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
| Device Type ID | 3110 |
| Device Name | Brain Trauma Assessment Test |
| Physical State | Assay Kit Containing Antibodies, Reagents And Plate/or Beads. General Microplate Reader Or Automated Instrument With Software |
| Technical Method | Enzyme-linked Immunosorbent Assay |
| Target Area | Blood |
| Regulation Description | Brain Trauma Assessment Test. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5830 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QAT |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3110 |
| Device | Brain Trauma Assessment Test |
| Product Code | QAT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Brain Trauma Assessment Test. |
| CFR Regulation Number | 866.5830 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BANYAN BIOMARKERS, INC. | ||
GRANTED | 1 | |