De Novo · Granted
GrantedBanyan BTI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Banyan Biomarkers, Inc. · QAT Brain Trauma Assessment Test
Granted on Feb 14, 2018 as a new device type through De Novo after a 170-day review. 5 later devices descend from it.
- Decided
- Feb 14, 2018
- Review
- 170 days
- Class
- Class II
- Product code
- QAT
- Recalls
- None
5 later devices descend from it, 3 citing it directly.
- This deviceDEN170045 Banyan BTIBanyan Biomarkers, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK223602 Traumatic brain injury (TBI) testAbbott Laboratories · 2023
- Descendant · cites it directly · 1 of its ownK201778 i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemAbbott Laboratories · 2021
- Descendant · cites it directly · 0 of its ownK240279 Vidas Tbi (Gfap, Uch-L1)bioMerieux, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK234143 i-STAT TBI Cartridge with the i-STAT Alinity SystemAbbott Point of Care · 2024
- Descendant · 2 generations on · 0 of its ownK232669 TBIAbbott Laboratories · 2023
Most influential descendants
Showing 5 of 5 · See all- K223602Traumatic brain injury (TBI) testAbbott Laboratories · 2023 · cites it directly1descendant
- K201778i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemAbbott Laboratories · 2021 · cites it directly1descendant
- K240279Vidas Tbi (Gfap, Uch-L1)bioMerieux, Inc. · 2024 · cites it directly0descendants
- K234143i-STAT TBI Cartridge with the i-STAT Alinity SystemAbbott Point of Care · 2024 · 2 generations on0descendants
- K232669TBIAbbott Laboratories · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170045 | Banyan BTI | Banyan Biomarkers, Inc. | 2018 | — |
| +1 | K223602 | Traumatic brain injury (TBI) test | Abbott Laboratories | 2023 | — |
| +1 | K201778 | i-STAT TBI Plasma cartridge with the i-STAT Alinity System | Abbott Laboratories | 2021 | — |
| +1 | K240279 | Vidas Tbi (Gfap, Uch-L1) | bioMerieux, Inc. | 2024 | — |
| +2 | K234143 | i-STAT TBI Cartridge with the i-STAT Alinity System | Abbott Point of Care | 2024 | — |
| +2 | K232669 | TBI | Abbott Laboratories | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K223602 (Abbott Laboratories, 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QAT devicesQAT Brain Trauma Assessment Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Banyan BTI is an vitro diagnostic chemiluminescent enzyme-linked immunosorbent assay (ELISA). The assay provides a semi-quantitative measurement of the concentrations of ubiquitin C-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) in human serum, and is used with the Synergy 2 Multi-mode Reader. The assay results obtained from serum collected within 12 hours of suspected head injury are used, along with other available…
Read the full statement (118 words)
The Banyan BTI is an vitro diagnostic chemiluminescent enzyme-linked immunosorbent assay (ELISA). The assay provides a semi-quantitative measurement of the concentrations of ubiquitin C-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) in human serum, and is used with the Synergy 2 Multi-mode Reader.
The assay results obtained from serum collected within 12 hours of suspected head injury are used, along with other available clinical information, to aid in the evaluation of patients 18 years of age and older with suspected traumatic brain injury (Glasgow Coma Scale score 13-15). A negative assay result is associated with the absence of acute intracranial lesions visualized on a head CT (computed tomography) scan.
The Banyan BTI is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170045 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170045: Banyan BTI.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170045
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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