510(k) · Cleared
ClearedQuickScreen Pro Multi Drug Screening Test, Model 9395Z
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phamatech, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Oct 18, 2018 as substantially equivalent to K070009 (Phamatech, Inc., 2007) after a 90-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Oct 18, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070009 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK070009 AT Home Drug Test Models, 9308T and 9308XPhamatech, Inc. · 2007
- This deviceK181945 QuickScreen Pro Multi Drug Screening Test, Model 9395ZPhamatech, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070009 | AT Home Drug Test Models, 9308T and 9308X | Phamatech, Inc. | 2007 | — |
| 0 (this device) | K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395Z | Phamatech, Inc. | 2018 | — |
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 DKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K070009 | AT Home Drug Test Models, 9308T and 9308XSummary page 6…ening Test Model 9395Z CONFIDENTIAL Page 5-1 III. PREDICATE DEVICE Primary Predicate Device At Home Drug Test 12: Model 9308Z, K070009 The predicate device has not been subject to a recall. IV. DEVICE DESCRIPTION The QuickScreen™ Pro Multi Drug Scr… | 2007 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K070009.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, 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 | 0 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (184 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181945 · printed Nov 4, 2026
Cite this page
510(k) Report. “K181945: QuickScreen Pro Multi Drug Screening Test, Model 9395Z.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K181945
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026