# K131069: Quickscreen Amphetine 500 Test

- Pathway: 510(k) (Traditional)
- Applicant: Phamatech, Inc.
- Decided: May 14, 2014 after 392 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 K971218 (1997). 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)
- K971218: Quikstrip One Step Amphetamine Test, Drial Consultants, Inc. (1997) Summary page 1.
- (no number) Phamatech QuickScreen At Home Drug Test: 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
The QuickScreen Amphetamine 500 Test Model 9058 is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only. 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. The QuickScreen Amphetamine 500 Test Model 9054 is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only. 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. The QuickScreenTM Multi Drug Screening Test Model 9346T is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, Barbiturates, benzodiazepines, methadone and THC in urine. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinguish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only. Amphetamine (d amphetamine) 500 ng/ml Cocaine (benzoylecgonine) 150 ng/ml Methamphetamine (d methamphetamine) 500 ng/ml Opiates (morphine) 300 ng/ml PCP (phencyclidine) 25 ng/ml Barbiturates (Secobarbital) 300 ng/ml Benzodiazepines (Oxazepam) 200 ng/ml Methadone (Methadone) 300 ng/ml Oxycodone (Oxycodone) 100 ng/ml THC (Cannabinoids) 50 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. The QuickScreenTM Drug Cup Model 9346Z is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, barbiturates, benzodiazepines, methadone and THC in urine at the cut-off concentrations listed below. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinguish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only. Amphetamine (d amphetamine) 500 ng/ml Cocaine (benzoylecgonine) 150 ng/ml Methamphetamine (d methamphetamine) 500 ng/ml Opiates (morphine) 300 ng/ml PCP (phencyclidine) 25 ng/ml Barbiturates (Secobarbital) 300 ng/ml Benzodiazepines (Oxazepam) 200 ng/ml Methadone (Methadone) 300 ng/ml Oxycodone (Oxycodone) 100 ng/ml THC (Cannabinoids) 50 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/K131069
Methodology: https://510kreport.com/methodology