Identifiers
- 510(k) Number
- K941255 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 CEDIA Digoxin Plus Assay is an enzyme immunoassay designed for the quantitative measurement of digoxin in human serum or plasma. Digoxin is a cardiac glycoside used to treat heart failure and arrhythmias, and accurate monitoring of its levels is critical to ensure therapeutic efficacy and avoid toxicity. This assay employs chemiluminescent enzyme immunoassay technology to provide precise and reliable results, supporting clinical decision-making in toxicology and cardiology settings.
This assay is intended for in vitro diagnostic use in clinical laboratories and is supplied as a reagent kit. It has received FDA 510(k) clearance under product code KXT, classified as a Class II device under Special Controls. The assay is not described as single-use or reusable in the provided data, nor is there mention of MRI safety or sterility requirements. It is regulated under the FDA’s 510(k) pathway, with the most recent clearance (K941255) issued in 1994, and is intended for use in clinical toxicology applications as per the advisory committee classification.
Frequently asked questions
What is the CEDIA Digoxin Plus Assay used for?
The CEDIA Digoxin Plus Assay is designed for the quantitative measurement of digoxin levels in human serum or plasma. Digoxin is a cardiac glycoside used to treat heart failure and arrhythmias, so precise monitoring ensures therapeutic effectiveness while minimizing the risk of toxicity. This assay supports clinical decision-making in toxicology and cardiology settings by providing reliable results.
How is the CEDIA Digoxin Plus Assay supplied?
The assay is supplied as a reagent kit, intended for use in clinical laboratories. It employs chemiluminescent enzyme immunoassay technology to deliver precise and reproducible measurements of digoxin concentrations. The kit format ensures all necessary components are included for immediate use upon receipt.
Is the CEDIA Digoxin Plus Assay single-use or reusable?
The provided data does not specify whether the assay components are single-use or reusable. However, enzyme immunoassay reagents are typically designed for single-use per test to maintain accuracy and prevent cross-contamination. Laboratories should follow manufacturer guidelines for proper usage and disposal.
What regulatory pathway does the CEDIA Digoxin Plus Assay follow?
The CEDIA Digoxin Plus Assay has received FDA 510(k) clearance under product code KXT, classified as a Class II device under Special Controls. It was cleared in 1994 (K941255) and is intended for use in clinical toxicology applications, as indicated by its advisory committee classification. The clearance confirms it meets FDA requirements for safety and effectiveness.
Are there specific storage requirements for the CEDIA Digoxin Plus Assay?
The provided data does not detail storage instructions, but enzyme immunoassay reagents generally require refrigeration (typically 2–8°C) to preserve stability and performance. Laboratories should consult the included kit documentation or manufacturer guidelines for precise storage conditions to ensure accurate and reliable assay results.
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: K923853 FDA 510 (k) - CEDIA DIGOXIN PLUS ASSAY, K934168 - CEDIA DIGOXIN PLUS ASSAY | FDA 510 (k), CEDIA DIGOXIN PLUS ASSAY (K941255) — FDA 510 (k) | Innolitics, K934168 - CEDIA DIGOXIN PLUS ASSAY | FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K941255 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (1)
- FDA 510(k) K941255 24 fields · synced Oct 1, 2026