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EMIT ST Urine Ethyl Alcohol Assay

by Syva Co. 510(k)

Active United States

510(k) K840171

Overview

The EMIT ST Urine Ethyl Alcohol Assay is a specific reagent for alcohol enzyme method used in clinical toxicology. It is designed for the quantitative determination of ethyl alcohol in urine specimens.

This in vitro diagnostic device is supplied as a reagent assay and is intended for use in laboratory settings. It is classified as a Class II medical device under FDA regulation 862.3040 and received traditional 510(k) clearance (K840171) on March 19, 1984, based on substantial equivalence to a predicate device.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK840171 Date19 Mar 1984ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
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  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

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

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Questions

  • What is the EMIT ST Urine Ethyl Alcohol Assay used for?

    The EMIT ST Urine Ethyl Alcohol Assay is used for the quantitative determination of ethyl alcohol in urine specimens as part of clinical toxicology testing. It is a specific reagent designed for the alcohol enzyme method, enabling laboratories to measure alcohol levels in urine samples for diagnostic or monitoring purposes.

  • How is the EMIT ST Urine Ethyl Alcohol Assay supplied and intended for use?

    The assay is supplied as a reagent kit for in vitro diagnostic use and is intended for use in laboratory settings. It is not a standalone instrument but a chemical reagent used with appropriate analyzers to perform enzymatic assays on urine samples. The product is designed for professional laboratory use only.

  • Is the EMIT ST Urine Ethyl Alcohol Assay a single-use or reusable reagent?

    The EMIT ST Urine Ethyl Alcohol Assay is a reagent intended for single-use per test run, as is standard for in vitro diagnostic reagents. Once reconstituted or prepared according to the manufacturer’s instructions, it is used to process patient specimens and is not intended for reuse due to potential degradation, contamination, or loss of reactivity that could compromise test accuracy.