Chrysalis Intelligence · Product Codes · QAT

QAT · Brain Trauma Assessment Test

Immunology · 5 clearances · 3 unique sponsors

Device class
Class II
Regulation 866.5830
Total clearances
5
2021-01-08 → 2024-05-01
Last 12 months
0
Unique sponsors
3
Definition

What is Brain Trauma Assessment Test

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
Medical specialty
Immunology
Review panel
IM
Regulation number
866.5830
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Abbott Laboratories 3 0 2023-09-29
bioMerieux, Inc. 1 0 2024-05-01
Abbott Point of Care 1 0 2024-03-27
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
80053 CPT Medium CPT for comprehensive metabolic panel with immunology markers for TBI
81050 CPT Medium CPT for protein marker testing for traumatic brain injury adjunctive assessment
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2024-05-01 K240279 bioMerieux, Inc. VIDAS TBI (GFAP, UCH-L1)
2024-03-27 K234143 Abbott Point of Care i-STAT TBI Cartridge with the i-STAT Alinity System
2023-09-29 K232669 Abbott Laboratories TBI
2023-03-02 K223602 Abbott Laboratories Traumatic brain injury (TBI) test
2021-01-08 K201778 Abbott Laboratories i-STAT TBI Plasma cartridge with the i-STAT Alinity System