Toxcup Drug Screen Cup Amp/Coc/Met/Opi/Pcp/Thc

• • Terminated Z-3045-2020 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-1508-2014 FDA Class II ·initiated 26 Mar 2014

  May be labeled with incorrect result interpretation graphics on the ToxCup lid label.

510(k) Number

K032057 ↗

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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