# K062024: Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin, Theophylline Flex Reagent Cartridge

- Pathway: 510(k) (Special)
- Applicant: Dade Behring, Inc.
- Decided: Jul 28, 2006 after 10 days
- Product code: LFM (Enzyme Immunoassay, Digitoxin)
- Device class: 2
- Regulation: 21 CFR 862.3300
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K891094 (1989). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990251: DGTX Flex Reagent Cartridge, Model DF36, Dade Behring, Inc. (1999) Summary page 1.
- K946153: Digoxin Flex (TM) Reagent Cartridge, E.I. Dupont DE Nemours & Co., Inc. (1995) Summary page 1.
- K962819: Gentamicin Flex Reagent Cartridge, Dade Intl., Inc. (1996) Summary page 1.
- K032564: Dimension N-Acetylprocainamide (Napa) Flex Reagent Cartridge Method, Model DF111, Dade Behring, Inc. (2003) Summary page 1.
- K911056: DU Pont Dimension (R) Phenytoin (PTN) Method, E.I. Dupont DE Nemours & Co., Inc. (1991) Summary page 2.
- K862955: Methods for the Dimension Clinical Chem. System, E.I. Dupont DE Nemours & Co., Inc. (1986) Summary page 2.

## Recalls of this device
- Apr 19, 2018 · Class II · Z-2182-2018: 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 bet
- Apr 19, 2018 · Class II · Z-2181-2018: 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 bet
- Aug 9, 2012 · Class II · Z-0408-2013: 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 m
- Nov 30, 2010 · Not classified · Z-1739-2011: 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,CYS

## Indications for use
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.

Source page: https://510kreport.com/device/K062024
Methodology: https://510kreport.com/methodology