510(k) K234143

i-STAT TBI Cartridge with the i-STAT Alinity System by Abbott Point of Care — Product Code QAT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 27, 2024
Date Received: December 29, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Brain Trauma Assessment Test
Device Class: Class II
Regulation Number: 866.5830
Review Panel: IM
Submission Type

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

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K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System (January 3, 2025)
K230300 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
K230275 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
K223857 — i-STAT G3+ cartridge with the i-STAT 1 System (September 15, 2023)
K223755 — i-STAT G cartridge with the i-STAT 1 System (September 11, 2023)
K223710 — i-STAT CG8+ cartridge with the i-STAT 1 System (July 28, 2023)
K210958 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (August 13, 2021)
K200492 — i-STAT CG4+ Cartridge with the i-STAT 1 System (April 9, 2020)

510(k) K234143

Clearance Details

Device Classification

Other clearances by Abbott Point of Care

Other clearances for product code QAT