# K980865: Quickscreen Pro Multi Drug Screening Test , Model 9140-9147, 9061,9066, 9071, 9076, 9081 and 9131

- Pathway: 510(k) (Traditional)
- Applicant: Phamatech
- Decided: Apr 1, 1998 after 26 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
An in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, methamphetamine, opiates, PCP and THC in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse.

Source page: https://510kreport.com/device/K980865
Methodology: https://510kreport.com/methodology