EMIT 2000 Digoxin Assay
by Syva Co. 510(k)
Active
510(k) K943500
Overview
An Enzyme Immunoassay for Digoxin is a device type used to measure digoxin levels in clinical specimens. This assay is classified under product code KXT and falls within the Clinical Toxicology medical specialty.
It is supplied as an in vitro diagnostic reagent kit for use in laboratory settings. The device received FDA 510(k) clearance (K943500) on November 15, 1994, and is regulated as a Class II device with special controls.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK943500 | Date15 Nov 1994 | 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- Withdrawn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 is the EMIT 2000 Digoxin Assay used for?
The EMIT 2000 Digoxin Assay is used to measure digoxin levels in clinical specimens as an enzyme immunoassay, enabling quantitative detection of digoxin in samples such as serum or plasma for therapeutic drug monitoring and toxicity assessment in patients receiving digoxin therapy.
How is the EMIT 2000 Digoxin Assay supplied and what is its intended use setting?
The EMIT 2000 Digoxin Assay is supplied as an in vitro diagnostic reagent kit designed for use in laboratory settings, containing the necessary reagents to perform the enzyme immunoassay for digoxin measurement on clinical specimens using appropriate laboratory instrumentation.
Is the EMIT 2000 Digoxin Assay a single-use or reusable device, and what does its reagent kit format imply for usage?
As an in vitro diagnostic reagent kit, the EMIT 2000 Digoxin Assay is intended for single-use per test run, where reagents are consumed during the assay process and not reused, ensuring consistent performance and preventing cross-contamination between patient samples in the laboratory.