# K181945: QuickScreen Pro Multi Drug Screening Test, Model 9395Z

- Pathway: 510(k) (Traditional)
- Applicant: Phamatech, Inc.
- Decided: Oct 18, 2018 after 90 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
Longest line of descent: 1 generation back to K070009 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070009: AT Home Drug Test Models, 9308T and 9308X, Phamatech, Inc. (2007) Summary page 6.

## Indications for use
The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a screening test for the qualitative detection of amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, methadone, methamphetamine, opiates, oxycodone, phencyclidine, marijuana, tricyclic antidepressants (imipramine) and buprenorphine in urine at the cut-off concentrations listed below. Test for barbiturates, benzodiazepine, oxycodone, buprenorphine and tricyclic antidepressants (imipramine) cannot distinguish between abused drugs and certain prescription medications. The test is intended for professional use only. Amphetamines (AMP): 1000 ng/ml Barbiturates (BAR): 200 ng/ml Benzodiazepines (BZD): 200 ng/ml Cocaine (COC): 300 ng/ml Ecstasy (MDMA): 500 ng/ml Methadone (MTD): 300 ng/ml Methamphetamine (MET): 500 ng/ml Opiates (OPI): 300 ng/ml Oxycodone (OXY): 100 ng/ml Phencyclidine (PCP): 25 ng/ml Marijuana (THC): 50 ng/ml Tricyclic Antidepressants (TCA) (Imipramine): 1000 ng/ml Buprenorphine (BUP): 10 ng/ml This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

Source page: https://510kreport.com/device/K181945
Methodology: https://510kreport.com/methodology