Alinity i STAT High Sensitivity Troponin-I
FDA 510(k) clearance K230994 · decided 2023-05-04
Clearance details
- K-number
- K230994
- Device name
- Alinity i STAT High Sensitivity Troponin-I
- Applicant
- Abbott Laboratories Diagnostics Division
- Decision
- Substantially Equivalent
- Date received
- 2023-04-07
- Decision date
- 2023-05-04
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- MMI
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| i-STAT hs-TnI cartridge with the i-STAT Alinity System (K253051) | Abbott Point of Care, Inc. | 2026-06-11 |
| VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (K252393) | Ortho-Clinical Diagnostics, Inc. | 2025-10-29 |
| Access hsTnI (K243483) | Beckman Coulter, Inc. | 2025-08-01 |
| Access hsTnI (K242870) | Beckman Coulter, Inc. | 2025-06-16 |
| i-STAT hs-TnI cartridge with the i-STAT 1 System (K240984) | Abbott Point of Care, Inc. | 2025-01-03 |
| Atellica® IM High-Sensitivity Troponin I (TnIH) (K241165) | Siemens Healthcare Diagnostics, Inc. | 2024-07-25 |
| PATHFAST®hs-cTnI-II (K231974) | Phc Corporation | 2024-03-20 |
| Access hsTnI (K222881) | Beckman Coulter, Inc. | 2023-12-18 |
| Access hsTnI (K230648) | Beckman Coulter, Inc. | 2023-12-04 |
| Alinity i STAT High Sensitivity Troponin-I (K202525) | Abbott Laboratories Diagnostics Division | 2022-05-19 |
| Elecsys Troponin T Gen 5 (K201441) | Roche Diagnostics | 2021-09-21 |
| ARCHITECT STAT High Sensitivity Troponin-I (K191595) | Abbott Laboratories Diagnostics Division | 2019-09-13 |
Recalls involving this device
No recalls on record reference this clearance.