EMIT Auto Digoxin Assay
by Syva Co. 510(k)
Active
510(k) K790937
Overview
The EMIT Auto Digoxin Assay is an enzyme immunoassay designed for the quantitative measurement of digoxin in human serum or plasma. Digoxin is a cardiac glycoside used to treat heart conditions, and this assay provides a rapid and accurate method for monitoring its therapeutic levels, helping to prevent toxicity while ensuring effective treatment.
This assay is intended for use in clinical toxicology laboratories and is supplied as a reagent kit for automated immunoassay systems. It is classified as a Class II device under FDA regulations and received 510(k) clearance in 1979. The assay is not described as single-use or reusable in the data, and no MRI safety or sterility specifications are provided. Storage conditions and additional regulatory details are not specified beyond its FDA clearance under product code KXT.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK790937 | Date15 Jun 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 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 clinical setting is the EMIT Auto Digoxin Assay intended for use in, and how does it help clinicians?
The EMIT Auto Digoxin Assay is designed for clinical toxicology laboratories, where it provides a rapid and precise way to measure digoxin levels in human serum or plasma. Clinicians use this assay to monitor therapeutic digoxin levels in patients with heart conditions, ensuring they remain within an effective range while avoiding toxicity. This helps optimize treatment and reduce adverse effects.
How is the EMIT Auto Digoxin Assay supplied, and what type of system does it require for operation?
The EMIT Auto Digoxin Assay is supplied as a reagent kit specifically for automated immunoassay systems. It is not a standalone device but requires integration with compatible automated analyzers to perform the quantitative measurement of digoxin in patient samples.
Is there any information provided about whether the assay components are single-use or reusable?
The provided data does not explicitly state whether the components of the EMIT Auto Digoxin Assay are single-use or reusable. Typically, reagent kits like this are designed for single-use per test to ensure accuracy and prevent cross-contamination, but this should be confirmed with the manufacturer or product documentation.
What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its use?
The EMIT Auto Digoxin Assay received FDA clearance through a 510(k) premarket notification, specifically under the Traditional clearance type, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it met the same performance standards as an existing, legally marketed device and is classified as a Class II medical device, requiring special controls to ensure safety and effectiveness.