i-STAT Alinity device, producing a result within 15 minutes after the patient’s blood plasma sample is inserted.

The diagnostic assesses plasma samples for biomarkers UCH-L1 and GFAP, two proteins that are seen after a concussion or head trauma.