The Digoxin Test System is a diagnostic device used to measure the levels of digoxin in a patient’s blood. This measurement is crucial for monitoring patients who are prescribed digoxin, a medication commonly used for heart conditions. Monitoring helps to ensure therapeutic levels are reached while avoiding toxicity. The device typically utilizes immunoassay techniques and provides quick and accurate results, enhancing patient care and treatment effectiveness.

Intended Use of Digoxin Test System

A Digoxin Test System is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

Intended Use:

This device is used for in vitro diagnostics to quantitatively determine digoxin levels in serum and plasma, specifically EDTA and lithium heparin, aiding in the diagnosis and treatment of digoxin overdose and monitoring digoxin levels for appropriate therapy.

Device Description:

The Digoxin assay reagents come in two configurations: one or five Ready Pack primary reagent packs and the DIG Master Curve. Each pack includes a monoclonal mouse anti-digoxin antibody labeled with acridinium ester in protein buffered saline with sodium azide and preservatives, and a Solid Phase Reagent with digitoxin covalently coupled to paramagnetic particles in protein buffered saline with sodium azide and preservatives.

Performance Testing (Analytical) for Digoxin Test System

• Reagent Stability
• Precision/Reproducibility
• Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
• Linearity/assay reportable range
• Traceability (controls, calibrators, or method)
• Analytical specificity (cross reactivity)
• Accuracy(recovery)
• Interfering Substances

Clinical Testing:

No Guidance available  for 510k submission