# K052503: Troponin I Ultra Assay and Calibrator for the Advia Ims System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Dec 14, 2005 after 92 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Bayer ACS: 180 cTnI Assay: named in the summary without a submission number

## Indications for use
The ADVIA IMSe Troponin I Ultra (Tnl-Ultra) method is for in vitro diagnostic use to quantitatively measure the cardiac Troponin I in human serum and plasma (lithium heparin). When used in conjunction with other clinical data such as presenting symptoms and diagnostic procedures, measurements of cardiac Troponin I aid in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with non-ST segment-elevation, acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures. The ADVIA IMS® TnI-Ultra Calibrator is for the in vitro diagnostic use in the calibration of the Tni-Ultra assay on the ADVIA IMS® system

Source page: https://510kreport.com/device/K052503
Methodology: https://510kreport.com/methodology