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TDX Methadone Assay

by Abbott Laboratories 510(k)

Active United States

510(k) K884968

Overview

The TDX Methadone Assay is an enzyme immunoassay for methadone, classified under device class 2 and product code DJR. It is designed for the qualitative analysis of methadone in human urine with a cutoff of 300 ng/mL, as stated in the device's intended use.

This assay is intended for use in clinical laboratories to support the diagnosis and treatment of methadone use. It received FDA 510(k) clearance (K884968) on December 16, 1988, and is manufactured by Abbott Laboratories in Abbott Park, Illinois. The device is regulated under regulation number 862.3620 and falls within the clinical toxicology medical specialty.

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

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK884968 Date16 Dec 1988ClearedStatusActive

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
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  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0510-04 FDA Unclassified (pre-2012) initiated 5 Dec 2003 via K884968, on the same 510(k)
    • Terminated Z-0511-04 FDA Unclassified (pre-2012) initiated 5 Dec 2003 via K884968, 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

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

Specification

510(k)

510(k) Number
FDA Product Code
DJR
Device Class
Class II
Regulation
21 CFR Part 862.3620
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Other devices from Abbott Laboratories

See all devices from Abbott Laboratories →

Questions

  • What is the TDX Methadone Assay used for?

    The TDX Methadone Assay is designed for the qualitative analysis of methadone in human urine to support the diagnosis and treatment of methadone use in clinical laboratories, with a cutoff concentration of 300 ng/mL as specified in its intended use.

  • How is the TDX Methadone Assay supplied and what type of test is it?

    The TDX Methadone Assay is an enzyme immunoassay supplied as a diagnostic reagent system for use in clinical laboratories, intended for qualitative detection of methadone in urine specimens based on antigen-antibody binding principles.

  • What regulatory clearance does the TDX Methadone Assay have and when was it granted?

    The TDX Methadone Assay received FDA 510(k) clearance under submission K884968 on December 16, 1988, based on a determination of substantial equivalence to a legally marketed predicate device.