Cleared Traditional

i-STAT TBI Cartridge with the i-STAT Alinity System

K234143 · Abbott Point of Care · Immunology

Mar 2024

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K234143 is an FDA 510(k) clearance for the i-STAT TBI Cartridge with the i-STAT Alinity System, a Brain Trauma Assessment Test (Class II — Special Controls, product code QAT), submitted by Abbott Point of Care (Princton, US). The FDA issued a Cleared decision on March 27, 2024, 89 days after receiving the submission on December 29, 2023. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5830.

Submission Details

510(k) Number	K234143 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2023
Decision Date	March 27, 2024
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	QAT — Brain Trauma Assessment Test
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5830
Definition	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