Not Cleared Direct

DEN170045 - Banyan BTI (FDA 510(k) Clearance)

Class II Immunology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN170045 · Banyan Biomarkers, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
170d
Days
Class 2
Risk

DEN170045 is an FDA 510(k) submission (not cleared) for the Banyan BTI. Classified as Brain Trauma Assessment Test (product code QAT), Class II - Special Controls.

Submitted by Banyan Biomarkers, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on February 14, 2018 after a review of 170 days.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5830 - the FDA immunology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Immunology review framework.

View all Banyan Biomarkers, Inc. devices

Submission Details

510(k) Number DEN170045 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 28, 2017
Decision Date February 14, 2018
Days to Decision 170 days
Submission Type Direct
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 104d · This submission: 170d
Pathway characteristics

Device Classification

Product Code QAT Brain Trauma Assessment Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5830
Definition Intended For In Vitro Diagnostic Use As An Aid In The Evaluation Of Patients With Suspected Mild Traumatic Brain Injury (tbi) In Conjunction With Other Clinical Information To Assist In Determining The Need For Radiologic (e.g., Ct, Mr) Head Imaging Per Current Standard Of Care
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - QAT Brain Trauma Assessment Test

Devices cleared under the same product code (QAT) and FDA review panel - the closest regulatory comparables to DEN170045.
VIDAS TBI (GFAP, UCH-L1)
K240279 · bioMerieux, Inc. · May 2024
i-STAT TBI Cartridge with the i-STAT Alinity System
K234143 · Abbott Point of Care · Mar 2024
TBI
K232669 · Abbott Laboratories · Sep 2023
Traumatic brain injury (TBI) test
K223602 · Abbott Laboratories · Mar 2023
i-STAT TBI Plasma cartridge with the i-STAT Alinity System
K201778 · Abbott Laboratories · Jan 2021