Cleared Traditional

K234143 - i-STAT TBI Cartridge with the i-STAT Alinity System (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K234143 · Abbott Point of Care · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
89d
Days
Class 2
Risk

K234143 is an FDA 510(k) clearance for the i-STAT TBI Cartridge with the i-STAT Alinity System. Classified as Brain Trauma Assessment Test (product code QAT), Class II - Special Controls.

Submitted by Abbott Point of Care (Princton, US). The FDA issued a Cleared decision on March 27, 2024 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5830 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K234143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 104d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QAT Brain Trauma Assessment Test
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.