# DEN170045: Banyan BTI

- Pathway: De Novo (Direct)
- Applicant: Banyan Biomarkers, Inc.
- Decided: Feb 14, 2018 after 170 days
- Product code: QAT (Brain Trauma Assessment Test)
- Device class: 2
- Regulation: 21 CFR 866.5830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K223602: Traumatic brain injury (TBI) test (2023), 1 descendant of its own
- K201778: i-STAT TBI Plasma cartridge with the i-STAT Alinity System (2021), 1 descendant of its own
- K240279: Vidas Tbi (Gfap, Uch-L1) (2024), 0 descendants of its own
- K234143: i-STAT TBI Cartridge with the i-STAT Alinity System (2024), 0 descendants of its own
- K232669: TBI (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN170045
Methodology: https://510kreport.com/methodology