510(k) · Cleared
ClearedRandox Digitoxin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · LFM Enzyme Immunoassay, Digitoxin
Cleared on Jan 11, 2002 after a 189-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 11, 2002
- Review
- 189 days
- Class
- Class II
- Product code
- LFM
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
Randox Laboratories Ltd. Digitoxin Test Kit is an in vitro diagnostic reagent for the quantitative determination of digitoxin in serum. The method is a latex-enhanced turbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with digitoxin and, in the presence of digitoxin antibody solution, agglutination occurs. When a sample containing digitoxin is introduced the agglutination reaction is partially…
Read the full statement (172 words)
Randox Laboratories Ltd. Digitoxin Test Kit is an in vitro diagnostic reagent for the quantitative determination of digitoxin in serum. The method is a latex-enhanced turbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with digitoxin and, in the presence of digitoxin antibody solution, agglutination occurs. When a sample containing digitoxin is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of digitoxin in the sample. By monitoring the change in scattered light as a change in absorbance, a concentration curve can be obtained. The actual change in absorbance is inversely proportional to the concentration of digitoxin in the sample.
Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.
Assay Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012112: Randox Digitoxin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012112
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026