Product code QAT— Immunology

“Intended for in vitro diagnostic use as an aid in the evaluation of patients with suspected mild traumatic brain injury (TBI) in conjunction with other clinical information to assist in determining the need for radiologic (e.g., CT, MR) head imaging per current standard of care”

FDA has cleared 6 devices under product code QAT between 2018 and 2024, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20242 clearances
• 20232 clearances
• 20211 clearance
• 20181 clearance

• Abbott Laboratories3 clearances
• bioMerieux, Inc.1 clearance
• Banyan Biomarkers, Inc.1 clearance
• Abbott Point of Care1 clearance

• K240279 — VIDAS TBI (GFAP, UCH-L1)bioMerieux, Inc.·2024-05-01
• K234143 — i-STAT TBI Cartridge with the i-STAT Alinity SystemAbbott Point of Care·2024-03-27
• K232669 — TBIAbbott Laboratories·2023-09-29
• K223602 — Traumatic brain injury (TBI) testAbbott Laboratories·2023-03-02
• K201778 — i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemAbbott Laboratories·2021-01-08
• DEN170045 — Banyan BTIBanyan Biomarkers, Inc.·2018-02-14