510(k) · Cleared
Recalled · 2007Vitros Immunodiagnostic Products Troponin I Reagent Pack and Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · MMI Immunoassay Method, Troponin Subunit
Cleared on Sep 29, 2003 as substantially equivalent to K973650 (Dade Chemistry Systems, Inc., 1997) after a 181-day review. Its family tree reaches back 1 generation to 1997. It has been recalled 2 times.
- Decided
- Sep 29, 2003
- Review
- 181 days
- Class
- Class II
- Product code
- MMI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973650 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK973650 Troponin (Trop) MethodDade Chemistry Systems, Inc. · 1997
- This deviceK031031 Vitros Immunodiagnostic Products Troponin I Reagent Pack and…Ortho-Clinical Diagnostics, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973650 | Troponin (Trop) Method | Dade Chemistry Systems, Inc. | 1997 | — |
| 0 (this device) | K031031 | Vitros Immunodiagnostic Products Troponin I Reagent Pack and Calibrators | Ortho-Clinical Diagnostics, Inc. | 2003 | — |
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 |
|---|---|---|---|
| * | K973650 | Troponin (Trop) MethodSummary page 2…oducts Troponin I Calibrators are substantially equivalent to the DADE Dimension RxL Cardiac Troponin-I (TROP) Method, which was cleared by the FDA (K973650) for IVD use. Additional data is being provided on hemoglobin interference and precision. A summary of this data is… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 27, 2007 | Not classified | Z-0820-2007 | Nonconforming Material/Component | Quality control and patient results can be lower than expected when the true Troponin I value is less than or equal to 0.2 ng/mL which may result in the device failing to detect myocardial injury. |
| Jun 7, 2004 | Not classified | Z-1053-04 | Other | Random occurrence of false positive test results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K973650.
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?
For the in vitro quantitative measurement of Troponin I (cTnI) in human heparin plasma to aid in the diagnosis of myocardial infarction.
For use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human hepan
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031031: Vitros Immunodiagnostic Products Troponin I Reagent Pack and Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031031
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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