510(k) · Cleared
ClearedVINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advin Biotech, Inc. · NFT Test, Amphetamine, Over The Counter
Cleared on Oct 9, 2025 as substantially equivalent to K244043 (Hangzhou AllTest Biotech Co., Ltd., 2025) after a 30-day review. Its family tree reaches back 10 generations to 2000.
- Decided
- Oct 9, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- NFT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K001178 (2000). 20 ancestors in all, the oldest K971218 (1997). No later device cites it as a predicate yet.
- Root · 10 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 6 generations between
- 3 generations backK182738 Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)…Hangzhou AllTest Biotech Co., Ltd. · 2019
- 2 generations backK233019 AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test…Hangzhou AllTest Biotech Co., Ltd. · 2023
- 1 generation backK244043 AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd. · 2025
- This deviceK252867 VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupAdvin Biotech, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 9 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- 8 generations backK042988 Rapid One Step Buprenorphine Test CardTianjin New Bay Bioresearch Co., Ltd. · 2005
- 7 generations backK060527 Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine…Alfa Scientific Designs, Inc. · 2006
- 6 generations backK063545 Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine…Alfa Scientific Designs, Inc. · 2007
- 5 generations backK152122 Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View…Alfa Scientific Designs, Inc. · 2016
- 4 generations backK173303 INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC…Alfa Scientific Designs, Inc. · 2018
- 3 generations backK182738 Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)…Hangzhou AllTest Biotech Co., Ltd. · 2019
- 2 generations backK233019 AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test…Hangzhou AllTest Biotech Co., Ltd. · 2023
- 1 generation backK244043 AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd. · 2025
- This deviceK252867 VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupAdvin Biotech, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −9 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| −8 | K042988 | Rapid One Step Buprenorphine Test Card | Tianjin New Bay Bioresearch Co., Ltd. | 2005 | — |
| −7 | K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test… | Alfa Scientific Designs, Inc. | 2006 | — |
| −6 | K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test… | Alfa Scientific Designs, Inc. | 2007 | — |
| −5 | K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug… | Alfa Scientific Designs, Inc. | 2016 | — |
| −4 | 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 | — |
| −2 | K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel… | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| −1 | K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2025 | — |
| 0 (this device) | K252867 | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup | Advin Biotech, Inc. | 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 |
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 NFT? 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 NFT device
- #1 K244043 AllTest Multi-Drug Rapid Test Cup ; AllTest…score 20.3 · 9 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 |
|---|---|---|---|
| * | K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupSummary page 7…862.3870, Cannabinoids Test System Toxicology Cannabinoids (THC) 6. Predicate Devices: AllTest Multi-Drug Rapid Test Cup (K244043) 7. Intended Use The VINScreen Urine Drug Home Test Cup is lateral flow immunoassays for rapid detection of multiple… | 2025 |
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 25 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- None of the 20 ancestors has a recall.
- 2 other devices also cite its predicate K244043.
How does its category compare?
All NFT devicesNFT Test, Amphetamine, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NFT
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NFT
37in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFT
No recall names NFT since 2007.
Adverse event reports per year · NFT
No MAUDE report names NFT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 6 | 56 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 3 | 63 | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 4 | 31 | 0 | 0 |
| 2025 | 8 | 37 | 0 | 0 |
| 2026 | 5 | 35 | 0 | — |
What is it indicated for?
The VINScreen Urine Drug Test Cup is lateral flow immunoassays for rapid detection of multiple commonly abused drugs in human urine. The detectable drugs and their cutoff concentrations are listed below: Abbreviation Analyte Calibrator Cut-off (ng/mL) 6AM 6-Acetylmorphine 6-Monoacetylmorphine 10 AMP Amphetamine d-Amphetamine 500 or 1000 BAR Secobarbital Secobarbital 300 BUP Buprenorphine Buprenorphine 10 BZO Oxazepam Oxazepam 300 COC Cocaine…
Read the full statement (356 words)
The VINScreen Urine Drug Test Cup is lateral flow immunoassays for rapid detection of multiple commonly abused drugs in human urine. The detectable drugs and their cutoff concentrations are listed below:
Abbreviation Analyte Calibrator Cut-off (ng/mL)
6AM 6-Acetylmorphine 6-Monoacetylmorphine 10
AMP Amphetamine d-Amphetamine 500 or 1000
BAR Secobarbital Secobarbital 300
BUP Buprenorphine Buprenorphine 10
BZO Oxazepam Oxazepam 300
COC Cocaine Benzoylecgonine 150 or 300
EDDP EDDP 2-ethylidene-1,5-dimethyl- 300
3,3-diphenylpyrrolidine
FEN Fentanyl Fentanyl 1
FEN Norfentanyl Norfentanyl 5
MDMA Ecstasy d,l-Methylenedioxymethamphetamine 500
MET Methamphetamine d-Methamphetamine 500 or 1000
MOR Morphine Morphine 300
MTD Methadone d/l-Methadone 300
OPI Opiates Morphine 2000
OXY Oxycodone Oxycodone 100
PCP Phencyclidine Phencyclidine 25
PPX Propoxyphene Propoxyphene 300
TCA Nortriptyline Nortriptyline 1000
THC Marijuana 11-nor-Δ9-THC-9 COOH 20 or 50
The single or multi-test cup can include any combination of the analytes listed above, with and without on-board adulteration tests. However, only one cut-off concentration can be included per analyte per device.
This in vitro diagnostic device provides only a preliminary test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical test result. GC/MS or LC/MS is the preferred confirmatory method.
The VINScreen Urine Drug Home Test Cup is lateral flow immunoassays for rapid detection of multiple commonly abused drugs in human urine. The detectable drugs and their cutoff concentrations are listed below:
Drug Cut-off (ng/mL) Abbreviation
6-monoacetylmorphine 10 6AM
Amphetamine 500 / 1000 AMP
Secobarbital 300 BAR
Buprenorphine 10 BUP
Oxazepam 300 BZO
Cocaine 150 / 300 COC
EDDP 300 EDDP
Fentanyl 1 FEN
Norfentanyl 5 FEN
Ecstasy 500 MDMA
Methamphetamine 500 / 1000 MET
Methadone 300 MTD
Opiates 300 / 2000 MOR/OPI
Oxycodone 100 OXY
Phencyclidine 25 PCP
Propoxyphene 300 PPX
Nortriptyline 1000 TCA
Marijuana 20 / 50 THC
The single or multi-test cup can include any combination of the analytes listed above, with and without on-board adulteration tests. However, only one cut-off concentration can be included per analyte per device.
This device provides only a preliminary test result. A more specific alternate method must be used in order to obtain a confirmed analytical test result. GC/MS or LC/MS is the preferred confirmatory method.
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/K252867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252867: VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252867
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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