510(k) · Cleared
ClearedImmulite 2000 Digoxin, Models L2KDI2 (200 Tests) and L2KDI6 (600 Tests)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · KXT Enzyme Immunoassay, Digoxin
Cleared on Sep 19, 2001 as substantially equivalent to K914833 (Cirrus Diagnostics, Inc., 1991) after a 61-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Sep 19, 2001
- Review
- 61 days
- Class
- Class II
- Product code
- KXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914833 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK914833 Immulite DigoxinCirrus Diagnostics, Inc. · 1991
- This deviceK012301 Immulite 2000 Digoxin, Models L2KDI2 (200 Tests) and L2KDI6 (600…Diagnostic Products Corp. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914833 | Immulite Digoxin | Cirrus Diagnostics, Inc. | 1991 | — |
| 0 (this device) | K012301 | Immulite 2000 Digoxin, Models L2KDI2 (200 Tests) and L2KDI6 (600 Tests) | Diagnostic Products Corp. | 2001 | — |
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 |
|---|---|---|---|
| * | K914833 | Immulite DigoxinSummary page 2…00 West 96" Street Los Angeles, California 90045-5597 DPC’s Registration Number 1s 2017183 Substantiall Equivalent Predicate Device: IMMULITE® Digoxin (K914833) Description of Device: IMMULITE® 2000 Digoxin is a solid phase, chemiluminescent enzyme-labeled competitive immunoassay for use… | 1991 |
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.
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 IMMULITE® 2000 Digoxin assay is for in vitro diagnostic use with the IMMULITE® 2000 Analyzer — for the quantitative measurement of digoxin in serum or heparinized plasma, as an aid in monitoring the therapeutic administration of this cardioglycoside, while avoiding toxicity.
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/K012301 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012301: Immulite 2000 Digoxin, Models L2KDI2 (200 Tests) and L2KDI6 (600 Tests).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012301
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026