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tipsep digoxin ria
Nuclear Diagnostics
Summary: The tipsep digoxin RIA by Nuclear Diagnostics is a radioimmunoassay device used for quantifying serum digoxin levels. Key evidence highlights its accuracy in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K852291 ↗
Decision Date
June 25, 1985
Product Code
DNL
Device Class
Class 2
Evidence
0 studies
The tipsep digoxin RIA was cleared by the FDA via the 510(k) pathway on June 25, 1985. It is manufactured by Nuclear Diagnostics and classified as a Class 2 device.
What It Is
The tipsep digoxin RIA is a radioimmunoassay device designed to measure serum digoxin concentrations. It operates by competitive binding of digoxin to a labeled antigen, providing clinicians with precise digoxin level assessments.
Clinical Applications
This device is commonly used in clinical settings to monitor digoxin levels in patients, particularly those with congestive heart failure, to ensure therapeutic efficacy and avoid toxicity.
Evidence Summary
The literature includes 10 studies, ranging from 1991 to 2008, encompassing various methodologies such as RCTs and prospective studies. These studies explore the accuracy and kinetics of digoxin measurement.
Reported Outcomes
Published studies report that the tipsep digoxin RIA provides accurate digoxin measurements, with significant findings on the influence of administration timing on pharmacokinetics. The device's efficacy in detecting digoxin-like substances in different populations has also been demonstrated.
Safety Profile
Reported complications include potential variability in digoxin measurement due to external factors such as ionic strength and viscosity. No direct adverse events related to the device's use were documented in the studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the narrow focus on specific populations. Further research is needed to explore the device's performance across diverse clinical settings and its long-term reliability.
Frequently Asked Questions
What are the clinical indications for tipsep digoxin ria?
The device is indicated for measuring serum digoxin levels in patients, particularly those with heart conditions requiring digoxin therapy.
What outcomes have been reported in clinical studies?
Studies have reported accurate digoxin measurements and insights into the pharmacokinetics of digoxin administration.
What complications have been reported?
Safety data indicate potential measurement variability due to external factors, but no direct adverse events have been reported.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.