Cleared Traditional

i-STAT TBI Plasma cartridge with the i-STAT Alinity System

K201778 · Abbott Laboratories · Immunology

Jan 2021

Decision

192d

Days

Class 2

Risk

About This 510(k) Submission

K201778 is an FDA 510(k) clearance for the i-STAT TBI Plasma cartridge with the i-STAT Alinity System, a Brain Trauma Assessment Test (Class II — Special Controls, product code QAT), submitted by Abbott Laboratories (Princton, US). The FDA issued a Cleared decision on January 8, 2021, 192 days after receiving the submission on June 30, 2020. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5830.

Submission Details

510(k) Number	K201778 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2020
Decision Date	January 08, 2021
Days to Decision	192 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