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Stc Diagnostics Auto-Lyte Ethyl Alcohol Assay

by Solarcare Technologies Corp, Inc.

510(k) K931516

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK931516 Date19 Jul 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Stc Diagnostics Auto-Lyte(Tm) Ethyl Alcohol Assay
510(k) Number
FDA Product Code
DIC
FDA applicant
Solarcare Technologies Corp,Inc.
Device Class
Class II
Regulation
21 CFR Part 862.3040
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is an Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method, used for the quantitative determination of ethyl alcohol in clinical specimens. It is classified under product code DIC and regulation number 862.3040.

The assay is supplied as a reagent for in vitro diagnostic use and is intended for use in clinical laboratory settings. It received FDA 510(k) clearance (K931516) on July 19, 1993, as substantially equivalent to a legally marketed device.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the STC Diagnostics Auto-Lyte Ethyl Alcohol Assay used for?

    This assay is used for the quantitative determination of ethyl alcohol in clinical specimens. It is an Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method designed for in vitro diagnostic use in clinical laboratory settings.

  • How is the STC Diagnostics Auto-Lyte Ethyl Alcohol Assay supplied?

    The assay is supplied as a reagent for in vitro diagnostic use. It is intended for use in clinical laboratory settings and should be handled according to laboratory protocols for reagent storage and handling.

  • What is the regulatory status of the STC Diagnostics Auto-Lyte Ethyl Alcohol Assay?

    The assay received FDA 510(k) clearance (K931516) on July 19, 1993, as substantially equivalent to a legally marketed device. It is classified under product code DIC and regulation number 862.3040.

  • What is the purpose of the advisory committee review for this assay?

    The device was reviewed by the Clinical Toxicology advisory committee, which provides expertise on devices related to toxicology testing. This review helps ensure the device meets appropriate safety and effectiveness standards for its intended use.