510(k) · Cleared
ClearedDGTX Flex Reagent Cartridge, Model DF36
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · LFM Enzyme Immunoassay, Digitoxin
Cleared on Mar 31, 1999 as substantially equivalent to K891094 (E.I. Dupont DE Nemours & Co., Inc., 1989) after a 63-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- Mar 31, 1999
- Review
- 63 days
- Class
- Class II
- Product code
- LFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891094 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK891094 Aca (R) Digitoxin (DGTX) MethodE.I. Dupont DE Nemours & Co., Inc. · 1989
- This deviceK990251 DGTX Flex Reagent Cartridge, Model DF36Dade Behring, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK062024 Dimension Vista Digitoxin, Digoxin, Gentamicin…Dade Behring, Inc. · 2006 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K062024Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin…Dade Behring, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891094 | Aca (R) Digitoxin (DGTX) Method | E.I. Dupont DE Nemours & Co., Inc. | 1989 | — |
| 0 (this device) | K990251 | DGTX Flex Reagent Cartridge, Model DF36 | Dade Behring, Inc. | 1999 | — |
| +1 | K062024 | Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide… | Dade Behring, Inc. | 2006 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
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 |
|---|---|---|---|
| * | K891094 | Aca (R) Digitoxin (DGTX) MethodSummary page 1…101 Date of Preparation: 1/22/99 Name of Product: DGTX Flex™ reagent cartridge FDA Classification Name: Digitoxin Test System Predicate Device: aca® Digitoxin Method (K891094) Device Description: The digitoxin assay uses an immunoassay technique in which free and digitoxin-bound antibody-enzyme species… | 1989 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062024 | Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin… | 2006 | 0 |
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.
- Of its descendants, K062024 (Dade Behring, Inc., 2006) has gone furthest, with 0 descendants of its own.
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 DGTX Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure digitoxin in human serum and plasma. Measurements of digitoxin are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.
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/K990251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990251: DGTX Flex Reagent Cartridge, Model DF36.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990251
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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