510(k) · Cleared
Recalled · Class II · 2025Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the Access 2 Immunoassay System
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 14, 2013 as substantially equivalent to K053020 (Bayer Healthcare, LLC, 2005) and 1 other predicate after a 417-day review. Its family tree reaches back 1 generation to 1992. 8 later devices descend from it. It has been recalled 5 times.
- Decided
- Jun 14, 2013
- Review
- 417 days
- Class
- Class II
- Product code
- MMI
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922823 (1992). 2 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK922823 Access Theophylline Immunoassay ReagentsBio-Rad Laboratories, Inc. · 1992 · Recalled
- This deviceK121214 Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on…Beckman Coulter, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK172787 Access hsTnlBeckman Coulter, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 2 of its ownK230648 Access hsTnIBeckman Coulter, Inc. · 2023 · Recalled
- Descendant · 3 generations on · 0 of its ownK243483 Access hsTnIBeckman Coulter, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK242870 Access hsTnIBeckman Coulter, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK242190 Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc. · 2025 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K172787Access hsTnlBeckman Coulter, Inc. · 2018 · cites it directly4descendants
- K230648Access hsTnIBeckman Coulter, Inc. · 2023 · 2 generations on2descendants
- K243483Access hsTnIBeckman Coulter, Inc. · 2025 · 3 generations on0descendants
- K242870Access hsTnIBeckman Coulter, Inc. · 2025 · 3 generations on0descendants
- K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922823 | Access Theophylline Immunoassay Reagents | Bio-Rad Laboratories, Inc. | 1992 | 19 |
| 0 (this device) | K121214 | Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the… | Beckman Coulter, Inc. | 2013 | — |
| +1 | K172787 | Access hsTnl | Beckman Coulter, Inc. | 2018 | 1 |
| +2 | K230648 | Access hsTnI | Beckman Coulter, Inc. | 2023 | 1 |
| +3 | K243483 | Access hsTnI | Beckman Coulter, Inc. | 2025 | — |
| +3 | K242870 | Access hsTnI | Beckman Coulter, Inc. | 2025 | — |
| +1 | K242190 | Access Cortisol; DxC 500i Clinical Analyzer | Beckman Coulter, Inc. | 2025 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K053020 | TNL-Ultra Assay for the Advia Centaur SystemSummary page 2…rs claim substantial equivalence to the ADVIA Centaur Tnl-Ultra™ Assay and ADVIA Centaur Tnl- Ultra™ Calibrators for the Siemens ADVIA Centaur® System, FDA 510(k) Number K053020, cleared December 30, 2005, The Access 2 Immunoassay System claims substantial equivalence to the Access 2 Immunoassay System (K… | 2005 |
| * | K922823 | Access Theophylline Immunoassay ReagentsSummary page 2…entaur® System, FDA 510(k) Number K053020, cleared December 30, 2005, The Access 2 Immunoassay System claims substantial equivalence to the Access 2 Immunoassay System (K922823/A007), cleared July 2, 2001. Device Description: The Access AccuTnl+3 reagents, AccuTnl+3 calibrators and the Access 2 Immunoass… | 1992 |
What descends from it? (8)
4 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 |
|---|---|---|---|---|
| Nov 7, 2025 | Class II | Z-0889-2026 | Process design | It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing… |
| Feb 5, 2025 | Class II | Z-1386-2025 | Nonconforming Material/Component | Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production… |
| 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… |
| Jan 26, 2023 | Class II | Z-1257-2023 | Component change control | An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm motion failures, system check failures, and/or assay performance leading to a… |
| Oct 6, 2014 | Class II | Z-0175-2015 | Vendor change control | Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the Access 2 Immunoassay systems because it may experience a "MFC Exception" error during normal operation of the Access 2 Immunoassay Systems. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MMI devicesMMI Immunoassay Method, Troponin Subunit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The Access AccuTnI+3 Reagent is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction. The Access AccuTnI+3 Calibrators are intended to calibrate the Access AccuTnI+3 Reagent for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma…
Read the full statement (108 words)
The Access AccuTnI+3 Reagent is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction.
The Access AccuTnI+3 Calibrators are intended to calibrate the Access AccuTnI+3 Reagent for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction.
The Access 2 Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
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/K121214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121214: Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the Access 2 Immunoassay System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121214
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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