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First Check Multi Drug Cup 12 for Marijuana (Thc), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Met), Ecstasy

by First Check Diagnostics, LLC

510(k) K052115

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

86 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052115 Date29 Dec 2005ClearedStatusActive

Recalls

86 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-3050-2020 FDA Class II initiated 18 Aug 2020
    • Terminated Z-3031-2020 FDA Class II initiated 18 Aug 2020 on shared 510(k) K052115
    • Terminated Z-3046-2020 FDA Class II initiated 18 Aug 2020 on shared 510(k) K052115
    • Terminated Z-3048-2020 FDA Class II initiated 18 Aug 2020
    • Terminated Z-3049-2020 FDA Class II initiated 18 Aug 2020
    • Terminated Z-3042-2020 FDA Class II initiated 18 Aug 2020 on shared 510(k) K052115
    • Terminated Z-3036-2020 FDA Class II initiated 18 Aug 2020 on shared 510(k) K052115

    Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

  • 58 recalls, same reason

    • Terminated Z-0505-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0536-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0518-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0486-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0522-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0511-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0527-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0539-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0485-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0490-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0516-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0537-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0510-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0493-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0497-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0504-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0530-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0519-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0538-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0494-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0499-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0517-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0521-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0495-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0532-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0531-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0500-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0487-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0512-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0507-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0526-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0488-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0529-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0528-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0484-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0520-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0524-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0491-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0508-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0515-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0534-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0541-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0496-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0535-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0540-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0503-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0489-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0501-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0525-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0506-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0498-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0523-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0542-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0502-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0513-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0509-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0514-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115
    • Terminated Z-0492-2016 FDA Class III initiated 16 Nov 2015 on shared 510(k) K052115

    Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

  • 20 recalls, same reason

    • Terminated Z-0302-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0304-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0307-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0298-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0308-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0310-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0314-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0315-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0311-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0306-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0303-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0301-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0309-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0300-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0316-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0305-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0317-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0313-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0312-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115
    • Terminated Z-0299-2016 FDA Class II initiated 20 Oct 2015 on shared 510(k) K052115

    Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

    • Terminated Z-0152-2012 FDA Unclassified (pre-2012) initiated 7 Jun 2011

    The recall was initiated because Ameditech, Inc. received a complaint from US Diagnostics (USD) that First Check Drug Screen Cups were packaged in the ProScreen Cup boxes. Some of US Diagnostics' customers received ProScreen 5-panel cups that contain First Check THC cups. The recalled products are mislabeled. If the USD customer receives the FirstCheck tes, there will be no instructions for use

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DKZ
Device Class
Class II
Regulation
21 CFR Part 862.3100
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent