VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup
Device Facts
| Record ID | K252867 |
|---|---|
| Device Name | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup |
| Applicant | Advin Biotech, Inc. |
| Product Code | NFT · Clinical Toxicology |
| Decision Date | Oct 9, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Indications for Use
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: [Table of drugs/cutoffs]. 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. 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: [Table of drugs/cutoffs]. 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.
Device Story
Lateral flow immunochromatographic assay cup for qualitative drug screening in human urine. Device uses competitive binding principle; drug in sample competes with drug-protein conjugate for limited monoclonal antibody binding sites. Absence of colored test line indicates preliminary positive result; presence of line indicates negative result. Control line confirms proper test performance. Used in clinical or home settings; operated by healthcare professionals or lay users. Provides preliminary results; requires confirmation via GC/MS or LC/MS. Benefits patient by enabling rapid, point-of-care screening for drug presence.
Clinical Evidence
Bench testing only. Performance validated via precision/reproducibility studies (25 days, 3 lots), analytical specificity/interference testing, and method comparison against LC-MS/MS (80 samples per drug). Lay-user study (n=280) confirmed ease of use and performance across diverse demographics. No clinical prospective/retrospective studies performed.
Technological Characteristics
Lateral flow immunochromatographic assay. Competitive binding principle. Ready-to-use cup format. Stable at 2-30°C for 24 months. No electronic components or software algorithms. Qualitative visual readout.
Indications for Use
Indicated for rapid, qualitative detection of multiple commonly abused drugs in human urine. Intended for both professional (prescription) and over-the-counter (home) use. Detectable analytes include 6AM, AMP, BAR, BUP, BZO, COC, EDDP, FEN, Norfentanyl, MDMA, MET, MOR, MTD, OPI, OXY, PCP, PPX, TCA, and THC at specified cutoff concentrations.
Regulatory Classification
Identification
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
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