510(k) · Cleared
Recalled · 2006Stratus CS Cardiac Troponin I Testpak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · MMI Immunoassay Method, Troponin Subunit
Cleared on Apr 27, 1998 after a 32-day review. The FDA summary names its predicate without a number. 8 later devices descend from it. It has been recalled once.
- Decided
- Apr 27, 1998
- Review
- 32 days
- Class
- Class II
- Product code
- MMI
- Recalls
- 1
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK981098 Stratus CS Cardiac Troponin I TestpakDade Behring, Inc. · 1998
- Descendant · cites it directly · 7 of its ownK984093 Stratus (R) CS Cardiac Troponin I (Trop) TestpakDade Behring, Inc. · 1998
- Descendant · cites it directly · 6 of its ownK033487 Stratus CS Acute Care Troponin I Testpak, Model CctniDade Behring, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 4 of its ownK100130 Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample…Mitsubishi Chemical Medience CO · 2011
- Descendant · 3 generations on · 2 of its ownK231974 PATHFAST®hs-cTnI-IIPhc Corporation · 2024
- Descendant · 4 generations on · 1 of its ownK240984 i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K984093Stratus (R) CS Cardiac Troponin I (Trop) TestpakDade Behring, Inc. · 1998 · cites it directly7descendants
- K033487Stratus CS Acute Care Troponin I Testpak, Model CctniDade Behring, Inc. · 2003 · cites it directly6descendants
- K100130Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2Mitsubishi Chemical Medience CO · 2011 · 2 generations on4descendants
- K231974PATHFAST®hs-cTnI-IIPhc Corporation · 2024 · 3 generations on2descendants
- K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981098 | Stratus CS Cardiac Troponin I Testpak | Dade Behring, Inc. | 1998 | — |
| +1 | K984093 | Stratus (R) CS Cardiac Troponin I (Trop) Testpak | Dade Behring, Inc. | 1998 | — |
| +1 | K033487 | Stratus CS Acute Care Troponin I Testpak, Model Cctni | Dade Behring, Inc. | 2003 | 1 |
| +2 | K100130 | Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2 | Mitsubishi Chemical Medience CO | 2011 | — |
| +3 | K231974 | PATHFAST®hs-cTnI-II | Phc Corporation | 2024 | — |
| +4 | K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | Dade Stratus® analyzer Named without a submission number |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 3, 2006 | Not classified | Z-0882-06 | Other | Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K984093 (Dade Behring, Inc., 1998) has gone furthest, with 7 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?
The TROP TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic product for the measurement of cardiac troponin I in heparinized plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
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/K981098 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981098: Stratus CS Cardiac Troponin I Testpak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981098
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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