Quicktox Multiple Drug Dipcard Coc/Met/Thc/Amp/Pcp/Bzo/Bar/Mtd/Tca, Model QT61

• • Terminated Z-3034-2020 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.

• • Terminated Z-0692-2020 FDA Class III ·initiated 15 Feb 2019 ·on shared 510(k) K022355

  Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere iScreen Drugs of Abuse Dip Test (P/N X11-IS10-22015-DX LOT #188744)

• • Terminated Z-1542-2018 FDA Class III ·initiated 15 Dec 2017 ·on shared 510(k) K022355

  The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.

• • Terminated Z-3084-2017 FDA Class III ·initiated 26 Jun 2017 ·on shared 510(k) K022355

  The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly.

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

510(k) Number

K022355 ↗

FDA Product Code

DIO

Device Class

Class II

Regulation

21 CFR Part 862.3250

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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