Stratus Digoxin Fluorometric Enzyme Immunoassay
by American Dade 510(k)
Active
510(k) K831177
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK831177 | Date17 May 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- Full name
- Stratus Digoxin Fluorometric Enzyme Imm-
- 510(k) Number
- FDA Product Code
- KXT
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3320
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Stratus Digoxin Fluorometric Enzyme Immunoassay is an enzyme-linked immunoassay designed for the quantitative measurement of digoxin in human serum or plasma. It employs a fluorometric detection method to detect and quantify low concentrations of the cardiac glycoside, aiding in the monitoring of patients receiving digoxin therapy or those with suspected toxicity. Classified as an enzyme immunoassay, this device leverages immunochemical principles to provide rapid and precise results, supporting clinical decision-making in toxicology and cardiology settings.
This device is intended for use in clinical laboratories and hospital settings, supplied as a single-use reagent kit requiring manual handling. The assay is not sterile as packaged but is designed for use with sterile patient samples. It is classified under FDA product code KXT and falls under Class II regulatory controls, with a 510(k) clearance from the FDA. Storage conditions and shelf life are specified in the accompanying instructions, though no additional regulatory approvals beyond the 510(k) are referenced in the data. The device adheres to Special Controls for enzyme immunoassays, ensuring compliance with performance standards for accuracy and reliability.
Other devices from American Dade
Questions
AI-generated answers, 1 Oct 2026
What is the Stratus Digoxin Fluorometric Enzyme Immunoassay used for?
This device measures digoxin levels in human serum or plasma using a fluorometric enzyme immunoassay. It helps clinicians monitor patients on digoxin therapy or assess suspected toxicity by providing precise quantitative results, supporting decisions in cardiology and toxicology.
How is the Stratus Digoxin Fluorometric Enzyme Immunoassay supplied?
The assay is supplied as a single-use reagent kit. It requires manual handling in a clinical laboratory or hospital setting, and it is designed for use with sterile patient samples—though the kit itself is not sterile as packaged.
Is the Stratus Digoxin Fluorometric Enzyme Immunoassay sterile?
No, the kit is not sterile as packaged. However, it is intended for use with sterile patient samples, ensuring that the sample itself meets clinical sterility standards before testing.
What regulatory pathway does this device follow?
The Stratus Digoxin Fluorometric Enzyme Immunoassay received FDA 510(k) clearance under product code KXT, classified as an enzyme immunoassay under Class II regulatory controls. It adheres to Special Controls for enzyme immunoassays, ensuring compliance with performance standards for accuracy and reliability.
What clinical specialties benefit most from this assay?
This assay is primarily used in Clinical Toxicology and Cardiology. It aids toxicologists in evaluating digoxin toxicity and cardiologists in managing patients on digoxin therapy by providing rapid, precise measurements of the drug’s concentration in blood.