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DrugSmart Cup 60505D

by Twin Spirit Inc. GUDID

Withdrawn United States

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00859144006191 UDI-DIDate1 Sep 2016ListedStatusWithdrawn

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 — GUDID listing Listed

Recalls

79 recalls · FDA

    • Terminated Z-3051-2020 FDA Class II initiated 18 Aug 2020

    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-0539-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0485-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0490-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0516-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0537-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0510-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0505-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0494-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0497-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0504-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0530-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0519-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0538-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0499-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0517-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0521-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0527-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0495-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0532-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0531-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0500-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0487-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0512-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0507-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0526-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0488-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0529-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0528-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0536-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0518-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0486-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0522-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0511-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0484-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0520-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0524-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0491-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0508-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0515-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0534-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0541-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0496-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0535-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0540-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0503-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0489-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0501-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0525-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0506-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0498-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0523-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0542-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0502-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0513-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0509-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0514-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0492-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)
    • Terminated Z-0493-2016 FDA Class III initiated 16 Nov 2015 via K113501, on the same 510(k)

    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-0317-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0308-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0309-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0316-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0305-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0315-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0311-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0301-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0303-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0300-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0298-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0310-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0312-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0306-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0313-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0299-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0314-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0302-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0304-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)
    • Terminated Z-0307-2016 FDA Class II initiated 20 Oct 2015 via K113501, on the same 510(k)

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

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

Specification

GUDID

Trade Name
DrugSmart Cup
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
60505D
Primary DI / UDI-DI
00859144006191
510(k) Number
FDA Product Code
DJG, LCM, DKZ, DIO, LDJ
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
862.3650, 862.3100, 862.3250, 862.3870
Commercial Distribution
Not in Commercial Distribution

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No