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DrugSmart Dip 30300D

by Twin Spirit Inc. GUDID

Withdrawn United States

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00859144006320 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

84 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-3051-2020 FDA Class II initiated 18 Aug 2020
    • Terminated Z-3036-2020 FDA Class II initiated 18 Aug 2020 via K113046, on the same 510(k)
    • Terminated Z-3042-2020 FDA Class II initiated 18 Aug 2020 via K113046, on the same 510(k)

    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-0494-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0499-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0517-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0521-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0527-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0495-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0532-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0531-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0500-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0537-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0487-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0512-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0507-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0526-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0488-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0529-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0539-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0510-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0484-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0520-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0524-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0491-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0508-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0505-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0515-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0534-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0541-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0496-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0535-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0540-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0503-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0489-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0501-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0525-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0506-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0498-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0485-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0536-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0490-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0523-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0542-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0502-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0518-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0486-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0513-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0509-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0514-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0492-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0493-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0522-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0511-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0497-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0504-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0530-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0538-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0519-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0528-2016 FDA Class III initiated 16 Nov 2015 via K113046, on the same 510(k)
    • Terminated Z-0516-2016 FDA Class III initiated 16 Nov 2015 via K113046, 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-0308-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0312-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0313-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0317-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0309-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0301-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0303-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0300-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0298-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0314-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0299-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0302-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0304-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0307-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0315-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0311-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0316-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0305-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0310-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)
    • Terminated Z-0306-2016 FDA Class II initiated 20 Oct 2015 via K113046, on the same 510(k)

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

  • 3 recalls, same reason

    • Terminated Z-0072-2015 FDA Class II initiated 23 Sep 2014 via K113046, on the same 510(k)
    • Terminated Z-0073-2015 FDA Class II initiated 23 Sep 2014 via K113046, on the same 510(k)
    • Terminated Z-0071-2015 FDA Class II initiated 23 Sep 2014 via K113046, on the same 510(k)

    Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert.

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

Specification

GUDID

Trade Name
DrugSmart Dip
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
30300D
Primary DI / UDI-DI
00859144006320
510(k) Number
FDA Product Code
LDJ, DJC, DIO
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
862.3870, 862.3610, 862.3250
Commercial Distribution
Not in Commercial Distribution

Related devices

Cleared under the same submission (K113046)

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