510(k) · Cleared
ClearedQuickscreen Amphetine 500 Test
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 May 14, 2014 as substantially equivalent to K971218 (Drial Consultants, Inc., 1997) after a 392-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- May 14, 2014
- Review
- 392 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971218 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK971218 Quikstrip One Step Amphetamine TestDrial Consultants, Inc. · 1997
- This deviceK131069 Quickscreen Amphetine 500 TestPhamatech, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971218 | Quikstrip One Step Amphetamine Test | Drial Consultants, Inc. | 1997 | — |
| 0 (this device) | K131069 | Quickscreen Amphetine 500 Test | Phamatech, Inc. | 2014 | — |
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? (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 |
|---|---|---|---|
| * | K971218 | Quikstrip One Step Amphetamine TestSummary page 1…1 CFR 862.3100 Amphetamine test system Product Code: DKZ Predicate Device: QuilkStrip OneStep Amphetamine Test - Syntron Bioresearch Predicate 510(k) #: K971218 Intended Use: QuickScreen T M Amphetamine 500 Test Model 9058 (dip card) The QuickScreen Amphetamine 500 Test is a qualitative… | 1997 |
| * | — | Phamatech QuickScreen At Home Drug Test Named without a submission number | |
| * | — | Phamatech QuickScreen Pro Multi Drug Screening Test Named without a submission number | |
| † | K103295 | Quickscreen Cocaine 150 Screening Test | 2012 |
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.
- 2 other devices also cite its predicate K971218.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 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…
Read the full statement (560 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131069 · printed Nov 3, 2026
Cite this page
510(k) Report. “K131069: Quickscreen Amphetine 500 Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K131069
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026