# K252867: VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup

- Pathway: 510(k) (Traditional)
- Applicant: Advin Biotech, Inc.
- Decided: Oct 9, 2025 after 30 days
- Product code: NFT (Test, Amphetamine, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K001178 (2000). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K244043: AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup, Hangzhou AllTest Biotech Co., Ltd. (2025) Summary page 7.

## Indications for use
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.

Source page: https://510kreport.com/device/K252867
Methodology: https://510kreport.com/methodology