510(k) · Cleared
ClearedArchitect Idigoxin and Architect Idigoxin Calibrators, Models 1P32-25 and IP32-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biokit, S.A. · KXT Enzyme Immunoassay, Digoxin
Cleared on Dec 22, 2008 as substantially equivalent to K023058 (Seradyn, 2002) after an 80-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Dec 22, 2008
- Review
- 80 days
- Class
- Class II
- Product code
- KXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023058 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK023058 QMS Digoxin Reagent System on the Abbott Aeroset SystemSeradyn · 2002
- This deviceK082953 Architect Idigoxin and Architect Idigoxin Calibrators, Models…Biokit, S.A. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023058 | QMS Digoxin Reagent System on the Abbott Aeroset System | Seradyn | 2002 | — |
| 0 (this device) | K082953 | Architect Idigoxin and Architect Idigoxin Calibrators, Models 1P32-25 and… | Biokit, S.A. | 2008 | — |
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 |
|---|---|---|---|
| * | K023058 | QMS Digoxin Reagent System on the Abbott Aeroset SystemSummary page 1…0 Device Classification: Class II Classification Panel: Toxicology Product Code: DLJ Legally marketed device to which equivalency is claimed: Aeroset Multigent Digoxin (k023058) Page 1 of 2 Intended Use of Device: The… | 2002 |
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.
How does its category compare?
All KXT devicesKXT Enzyme Immunoassay, Digoxin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The ARCHITECT iDigoxin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of digoxin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used to aid in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to help ensure appropriate therapy.
The ARCHITECT iDigoxin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of digoxin in human serum or plasma.
For in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082953: Architect Idigoxin and Architect Idigoxin Calibrators, Models 1P32-25 and IP32-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082953
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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