510(k) · Cleared
Recalled · Class II · 2021Elecsys Troponin I and Troponin I Stat Test Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · MMI Immunoassay Method, Troponin Subunit
Cleared on Aug 19, 2009 as substantially equivalent to K021814 (Beckman Coulter, Inc., 2002) and 1 other predicate after a 338-day review. Its family tree reaches back 6 generations to 1993. 9 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 19, 2009
- Review
- 338 days
- Class
- Class II
- Product code
- MMI
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 6 generations to K931172 (1993). 13 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 5 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 4 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 3 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 2 generations backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- 1 generation backK072437 Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics · 2008
- This deviceK082699 Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics · 2009
- Descendant · cites it directly · 8 of its ownK162895 Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT…Roche Diagnostics · 2017
- Descendant · 2 generations on · 2 of its ownK191595 ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019
- Descendant · 3 generations on · 1 of its ownK202525 Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2022
- Descendant · 4 generations on · 0 of its ownK230994 Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2023
- Descendant · 2 generations on · 0 of its ownK201441 Elecsys Troponin T Gen 5Roche Diagnostics · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics · 2017 · cites it directly8descendants
- K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019 · 2 generations on2descendants
- K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2022 · 3 generations on1descendant
- K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2023 · 4 generations on0descendants
- K201441Elecsys Troponin T Gen 5Roche Diagnostics · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −5 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −4 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −3 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −2 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| −1 | K072437 | Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset | Roche Diagnostics | 2008 | — |
| 0 (this device) | K082699 | Elecsys Troponin I and Troponin I Stat Test Systems | Roche Diagnostics | 2009 | — |
| +1 | K162895 | Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet… | Roche Diagnostics | 2017 | — |
| +2 | K191595 | ARCHITECT STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2019 | — |
| +3 | K202525 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2022 | — |
| +4 | K230994 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2023 | — |
| +2 | K201441 | Elecsys Troponin T Gen 5 | Roche Diagnostics | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K021814 | Accutni and Accutni Calibrators on the Access Immunoassay Systems, Model #33340, 33345Summary page 4…1.) Elecsys Troponin I and Troponin I STAT Immunoassays are equivalent to the Beckman Coulter Access AccuTnI Immunoassay (K021814). 2.) Elecsys PreciControl Troponi.n is equivalent to Elecsys PreciControl Cardiac II (K07… | 2002 |
| * | K072437 | Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetSummary page 4…Immunoassay (K021814). 2.) Elecsys PreciControl Troponi.n is equivalent to Elecsys PreciControl Cardiac II (K072437). 3.) Elecsys Troponin I CalSet and Troponin I STAT CalSet are equivalent to Elecsys proBN… | 2008 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162895 | Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys… | 2017 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 7, 2021 | Class II | Z-1596-2021 | Device Design | Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When… |
| Apr 7, 2021 | Class II | Z-1595-2021 | Device Design | Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When… |
| Mar 12, 2012 | Not classified | Z-1388-2012 | Nonconforming Material/Component | An investigation has confirmed a considerably reduced recovery of Li-heparin plasma samples for Troponin I lot 163176 and Troponin I STAT lot 163177. In the worst case, Li-Heparin sample recovery may be as low as 50% of the serum… |
| Mar 12, 2012 | Not classified | Z-1387-2012 | Nonconforming Material/Component | An investigation has confirmed a considerably reduced recovery of Li-heparin plasma samples for Troponin I lot 163176 and Troponin I STAT lot 163177. In the worst case, Li-Heparin sample recovery may be as low as 50% of the serum… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K162895 (Roche Diagnostics, 2017) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K021814.
How does its category compare?
All MMI devicesMMI Immunoassay Method, Troponin Subunit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma. The Elecsys Troponin i assay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and MODULAR Analytics E170 immunoassay analyzers. Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma. The Elecsys Troponin I…
Read the full statement (161 words)
Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma. The Elecsys Troponin i assay is intended to aid in the diagnosis of myocardial infarction.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and MODULAR Analytics E170 immunoassay analyzers.
Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma. The Elecsys Troponin I STAT assay is intended to aid in the diagnosis of myocardial infarction.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys analyzers.
Elecsys PreciControl Troponin is used for quality control of the Elecsys Troponin-I and Elecsys Troponin I STAT immunoassays on the Elecsys and MODULAR Analytics El170 Analyzers.
Elecsys Troponin I CalSet is used for calibrating the quantitative Elecsys Troponin I assay on the Elecsys and MODULAR Analytics El 70 analyzers.
Elecsys Troponin I STAT CalSet is used for calibrating the quantitative Elecsys Troponin I STAT assay on the Elecsys analyzers.
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/K082699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082699: Elecsys Troponin I and Troponin I Stat Test Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082699
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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