510(k) · Cleared
Recalled · Class II · 2017Dimension Vista Loci Digoxin Flex Reagent Cartridge (Digxn), Model K6435
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · KXT Enzyme Immunoassay, Digoxin
Cleared on Apr 7, 2010 as substantially equivalent to K011035 (Dade Behring, Inc., 2001) after a 153-day review. Its family tree reaches back 1 generation to 2001. It has been recalled 2 times.
- Decided
- Apr 7, 2010
- Review
- 153 days
- Class
- Class II
- Product code
- KXT
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K011035 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK011035 Dimension Drug Calibrator, Model DC22BDade Behring, Inc. · 2001
- This deviceK093441 Dimension Vista Loci Digoxin Flex Reagent Cartridge (Digxn), Model…Siemens Healthcare Diagnostics · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011035 | Dimension Drug Calibrator, Model DC22B | Dade Behring, Inc. | 2001 | — |
| 0 (this device) | K093441 | Dimension Vista Loci Digoxin Flex Reagent Cartridge (Digxn), Model K6435 | Siemens Healthcare Diagnostics | 2010 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KXT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KXT device
- #1 K193397 ADVIA Centaur® Digoxin assayscore 1.7 · 1 generation · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| 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 | |
| * | K011035 | Dimension Drug Calibrator, Model DC22BSummary page 2…predicate devices, Dimension® Digoxin Flex® reagent cartridge, DGNA (DF35A), cleared under K94615 and Dimension® Drug Calibrator, DRUG CAL (0C22B), cleared under K01 1035. A comparison of the important similarities and differences between the devices is provided in the following tables: Metho… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 21, 2017 | Class II | Z-2607-2017 | Under Investigation by firm | 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, FERR, PRL, and TSH have incorrect units… |
| Feb 21, 2013 | Class II | Z-1151-2013 | Process control | 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 2KD052 or Drug 4 Cal (KC460A) lot… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K011035.
How does its category compare?
All KXT devicesKXT Enzyme Immunoassay, Digoxin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KXT
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · KXT
Too few KXT 510(k)s in any year since 2007 to give a median.
Recalls per year · KXT
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KXT
7in 2024
MAUDE reports naming product code KXT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 3 | 310 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 1 | — | 0 | 11 |
| 2011 | 1 | — | 0 | 19 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 39 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093441: Dimension Vista Loci Digoxin Flex Reagent Cartridge (Digxn), Model K6435.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093441
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026