510(k) · Cleared
ClearedInstant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Scientific Designs, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Oct 7, 2013 as substantially equivalent to K063545 (Alfa Scientific Designs, Inc., 2007) after a 124-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Oct 7, 2013
- Review
- 124 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001178 (2000). 15 ancestors in all, the oldest K971218 (1997). No later device cites it as a predicate yet.
- Root · 5 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 4 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- 3 generations backK042988 Rapid One Step Buprenorphine Test CardTianjin New Bay Bioresearch Co., Ltd. · 2005
- 2 generations backK060527 Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine…Alfa Scientific Designs, Inc. · 2006
- 1 generation backK063545 Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine…Alfa Scientific Designs, Inc. · 2007
- This deviceK131645 Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette)Alfa Scientific Designs, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −4 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| −3 | K042988 | Rapid One Step Buprenorphine Test Card | Tianjin New Bay Bioresearch Co., Ltd. | 2005 | — |
| −2 | K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test… | Alfa Scientific Designs, Inc. | 2006 | — |
| −1 | K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test… | Alfa Scientific Designs, Inc. | 2007 | — |
| 0 (this device) | K131645 | Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette) | Alfa Scientific Designs, Inc. | 2013 | — |
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 |
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 |
|---|---|---|---|
| * | K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette…Summary page 2…i Si...Telephone:CA 92064 qaaPowy 858-513-3888.# Fax: 858-513-8388 Predicate INSTANT-VIEW® Multi-Drug of Abuse Urine Test (K(063545) Devices Manufacture is Alfa Scientific Designs, Inc.… | 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 15 ancestors has a recall.
- 2 other devices also cite its predicate K063545.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Instant-View Multi-Drug of Abuse Urine Test Cup is a rapid, qualitative immunoassay for the detection of one or more of the following drugs in human urine. This device is for over the counter use and may detect any combination of the drugs or drug metabolites at or above the specified cut-off level listed below. Abbreviation — Test — Cutoff AMP — Amphetamine — 1000 ng/mL BAR — Barbiturates — 200 ng/mL BZD — Benzodiazepine — 300 ng/mL COC — Cocaine —…
Read the full statement (400 words)
The Instant-View Multi-Drug of Abuse Urine Test Cup is a rapid, qualitative immunoassay for the detection of one or more of the following drugs in human urine. This device is for over the counter use and may detect any combination of the drugs or drug metabolites at or above the specified cut-off level listed below.
Abbreviation — Test — Cutoff
AMP — Amphetamine — 1000 ng/mL
BAR — Barbiturates — 200 ng/mL
BZD — Benzodiazepine — 300 ng/mL
COC — Cocaine — 300 ng/mL
MDMA — MDMA or Ecstasy — 500 ng/mL
MET — Methamphetamine — 1000 ng/mL
MTD — Methadone — 300 ng/mL
MOR — Morphine/Opiates — 2000 ng/mL
OXY — Oxycodone — 100 ng/mL
PCP — Phencyclidine — 25 ng/mL
TCA — Tricyclic antidepressants — 1000 ng/mL
THC — Marijuana — 50 ng/mL
The drug tests will provide a preliminary result only. A more specific, alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and High-Performance Liquid Chromatography (HPLC), or the like, are the preferred confirmation methods for most drugs in urine. Clinical consideration and professional judgment should be applied to any drug test result, particularly when evaluating preliminary positive results.
The Instant-View Multi-Drug of Abuse Urine Test Panel is a rapid, qualitative immunoassay for the detection of one or more of the following drugs in human urine. This device is for over the counter use and may detect any combination of the drugs or drug metabolites at or above the specified cut-off level listed below.
Abbreviation — Test — Cutoff
AMP — Amphetamine — 1000 ng/mL
BAR — Barbiturates — 200 ng/mL
BZD — Benzodiazepine — 300 ng/mL
COC — Cocaine — 300 ng/mL
MDMA — MDMA or Ecstasy — 500 ng/mL
MET — Methamphetamine — 1000 ng/mL
MTD — Methadone — 300 ng/mL
MOR — Morphine/Opiates — 300 ng/mL
OXY — Oxycodone — 100 ng/mL
PCP — Phencyclidine — 25 ng/mL
TCA — Tricyclic antidepressants — 1000 ng/mL
THC — Marijuana — 50 ng/mL
The drug tests will provide a preliminary result only. A more specific, alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and High-Performance Liquid Chromatography (HPLC), or the like, are the preferred confirmation methods for most drugs in urine. Clinical consideration and professional judgment should be applied to any drug test result, particularly when evaluating preliminary positive results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131645 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131645: Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131645
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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