510(k) · Cleared
ClearedImmage System Digoxin (Dig) Reagent/Beckman Drug Calibrator 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · KXT Enzyme Immunoassay, Digoxin
Cleared on Dec 13, 1996 as substantially equivalent to K882233 (Abbott Laboratories, 1988) after a 128-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Dec 13, 1996
- Review
- 128 days
- Class
- Class II
- Product code
- KXT
- Recalls
- None
- Predicates
- 2
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 deviceK963062 Immage System Digoxin (Dig) Reagent/Beckman Drug Calibrator 2Beckman Instruments, Inc. · 1996
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) | K963062 | Immage System Digoxin (Dig) Reagent/Beckman Drug Calibrator 2 | Beckman Instruments, Inc. | 1996 | — |
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K542328 | Behring Diagnostics N Latex RF Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | K882233 | TDX (R) Digoxin NXTSummary page 1…t system (21 CFR 888.5775) Clinical toxicology calibrator (21 CFR 882.3200) Predicate Device(s): Behring Diagnostics N Latex RF, KS42328 Abbott TDx Digoxin || Reagent, K882233 Description: #7557 P.Q2/0S The IMMAGE System Digoxin (DIG) Reagent is designed for oplimal performance on the IMMAGE Immunoche… | 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 IMMAGE Immunochemistry System Digoxin (DIG) Reegent, in conjunction with Beckman Drug Calibrator 2, is intended for use in the quantitative determination of digoxin in human serum and piasma sampies by turbidimetric immunoaseay. This assay is designed for use with the IMMAGE Immunochemistry System.
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/K963062 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963062: Immage System Digoxin (Dig) Reagent/Beckman Drug Calibrator 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963062
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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