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Psychemedics Cocaine EIA

by Psychemedics Corp. 510(k)

Active United States

510(k) K111925

Overview

The Psychemedics Cocaine EIA is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cocaine and metabolites in human head and body hair samples. It uses a cocaine calibrator at a 5 ng/10 mg hair cutoff to identify cocaine use.

The device is supplied as a test kit for use in clinical toxicology settings. It is classified as a Class II medical device under FDA regulation 862.3250 with product code JXO and received FDA 510(k) clearance (K111925) on May 1, 2012, following a determination of substantial equivalence.

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

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111925 Date1 May 2012ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JXO
Device Class
Class II
Regulation
21 CFR Part 862.3250
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Psychemedics Cocaine EIA used for?

    The Psychemedics Cocaine EIA is used for the preliminary qualitative detection of cocaine and its metabolites in human head and body hair samples, helping to identify cocaine use in clinical toxicology settings.

  • How is the Psychemedics Cocaine EIA supplied and what is its format?

    The device is supplied as a test kit designed for use in clinical toxicology laboratories, containing the reagents and materials needed to perform the enzyme immunoassay for cocaine detection in hair specimens.

  • What is the cutoff value used in the Psychemedics Cocaine EIA for detecting cocaine in hair?

    The assay uses a cocaine calibrator at a 5 ng/10 mg hair cutoff to determine a preliminary positive result, which helps identify specimens that may require further confirmation testing.