The Cannabinoid Test System is an in vitro diagnostic (IVD) device designed for the qualitative and/or quantitative detection of cannabinoids and their metabolites in human specimens such as urine, blood, saliva, or hair. This system is primarily used in clinical laboratories, forensic testing, workplace drug screening, and home-use applications to determine recent cannabis exposure or monitor abstinence.

The system employs immunoassay-based methods, including enzyme-linked immunosorbent assays (ELISA) and lateral flow assays (LFA), for rapid screening. Confirmatory testing, if required, is typically conducted via gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-tandem mass spectrometry (LC-MS/MS) to enhance accuracy and specificity.

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use. Class II (special controls)

Intended Use: The THC Urine Test is a rapid immunoassay for qualitative detection of tetrahydrocannabinol in human urine. It provides a visual qualitative result and is intended for laboratory use only. It requires clinical consideration and professional judgment for a confirmed analytical result, and Gas Chromatography/Mass Spectroscopy (GC/MS) analysis is preferred.

Device Description: The test involves a nitrocellulose membrane strip with a drug-protein conjugate and a colored antibody-colloidal gold conjugate. The urine sample is allowed to migrate upward and hydrate the conjugate, which migrates along the membrane chromatographically to the immobilized drug-protein band. When the drug is absent, the colored antibody-colloidal gold conjugate and immobilized drug-protein bind to form a visible line in the test region. When THC is present, it competes with the drug-protein conjugate for limited antibody binding sites, making the test line less intense with increasing drug concentration. When the drug is present, it fills the limited antibody binding sites, inhibiting the attachment of the colored antibody-colloidal gold conjugate to the drug-protein conjugate. The presence of the test line indicates a negative result for THC, while the absence indicates a preliminary positive result.

Intended Use: The Marijuana Test Dip Card and Marijuana Test Strip are assays used for the qualitative detection of marijuana in human urine at cutoff concentrations of 50 ng/mL. These tests provide preliminary results and require a more specific chemical method, such as GC/MS or LC/MS, for confirmed analytical results. Both tests are designed for in vitro diagnostic use only and are competitive binding, lateral flow immunochromatographic assays. The preferred confirmatory method is GC/MS or LC/MS.

Device Description: Each test kit contains a Test Device and a package insert.  Each test device is sealed with a desiccant in a 1 aluminium pouch.

• Stability Studies
• Precision/Reproducibility
• Detection studies
• Detection limit
• Analytical specificity
• Traceability (controls, calibrators, or method)
• Retrospective Study
• Analytical Sensitivity
• Assay cut-off.
• Analytical Specificity (Cross-Reactivity)
• Interfering Substances
• Precision – Intra and Inter-assay
• Prozone effect study

The same is applicable for CE Marking under IVDR also.

Not Applicable for 510k submission and IVDR CE Marking