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TDXR REA Ethanol

by Abbott Laboratories 510(k)

Active United States

510(k) K871645

Overview

The TDXR REA Ethanol is an Alcohol Dehydrogenase, Specific Reagent for Ethanol (Enzyme Method) diagnostic reagent, classified under product code DIC. This in vitro device measures ethanol levels in biological samples using an enzyme-based assay, enabling clinical toxicology assessments for alcohol detection and quantification.

Intended for use in clinical toxicology laboratories, the TDXR REA Ethanol is supplied as a reagent kit for automated immunoassay analyzers. It is a single-use, non-sterile diagnostic reagent with no MRI safety considerations. The device requires proper storage as specified in the manufacturer’s instructions and is authorized under FDA 510(k) clearance (K871645) via the Traditional pathway. No additional regulatory markings beyond the stated clearance are provided.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK871645 Date11 Jun 1987ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

    • Terminated Z-0508-04 FDA Unclassified (pre-2012) initiated 5 Dec 2003 via K871645, on the same 510(k)

    The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table

    • Terminated Z-0278-04 FDA Unclassified (pre-2012) initiated 17 Nov 2003 via K871645, on the same 510(k)

    The package inserts contain incorrect values for the alternate unit (mol/L) Control Ranges

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

Full name
Tdxr Rea(Tm) Ethanol
510(k) Number
FDA Product Code
DIC
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 TDXR REA Ethanol diagnostic reagent used for?

    The TDXR REA Ethanol is an in vitro diagnostic reagent that measures ethanol levels in biological samples using an enzyme-based assay. It is specifically designed for clinical toxicology assessments to detect and quantify alcohol in patient samples.

  • How is the TDXR REA Ethanol supplied and what are its storage requirements?

    The TDXR REA Ethanol is supplied as a reagent kit for automated immunoassay analyzers. It requires proper storage as specified in the manufacturer's instructions to maintain its integrity and performance for diagnostic testing purposes.

  • Is the TDXR REA Ethanol single-use or reusable?

    The TDXR REA Ethanol is a single-use diagnostic reagent. It is not designed for reuse and should be handled according to laboratory protocols for single-use medical devices to ensure accurate test results and patient safety.

  • What regulatory authorization does the TDXR REA Ethanol have?

    The TDXR REA Ethanol is authorized under FDA 510(k) clearance (K871645) via the Traditional pathway. It is classified as substantially equivalent and is intended for use in clinical toxicology laboratories for ethanol measurement in biological samples.