510(k) · Cleared
ClearedImmage Immunochemistry System Digoxin (Dig) Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · KXT Enzyme Immunoassay, Digoxin
Cleared on Nov 5, 1998 as substantially equivalent to K882233 (Abbott Laboratories, 1988) after a 57-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Nov 5, 1998
- Review
- 57 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 deviceK983151 Immage Immunochemistry System Digoxin (Dig) ReagentBeckman Coulter, Inc. · 1998
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) | K983151 | Immage Immunochemistry System Digoxin (Dig) Reagent | Beckman Coulter, Inc. | 1998 | — |
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…ames IMMAGE® Immunochemistry System Digoxin (DIG) Reagent 3.2 Classification Name Digoxin Test System (21 CFR §862.3320) TDx®* Digoxin | Abbott*™* Laboratories, Inc | K882233 (DIG) ~ *Trademark of Abbott Laboratories **Abbott Laboratories, Abbott Park, IL 60064 5.0 Description: The IMMAGE® immunochemis… | 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) Reagent, when used
in conjunction with Beckman IMMAGE® Immunochemistry Systems and
Beckman Drug Calibrator 2, is intended for the quantitative determination of
digoxin in human serum or plasma by turbidimetric 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/K983151 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983151: Immage Immunochemistry System Digoxin (Dig) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983151
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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