Modification of the Cedia Digoxin Assay
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K884054 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)
This device is an enzyme immunoassay for digoxin, classified under Clinical Toxicology. It is a modification of the CEDIA Digoxin Assay, designed for the quantitative in vitro diagnostic test for measuring digoxin levels in human serum or plasma.
It is supplied as a reagent kit for use in clinical laboratory settings. The device is intended for in vitro diagnostic use only and is regulated under FDA 510(k) clearance (K884054) as a Class II medical device with product code KXT.
Frequently asked questions
What is the Modification of the CEDIA Digoxin Assay used for?
This device is an enzyme immunoassay designed for the quantitative in vitro diagnostic measurement of digoxin levels in human serum or plasma, used in clinical toxicology to monitor therapeutic drug levels or detect toxicity.
How is the Modification of the CEDIA Digoxin Assay supplied and what is its intended use setting?
The device is supplied as a reagent kit intended for use in clinical laboratory settings, where it performs in vitro diagnostic testing on human serum or plasma samples to quantify digoxin concentration.
Is the Modification of the CEDIA Digoxin Assay a single-use or reusable device?
As a reagent kit for in vitro diagnostic testing, the assay components are consumed during the test process and are intended for single-use per test run; the kit is not designed for reuse of reagents after initial use.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K884054 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (1)
- FDA 510(k) K884054 24 fields · synced Sep 23, 2026