510(k) · Cleared
ClearedCedia Digoxin II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · KXT Enzyme Immunoassay, Digoxin
Cleared on May 21, 1997 as substantially equivalent to K882233 (Abbott Laboratories, 1988) after a 72-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- May 21, 1997
- Review
- 72 days
- Class
- Class II
- Product code
- KXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K882233 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK882233 TDX (R) Digoxin NXTAbbott Laboratories · 1988
- This deviceK970883 Cedia Digoxin IIBoehringer Mannheim Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882233 | TDX (R) Digoxin NXT | Abbott Laboratories | 1988 | — |
| 0 (this device) | K970883 | Cedia Digoxin II | Boehringer Mannheim Corp. | 1997 | — |
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? (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 |
|---|---|---|---|
| * | K882233 | TDX (R) Digoxin NXTSummary page 1…o other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Abbott TDx® Digoxin II Assay (K882233}. Continued on next page page 28 510( BOEHRINGER MANNHEIM CORPORATION 4. Device Description The CEDIA® Digo… | 1988 |
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.
- 6 other devices also cite its predicate K882233.
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 CEDIA Digoxin II homogeneous enzyme immunoassay is for the quantitation of digoxin in human serum or plasma using automated clinical chemistry analyzers. Measurements are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure proper therapy. Digoxin is widely prescribed for the treatment of congestive heart failure and various disturbances of cardiac rhythm. Therapeutic use of digoxin improves the…
Read the full statement (384 words)
The CEDIA Digoxin II homogeneous enzyme immunoassay is for the quantitation of digoxin in human serum or plasma using automated clinical chemistry analyzers. Measurements are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure proper therapy.
Digoxin is widely prescribed for the treatment of congestive heart failure and various disturbances of cardiac rhythm. Therapeutic use of digoxin improves the strength of myocardial contraction and results in the beneficial effects of increased cardiac output, decreased heart size, decreased venous pressure and decreased blood volume. Digoxin therapy also results in stabilized and slowed ventricular pulse rate.
Although the availability of crystalline digoxin has permitted the standardization of drug dosage, therapeutic administration inadvertently, yet frequently, results in toxicity. Importantly, symptoms of digoxin toxicity often mimic the cardiac arthythmias for which the drug was originally prescribed. Studies suggest that up to 25% of all hospitalized patients treated with digoxin experienced some degree of toxicity, and that the mortality rate among toxic patients was more than twice that of nontoxic patients. Digoxin concentrations of 0.9 to 2.0 ng/mL in serum or plasma are normally considered to be therapeutic. Symptoms of human toxicity generally only appear at concentrations above 2.0 ng/mL; however, concentrations as low as 1.4 ng/mL may be toxic for others.
Toxicity of digoxin may reflect several factors: a) The drug has a low therapeutic ratio (i.e., a very small difference exists between therapeutic and toxic tissue levels). b) Individuals vary in their response to digoxin. c) Absorption of various tablet forms of digoxin may vary over a two-fold range. d) Susceptibility to digitalis toxicity apparently increases with age.
In combination with other clinical data, monitoring serum or plasma levels may provide the physician with useful information to aid in adjusting patient dosage, and achieving optimal therapeutic effect, while avoiding both subtherapeutic and harmful toxic drug levels.
The CEDIA Digoxin II Assay performance has not been established with body fluids other than human serum and plasma (Na or Li heparin; Na EDTA).
Digoxin-like immunoreactive substances (DLIS) have been identified in blood from patients in renal failure, liver failure, and pregnant women in the third trimester. Studies have established that the presence of DLIS in a sample can result in a false elevation of digoxin when assayed by commercially available immunoassay.
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/K970883 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970883: Cedia Digoxin II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970883
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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