510(k) · Cleared
ClearedQuickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening Test, Model 9317T; Cup Multi Drug SC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phamatech, Inc. · DIS Enzyme Immunoassay, Barbiturate
Cleared on Dec 7, 2007 after a 331-day review. The FDA summary names its predicate without a number.
- Decided
- Dec 7, 2007
- Review
- 331 days
- Class
- Class II
- Product code
- DIS
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DIS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | ABMC RapidOne BZD test Named without a submission number | |
| * | — | Phamatech QuickScreen At Home Drug Test Named without a submission number | |
| * | — | Phamatech QuickScreen Multi Drug Screening Test Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DIS devicesDIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DIS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIS
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIS
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIS
1in 2018
MAUDE reports naming product code DIS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 331 | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 29 | 0 | 0 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (400 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070098 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070098: Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening Test, Model 9317T; Cup Multi Drug SC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070098
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026