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ProScreen PSCup-6MB-W

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

86 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 Number00858998006524 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: not in commercial distribution

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
    • 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
    • Terminated Z-0536-2016 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-0522-2016 FDA Class III initiated 16 Nov 2015
    • Terminated Z-0511-2016 FDA Class III initiated 16 Nov 2015
    • Terminated Z-0527-2016 FDA Class III initiated 16 Nov 2015
    • Terminated Z-0539-2016 FDA Class III initiated 16 Nov 2015
    • Terminated Z-0485-2016 FDA Class III initiated 16 Nov 2015
    • Terminated Z-0490-2016 FDA Class III initiated 16 Nov 2015
    • Terminated Z-0516-2016 FDA Class III initiated 16 Nov 2015
    • Terminated Z-0537-2016 FDA Class III initiated 16 Nov 2015
    • Terminated Z-0510-2016 FDA Class III initiated 16 Nov 2015
    • Terminated Z-0493-2016 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-0519-2016 FDA Class III initiated 16 Nov 2015
    • Terminated Z-0538-2016 FDA Class III initiated 16 Nov 2015
    • 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-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-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-0528-2016 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-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-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-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

    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
    • Terminated Z-0304-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0307-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0298-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0308-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0310-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0314-2016 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-0306-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0303-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0301-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0309-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0300-2016 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-0317-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0313-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0312-2016 FDA Class II initiated 20 Oct 2015
    • Terminated Z-0299-2016 FDA Class II initiated 20 Oct 2015

    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 — GUDID listing Listed

Specification

GUDID

Trade Name
ProScreen
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
PSCup-6MB-W
Primary DI / UDI-DI
00858998006524
510(k) Number
FDA Product Code
DIO, DJC, DJG, DKZ, LDJ, JXM
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
862.3250, 862.3610, 862.3650, 862.3100, 862.3870, 862.3170
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K052115)

Show all (12)

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