510(k) · Cleared
ClearedTroponin (Trop) Method
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Chemistry Systems, Inc. · MMI Immunoassay Method, Troponin Subunit
Cleared on Oct 20, 1997 after a 25-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Oct 20, 1997
- Review
- 25 days
- Class
- Class II
- Product code
- MMI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK973650 Troponin (Trop) MethodDade Chemistry Systems, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK020662 Modification to Vitros Immunodiagnostic Products Troponin I Reagent…Ortho-Clinical Diagnostics · 2002
- Descendant · cites it directly · 0 of its ownK033745 Ramp Troponin I AssayResponse Biomedical Corp. · 2004
- Descendant · cites it directly · 0 of its ownK031031 Vitros Immunodiagnostic Products Troponin I Reagent Pack and…Ortho-Clinical Diagnostics, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 0 of its ownK024193 Modification to Vitros Immundodiagnostic Products Troponin I Reagent…Ortho-Clinical Diagnostics · 2003
- Descendant · cites it directly · 0 of its ownK992366 Vitros Immunodiagnostic Products Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc. · 1999 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K020662Modification to Vitros Immunodiagnostic Products Troponin I Reagent Pack/ CalibratorsOrtho-Clinical Diagnostics · 2002 · cites it directly1descendant
- K033745Ramp Troponin I AssayResponse Biomedical Corp. · 2004 · cites it directly0descendants
- K031031Vitros Immunodiagnostic Products Troponin I Reagent Pack and CalibratorsOrtho-Clinical Diagnostics, Inc. · 2003 · cites it directly0descendants
- K024193Modification to Vitros Immundodiagnostic Products Troponin I Reagent Pack/CalibratorsOrtho-Clinical Diagnostics · 2003 · 2 generations on0descendants
- K992366Vitros Immunodiagnostic Products Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973650 | Troponin (Trop) Method | Dade Chemistry Systems, Inc. | 1997 | — |
| +1 | K020662 | Modification to Vitros Immunodiagnostic Products Troponin I Reagent Pack/… | Ortho-Clinical Diagnostics | 2002 | — |
| +1 | K033745 | Ramp Troponin I Assay | Response Biomedical Corp. | 2004 | — |
| +1 | K031031 | Vitros Immunodiagnostic Products Troponin I Reagent Pack and Calibrators | Ortho-Clinical Diagnostics, Inc. | 2003 | 2 |
| +2 | K024193 | Modification to Vitros Immundodiagnostic Products Troponin I Reagent… | Ortho-Clinical Diagnostics | 2003 | — |
| +1 | K992366 | Vitros Immunodiagnostic Products Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. | 1999 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | — | Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay Named without a submission number |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020662 | Modification to Vitros Immunodiagnostic Products Troponin I Reagent Pack/ Calibrators | 2002 | 1 |
| K033745 | Ramp Troponin I Assay | 2004 | 0 |
| K031031 | Vitros Immunodiagnostic Products Troponin I Reagent Pack and Calibrators | 2003 | 0 |
| K992366 | Vitros Immunodiagnostic Products Troponin I Reagent Pack | 1999 | 0 |
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?
- Of its descendants, K020662 (Ortho-Clinical Diagnostics, 2002) has gone furthest, with 1 descendant 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 method for the Dimension® RxL with the heterogeneous immunoassay module is a device used to measure cardiac troponin-I in serum and plasma to aid in the diagnosis of myocardial infarction and 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/K973650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973650: Troponin (Trop) Method.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973650
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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