Atellica® IM High-Sensitivity Troponin I (TnIH)
FDA 510(k) K241165 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK241165
Submission
- Device name
- Atellica® IM High-Sensitivity Troponin I (TnIH)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Newark, DE, US - Received
- April 26, 2024
- Decision date
- July 25, 2024
- 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 |
| 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 |
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| K251630 | Atellica IM Total PSA II (tPSAII)LTJ · Traditional | 01/05/2026SE |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII)JNL · Traditional | 12/04/2025SE |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase IIJZO · Traditional | 10/17/2025SE |
| K242981 | Atellica IM Thyroglobulin (Tg)MSW · Traditional | 06/20/2025SE |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI…JLW · Traditional | 04/25/2025SE |
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Questions and answers
When was Atellica® IM High-Sensitivity Troponin I (TnIH) cleared by the FDA?
Atellica® IM High-Sensitivity Troponin I (TnIH) (K241165) received a 510(k) decision of Substantially Equivalent on July 25, 2024, 90 days after the submission was received.
What is the product code of K241165?
The FDA product code is MMI – Immunoassay Method, Troponin Subunit, a Class II (moderate risk) device regulated under 21 CFR 862.1215.