Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K153301 FDA 510(k)
- FDA Product Code
- KXT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3320 FDA 510(k)
- Regulation Number
- 862.3320 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Elecsys Digoxin Immunoassay is an in vitro diagnostic test designed for the quantitative measurement of digoxin in human serum and plasma. It utilizes a competitive electrochemiluminescence immunoassay principle where the patient sample competes with a biotin-labeled digoxin derivative for binding sites on a ruthenylated monoclonal antibody.
This device is intended for use on Elecsys and cobas e immunoassay analyzers to assist in the diagnosis and treatment of digoxin overdose and to monitor digoxin levels for therapeutic management. The product has received FDA 510(k) clearance and is classified as a class 2 enzyme immunoassay for clinical toxicology applications.
Frequently asked questions
What is the primary purpose of the Elecsys Digoxin Immunoassay?
This device is designed for the quantitative measurement of digoxin in human serum and plasma. It is used on Elecsys and cobas e immunoassay analyzers to assist clinicians in monitoring therapeutic digoxin levels and diagnosing potential digoxin overdose.
How does the Elecsys Digoxin Immunoassay function?
The test utilizes a competitive electrochemiluminescence immunoassay principle. In this process, the digoxin present in the patient sample competes with a biotin-labeled digoxin derivative for binding sites on a ruthenylated monoclonal antibody.
What is the regulatory status of this device?
The Elecsys Digoxin Immunoassay has received FDA 510(k) clearance under K153301. It is classified as a class 2 enzyme immunoassay for clinical toxicology applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II, Elecsys® Digoxin - Roche Diagnostics USA, Elecsys® Digoxin - Roche Diagnostics USA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153301 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics
Sources (1)
- FDA 510(k) K153301 24 fields · synced Sep 21, 2026