VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup

The VINScreen Urine Drug Test Cup is a lateral flow immunoassay device for rapid, qualitative detection of multiple commonly abused drugs in human urine. It is available in single or multi-test configurations with optional on-board adulteration tests. The device provides preliminary screening results and requires confirmatory testing by GC/MS or LC/MS for definitive results.

The device uses competitive binding lateral flow immunochromatographic assay technology with drug monoclonal antibodies on a pre-coated membrane. Urine is absorbed by capillary action, mixes with antibody conjugates, and flows across the membrane. Results are indicated by colored lines at test and control regions. The device is cup format, sealed with desiccant in an aluminum pouch, and requires no assembly before use.

Not stated in this summary.

The VINScreen device is substantially equivalent to the predicate AllTest Multi-Drug Rapid Test Cup (K244043) based on identical intended use (qualitative drug detection in urine for over-the-counter screening), identical test methodology (competitive immunochromatographic assay), same specimen type (human urine), same test configuration (cup format), and comprehensive analytical performance data demonstrating precision, specificity, accuracy, and lay-user usability equivalent to the predicate across all target drugs and cutoff concentrations.