510(k) · Cleared
ClearedBayer Advia Digoxin Assay for the Integrated Module System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Diagnostics Corp. · KXT Enzyme Immunoassay, Digoxin
Cleared on Nov 14, 2003 as substantially equivalent to K912616 (Technicon Instruments Corp., 1991) and 1 other predicate after a 49-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Nov 14, 2003
- Review
- 49 days
- Class
- Class II
- Product code
- KXT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K885226 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK885226 Technicon Axon (TM) SystemTechnicon Instruments Corp. · 1989
- This deviceK033007 Bayer Advia Digoxin Assay for the Integrated Module SystemBayer Diagnostics Corp. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K885226 | Technicon Axon (TM) System | Technicon Instruments Corp. | 1989 | — |
| 0 (this device) | K033007 | Bayer Advia Digoxin Assay for the Integrated Module System | Bayer Diagnostics Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K912616 | Technicon Immuno 1 TM System Additional AnalytesSummary page 1…digoxin overdose and in monitoring therapeutic levels of digoxin to ensure appropriate therapy. 2. Predicate Device Immuno I Dieoxin Assav I K9126 16 K88.5226 3. Device / Method Product Name 1 I ADVIA IMS Dieoxin Assav I… | 1991 |
| * | K885226 | Technicon Axon (TM) System | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All KXT devicesKXT Enzyme Immunoassay, Digoxin: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Buyer ADVLA@IMS TM Digoxin assay is for in vitro diagnostic use to quantitatively measure digoxin, a cardioactive drug, in human serum. Measurements obtained are used as an aid in the diagnosis of digoxin overdose and in monitoring therapeutic levels of digoxin to ensure appropriate therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033007 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033007: Bayer Advia Digoxin Assay for the Integrated Module System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033007
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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