I-Stat Cardiac Troponin (Ctni) Test
FDA 510(k) K031739 · I-Stat Corporation
510(k) numberK031739
Submission
- Device name
- I-Stat Cardiac Troponin (Ctni) Test
- Applicant
- I-Stat Corporation
East Windsor, NJ, US - Received
- June 4, 2003
- Decision date
- September 2, 2003
- 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 |
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 SystemMMI · Traditional | Abbott Point of Care, Inc. | 01/03/2025SE |
| 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 |
More from Abbott Laboratories Diagnostics Division
| 510(k) | Device | Decision |
|---|---|---|
| K053597 | I-Stat B-Type Natriuretic Peptide (BNP)NBC · Traditional | 07/21/2006SE |
| K053110 | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge…JGS · Special | 01/13/2006SE |
| K051433 | I-Stat Creatine Kinase MB (Ck-Mb)MYT · Traditional | 12/15/2005SE |
| K031873 | I-Stat Cardiac Markers Control Level 1, 2, and 3; Cardiac Markers Calibration…JJX · Traditional | 10/07/2003SE |
| K023582 | I-Stat Kaolin Act TestJBP · Traditional | 09/08/2003SE |
| K020355 | I-Stat Prothrombin Time TestGJS · Traditional | 05/14/2002SE |
| K012478 | Modification to: I-Stat Portable Clinical AnalyzerCHL · Special | 08/20/2001SE |
| K011478 | I-Stat SystemKHP · Traditional | 07/02/2001SE |
| K001387 | I-Stat Portable Clinical Analyzer, Model 300CGA · Traditional | 10/05/2000SE |
| K001154 | I-Stat Model 200 Portable Clinical AnalyzerJGS · Special | 04/18/2000SE |
Questions and answers
When was I-Stat Cardiac Troponin (Ctni) Test cleared by the FDA?
I-Stat Cardiac Troponin (Ctni) Test (K031739) received a 510(k) decision of Substantially Equivalent on September 2, 2003, 90 days after the submission was received.
What is the product code of K031739?
The FDA product code is MMI – Immunoassay Method, Troponin Subunit, a Class II (moderate risk) device regulated under 21 CFR 862.1215.