# K081643: Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models, RF621, KD692

- Pathway: 510(k) (Special)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Jul 3, 2008 after 21 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
Longest line of descent: 2 generations back to K010313 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063756: Dimension Vista Ctni Flex Reagent Cartridge, Dade Behring, Inc. (2007) Summary page 1.
- K053577: Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample Diluent, Dade Behring, Inc. (2006) Summary page 1.

## Recalls of this device
- Mar 21, 2018 · Class II · Z-2436-2018: The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted o
- Mar 21, 2017 · Class II · Z-2606-2017: The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FE
- Aug 31, 2011 · Not classified · Z-0069-2012: Firm has confirmed customer complaints for low recovery of QC and patient samples.
- Apr 12, 2010 · Not classified · Z-0460-2011: Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate t

## Indications for use
The TNI method is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in human serum and plasma on the Dimension® EXLTM integrated chemistry system with LOCI® module. Measurements of cardiac troponin I are used as an 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 Sample Diluent is an in vitro diagnostic product for manual dilution of samples with elevated cardiac troponin I results processed on the Dimension Vista® and Dimension® EXL TM integrated chemistry system with LOCI® module.

Source page: https://510kreport.com/device/K081643
Methodology: https://510kreport.com/methodology