510(k) · Cleared
Recalled · 2006Elecsys Troponin T Stat Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · MMI Immunoassay Method, Troponin Subunit
Cleared on May 17, 2004 as substantially equivalent to K984105 (Boehringer Mannheim Corp., 1998) after a 56-day review. Its family tree reaches back 2 generations to 1996. 10 later devices descend from it. It has been recalled once.
- Decided
- May 17, 2004
- Review
- 56 days
- Class
- Class II
- Product code
- MMI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961500 (1996). 10 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK961500 Elecsys Troponin TBoehringer Mannheim Corp. · 1996
- 1 generation backK984105 Elecsys Troponin T Stat TestBoehringer Mannheim Corp. · 1998 · Recalled
- This deviceK040733 Elecsys Troponin T Stat TestRoche Diagnostics Corp. · 2004
- Descendant · cites it directly · 9 of its ownK051752 Roche Elecsys Troponin T Stat (Short Turnaround Time)Roche Diagnostics · 2005 · Recalled
- Descendant · 2 generations on · 8 of its ownK162895 Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT…Roche Diagnostics · 2017
- Descendant · 3 generations on · 2 of its ownK191595 ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019
- Descendant · 4 generations on · 1 of its ownK202525 Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2022
- Descendant · 5 generations on · 0 of its ownK230994 Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K051752Roche Elecsys Troponin T Stat (Short Turnaround Time)Roche Diagnostics · 2005 · cites it directly9descendants
- K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics · 2017 · 2 generations on8descendants
- K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019 · 3 generations on2descendants
- K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2022 · 4 generations on1descendant
- K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961500 | Elecsys Troponin T | Boehringer Mannheim Corp. | 1996 | — |
| −1 | K984105 | Elecsys Troponin T Stat Test | Boehringer Mannheim Corp. | 1998 | 2 |
| 0 (this device) | K040733 | Elecsys Troponin T Stat Test | Roche Diagnostics Corp. | 2004 | — |
| +1 | K051752 | Roche Elecsys Troponin T Stat (Short Turnaround Time) | Roche Diagnostics | 2005 | 1 |
| +2 | K162895 | Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet… | Roche Diagnostics | 2017 | — |
| +3 | K191595 | ARCHITECT STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2019 | — |
| +4 | K202525 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2022 | — |
| +5 | K230994 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K984105 | Elecsys Troponin T Stat TestSummary page 1…thod, troponin subunit Predicate The Elecsys Troponin T STAT is substantially equivalent to the currently device marketed Elecsys ® Troponin T STAT (K984105). Device The Elecsys Troponin T STAT is a two step sandwich immunoassay with Description streptavidin micro pa… | 1998 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051752 | Roche Elecsys Troponin T Stat (Short Turnaround Time) | 2005 | 9 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 31, 2006 | Not classified | Z-0512-06 | Other | A false negative result may be reported. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K051752 (Roche Diagnostics, 2005) has gone furthest, with 9 descendants of its own.
How does its category compare?
All MMI devicesMMI Immunoassay Method, Troponin Subunit: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 troponin T in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of immunoassay analyzers.
Elecsys Troponin T can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g., acute myocardial infarction. The test is further indicated for the risk stratification of patients presenting with acute coronary syndrome and for cardiac risk in patients with chronic renal failure. The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040733 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040733: Elecsys Troponin T Stat Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040733
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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