EMIT ST Serum Ethyl Alcohol Assay
by Syva Co. 510(k)
Active
510(k) K840400
Overview
The EMIT ST Serum Ethyl Alcohol Assay is a specific reagent for alcohol enzyme method used in clinical toxicology. It is designed to measure ethyl alcohol levels in serum samples using an enzymatic method with alcohol dehydrogenase and ultraviolet detection.
This device is supplied as a Class II medical device under product code DML with FDA 510(k) clearance K840400. It is manufactured by Syva Co. and is intended for laboratory use in clinical settings. The assay is regulated under 862.3040 and is not specified as single-use or reusable.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK840400 | Date23 Mar 1984 | 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- Withdrawn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
- DML
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3040
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What is the EMIT ST Serum Ethyl Alcohol Assay used for?
The EMIT ST Serum Ethyl Alcohol Assay is a specific reagent used in clinical toxicology to measure ethyl alcohol levels in serum samples using an enzymatic method with alcohol dehydrogenase and ultraviolet detection.
How is the EMIT ST Serum Ethyl Alcohol Assay supplied?
The assay is supplied as a Class II medical device under product code DML. It is manufactured by Syva Co. and is intended for laboratory use in clinical settings, though the device data does not specify whether it is single-use or reusable.
What is the regulatory status of the EMIT ST Serum Ethyl Alcohol Assay?
The EMIT ST Serum Ethyl Alcohol Assay has FDA 510(k) clearance K840400 and is regulated under 862.3040. It is classified as a Class II medical device and was determined to be substantially equivalent to predicate devices.
What laboratory specialties use the EMIT ST Serum Ethyl Alcohol Assay?
The assay is intended for use in clinical toxicology laboratories. It was reviewed under the Clinical Toxicology advisory committee and is specifically designed for measuring ethyl alcohol levels in serum samples using enzymatic methodology.