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
Boehringer Mannheim Corp. · MMI Immunoassay Method, Troponin Subunit
Cleared on Dec 8, 1998 as substantially equivalent to K961500 (Boehringer Mannheim Corp., 1996) after a 21-day review. Its family tree reaches back 1 generation to 1996. 11 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 8, 1998
- Review
- 21 days
- Class
- Class II
- Product code
- MMI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961500 (1996). 11 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK961500 Elecsys Troponin TBoehringer Mannheim Corp. · 1996
- This deviceK984105 Elecsys Troponin T Stat TestBoehringer Mannheim Corp. · 1998
- Descendant · cites it directly · 10 of its ownK040733 Elecsys Troponin T Stat TestRoche Diagnostics Corp. · 2004 · Recalled
- Descendant · 2 generations on · 9 of its ownK051752 Roche Elecsys Troponin T Stat (Short Turnaround Time)Roche Diagnostics · 2005 · Recalled
- Descendant · 3 generations on · 8 of its ownK162895 Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT…Roche Diagnostics · 2017
- Descendant · 4 generations on · 2 of its ownK191595 ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019
- Descendant · 5 generations on · 1 of its ownK202525 Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K040733Elecsys Troponin T Stat TestRoche Diagnostics Corp. · 2004 · cites it directly10descendants
- K051752Roche Elecsys Troponin T Stat (Short Turnaround Time)Roche Diagnostics · 2005 · 2 generations on9descendants
- K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics · 2017 · 3 generations on8descendants
- K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019 · 4 generations on2descendants
- K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2022 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961500 | Elecsys Troponin T | Boehringer Mannheim Corp. | 1996 | — |
| 0 (this device) | K984105 | Elecsys Troponin T Stat Test | Boehringer Mannheim Corp. | 1998 | — |
| +1 | K040733 | Elecsys Troponin T Stat Test | Roche Diagnostics Corp. | 2004 | 1 |
| +2 | K051752 | Roche Elecsys Troponin T Stat (Short Turnaround Time) | Roche Diagnostics | 2005 | 1 |
| +3 | K162895 | Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet… | Roche Diagnostics | 2017 | — |
| +4 | K191595 | ARCHITECT STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2019 | — |
| +5 | K202525 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K961500 | Elecsys Troponin TSummary page 2…ts in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the Boehringer Mannheim Elecsys Troponin T test cleared by FDA in K961500. Continued on next page 2 |93] 11/09/98 510(k) Summary, Continued Similarities The following table compares… | 1996 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040733 | Elecsys Troponin T Stat Test | 2004 | 10 |
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. |
| Apr 25, 2003 | Not classified | Z-0870-03 | Other | Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
Troponin T (TnT) is a component of the contractile apparatus of the striated musculature. Although the function of TnT is the same in all striated muscles, TnT originating exclusively from the myocardium (cardiac TnT, molecular weight 39.7 kD) clearly differs from skeletal muscle TnT. As a result of its high tissue-specificity, cardiac troponin T (¢TnT) is a cardiospecific, highly sensitive marker for myocardial damage. In cases of acute myocardial…
Read the full statement (232 words)
Troponin T (TnT) is a component of the contractile apparatus of the striated musculature. Although the function of TnT is the same in all striated muscles, TnT originating exclusively from the myocardium (cardiac TnT, molecular weight 39.7 kD) clearly differs from skeletal muscle TnT. As a result of its high tissue-specificity, cardiac troponin T (¢TnT) is a cardiospecific, highly sensitive marker for myocardial damage. In cases of acute myocardial infarction, troponin T levels in serum rise about 3-4 hours after the occurrence of cardiac symptoms and can remain elevated for up to 14 days.
The determination of ¢TnT in serum is an important component in the diagnosis of myocardial ischemia, e.g. AMI and myocarditis, as well as in monitoring the course of unstable angina pectoris and assessing the associated risk. -6
Comparative studies on 770 patients confirm the prognostic utility of cTnT. "It has also been shown that cTnT-positive patients benefit particularly from antithrombotic therapy strategies (e.g. low molecular weight heparin, BPIIb/IIIa antagonists). 89
Elevated serum cTnT values are detectable in about 30% of patients suffering from renal failure (e.g. chronic hemodialysis patients). The cTnT detected in these patients is of cardiac origin. It has been demonstrated e.g. with RT-PCR, that cTnT is not expressed in regenerated skeletal musculature of patients with renal failure. 111 Clinical data increasingly demonstrate that such patients have a high risk of subsequently suffering cardiovascular complications. 12-15
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/K984105 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984105: 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/K984105
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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