# K011952: Drugs of Abuse Multi-Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Microdiagnostics, Inc.
- Decided: Oct 25, 2001 after 126 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Microdiagnostics, Inc.'Drugs of Abuse Multi-Test Strip is an immunoassay that qualitatively detects the metabolites of Amphetamine, Cocaine, Marijuana, Opiates and Phencyclidine in human urine at the SAMHSA cutoff levels. This test is intended for professional use only.

Source page: https://510kreport.com/device/K011952
Methodology: https://510kreport.com/methodology