Identifiers
- 510(k) Number
- K872583 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 CR Assay is an enzyme immunoassay device used for the quantitative determination of digoxin in human serum or plasma. This assay is designed to measure digoxin levels, a medication used to treat heart conditions, by employing competitive binding methodology with cloned enzyme donor immunoassay technology.
The assay is supplied as a ready-to-use system and is intended for in vitro diagnostic use. It is a single-use device with no specific MRI safety information provided. The device is classified under product code KXT and received FDA 510(k) clearance on August 28, 1987, with the K number K872583. No storage conditions or sterility information is specified in the provided data.
Frequently asked questions
What is the CEDIA Digoxin CR Assay used for?
The CEDIA Digoxin CR Assay is an enzyme immunoassay device used for the quantitative determination of digoxin levels in human serum or plasma. Digoxin is a medication commonly used to treat various heart conditions, and this assay helps measure its concentration in patients.
How is the CEDIA Digoxin CR Assay supplied?
The assay is supplied as a ready-to-use system designed for in vitro diagnostic use. It is a single-use device, meaning it should not be reused or repurposed after initial use. No specific storage conditions are provided in the available information.
What is the regulatory status of the CEDIA Digoxin CR Assay?
The CEDIA Digoxin CR Assay received FDA 510(k) clearance on August 28, 1987, with the K number K872583. It is classified under product code KXT and is considered substantially equivalent to predicate devices in the enzyme immunoassay category for digoxin testing.
Is the CEDIA Digoxin CR Assay sterile?
No specific sterility information is provided for the CEDIA Digoxin CR Assay in the available device data. While it is designed for in vitro diagnostic use, details regarding sterility status are not included in the specifications.
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: CEDIA DIGOXIN CR ASSAY (K872583) - FDA 510 (k), CEDIA DIGOXIN CR ASSAY (K872583) — FDA 510(k) | Innolitics, Cedia Digoxin Cr Assay 510 (k) K872583 - FDA.report, CEDIA DIGOXIN ASSAY (K854638) - 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 | K872583 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (1)
- FDA 510(k) K872583 24 fields · synced Sep 24, 2026