i-STAT TBI Plasma cartridge with the i-STAT Alinity System
FDA 510(k) K201778 · Abbott Laboratories
510(k) numberK201778
Submission
- Device name
- i-STAT TBI Plasma cartridge with the i-STAT Alinity System
- Applicant
- Abbott Laboratories
Princton, NJ, US - Received
- June 30, 2020
- Decision date
- January 8, 2021
- 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 |
| K234143 | i-STAT TBI Cartridge with the i-STAT Alinity SystemQAT · Traditional | Abbott Point of Care | 03/27/2024SE |
| K232669 | TbiQAT · Special | Abbott Laboratories | 09/29/2023SE |
| K223602 | Traumatic brain injury (TBI) testQAT · Traditional | Abbott Laboratories | 03/02/2023SE |
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Questions and answers
When was i-STAT TBI Plasma cartridge with the i-STAT Alinity System cleared by the FDA?
i-STAT TBI Plasma cartridge with the i-STAT Alinity System (K201778) received a 510(k) decision of Substantially Equivalent on January 8, 2021, 192 days after the submission was received.
What is the product code of K201778?
The FDA product code is QAT – Brain Trauma Assessment Test, a Class II (moderate risk) device regulated under 21 CFR 866.5830.