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Propoxyphene

by Abbott Laboratories 510(k)

Active United States

510(k) K013100

Overview

Propoxyphene is an enzyme immunoassay device used for the qualitative analysis of propoxyphene in human urine. It is classified as a Class 2 device in the Clinical Toxicology specialty with product code JXN.

The device is supplied for use in clinical laboratories and has received FDA 510(k) clearance under K013100 via the Traditional pathway. It is intended for use in the diagnosis and treatment of propoxyphene use, with measurements obtained supporting clinical decision-making in toxicology settings.

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 NumberK013100 Date20 Mar 2002ClearedStatusActive

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: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
JXN
Device Class
Class II
Regulation
21 CFR Part 862.3700
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Propoxyphene enzyme immunoassay device used for?

    The Propoxyphene enzyme immunoassay device is used for the qualitative analysis of propoxyphene in human urine to support clinical decision-making in toxicology settings, aiding in the diagnosis and treatment of propoxyphene use.

  • How is the Propoxyphene enzyme immunoassay device supplied and intended for use?

    The device is supplied for use in clinical laboratories and is intended for qualitative analysis of propoxyphene in human urine, supporting clinical decision-making in toxicology settings as part of diagnosis and treatment processes.

  • What regulatory pathway and clearance does the Propoxyphene enzyme immunoassay device have?

    The device received FDA 510(k) clearance under K013100 via the Traditional pathway, classified as a Class 2 device in the Clinical Toxicology specialty with product code JXN, and was found substantially equivalent to a predicate device.