# K053020: TNL-Ultra Assay for the Advia Centaur System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Dec 30, 2005 after 65 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ACS: 180®: named in the summary without a submission number
- (no number) ADVIA Centaur® Cardiac Troponin I (cTnI) Assay: named in the summary without a submission number

## Most influential descendants
- K121214: Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the Access 2 Immunoassay System (2013), 8 descendants of its own
- K172787: Access hsTnl (2018), 4 descendants of its own
- K230648: Access hsTnI (2023), 2 descendants of its own
- K243483: Access hsTnI (2025), 0 descendants of its own
- K242870: Access hsTnI (2025), 0 descendants of its own

## Recalls of this device
- May 2, 2016 · Class II · Z-2041-2016: 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: 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: 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: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K053020
Methodology: https://510kreport.com/methodology