510(k) · Cleared
Recalled · Class II · 2016TNL-Ultra Assay for the Advia Centaur System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · MMI Immunoassay Method, Troponin Subunit
Cleared on Dec 30, 2005 after a 65-day review. The FDA summary names its predicate without a number. 10 later devices descend from it. It has been recalled 4 times.
- Decided
- Dec 30, 2005
- Review
- 65 days
- Class
- Class II
- Product code
- MMI
- Recalls
- 4
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK053020 TNL-Ultra Assay for the Advia Centaur SystemBayer Healthcare, LLC · 2005
- Descendant · cites it directly · 8 of its ownK121214 Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on…Beckman Coulter, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 4 of its ownK172787 Access hsTnlBeckman Coulter, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 2 of its ownK230648 Access hsTnIBeckman Coulter, Inc. · 2023 · Recalled
- Descendant · 4 generations on · 0 of its ownK243483 Access hsTnIBeckman Coulter, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK242870 Access hsTnIBeckman Coulter, Inc. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K121214Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the Access 2…Beckman Coulter, Inc. · 2013 · cites it directly8descendants
- K172787Access hsTnlBeckman Coulter, Inc. · 2018 · 2 generations on4descendants
- K230648Access hsTnIBeckman Coulter, Inc. · 2023 · 3 generations on2descendants
- K243483Access hsTnIBeckman Coulter, Inc. · 2025 · 4 generations on0descendants
- K242870Access hsTnIBeckman Coulter, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053020 | TNL-Ultra Assay for the Advia Centaur System | Bayer Healthcare, LLC | 2005 | — |
| +1 | K121214 | Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the… | Beckman Coulter, Inc. | 2013 | 5 |
| +2 | K172787 | Access hsTnl | Beckman Coulter, Inc. | 2018 | 1 |
| +3 | K230648 | Access hsTnI | Beckman Coulter, Inc. | 2023 | 1 |
| +4 | K243483 | Access hsTnI | Beckman Coulter, Inc. | 2025 | — |
| +4 | K242870 | Access hsTnI | Beckman Coulter, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | — | ACS: 180® Named without a submission number | |
| * | — | ADVIA Centaur® Cardiac Troponin I (cTnI) Assay Named without a submission number |
What descends from it? (10)
2 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 |
|---|---|---|---|---|
| May 2, 2016 | Class II | Z-2041-2016 | Component design/selection | Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L). Instructions for Use (IFU) states that specimens that have up to 10 ng/mL (41 nmol/L) of biotin |
| May 19, 2015 | Class II | Z-2207-2015 | Under Investigation by firm | System-to-system bias between the Tni-Ultra assay on the ADVIA Centaur CP and ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems. |
| May 30, 2014 | Class II | Z-1991-2014 | Nonconforming Material/Component | The solid phase reagent in some of the ADVIA Centaur¿ TnI -Ultra ReadyPacks¿, lot 084, is darker in appearance, creating a potential for incorrect control and patient results. |
| Jun 7, 2007 | Not classified | Z-0580-2008 | Material/Component Contamination | Incorrect results: Falsely elevated Troponin values have been reported which are inconsistent with the patient's clinical picture and test negative by other Troponin assays. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K121214 (Beckman Coulter, Inc., 2013) has gone furthest, with 8 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 ADVIA Centaur® TnI-Ultra (TnI-Ultra) method is for in vitro diagnostic use in the quantitative determination of cardiac Troponin I in human serum and heparinized and EDTA plasma. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respective to relative risk mortality, myocardial infarction or increased probability of ischemic events requiring urgent revascularization procedures.
The ADVIA Centaur® TnI-Ultra Calibrator is for the in vitro diagnostic use in the calibration of the TnI-Ultra assay on the ADVIA Centaur® system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053020: TNL-Ultra Assay for the Advia Centaur System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053020
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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