K201778 is an FDA 510(k) clearance for the i-STAT TBI Plasma 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 Laboratories (Princton, US). The FDA issued a Cleared decision on January 8, 2021, 192 days after receiving the submission on June 30, 2020.
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 | K201778 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2020 |
| Decision Date | January 08, 2021 |
| Days to Decision | 192 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 |