510(k) · Cleared
Recalled · Class II · 2023Vitros Immunodiagnostic Products Troponin I Reagent Pack
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 Oct 8, 1999 as substantially equivalent to K973650 (Dade Chemistry Systems, Inc., 1997) after an 85-day review. Its family tree reaches back 1 generation to 1997. It has been recalled 2 times.
- Decided
- Oct 8, 1999
- Review
- 85 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 deviceK992366 Vitros Immunodiagnostic Products Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc. · 1999
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) | K992366 | Vitros Immunodiagnostic Products Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
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 3…nodiagnostic Products Troponin I Calibrators are device substantially equivalent to the DADE Dimension RxL Cardiac Troponin-I (TROP) Method which was cleared by the FDA (K973650) for IVD use. The relationship between the VITROS Troponin I assay and the DADE Dimension RxL Cardiac Troponin-I assay, determin… | 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 |
|---|---|---|---|---|
| Jun 5, 2023 | Class II | Z-2357-2023 | Process control | Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results. |
| Jun 5, 2023 | Class II | Z-2358-2023 | Process control | Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, 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 (¢Tnl) in human serum or plasma (EDTA or heparin), to aid in the diagnosis of myocardial infarction.
For use in the éalibration of the Vitros Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnl) in human serum and plasma (EDTA or heparin).
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/K992366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992366: Vitros Immunodiagnostic Products Troponin I Reagent Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992366
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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