i-STAT hs-TnI cartridge with the i-STAT 1 System
FDA 510(k) K240984 · Abbott Point of Care, Inc.
510(k) numberK240984
Submission
- Device name
- i-STAT hs-TnI cartridge with the i-STAT 1 System
- Applicant
- Abbott Point of Care, Inc.
Princton, NJ, US - Received
- April 10, 2024
- Decision date
- January 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MMI – Immunoassay Method, Troponin Subunit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity SystemMMI · Traditional | Abbott Point of Care, Inc. | 06/11/2026SE |
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI · Traditional | Ortho-Clinical Diagnostics, Inc. | 10/29/2025SE |
| K243483 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 08/01/2025SE |
| K242870 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 06/16/2025SE |
| K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH)MMI · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/25/2024SE |
| K231974 | PATHFAST®hs-cTnI-IIMMI · Traditional | Phc Corporation | 03/20/2024SE |
| K222881 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 12/18/2023SE |
| K230648 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 12/04/2023SE |
| K230994 | Alinity i STAT High Sensitivity Troponin-IMMI · Special | Abbott Laboratories Diagnostics Division | 05/04/2023SE |
| K202525 | Alinity i STAT High Sensitivity Troponin-IMMI · Traditional | Abbott Laboratories Diagnostics Division | 05/19/2022SE |
More from Abbott Laboratories Diagnostics Division
| 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 |
| K234143 | i-STAT TBI Cartridge with the i-STAT Alinity SystemQAT · Traditional | 03/27/2024SE |
| 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 hs-TnI cartridge with the i-STAT 1 System cleared by the FDA?
i-STAT hs-TnI cartridge with the i-STAT 1 System (K240984) received a 510(k) decision of Substantially Equivalent on January 3, 2025, 268 days after the submission was received.
What is the product code of K240984?
The FDA product code is MMI – Immunoassay Method, Troponin Subunit, a Class II (moderate risk) device regulated under 21 CFR 862.1215.