510(k) · Cleared
Recalled · Class II · 2024Access hsTnI
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 Dec 18, 2023 as substantially equivalent to K172787 (Beckman Coulter, Inc., 2018) after a 452-day review. Its family tree reaches back 3 generations to 1992. It has been recalled once.
- Decided
- Dec 18, 2023
- Review
- 452 days
- Class
- Class II
- Product code
- MMI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922823 (1992). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK922823 Access Theophylline Immunoassay ReagentsBio-Rad Laboratories, Inc. · 1992 · Recalled
- 2 generations backK121214 Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on…Beckman Coulter, Inc. · 2013 · Recalled
- 1 generation backK172787 Access hsTnlBeckman Coulter, Inc. · 2018 · Recalled
- This deviceK222881 Access hsTnIBeckman Coulter, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922823 | Access Theophylline Immunoassay Reagents | Bio-Rad Laboratories, Inc. | 1992 | 19 |
| −2 | K121214 | Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the… | Beckman Coulter, Inc. | 2013 | 5 |
| −1 | K172787 | Access hsTnl | Beckman Coulter, Inc. | 2018 | 1 |
| 0 (this device) | K222881 | Access hsTnI | Beckman Coulter, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K172787 | Access hsTnlSummary page 4…ommon Name: Troponin I Enzyme Immunoassay Classification Regulation: 21 CFR 862.1215 Classification Product Code: MMI Predicate Devices: Access hsTnI, FDA 510(k) Number K172787 Device Description The Access hsTnI assay is a sandwich immunoenzymatic assay. The Access hsTnI assay consists of the reagent p… | 2018 |
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 |
|---|---|---|---|---|
| Nov 18, 2024 | Class II | Z-0727-2025 | Component design/selection | Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,000 pg/mL) can contaminate an analyzers probe and cause inter-assay carryover due to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- 4 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K172787.
How does its category compare?
All MMI devicesMMI Immunoassay Method, Troponin Subunit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the DxI Access Immunoassay Analyzers to aid in the diagnosis of myocardial infarction (MI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222881: Access hsTnI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222881
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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