# K993165: Quickscreen Pro Multi Drug Screen, Model 9177 & 9178

- Pathway: 510(k) (Special)
- Applicant: Phamatech
- Decided: Oct 20, 1999 after 28 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- 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. The FDA summary names its predicate without a number.
- (no number) Phamatech QuickScreen At Home DrugTest: named in the summary without a submission number
- (no number) Phamatech QuickScreen Pro Multi Drug ScreeningTest: named in the summary without a submission number

## Indications for use
An in vitro diagnostie 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. It is intended for professional use only.

Source page: https://510kreport.com/device/K993165
Methodology: https://510kreport.com/methodology