Device |
brain trauma assessment test |
Regulation Description |
Brain trauma assessment test. |
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 |
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 Medical Specialty |
Immunology |
Review Panel |
Immunology |
Product Code | QAT |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Immunology and Hematology Devices
(DIHD)
|
Submission Type |
510(k)
|
Regulation Number |
866.5830
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|