# K182225: Dimension Vista High-Sensitivity Troponin I (TNIH) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Mar 4, 2019 after 200 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K931172 (1993). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162895: Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5, Roche Diagnostics (2017) Summary page 5.

## Recalls of this device
- Jul 24, 2020 · Class II · Z-2927-2020: Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples

## Indications for use
The Dimension Vista® High-Sensitivity Troponin I (TNIH) assay is for in vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma using the Dimension Vista system. The assay can be used to aid in the diagnosis of acute myocardial infarction (AMI).

Source page: https://510kreport.com/device/K182225
Methodology: https://510kreport.com/methodology