510(k) · Cleared

Cleared

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

K234143510(k) TraditionalCleared Mar 27, 202489-day reviewClass II21 CFR 866.5830

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Abbott Point of Care · QAT Brain Trauma Assessment Test

Cleared on Mar 27, 2024 as substantially equivalent to K201778 (Abbott Laboratories, 2021) after an 89-day review. Its family tree reaches back 2 generations to 2018.

Decided: Mar 27, 2024
Review: 89 days
Class: Class II
Product code: QAT
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to DEN170045 (2018). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backDEN170045 Banyan BTIBanyan Biomarkers, Inc. · 2018
1 generation backK201778 i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemAbbott Laboratories · 2021
This deviceK234143 i-STAT TBI Cartridge with the i-STAT Alinity SystemAbbott Point of Care · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	DEN170045	Banyan BTI	Banyan Biomarkers, Inc.	2018	—
−1	K201778	i-STAT TBI Plasma cartridge with the i-STAT Alinity System	Abbott Laboratories	2021	—
0 (this device)	K234143	i-STAT TBI Cartridge with the i-STAT Alinity System	Abbott Point of Care	2024	—

FIG. 1 — Lineage of K234143, 2018–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in QAT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new QAT device

#1 K223602 Traumatic brain injury (TBI) testscore 7.9 · 1 generation · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K201778	i-STAT TBI Plasma cartridge with the i-STAT Alinity System Summary page 5 …controls) 3. Predicate Device Proprietary Name i-STAT TBI Plasma cartridge with the i-STAT Alinity System 510(k) Number K201778 Product Regulation Device Classification Name Cl…	Abbott Laboratories	2021	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All QAT devices

QAT Brain Trauma Assessment Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · QAT

2in 2024

2007high 2 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QAT

Too few QAT 510(k)s in any year since 2007 to give a median.

Recalls per year · QAT

No recall names QAT since 2007.

Adverse event reports per year · QAT

No MAUDE report names QAT since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	1	—	0
2022	0	—	0
2023	2	—	0
2024	2	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

Read the full statement (199 words)

The i-STAT TBI test is a panel of in vitro diagnostic immunoassays for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase Li (UCH-Li) in whole blood and a semi-quantitative interpretation of test results derived from these measurements, using the i-STAT Alinity instrument. The interpretation of test results is used, in conjunction with other clinical information, to aid in the evaluation of patients, 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale score 13-1 5), which may include one of the following four clinical criteria: 1) any period of loss of consciousness, 2) any loss of memory for events immediately before and after the accident, 3) any alteration in mental state at the time of accident, and/or 4) focal neurological deficits, within 24 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head. A 'Not Elevated' test interpretation is associated with the absence of acute traumatic intracranial lesions visualized on a head CT scan.

The test is to be used with venous whole blood collected with EDTA anticoagulant in point of care or clinical laboratory settings by a healthcare professional.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K234143 · printed Nov 6, 2026

Cite this page

510(k) Report. “K234143: i-STAT TBI Cartridge with the i-STAT Alinity System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K234143

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026