510(k) · Cleared
ClearedTDX (R) Digoxin NXT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · KXT Enzyme Immunoassay, Digoxin
Cleared on Jul 6, 1988 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Jul 6, 1988
- Review
- 40 days
- Class
- Class II
- Product code
- KXT
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 7 citing it directly.
- This deviceK882233 TDX (R) Digoxin NXTAbbott Laboratories · 1988
- Descendant · cites it directly · 1 of its ownK982935 Synchron Systems Digoxin (Dign) Reagent, Synchron Systems Drug…Beckman Coulter, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK973112 Elecsys DigoxinBoehringer Mannheim Corp. · 1997
- Descendant · 2 generations on · 0 of its ownK153301 Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche Diagnostics · 2016
- Descendant · 2 generations on · 0 of its ownK993473 Synchron Systems Drug Calibrator 2Beckman Coulter, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK983151 Immage Immunochemistry System Digoxin (Dig) ReagentBeckman Coulter, Inc. · 1998
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K982935Synchron Systems Digoxin (Dign) Reagent, Synchron Systems Drug CalibratorBeckman Coulter, Inc. · 1998 · cites it directly1descendant
- K973112Elecsys DigoxinBoehringer Mannheim Corp. · 1997 · cites it directly1descendant
- K153301Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche Diagnostics · 2016 · 2 generations on0descendants
- K993473Synchron Systems Drug Calibrator 2Beckman Coulter, Inc. · 1999 · 2 generations on0descendants
- K983151Immage Immunochemistry System Digoxin (Dig) ReagentBeckman Coulter, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K882233 | TDX (R) Digoxin NXT | Abbott Laboratories | 1988 | — |
| +1 | K982935 | Synchron Systems Digoxin (Dign) Reagent, Synchron Systems Drug Calibrator | Beckman Coulter, Inc. | 1998 | — |
| +1 | K973112 | Elecsys Digoxin | Boehringer Mannheim Corp. | 1997 | — |
| +2 | K153301 | Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II | Roche Diagnostics | 2016 | — |
| +2 | K993473 | Synchron Systems Drug Calibrator 2 | Beckman Coulter, Inc. | 1999 | — |
| +1 | K983151 | Immage Immunochemistry System Digoxin (Dig) Reagent | Beckman Coulter, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982935 | Synchron Systems Digoxin (Dign) Reagent, Synchron Systems Drug Calibrator | 1998 | 1 |
| K973112 | Elecsys Digoxin | 1997 | 1 |
| K983151 | Immage Immunochemistry System Digoxin (Dig) Reagent | 1998 | 0 |
| K970883 | Cedia Digoxin II | 1997 | 0 |
| K970881 | Cedia Digoxin | 1997 | 0 |
| K963062 | Immage System Digoxin (Dig) Reagent/Beckman Drug Calibrator 2 | 1996 | 0 |
| K962294 | Immage Immunochemistry System | 1996 | 0 |
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?
- Of its descendants, K982935 (Beckman Coulter, Inc., 1998) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K882233 · printed Nov 5, 2026
Cite this page
510(k) Report. “K882233: TDX (R) Digoxin NXT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K882233
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026