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ProScreen PSCupA-12PP

by Instant Tech Subsidiary Acquisition

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

84 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00858998006715 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: not in commercial distribution

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 on shared 510(k) K113046
    • Terminated Z-3042-2020 FDA Class II initiated 18 Aug 2020 on shared 510(k) K113046

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

    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
    • Terminated Z-0312-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0313-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0317-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0309-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0301-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0303-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0300-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0298-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0314-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0299-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0302-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0304-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0307-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0315-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0311-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0316-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0305-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0310-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0306-2016 FDA Class II initiated 20 Oct 2015

    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
    • Terminated Z-0073-2015 FDA Class II initiated 23 Sep 2014
    • Terminated Z-0071-2015 FDA Class II initiated 23 Sep 2014

    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 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 — GUDID listing Listed

Specification

GUDID

Trade Name
ProScreen
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
PSCupA-12PP
Primary DI / UDI-DI
00858998006715
510(k) Number
FDA Product Code
JXN, DJR, DIS, JXM, DJC, DKZ, LAF, DJG, LDJ, DIO, LCM
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
862.3700, 862.3620, 862.3150, 862.3170, 862.3610, 862.3100, 862.3650, 862.3870, 862.3250
GUDID distribution status
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