510(k) · Cleared
ClearedTBI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · QAT Brain Trauma Assessment Test
Cleared on Sep 29, 2023 as substantially equivalent to K223602 (Abbott Laboratories, 2023) after a 28-day review. Its family tree reaches back 2 generations to 2018.
- Decided
- Sep 29, 2023
- Review
- 28 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.
View FIG. 1 as a table
Line of descent and top descendants
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
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 | Decided |
|---|---|---|---|
| * | K223602 | Traumatic brain injury (TBI) testSummary page 4…ass II (Special controls) Classification Name: Brain trauma assessment test Governing Regulation: 21 CFR § 866.5830 Product Code: QAT Special 510(k) to K223602 TBI for Alinity i Page 1 III. Predicate Device TBI K223602 IV.… | 2023 |
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 5 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All QAT devicesQAT Brain Trauma Assessment Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QAT
2in 2024
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TBI test is a panel of in vitro diagnostic chemiluminescent microparticle immunoassays (CMIA) used for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L 1 (UCH-L 1) in human plasma and serum and provides a semi-quantitative interpretation of test results derived from these measurements using the ARCHITECT i 100OSR System. The interpretation of test results is used, in conjunction with…
Read the full statement (147 words)
The TBI test is a panel of in vitro diagnostic chemiluminescent microparticle immunoassays (CMIA) used for
the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal
hydrolase L 1 (UCH-L 1) in human plasma and serum and provides a semi-quantitative interpretation of test
results derived from these measurements using the ARCHITECT i 100OSR System.
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 negative test result is associated with the absence of acute
intracranial lesions visualized on a head CT scan.
The TBI test is intended for use in clinical laboratory settings by healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232669: TBI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232669
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