Identifiers
- 510(k) Number
- K923853 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. It employs chemiluminescent enzyme immunoassay technology to detect and quantify low concentrations of digoxin, a cardiac glycoside used to treat heart conditions. This assay provides a rapid and sensitive method for monitoring digoxin levels in clinical toxicology settings, aiding in therapeutic management and toxicity assessment.
The assay is supplied as a diagnostic reagent kit intended for in vitro use in clinical laboratories. It is classified under FDA product code KXT and has received FDA 510(k) clearance, indicating compliance with regulatory requirements for Class II medical devices under special controls. The device is not described as single-use or reusable in the provided data, though typical enzyme immunoassays are single-use per manufacturer guidelines. No MRI safety or sterility specifications are noted in the documentation, and storage conditions are not detailed beyond standard laboratory reagent handling.
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 in human serum or plasma. Digoxin is a cardiac glycoside used to treat heart conditions, and monitoring its levels is critical for managing therapy and assessing potential toxicity. This assay provides a rapid and sensitive method to detect low concentrations of digoxin, helping clinicians adjust dosages to optimize patient care.
How is the CEDIA Digoxin Plus Assay supplied, and is it single-use?
The CEDIA Digoxin Plus Assay is supplied as a diagnostic reagent kit intended for in vitro use in clinical laboratories. While the provided data does not explicitly state whether it is single-use or reusable, enzyme immunoassays like this are typically designed for single-use per manufacturer guidelines. This ensures accuracy and prevents cross-contamination between samples.
What regulatory approval does the CEDIA Digoxin Plus Assay hold?
The CEDIA Digoxin Plus Assay has received FDA 510(k) clearance, which means it is classified as a Class II medical device under special controls. This clearance indicates that the device meets regulatory requirements for safety and effectiveness as determined by the FDA. The assay is also categorized under product code KXT, which aligns with its use in clinical toxicology.
Are there any specific storage instructions for the CEDIA Digoxin Plus Assay?
The provided documentation does not specify detailed storage conditions beyond standard laboratory reagent handling. As with most diagnostic reagents, it is recommended to store the assay kit in a clean, dry environment at the manufacturer’s recommended temperature (typically 2–8°C or room temperature, depending on the components). Always follow the instructions provided in the kit to maintain the assay’s stability and performance.
What technology does the CEDIA Digoxin Plus Assay utilize for digoxin detection?
The CEDIA Digoxin Plus Assay employs chemiluminescent enzyme immunoassay (EIA) technology. This method combines the specificity of immunoassay with the sensitivity of chemiluminescence to detect and quantify digoxin levels in clinical samples. Chemiluminescence allows for highly sensitive detection of low concentrations, making it ideal for monitoring therapeutic levels and identifying potential toxicity in patients.
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 | K923853 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (1)
- FDA 510(k) K923853 24 fields · synced Oct 1, 2026