# K070098: Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening Test, Model 9317T; Cup Multi Drug SC

- Pathway: 510(k) (Traditional)
- Applicant: Phamatech, Inc.
- Decided: Dec 7, 2007 after 331 days
- Product code: DIS (Enzyme Immunoassay, Barbiturate)
- Device class: 2
- Regulation: 21 CFR 862.3150
- 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) ABMC RapidOne BZD test: named in the summary without a submission number
- (no number) Phamatech QuickScreen At Home Drug Test: named in the summary without a submission number
- (no number) Phamatech QuickScreen Multi Drug Screening Test: named in the summary without a submission number

## Indications for use
The QuickScreen Barbiturates Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Barbiturates in urine. Tests for barbiturates cannot distinguish between abused drugs and certain prescribed medications. The cut-off concentration will be 300 ng/ml (secobarbital). It is intended for professional 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. An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, Barbiturates, benzodiazepines, methadone and THC in urine. Tests for prescription drugs cannot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. It is intended for professional use only. Amphetamine 1000 ng/mI Cocaine 300 ng/ml Methamphetamine 1000 ng/ml Opiates 2000 ng/ml PCP 25 ng/mI Barbiturates (Secobarbital) 300 ng/ml Benzodiazepines 200 ng/ni Methadone 300 ng/mI THC 50 ng/mI 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. An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, Barbiturates, benzodiazepines, methadone and THC in urine. Tests for prescription drugs cannot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. It is intended for professional use only. Amphetamine 1000 ng/mI Cocaine 300 ng/ml Methamphetamnine 1000 ng/mI Opiates 2000 ng/mI PCP 25 ng/ml Barbiturates (Secobarbital) 300 ng/ml Benzodiazepines 200 ng/ml Methadone 300 ng/ml THC 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/K070098
Methodology: https://510kreport.com/methodology