Cleared Traditional

K201778 - i-STAT TBI Plasma 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.

K201778 · Abbott Laboratories · Immunology device
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Jan 2021
Decision
192d
Days
Class 2
Risk

K201778 is an FDA 510(k) clearance for the i-STAT TBI Plasma cartridge with the i-STAT Alinity System. Classified as Brain Trauma Assessment Test (product code QAT), Class II - Special Controls.

Submitted by Abbott Laboratories (Princton, US). The FDA issued a Cleared decision on January 8, 2021 after a review of 192 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K201778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 104d · This submission: 192d
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.