510(k) · Cleared
Recalled · 2010Accutni and Accutni Calibrators on the Access Immunoassay System # 33340, 33345
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · MMI Immunoassay Method, Troponin Subunit
Cleared on Jun 5, 2001 after a 112-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 5, 2001
- Review
- 112 days
- Class
- Class II
- Product code
- MMI
- Recalls
- 3
- Predicates
- 0
13 later devices descend from it, 1 citing it directly.
- This deviceK010429 Accutni and Accutni Calibrators on the Access Immunoassay System #…Beckman Coulter, Inc. · 2001
- Descendant · cites it directly · 12 of its ownK021814 Accutni and Accutni Calibrators on the Access Immunoassay Systems…Beckman Coulter, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 9 of its ownK082699 Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics · 2009 · Recalled
- Descendant · 3 generations on · 8 of its ownK162895 Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT…Roche Diagnostics · 2017
- Descendant · 4 generations on · 2 of its ownK191595 ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019
- Descendant · 5 generations on · 1 of its ownK202525 Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K021814Accutni and Accutni Calibrators on the Access Immunoassay Systems, Model #33340, 33345Beckman Coulter, Inc. · 2002 · cites it directly12descendants
- K082699Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics · 2009 · 2 generations on9descendants
- K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics · 2017 · 3 generations on8descendants
- K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019 · 4 generations on2descendants
- K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2022 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010429 | Accutni and Accutni Calibrators on the Access Immunoassay System # 33340, 33345 | Beckman Coulter, Inc. | 2001 | — |
| +1 | K021814 | Accutni and Accutni Calibrators on the Access Immunoassay Systems, Model… | Beckman Coulter, Inc. | 2002 | 3 |
| +2 | K082699 | Elecsys Troponin I and Troponin I Stat Test Systems | Roche Diagnostics | 2009 | 4 |
| +3 | K162895 | Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet… | Roche Diagnostics | 2017 | — |
| +4 | K191595 | ARCHITECT STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2019 | — |
| +5 | K202525 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021814 | Accutni and Accutni Calibrators on the Access Immunoassay Systems, Model #33340, 33345 | 2002 | 12 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 11, 2010 | Not classified | Z-1995-2010 | Other | The recall was initiated because as a follow up to PCA # 12605 dated December 16, 2009, Beckman Coulter has confirmed additional reports that each of the following assays may produce lower than expected results when run in conjunction… |
| Feb 6, 2010 | Not classified | Z-1318-2010 | Other | The recall was initiated because Beckman Coulter has confirmed customer reports that different results have been obtained using the same patient samples on Access/Access 2 and UniCel Dxl platforms. Values obtained with UniCel Dxl systems… |
| Dec 10, 2009 | Not classified | Z-1883-2011 | Other | The recall was initiated after Beckman Coulter confirmed that under certain circumstances, the following assays may produce elevated values at the low end when run in conjunction with the enhanced Access Accu Tnl assay (P/N A 78033): (1)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K021814 (Beckman Coulter, Inc., 2002) has gone furthest, with 12 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 | — |
https://510kreport.com/device/K010429 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010429: Accutni and Accutni Calibrators on the Access Immunoassay System # 33340, 33345.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010429
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026