510(k) · Cleared
ClearedAccess Troponin I Reagents on the Access Immunoassay Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · MMI Immunoassay Method, Troponin Subunit
Cleared on Nov 10, 1997 after a 12-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Nov 10, 1997
- Review
- 12 days
- Class
- Class II
- Product code
- MMI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK974075 Access Troponin I Reagents on the Access Immunoassay AnalyzerBeckman Instruments, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK062838 Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and…Ortho-Clinical Diagnostics · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK252393 VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK241165 Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See all- K062838Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range Verifiers…Ortho-Clinical Diagnostics · 2006 · cites it directly2descendants
- K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc. · 2025 · 2 generations on0descendants
- K241165Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974075 | Access Troponin I Reagents on the Access Immunoassay Analyzer | Beckman Instruments, Inc. | 1997 | — |
| +1 | K062838 | Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range… | Ortho-Clinical Diagnostics | 2006 | 2 |
| +2 | K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. | 2025 | — |
| +2 | K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) | Siemens Healthcare Diagnostics, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Baxter Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062838 | Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range Verifiers… | 2006 | 2 |
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, K062838 (Ortho-Clinical Diagnostics, 2006) has gone furthest, with 2 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?
The ACCESS® Troponin I assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I levels in human serum and plasma (EDTA), using the ACCESS® Immunoassay System.
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/K974075 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974075: Access Troponin I Reagents on the Access Immunoassay Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974075
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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