510(k) · Cleared
ClearedVidas Tbi (Gfap, Uch-L1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · QAT Brain Trauma Assessment Test
Cleared on May 1, 2024 as substantially equivalent to DEN170045 (Banyan Biomarkers, Inc., 2018) after a 90-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- May 1, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- QAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170045 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backDEN170045 Banyan BTIBanyan Biomarkers, Inc. · 2018
- This deviceK240279 Vidas Tbi (Gfap, Uch-L1)bioMerieux, Inc. · 2024
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) | K240279 | Vidas Tbi (Gfap, Uch-L1) | bioMerieux, Inc. | 2024 | — |
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 |
|---|---|---|---|
| * | DEN170045 | Banyan BTISummary page 4…test (21 CFR 866.5830, Product Code QAT) - Class 2 in vitro Diagnostic device C. Predicate Device Name Trade Name: BANYAN BTI™, Banyan, DEN170045 D. Device Description The VIDAS® TBI (GFAP, UCH-L1) test is composed of two automated assays – VIDAS® TBI (GFAP) and VIDAS® TB… | 2018 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN170045.
How does its category compare?
All QAT devicesQAT 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
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 VIDAS® TBI (GFAP, UCH-L1) test is composed of two automated assays - VIDAS® TBI (GFAP) and VIDAS® TBI (UCH-L1) - to be used on the VIDAS® 3 instrument for the quantitative measurement of Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase (UCH-L1) in human serum using the ELFA (Enzyme Linked Fluorescent Assay) technique. The results of both assays are required to obtain an overall qualitative test interpretation. The overall…
Read the full statement (152 words)
The VIDAS® TBI (GFAP, UCH-L1) test is composed of two automated assays - VIDAS® TBI (GFAP) and VIDAS® TBI (UCH-L1) - to be used on the VIDAS® 3 instrument for the quantitative measurement of Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase (UCH-L1) in human serum using the ELFA (Enzyme Linked Fluorescent Assay) technique. The results of both assays are required to obtain an overall qualitative test interpretation.
The overall qualitative VIDAS® TBI (GFAP, UCH-L1) test result is used, in conjunction with clinical information, to aid in the evaluation of patients (18 years of age or older), presenting within 12 hours of suspected mild traumatic brain injury (Glasgow Coma Scale score 13-15), to assist in determining the need for a Computed Tomography (CT) scan of the head. A negative interpretation of VIDAS® TBI (GFAP, UCH-L1) test is associated with the absence of acute intracranial lesions visualized on a head CT scan.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240279 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240279: Vidas Tbi (Gfap, Uch-L1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240279
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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