510(k) · Cleared

Cleared

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

K201778510(k) TraditionalCleared Jan 8, 2021192-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 Laboratories · QAT Brain Trauma Assessment Test

Cleared on Jan 8, 2021 as substantially equivalent to DEN170045 (Banyan Biomarkers, Inc., 2018) after a 192-day review. Its family tree reaches back 1 generation to 2018. 1 later device descends from it.

Decided: Jan 8, 2021
Review: 192 days
Class: Class II
Product code: QAT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN170045 (2018). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backDEN170045 Banyan BTIBanyan Biomarkers, Inc. · 2018
This deviceK201778 i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemAbbott Laboratories · 2021
Descendant · cites it directly · 0 of its ownK234143 i-STAT TBI Cartridge with the i-STAT Alinity SystemAbbott Point of Care · 2024

Most influential descendants

Showing 1 of 1 · See all

K234143i-STAT TBI Cartridge with the i-STAT Alinity SystemAbbott Point of Care · 2024 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2024	1	0

FIG. 1 — Lineage of K201778, 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

Get a 510(k) Report

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
*	DEN170045	Banyan BTI Summary page 6 …Page 1 of 25 3. Predicate Device Proprietary Name Banyan Brain Trauma Indicator (BTI) 510(k) Number DEN170045 Product Device Classification Regulation Class Panel code name…	Banyan Biomarkers, Inc.	2018	—

Also cleared against DEN170045: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K234143	i-STAT TBI Cartridge with the i-STAT Alinity System	Abbott Point of Care	2024	0

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?

Its one ancestor has no recall.
Of its descendants, K234143 (Abbott Point of Care, 2024) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate DEN170045.

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. 2021, 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 (163 words)

The i-STAT TBI Plasma test is a panel of in vitro diagnostic immunoassays for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in plasma and a semiquantitative 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 13-15) within 12 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 plasma prepared from EDTA anticoagulated specimens in clinical laboratory settings by a healthcare professional. The i-STAT TBI Plasma test is not intended to be used in point of care settings.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K201778 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201778: i-STAT TBI Plasma 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/K201778

Report an extraction error

Are you the manufacturer?

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