# K093441: Dimension Vista Loci Digoxin Flex Reagent Cartridge (Digxn), Model K6435

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Apr 7, 2010 after 153 days
- Product code: KXT (Enzyme Immunoassay, Digoxin)
- Device class: 2
- Regulation: 21 CFR 862.3320
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011035 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011035: Dimension Drug Calibrator, Model DC22B, Dade Behring, Inc. (2001) Summary page 2.

## Cited in the summary but kept off the family tree
- K094615: Dimension Digoxin Flex reagent cartridge, DGNA (DF35A). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Recalls of this device
- Mar 21, 2017 · Class II · Z-2607-2017: 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
- Feb 21, 2013 · Class II · Z-1151-2013: Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2

## Indications for use
Thie DIGXN method is an in vitro diagnostic test for the quantitative measurement of digoxin in human serum and plasma on the Dimension Vista® System. Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to help ensure appropriate therapy. The DRUG 4 CAL is an in vitro diagnostic product for the calibration of the LOCI Digoxin (DIGXN) method on the Dimension Vista® System.

Source page: https://510kreport.com/device/K093441
Methodology: https://510kreport.com/methodology