K234143 is an FDA 510(k) clearance for the i-STAT TBI Cartridge with the i-STAT Alinity System. This device is classified as a Brain Trauma Assessment Test (Class II - Special Controls, product code QAT).
Submitted by Abbott Point of Care (Princton, US). The FDA issued a Cleared decision on March 27, 2024, 89 days after receiving the submission on December 29, 2023.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5830. 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.
| 510(k) Number | K234143 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2023 |
| Decision Date | March 27, 2024 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | QAT - Brain Trauma Assessment Test |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5830 |
| 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 |