510(k) · Cleared
ClearedMulti-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette, Dip-Strip), Cocaine, Methamphetamine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Scientific Designs, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on May 7, 2007 as substantially equivalent to K994395 (Alfa Scientific Designs, Inc., 2000) and 8 other predicates after a 164-day review. Its family tree reaches back 4 generations to 2000. 16 later devices descend from it.
- Decided
- May 7, 2007
- Review
- 164 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 4 generations to K001178 (2000). 14 ancestors in all, the oldest K971218 (1997). 16 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 3 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- 2 generations backK042988 Rapid One Step Buprenorphine Test CardTianjin New Bay Bioresearch Co., Ltd. · 2005
- 1 generation backK060527 Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine…Alfa Scientific Designs, Inc. · 2006
- This deviceK063545 Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine…Alfa Scientific Designs, Inc. · 2007
- Descendant · cites it directly · 13 of its ownK152122 Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View…Alfa Scientific Designs, Inc. · 2016
- Descendant · 2 generations on · 12 of its ownK173303 INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC…Alfa Scientific Designs, Inc. · 2018
- Descendant · 3 generations on · 9 of its ownK182738 Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)…Hangzhou AllTest Biotech Co., Ltd. · 2019
- Descendant · 4 generations on · 8 of its ownK233019 AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test…Hangzhou AllTest Biotech Co., Ltd. · 2023
- Descendant · 5 generations on · 4 of its ownK244043 AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd. · 2025
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test…Alfa Scientific Designs, Inc. · 2016 · cites it directly13descendants
- K173303INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…Alfa Scientific Designs, Inc. · 2018 · 2 generations on12descendants
- K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug…Hangzhou AllTest Biotech Co., Ltd. · 2019 · 3 generations on9descendants
- K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest…Hangzhou AllTest Biotech Co., Ltd. · 2023 · 4 generations on8descendants
- K244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd. · 2025 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −3 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| −2 | K042988 | Rapid One Step Buprenorphine Test Card | Tianjin New Bay Bioresearch Co., Ltd. | 2005 | — |
| −1 | K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test… | Alfa Scientific Designs, Inc. | 2006 | — |
| 0 (this device) | K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test… | Alfa Scientific Designs, Inc. | 2007 | — |
| +1 | K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug… | Alfa Scientific Designs, Inc. | 2016 | — |
| +2 | K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)… | Alfa Scientific Designs, Inc. | 2018 | — |
| +3 | K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and… | Hangzhou AllTest Biotech Co., Ltd. | 2019 | — |
| +4 | K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel… | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| +5 | K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 0 |
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 DJG? 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 DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 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? (9)
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 |
|---|---|---|---|
| * | K994395 | Instant-View Amphetamine Urine Cassette TestSummary page 1…DKZ Date of Summary Preparation Nov. 16, 2006 INSTANT- VIE® Amphetamine Urine Test (510K Number: K994395) Predicate Devices By Alfa Scientific Designs, Inc. This assay i… | 2000 |
| * | K994403 | Instant-View Cocaine (Benzylecgonine) Urine Dip Strip TestSummary page 3…DIO Date of Summary Preparation Nov. 16, 2006 IANSTANT- VIEW® Cocaine Urine Test (510K Number: K994403) Predicate Devices By Alfa Scientific Designs, Inc. This assay i… | 2000 |
| * | K003845 | Modification to Instant-View Methamphetamine (Meth 1000) Urine Test (Dip Strip)Summary page 5…DJC Date of Summary Preparation Nov. 16, 2006 INSTANT-VIEW ®Methamphetamine Urine Test (5 10K Number: K003845) Predicate Devices By Alfa Scientific Designs, Inc. This assay… | 2001 |
| * | K033047 | Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step Oxycodone Test DeviceSummary page 7…mmary Preparation Nov. 16, 2006 OXYCODONE One Step Oxycodone Test Strip (5 10K Number: Predicate Devices K033047) By Acon Laboratories, Inc. This assay is a one-step lateral flow… | 2004 |
| * | K022564 | Instant-View Multi-Drug Screen Urine TestSummary page 12…Multi-Drug of Abuse Urine Test INSTANT-VIEW Multi-Drugs Urine Test (510K Number: K022564) INSTANT-VIEW® Propoxyphene Test (510K Number: K022915) INSTANT-V… | 2002 |
