# K041578: Quickscreen, Models 9177X and 9178X

- Pathway: 510(k) (Special)
- Applicant: Phamatech
- Decided: Sep 10, 2004 after 88 days
- Product code: LCM (Enzyme Immunoassay, Phencyclidine)
- Device class: U
- 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 At Home DrugTest: named in the summary without a submission number
- (no number) Phamatech QuickScreen Pro Multi Drug Screening Test: named in the summary without a submission number

## Indications for use
An in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, 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. An in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, opiates, methamphetaminles and THO 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/K041578
Methodology: https://510kreport.com/methodology