EMIT Column Digoxin Assay
by Syva Co. 510(k)
Active
510(k) K861393
Overview
The EMIT Column Digoxin Assay is an enzyme immunoassay designed for the quantitative measurement of digoxin in biological samples. Digoxin is a cardiac glycoside used to treat heart conditions, and its accurate monitoring is critical to avoid toxicity or therapeutic inefficacy. This assay employs enzyme-multiplied immunoassay technique (EMIT) principles to detect and quantify digoxin levels in serum or plasma samples, providing rapid and reliable results for clinical toxicology applications.
This device is intended for use in clinical laboratory settings and is supplied as a single-use reagent column. The assay requires no additional sterilization as it is designed for one-time use per test. It is classified under FDA product code KXT and has received FDA 510(k) clearance (K861393) as substantially equivalent to a predicate device. The assay adheres to regulatory standards for Class II medical devices under the Special Controls designation for enzyme immunoassays, ensuring compliance with clinical toxicology requirements.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK861393 | Date29 May 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KXT
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3320
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What is the EMIT Column Digoxin Assay used for?
The EMIT Column Digoxin Assay is designed for the quantitative measurement of digoxin levels in biological samples, specifically serum or plasma. Digoxin is a cardiac glycoside used to treat heart conditions, and precise monitoring is essential to balance therapeutic effectiveness while avoiding toxicity. This assay helps clinicians assess patient levels accurately for clinical toxicology applications.
How is the EMIT Column Digoxin Assay supplied, and is it reusable?
The EMIT Column Digoxin Assay is supplied as a single-use reagent column. It is not intended for reuse or additional sterilization, as it is engineered for one-time use per test. This design ensures consistency and reliability in results while minimizing contamination risks.
Does the EMIT Column Digoxin Assay require any special handling or storage conditions?
While specific storage instructions are not detailed in the provided data, the assay is designed for clinical laboratory use and should be stored according to standard protocols for enzyme immunoassays. It is critical to maintain proper temperature and environmental conditions to preserve the integrity of the reagent column until use. Always refer to the manufacturer’s guidelines for precise storage recommendations.
What regulatory pathway does the EMIT Column Digoxin Assay follow?
The EMIT Column Digoxin Assay received FDA 510(k) clearance (K861393) under the Special Controls designation for enzyme immunoassays, classified as a Class II medical device. This clearance was granted as substantially equivalent to a predicate device, ensuring compliance with regulatory standards for clinical toxicology applications. The device is filed under product code KXT and falls under the advisory committee for Clinical Toxicology.
Can this assay be used with any biological sample type, or are there specific requirements?
The EMIT Column Digoxin Assay is specifically designed for use with serum or plasma samples. While it is intended for quantitative measurement of digoxin, it is not universally applicable to all biological fluids. Clinicians should ensure the sample type aligns with the assay’s intended use to achieve accurate and reliable results for clinical toxicology purposes.