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# Abbott Alinity I Concussion Blood Test Cleared
- URL: https://www.fdaweb.com/abbott-alinity-i-concussion-blood-test-cleared/
- Published: 2023-03-07T12:00:00.000Z
- Updated: 2026-09-14T18:18:23.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153919

FDA has cleared an Abbott 510(k) for its Alinity i TBI test, the first commercially available laboratory blood test for traumatic brain injury (TBI). The test runs on Abbott's Alinity i laboratory instrument.

The test “offers a new reliable result in 18 minutes to help clinicians quickly assess concussion and triage patients,” the company says. “For those with negative results, it rules out the need for a CT scan and can eliminate wait time at the hospital. The test measures two biomarkers in the blood that, in elevated concentrations, are tightly correlated to brain injury.” Alinity measures Ubiquitin C-terminal Hydrolase L1 and Glial Fibrillary Acidic Protein.