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