510(k) · Cleared
ClearedINSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
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 Feb 23, 2018 as substantially equivalent to K152122 (Alfa Scientific Designs, Inc., 2016) after a 128-day review. Its family tree reaches back 6 generations to 2000. 12 later devices descend from it.
- Decided
- Feb 23, 2018
- Review
- 128 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001178 (2000). 16 ancestors in all, the oldest K971218 (1997). 12 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 5 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- 4 generations backK042988 Rapid One Step Buprenorphine Test CardTianjin New Bay Bioresearch Co., Ltd. · 2005
- 3 generations backK060527 Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine…Alfa Scientific Designs, Inc. · 2006
- 2 generations backK063545 Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine…Alfa Scientific Designs, Inc. · 2007
- 1 generation backK152122 Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View…Alfa Scientific Designs, Inc. · 2016
- This deviceK173303 INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC…Alfa Scientific Designs, Inc. · 2018
- Descendant · cites it directly · 9 of its ownK182738 Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)…Hangzhou AllTest Biotech Co., Ltd. · 2019
- Descendant · 2 generations on · 8 of its ownK233019 AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test…Hangzhou AllTest Biotech Co., Ltd. · 2023
- Descendant · 3 generations on · 4 of its ownK244043 AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd. · 2025
- Descendant · 3 generations on · 2 of its ownK241428 AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine…Hangzhou AllTest Biotech Co., Ltd. · 2024
- Descendant · 4 generations on · 1 of its ownK250727 AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine…Hangzhou AllTest Biotech Co., Ltd. · 2025
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug…Hangzhou AllTest Biotech Co., Ltd. · 2019 · cites it directly9descendants
- K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest…Hangzhou AllTest Biotech Co., Ltd. · 2023 · 2 generations on8descendants
- K244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd. · 2025 · 3 generations on4descendants
- K241428AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd. · 2024 · 3 generations on2descendants
- K250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −5 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| −4 | K042988 | Rapid One Step Buprenorphine Test Card | Tianjin New Bay Bioresearch Co., Ltd. | 2005 | — |
| −3 | K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test… | Alfa Scientific Designs, Inc. | 2006 | — |
| −2 | 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 | — |
| 0 (this device) | K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)… | Alfa Scientific Designs, Inc. | 2018 | — |
| +1 | K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and… | Hangzhou AllTest Biotech Co., Ltd. | 2019 | — |
| +2 | K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel… | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| +3 | K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2025 | — |
| +3 | K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2024 | — |
| +4 | K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine 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 |
|---|---|---|
| 2018 | 2 | 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 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 |
|---|---|---|---|
| * | K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test…Summary page 8…Oxycodone 862.3650 NGL DJG Date of 02/22/2018 Preparation Predicate k152122 Devices Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Dru… | 2016 |
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug… | 2019 | 9 |
| K180878 | BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test… | 2018 | 0 |
| K180879 | BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug… | 2018 | 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 18 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K182738 (Hangzhou AllTest Biotech Co., Ltd., 2019) has gone furthest, with 9 descendants of its own.
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 INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) device is a rapid, qualitative immunoassay device for the detection of one or more drugs or metabolites at the designated cutoff concentrations in human urine. The device can detect up to 13 drugs or their metabolites: Analyte Calibrator Cutoff (ng/mL) Amphetamines d-Amphetamine 1000 Barbiturates Secobarbital 200 Buprenorphine Buprenorphine 10 Benzodiazepines Oxazepam 300 Cocaine…
Read the full statement (392 words)
The INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) device is a rapid, qualitative immunoassay device for the detection of one or more drugs or metabolites at the designated cutoff concentrations in human urine. The device can detect up to 13 drugs or their metabolites:
Analyte Calibrator Cutoff (ng/mL)
Amphetamines d-Amphetamine 1000
Barbiturates Secobarbital 200
Buprenorphine Buprenorphine 10
Benzodiazepines Oxazepam 300
Cocaine Benzoylecgonine 300
Methamphetamine d-Methamphetamine 1000
Methadone Methadone 300
Phencyclidine Phencyclidine 25
Tricyclic
Antidepressants Nortriptyline 1000
Cannabinoids 11-nor-A9-THC-9-COOH 50
MDMA Methylenedioxymethamphetamine 500
Morphine Morphine 2000
Oxycodone Oxycodone 300
These assays may yield positive results when barbiturates, benzodiazepines, or tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized cutoff levels for barbiturates, benzodiazepines, or tricyclic antidepressants in urine. The assays are not intended to distinguish between prescription use or abuse of these drugs.
This device provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry 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 INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) device is a rapid, qualitative immunoassay device for the detection of one or more drugs or metabolites at the designated cutoff concentrations in human urine. The device can detect up to 13 drugs or their metabolites:
Analyte
Amphetamines
Barbiturates
Buprenorphine
Benzodiazepines
Cocaine
Methamphetamine
Methadone
Phencyclidine
Tricyclic
Antidepressants
Cannabinoids
MDMA
Morphine
Oxycodone
Calibrator
d-Amphetamine
Secobarbital
Buprenorphine
Oxazepam
Benzoylecgonine
d-Methamphetamine
Methadone
Phencyclidine
Nortriptyline
11-nor-A9-THC-9-COOH
Cutoff (ng/mL)
1000
200
10
300
300
1000
300
25
1000
50
Methylenedioxymethamphetamine 500
Morphine
Oxycodone
2000
300
These assays may yield positive results when barbiturates, benzodiazepines, or tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized cutoff levels for barbiturates, benzodiazepines, or tricyclic antidepressants in urine. The assays are not intended to distinguish between prescription use or abuse of these drugs.
This device provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173303: INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173303
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