# Brain Trauma Assessment Test
> **Product code: QAT** · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5830
## Classification
- **FDA Product Code:** QAT
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.5830
- **Review panel:** IM
- **Medical specialty:** Immunology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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

## Market data
- **Cleared 510(k) submissions:** 6
- **Registered establishments:** 9
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QAT)
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