MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST - Model MD23

• • Terminated Z-3034-2020 FDA Class II ·initiated 18 Aug 2020 ·on shared 510(k) K030113

  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.

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

510(k) Number

K030113 ↗

FDA Product Code

DJG

Models / Variants

Mc 23

Fastect Oxycodone Drug Screen Dipstick Test

Model MD23

Device Class

Class II

Regulation

21 CFR Part 862.3650

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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