510(k) · Cleared
Recalled · Class II · 2023Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range Verifiers, Models 680 2301, 2302 and 2303
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics · MMI Immunoassay Method, Troponin Subunit
Cleared on Dec 19, 2006 as substantially equivalent to K974075 (Beckman Instruments, Inc., 1997) and 1 other predicate after an 89-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 19, 2006
- Review
- 89 days
- Class
- Class II
- Product code
- MMI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K973517 (1997). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK973517 Vitros Immunodiagnostic Products Range VerifiersJohnson & Johnson Clinical Diagnostics, Inc. · 1997
- 1 generation backK992349 Vitros Immunodiagnostic Products Troponin I Range VerifiersOrtho-Clinical Diagnostics, Inc. · 1999
- This deviceK062838 Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and…Ortho-Clinical Diagnostics · 2006
- Descendant · cites it directly · 0 of its ownK252393 VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK241165 Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973517 | Vitros Immunodiagnostic Products Range Verifiers | Johnson & Johnson Clinical Diagnostics, Inc. | 1997 | — |
| −1 | K992349 | Vitros Immunodiagnostic Products Troponin I Range Verifiers | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
| 0 (this device) | K062838 | Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range… | Ortho-Clinical Diagnostics | 2006 | — |
| +1 | K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. | 2025 | — |
| +1 | K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) | Siemens Healthcare Diagnostics, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K974075 | Access Troponin I Reagents on the Access Immunoassay AnalyzerSummary page 2…the VITROS Troponin I ES assay) are substantially equivalent to the BECKMAN Access® AccuTnI Troponin I assay (K974075). The VITROS® Immunodiagnostic Products Troponin I ES Range Verifier… | 1997 |
| * | K992349 | Vitros Immunodiagnostic Products Troponin I Range VerifiersSummary page 2…Products Troponin I ES Range Verifiers are substantially equivalent to the VITROS Troponin I Range Verifiers (K992349). 5. Device Description 1.The VITROS Immunodiagnostic Products range o… | 1999 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| 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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K252393 (Ortho-Clinical Diagnostics, Inc., 2025) has gone furthest, with 0 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?
VITROS® Troponin I ES Reagent Pack: For in vitro diagnostic use only. For the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA) using the VITROS Immunodiagnostic System, to aid in the assessment of myocardial damage and risk stratification. Cardiac Troponin I measurement aids in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST-segment elevation acute…
Read the full statement (165 words)
VITROS® Troponin I ES Reagent Pack:
For in vitro diagnostic use only.
For the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA) using the VITROS Immunodiagnostic System, to aid in the assessment of myocardial damage and risk stratification.
Cardiac Troponin I measurement aids in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST-segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.
VITROS® Troponin I ES Calibrators:
For in vitro diagnostic use only.
For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnl) in human serum and plasma (heparin and EDTA).
VITROS® Troponin I ES Range Verifiers:
For in vitro diagnostic use only.
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of cardiac Troponin I (cTnI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062838 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062838: Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range Verifiers, Models 680 2301, 2302 and 2303.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062838
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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