510(k) · Cleared
ClearedVITROS Immunodiagnostic Products hs 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 29, 2025 as substantially equivalent to K062838 (Ortho-Clinical Diagnostics, 2006) after a 90-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Oct 29, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- MMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K973517 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK973517 Vitros Immunodiagnostic Products Range VerifiersJohnson & Johnson Clinical Diagnostics, Inc. · 1997
- 2 generations backK992349 Vitros Immunodiagnostic Products Troponin I Range VerifiersOrtho-Clinical Diagnostics, Inc. · 1999
- 1 generation backK062838 Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and…Ortho-Clinical Diagnostics · 2006 · Recalled
- This deviceK252393 VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973517 | Vitros Immunodiagnostic Products Range Verifiers | Johnson & Johnson Clinical Diagnostics, Inc. | 1997 | — |
| −2 | K992349 | Vitros Immunodiagnostic Products Troponin I Range Verifiers | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
| −1 | K062838 | Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range… | Ortho-Clinical Diagnostics | 2006 | 2 |
| 0 (this device) | K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K062838 | Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range Verifiers…Summary page 5…of this document, is substantially equivalent to the VITROS Immunodiagnostic Products Troponin I ES Reagent Pack K062838. Device Description The VITROS hs Troponin I assay is performed using the VITROS Immu… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K062838.
How does its category compare?
All MMI devicesMMI Immunoassay Method, Troponin Subunit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 In Vitro Diagnostic Use
For the quantitative measurement of cardiac troponin I (cTnI) in human plasma (heparin) using the VITROS 5600 Integrated System.
Cardiac troponin I is used to aid in the diagnosis of myocardial infarction (MI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252393 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252393: VITROS Immunodiagnostic Products hs Troponin I Reagent Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252393
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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