510(k) · Cleared
Recalled · Class II · 2018Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin, Theophylline Flex Reagent Cartridge
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 Jul 28, 2006 as substantially equivalent to K990251 (Dade Behring, Inc., 1999) and 5 other predicates after a 10-day review. Its family tree reaches back 2 generations to 1989. It has been recalled 4 times.
- Decided
- Jul 28, 2006
- Review
- 10 days
- Class
- Class II
- Product code
- LFM
- Recalls
- 4
- Predicates
- 6
Its longest line of descent runs back 2 generations to K891094 (1989). 8 ancestors in all, the oldest K833378 (1983). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891094 | Aca (R) Digitoxin (DGTX) Method | E.I. Dupont DE Nemours & Co., Inc. | 1989 | — |
| −1 | K990251 | DGTX Flex Reagent Cartridge, Model DF36 | Dade Behring, Inc. | 1999 | — |
| 0 (this device) | K062024 | Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide… | Dade Behring, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2003 | 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? (6)
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 |
|---|---|---|---|
| * | K990251 | DGTX Flex Reagent Cartridge, Model DF36Summary page 1…510(k) # class _______Code Dimension VistaTM Dimension® DGTX DGTX Flex® reagent Flex® reagent K990251 11 862.3300 LFM cartridge cartridge Dimension VistaTm Dimension® DGNA DIG Flex® reagent F… | 1999 |
| * | K946153 | Digoxin Flex (TM) Reagent CartridgeSummary page 1…K990251 11 862.3300 LFM cartridge cartridge Dimension VistaTm Dimension® DGNA DIG Flex® reagent Flex®& reagent cartridge K946 153 11 862.3320 KIXT cartridge Dimension VistaTm Dimension®P GENT GENT Flex® reagent Flex® reagent cartridge… | 1995 |
| * | K962819 | Gentamicin Flex Reagent CartridgeSummary page 1…Flex®& reagent cartridge K946 153 11 862.3320 KIXT cartridge Dimension VistaTm Dimension®P GENT GENT Flex® reagent Flex® reagent cartridge K962819 11 862.3450 LCD cartridge Dimension VistaTM Dimension® NAPA NAPA Flex®& reagent Flex® reagent… | 1996 |
| * | K032564 | Dimension N-Acetylprocainamide (Napa) Flex Reagent Cartridge Method, Model DF111Summary page 1…Flex® reagent cartridge K962819 11 862.3450 LCD cartridge Dimension VistaTM Dimension® NAPA NAPA Flex®& reagent Flex® reagent K032564 if 862.3320 LAN cartridge cartridge ______… | 2003 |
| * | K911056 | DU Pont Dimension (R) Phenytoin (PTN) MethodSummary page 2…) i _ __ class Code Dimension VistaTM Dimension® PTN PTN Flex® reagent Flex® reagent 1(911056 II 862.3350 DIP cartridge cartridge Dimension VistaTM Dimension® THEO THEO Flex® reagent Flex® re… | 1991 |
| * | K862955 | Methods for the Dimension Clinical Chem. SystemSummary page 2…® reagent 1(911056 II 862.3350 DIP cartridge cartridge Dimension VistaTM Dimension® THEO THEO Flex® reagent Flex® reagent K862955 II 862.3880 KLS cartridge cartridge Device Description: Dade Behring Dimension VistaTM Flex® reage… | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 19, 2018 | Class II | Z-2182-2018 | Under Investigation by firm | The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2… |
| Apr 19, 2018 | Class II | Z-2181-2018 | Under Investigation by firm | The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2… |
| Aug 9, 2012 | Class II | Z-0408-2013 | Nonconforming Material/Component | Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibrations, QC and patient samples. The Abnormal Reaction flag is being triggered by an internal check in the method for atypical particle reagent… |
| Nov 30, 2010 | Not classified | Z-1739-2011 | Other | False elevation of Dimension Vista(R) Gentamicin results for patients and QC when prior reagent aspirated by the reagent probe is any of the following plasma protein methods: ASL, B2MIC, B2MU, CRP,CYSC, HCYS, hcCRP, IGE, IGG3, IGG4, RF… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 9.9 years on median.
- 2 of the 8 ancestors have a recall of any class.
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 Dimension VistaTM Digitoxin (DGTX) Flex® reagent cartridge is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. 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. The Dimension VistaTM Digoxin (DIG) Flex® reagent cartridge is a device intended to measure digoxin, a cardiovascular drug, in serum and…
Read the full statement (286 words)
The Dimension VistaTM Digitoxin (DGTX) Flex® reagent cartridge is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. 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.
The Dimension VistaTM Digoxin (DIG) Flex® reagent cartridge is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.
The Dimension VistaTM Gentamicin (GENT) Flex® reagent cartridge is a device intended to measure gentamicin, an antibiotic drug, in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
The Dimension VistaTM N-acetylprocainamide (NAPA) Flex® reagent cartridge is a device intended to measure N-acetylprocainamide in human serum and plasma. Measurements obtained by this device maybe used in therapeutic drug monitoring to maintain adequate procainamide therapy.
The Dimension VistaTM Phenytoin (PTN) Flex® reagent cartridge is a device intended to measure diphenylhydantoin (phenytoin), an antiepileptic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin (phenytoin) overdose and in monitoring levels of diphenylhydantoin (phenytoin) to ensure appropriate therapy.
The Dimension VistaTM Theophylline (THEO) Flex® reagent cartridge is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems), in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062024 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062024: Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin, Theophylline Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062024
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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