510(k) · Cleared
Recalled · Class II · 2025Access Accutni Reagent, Access Accutni Calibrator, Unicel Dxi 800 Access 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 Sep 25, 2013 as substantially equivalent to K053020 (Bayer Healthcare, LLC, 2005) and 1 other predicate after a 464-day review. Its family tree reaches back 2 generations to 1992. It has been recalled 5 times.
- Decided
- Sep 25, 2013
- Review
- 464 days
- Class
- Class II
- Product code
- MMI
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 2 generations to K922823 (1992). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK922823 Access Theophylline Immunoassay ReagentsBio-Rad Laboratories, Inc. · 1992 · Recalled
- 1 generation backK023764 Unicel Dxi 800 Access Immunoassay System, Model 973100Beckman Coulter, Inc. · 2003 · Recalled
- This deviceK121790 Access Accutni Reagent, Access Accutni Calibrator, Unicel Dxi 800…Beckman Coulter, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922823 | Access Theophylline Immunoassay Reagents | Bio-Rad Laboratories, Inc. | 1992 | 19 |
| −1 | K023764 | Unicel Dxi 800 Access Immunoassay System, Model 973100 | Beckman Coulter, Inc. | 2003 | 31 |
| 0 (this device) | K121790 | Access Accutni Reagent, Access Accutni Calibrator, Unicel Dxi 800 Access… | Beckman Coulter, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 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? (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…munoassay Systems claim substantial equivalence to the Tnl-UltraTm Assay and ADVIA Centaur TnlUltra Calibrators for the Siemens ADVIA Centaur®)System, FDA 5 10(k) Number K053020, cleared December 30, 2005. The UniCel DAl 800 Access Immunoassay System claims substantial equivalence to the UniCel Dxl 800 Ac… | 2005 |
| * | K023764 | Unicel Dxi 800 Access Immunoassay System, Model 973100Summary page 2…Number K053020, cleared December 30, 2005. The UniCel DAl 800 Access Immunoassay System claims substantial equivalence to the UniCel Dxl 800 Access Immunoassay System (K023764). cleared January 28, 2003. Device Description: The Access AccuTnl+3 Reagents, AccuTnl+3 Calibrators and the UniCel Dxl 800 Acce… | 2003 |
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 26, 2025 | Class II | Z-1025-2026 | Device Design | Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be… |
| Nov 26, 2025 | Class II | Z-1026-2026 | Device Design | Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be… |
| Oct 1, 2025 | Class II | Z-0428-2026 | Process control | An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in… |
| Oct 1, 2025 | Class II | Z-0429-2026 | Process control | An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in… |
| Aug 21, 2014 | Class II | Z-2687-2014 | Under Investigation by firm | Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may been installed on newly manufactured and/or recently serviced UniCel DxI 600 and 800 Access Immunoassay Systems, UniCel DxC 660i, 680i, and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 10.7 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K053020.
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 UniCel DxI Access Immunoassay Systems 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…
Read the full statement (112 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 UniCel DxI Access Immunoassay Systems 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 UniCel DxI Access Immunoassay Systems to aid in the diagnosis of myocardial infarction.
The UniCel DxI 800 Access 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 as stated in the FDA summary.
https://510kreport.com/device/K121790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121790: Access Accutni Reagent, Access Accutni Calibrator, Unicel Dxi 800 Access 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/K121790
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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