# K053577: Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample Diluent

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Apr 14, 2006 after 113 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
Longest line of descent: 1 generation back to K010313 (2001). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010313: Dimension Ctni Flex Reagent Cartridge, Dade Behring, Inc. (2001) Summary page 1.
- K010314: Dimension Ctni Calibrator, Dade Behring, Inc. (2001) Summary page 1.

## Most influential descendants
- K081683: Loci Cardiac Troponin I Calibrator, Model RC621 (2008), 0 descendants of its own
- K081643: Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models, RF621, KD692 (2008), 0 descendants of its own

## Indications for use
The CTNI method is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in human serum on the Dimension Vistaim System. Measurements of cardiac troponin I are used to aid in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The CTNI CAL is an in vitro diagnostic product for the calibration of cardiac Troponin-l (CTNI) on the Dimension VistaTM system. For use on the Dimension Vista TM System to dilute samples with elevated CTNI results.

Source page: https://510kreport.com/device/K053577
Methodology: https://510kreport.com/methodology