| * | K022915 | Instant-View Propoxyphene (PPX) Urine TestSummary page 12…INSTANT-VIEW Multi-Drugs Urine Test (510K Number: K022564) INSTANT-VIEW® Propoxyphene Test (510K Number: K022915) INSTANT-VIE W TCA Urine Test (510K Number: K022693) INSTANT-VIEW… | 2002 |
| * | K022693 | Instant-View Tca Urine TestSummary page 12…022564) INSTANT-VIEW® Propoxyphene Test (510K Number: K022915) INSTANT-VIE W TCA Urine Test (510K Number: K022693) INSTANT-VIEW® MDMA Urine Test (510K Number: K022501) INS TANT-VI… | 2002 |
| * | K022501 | Instant-View Mdma (Ecstasy, XTC) Urine TestSummary page 12…K022915) INSTANT-VIE W TCA Urine Test (510K Number: K022693) INSTANT-VIEW® MDMA Urine Test (510K Number: K022501) INS TANT-VIEW- BUP/NBUP Urine Test (5 10K Number: K060527) INSTA… | 2002 |
| * | K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test…Summary page 12…3) INSTANT-VIEW® MDMA Urine Test (510K Number: K022501) INS TANT-VIEW- BUP/NBUP Urine Test (5 10K Number: K060527) INSTANT-VIEW® Amphetamine Urine Test (51OK Number: K994395) INST… | 2006 |
What descends from it? (16)
See all 163 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test… | 2016 | 13 |
| K131645 | Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette) | 2013 | 0 |
| K100051 | Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of… | 2010 | 0 |
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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K152122 (Alfa Scientific Designs, Inc., 2016) has gone furthest, with 13 descendants of its own.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
The Amphetamine (300) test is a qualitative immunoassay for the rapid detection of amphetamine from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the…
Read the full statement (989 words)
The Amphetamine (300) test is a qualitative immunoassay for the rapid detection of amphetamine from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only.
This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
The Cocaine (150) test device is a rapid qualitative immunoassay for the rapid detection of cocaine (benzoylecgonine) from human urine specimens at a cutoff concentration of 150 ng/ml. It is for health care professional use only.
This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
The Methamphetamine (300) test is a qualitative immunoassay for the rapid detection of methamphetamine from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only.
This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
The Oxycodone (100) test is a qualitative immunoassay for the rapid detection of oxycodone from human urine specimens at a cutoff concentration of 100 ng/ml. It is for health care professional use only.
This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
The Oxycodone (300) test is a qualitative immunoassay for the rapid detection of oxycodone from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only.
This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
The multi-drug of abuse device is a rapid qualitative immunoassay for screening potential abuse of one or more drugs listed below. The device detects any combination of the drugs or drug metabolites at or above the specified cut-off levels. It is for health care professional use.
Abbreviation Test Cutoff
AMP Amphetamine 1000 ng/ml
AMP300 Amphetamine 300 ng/ml
BAR Blarbiturates 200 ng/ml
BUP Buprenorphine/Norbuprenorphine 10 ng/ml
BZD Benzodiazepine 300 ng/ml
COC Cocaine 300 ng/ml
COC150 Cocaine 150 ng/ml
MET Methamphetamine 1000 ng/ml
MET500 Methamphetarmne 500 ng/ml
MET300 Methamphetamine 300 ng/ml
MOR Morphine 2000 ng/ml
MOR300 Morphine 300 ng/ml
MTD Methadone 300 ng/ml
OXY100 Oxycodone 100 ng/ml
0XY300 Oxycodone 300 ng/ml
PCP Phencyclidine 25 nglml
PPX Propoxyphene 300 ng/mir
TCA Tricyclics 1000 ng/mld
THZC Marijuana 50 ng/nilbo
XTC MDMA or Ecstasy 500 ng/mI
The BAR, BZD, TCA test will yield preliminary positive results when BA4R, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine, The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result, Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
The multi-drug of abuse device is a rapid qualitative immunoassay for screening potential abuse of one or more drugs listed below. The device detects any combination of the drugs or drug metabolites at or above the specified cut-off levels.
Abbreviation Test Cutoff
AMP Amphetamine 1000 ng/ml
BAR Barbiturates 200 ng/ml
BZD Benzodiazepine 300 ng/ml
COC Cocaine 300 ng/ml
MET Methamphetamine 1000 ng/ml
MOR Morphine 2000 ng/ml
MTD Methadone 300 ng/ml
PCP Phencyclidine 25 ng/ml
TCA Tricyclics 1000 ng/ml
THC Marijuana 50 ng/ml
XTC MDMA or Ecstasy 500 ng/ml
This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.
The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063545 · printed Nov 3, 2026
Cite this page
510(k) Report. “K063545: Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette, Dip-Strip), Cocaine, Methamphetamine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K063545
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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