510(k) · Cleared
ClearedAtellica® IM High-Sensitivity Troponin I (TnIH)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · MMI Immunoassay Method, Troponin Subunit
Cleared on Jul 25, 2024 as substantially equivalent to K062838 (Ortho-Clinical Diagnostics, 2006) after a 90-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Jul 25, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- MMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K973517 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK973517 Vitros Immunodiagnostic Products Range VerifiersJohnson & Johnson Clinical Diagnostics, Inc. · 1997
- 2 generations backK992349 Vitros Immunodiagnostic Products Troponin I Range VerifiersOrtho-Clinical Diagnostics, Inc. · 1999
- 1 generation backK062838 Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and…Ortho-Clinical Diagnostics · 2006 · Recalled
- This deviceK241165 Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973517 | Vitros Immunodiagnostic Products Range Verifiers | Johnson & Johnson Clinical Diagnostics, Inc. | 1997 | — |
| −2 | K992349 | Vitros Immunodiagnostic Products Troponin I Range Verifiers | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
| −1 | K062838 | Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range… | Ortho-Clinical Diagnostics | 2006 | 2 |
| 0 (this device) | K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) | Siemens Healthcare Diagnostics, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MMI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MMI device
- #1 K253051 i-STAT hs-TnI cartridge with the i-STAT…score 13.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062838 | Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range Verifiers…Summary page 4…Class II Review Panel Clinical Chemistry 4. Predicate Device Information Device Name: VITROS Troponin I ES Assay 510(k) Number: K062838 5. Intended Use / Indications for Use The Atellica® IM High-Sensitivity Troponin I (TnIH) assay is for in vitro diagnostic… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K062838.
How does its category compare?
All MMI devicesMMI Immunoassay Method, Troponin Subunit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MMI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MMI
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MMI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MMI
805in 2025
MAUDE reports naming product code MMI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 190 | 6 | 352 |
| 2008 | 1 | — | 2 | 837 |
| 2009 | 1 | — | 3 | 1,010 |
| 2010 | 2 | — | 5 | 1,335 |
| 2011 | 1 | — | 1 | 2,406 |
| 2012 | 0 | — | 6 | 1,841 |
| 2013 | 2 | — | 0 | 1,394 |
| 2014 | 0 | — | 1 | 1,150 |
| 2015 | 0 | — | 1 | 831 |
| 2016 | 0 | — | 0 | 487 |
| 2017 | 1 | — | 0 | 618 |
| 2018 | 4 | 344 | 0 | 487 |
| 2019 | 3 | 88 | 1 | 521 |
| 2020 | 0 | — | 1 | 387 |
| 2021 | 1 | — | 1 | 356 |
| 2022 | 1 | — | 0 | 507 |
| 2023 | 3 | 270 | 0 | 748 |
| 2024 | 2 | — | 1 | 921 |
| 2025 | 4 | 266 | 0 | 805 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Atellica® IM High-Sensitivity Troponin I (TnIH) assay is for in vitro diagnostic use in the quantitative measurement of cardiac troponin I in human serum or plasma (lithium heparin) using the Atellica® IM Analyzer. The assay can be used to aid in the diagnosis of acute myocardial infarction (AMI).
The Atellica IM TnlH assay can be used as an aid in prognosis for 30-, 90-, 182-, and 365-day all-cause mortality (ACM) and major adverse cardiac events (MACE) in patients presenting with signs and symptoms suggestive of acute coronary syndrome (ACS). MACE consists of myocardial infarction, urgent revascularization, cardiac death, or heart failure hospitalization.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241165: Atellica® IM High-Sensitivity Troponin I (TnIH).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241165
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026