510(k) K234143
K234143 is an FDA 510(k) premarket notification submitted by Abbott Point of Care for the device "i-STAT TBI Cartridge with the i-STAT Alinity System". The FDA issued a decision of Substantially Equivalent on March 27, 2024. The device falls under product code QAT (Brain Trauma Assessment Test), a Class II device regulated under 21 CFR 866.5830. Abbott Point of Care has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2024
- Date Received
- December 29, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brain Trauma Assessment Test
- Device Class
- Class II
- Regulation Number
- 866.5830
- Review Panel
- IM
- Submission Type
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