510(k) · Cleared
ClearedAbbott Axsym Digitoxin (Modify)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LFM Enzyme Immunoassay, Digitoxin
Cleared on Sep 10, 1996 after a 46-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 10, 1996
- Review
- 46 days
- Class
- Class II
- Product code
- LFM
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 LFM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | — | TDx/TDxFLx Digitoxin assay Named without a submission number |
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.
How does its category compare?
All LFM devicesLFM Enzyme Immunoassay, Digitoxin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFM
FDA has decided no LFM device since 2007.
Median 510(k) review, days · LFM
Too few LFM 510(k)s in any year since 2007 to give a median.
Recalls per year · LFM
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFM
18in 2025
MAUDE reports naming product code LFM, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 3 |
| 2013 | 0 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 29 |
| 2021 | 0 | — | 0 | 25 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 27 |
| 2024 | 0 | — | 2 | 1 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of both assays is for the quantitative determination of digitoxin in human serum or plasma (sodium heparin and potassium oxalate).
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/K963158 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963158: Abbott Axsym Digitoxin (Modify).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963158
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026