510(k) · Cleared
ClearedElecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · KXT Enzyme Immunoassay, Digoxin
Cleared on Apr 8, 2016 as substantially equivalent to K973112 (Boehringer Mannheim Corp., 1997) and 1 other predicate after a 147-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Apr 8, 2016
- Review
- 147 days
- Class
- Class II
- Product code
- KXT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K931172 (1993). 14 ancestors in all, the oldest K882233 (1988). No later device cites it as a predicate yet.
- Root · 7 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 6 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 5 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 4 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 3 generations backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- 2 generations backK072437 Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics · 2008
- 1 generation backK092649 Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset…Roche Diagnostics Corp. · 2010
- This deviceK153301 Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche Diagnostics · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −6 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −5 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −4 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −3 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| −2 | K072437 | Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset | Roche Diagnostics | 2008 | — |
| −1 | K092649 | Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models… | Roche Diagnostics Corp. | 2010 | — |
| 0 (this device) | K153301 | Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II | Roche Diagnostics | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K973112 | Elecsys DigoxinSummary page 6… KXT, 862.3320 Product Codes JJY, 862.1660 Predicate Devices Elecsys Digoxin Immunoassay (k973112) For the Elecsys Digoxin Immunoassay, the establishment registration number for… | 1997 |
| * | K092649 | Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160…Summary page 5…in monitoring levels of digoxin to ensure proper therapy. The purpose of this Traditional 510(k) Premarket Notification is to introduce Elecsys PreciControl Cardiac II (k092649) as the control for Elecsys Digoxin Immunoassay. Additionally, Roche is modernizing the label for the Elecsys Digoxin assay, whic… | 2010 |
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?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 14 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. 2016, 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?
Immunoassay for the in vitro quantitative determination of digoxin in human serum and plasma. Measurements are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure proper therapy. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
PreciControl Cardiac II is used for quality control of specified immunoassays on the Elecsys and cobas e immunoassay analyzers.
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/K153301 · printed Nov 4, 2026
Cite this page
510(k) Report. “K153301: Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K153301
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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