510(k) · Cleared
ClearedADVIA Centaur® Digoxin assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · KXT Enzyme Immunoassay, Digoxin
Cleared on Jul 16, 2021 as substantially equivalent to K931213 (Ciba Corning Diagnostics Corp., 1993) after a 588-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jul 16, 2021
- Review
- 588 days
- Class
- Class II
- Product code
- KXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931213 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK931213 Acs Digoxin ImmunoassayCiba Corning Diagnostics Corp. · 1993
- This deviceK193397 ADVIA Centaur® Digoxin assaySiemens Healthcare Diagnostics, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931213 | Acs Digoxin Immunoassay | Ciba Corning Diagnostics Corp. | 1993 | — |
| 0 (this device) | K193397 | ADVIA Centaur® Digoxin assay | Siemens Healthcare Diagnostics, Inc. | 2021 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K931213 | Acs Digoxin ImmunoassaySummary page 4…tion: Class II Regulation Section: 21 CFR § 862.3320 Product Code: KXT Panel: Toxicology III. PREDICATE DEVICE Name of Device: ADVIA Centaur® Digoxin assay 510 (k): K931213 IV. DEVICE DESCRIPTION The ADVIA Centaur Digoxin assay reagents come in the following configurations:… | 1993 |
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?
- Its one ancestor has no recall.
How does its category compare?
All KXT devicesKXT Enzyme Immunoassay, Digoxin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
For in vitro diagnostic use in the quantitative determination of digoxin in serum and plasma
(EDTA and lithium heparin) using the ADVIA Centaur® XP systems.
Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring
levels of digoxin to ensure appropriate therapy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193397 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193397: ADVIA Centaur® Digoxin assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193397
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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