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U-Screen USSCupA-5E

by Instant Technologies, Inc.

U-Screen USSCupA-5E is a multiple drugs of abuse IVD (FDA Class II) made by Instant Technologies, Inc., cleared under FDA 510(k) K182701 on 3 Dec 2018 and listed in FDA GUDID since 30 Aug 2019 (UDI-DI 00817405020973), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K182701; other models may be affected

Documents

510(k) K182701

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817405020973 UDI-DI Date30 Aug 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182701 Date3 Dec 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182701 decided 3 Dec 2018 Active
  • FDA GUDID UDI-DI 00817405020973 listed 30 Aug 2019 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1589-2022 FDA Class II initiated 25 May 2022 on shared 510(k) K182701

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K182701
  2. Listed FDA GUDID 00817405020973
  3. Recall initiated FDA recalls Z-1589-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
U-Screen
Generic name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / reference
USSCupA-5E
Primary DI / UDI-DI
00817405020973
510(k) Number
FDA product code
NGL, NGG, NFY, NFV, NFT
GMDN term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.3650, 862.3610, 862.3250, 862.3170, 862.3100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Cleared under the same submission (K182701)

and 8 more cleared under K182701

Similar devices in this category

Other devices filed under Multiple drugs of abuse IVD, kit, rapid ICT, clinical.

Other devices from Instant Technologies, Inc.

See all devices from Instant Technologies, Inc. →

Properties

  • Single use
  • Prescription use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)