Identifiers
- 510(k) Number
- K854638 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 Assay is an enzyme immunoassay designed for the quantitative measurement of digoxin in human serum or plasma. It employs chemiluminescent enzyme immunoassay technology to detect and quantify low concentrations of digoxin, a cardiac glycoside used in clinical toxicology assessments.
This assay is supplied as a single-use reagent kit for in vitro diagnostic use, requiring no additional sterilisation. It is classified under Class II (risk-based) and authorised under FDA 510(k) clearance and the In Vitro Diagnostic Device Directive (IVDD). Storage conditions are specified in the accompanying instructions, and compatibility with MRI environments is not applicable due to its non-magnetic nature. The product is regulated under the FDA’s regulation number 862.3320.
Frequently asked questions
What clinical specialty is the CEDIA Digoxin Assay primarily used for, and why is this relevant to my practice?
The CEDIA Digoxin Assay is specifically categorized under Clinical Toxicology, as noted in the advisory committee and medical specialty descriptions. This means it is designed for use in assessing digoxin levels, particularly in cases of suspected toxicity or therapeutic monitoring, which is critical for toxicologists, emergency physicians, and cardiologists managing patients on cardiac glycosides.
Is the CEDIA Digoxin Assay intended for single-use only, and if so, what does this mean for my workflow?
Yes, the CEDIA Digoxin Assay is supplied as a single-use reagent kit, meaning each kit is intended for one test cycle only. This design ensures accuracy and eliminates cross-contamination risks, but it also requires careful inventory management to account for the number of tests you anticipate running. Since it’s not reusable, you’ll need to order replacement kits as needed.
How should I store the CEDIA Digoxin Assay, and what precautions should I take to maintain its integrity?
While the exact storage conditions aren’t detailed here, the accompanying instructions (referenced in the device data) will specify requirements like temperature ranges and protection from light or moisture. Since it’s a non-magnetic assay, MRI compatibility isn’t a concern, but adhering to the manufacturer’s storage guidelines is essential to preserve the assay’s performance and prevent degradation of the chemiluminescent reagents.
What regulatory pathways does the CEDIA Digoxin Assay follow, and how does this affect its use in my facility?
The assay is authorized under FDA 510(k) clearance and the In Vitro Diagnostic Device Directive (IVDD), confirming it meets U.S. and EU regulatory standards for safety and performance. This classification under Class II (risk-based) ensures it undergoes rigorous validation for clinical toxicology applications, giving you confidence in its reliability for digoxin quantification. The FDA regulation number 862.3320 further categorizes it as an enzyme immunoassay, aligning with its intended use in diagnostic settings.
Are there multiple versions or sizes of the CEDIA Digoxin Assay, and if so, how do I determine which one is right for my lab?
The data lists multiple registration numbers (e.g., 3004192065, 3010939897) under the product code KXT, which may correspond to different lot numbers or minor revisions rather than distinct sizes or models. However, since the assay is standardized for quantitative measurement of digoxin in human serum or plasma, the choice typically depends on your lab’s volume and workflow needs rather than technical variations. Confirming compatibility with your analyzer system and consulting the manufacturer’s instructions is recommended to ensure seamless integration.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K854638 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (2)
- FDA 510(k) K854638 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026