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U.S. Department of Health and Human Services

Product Classification

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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 CodeQAT
Premarket Review Division of Immunology and Hematology Devices (DIHD)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons