i-STAT TBI Cartridge with the i-STAT Alinity System
FDA 510(k) K234143 · Abbott Point of Care
510(k) numberK234143
Submission
- Device name
- i-STAT TBI Cartridge with the i-STAT Alinity System
- Applicant
- Abbott Point of Care
Princton, NJ, US - Received
- December 29, 2023
- Decision date
- March 27, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QAT – Brain Trauma Assessment Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5830
- Specialty
- Immunology
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
Other 510(k)s with product code QAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240279 | Vidas Tbi (Gfap, UCH-L1)QAT · Traditional | bioMerieux, Inc. | 05/01/2024SE |
| K232669 | TbiQAT · Special | Abbott Laboratories | 09/29/2023SE |
| K223602 | Traumatic brain injury (TBI) testQAT · Traditional | Abbott Laboratories | 03/02/2023SE |
| K201778 | i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemQAT · Traditional | Abbott Laboratories | 01/08/2021SE |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K261039 | i-STAT Crea cartridge with the i-STAT 1 SystemCGL · Traditional | 06/26/2026SE |
| K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity SystemMMI · Traditional | 06/11/2026SE |
| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 SystemCHL · Traditional | 05/02/2025SE |
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 SystemMMI · Traditional | 01/03/2025SE |
| K230300 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJFP · Traditional | 10/27/2023SE |
| K230285 | i-STAT CG8+ cartridge with the i-STAT 1 SystemCHL · Traditional | 10/27/2023SE |
| K230275 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJGS · Traditional | 10/27/2023SE |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 SystemCHL · Traditional | 09/15/2023SE |
| K223755 | i-STAT G cartridge with the i-STAT 1 SystemCGA · Traditional | 09/11/2023SE |
| K223710 | i-STAT CG8+ cartridge with the i-STAT 1 SystemCGA · Traditional | 07/28/2023SE |
Questions and answers
When was i-STAT TBI Cartridge with the i-STAT Alinity System cleared by the FDA?
i-STAT TBI Cartridge with the i-STAT Alinity System (K234143) received a 510(k) decision of Substantially Equivalent on March 27, 2024, 89 days after the submission was received.
What is the product code of K234143?
The FDA product code is QAT – Brain Trauma Assessment Test, a Class II (moderate risk) device regulated under 21 CFR 866.5830.