Search Results

The Drug Detection Devices Marijuana Test is a rapid, qualitative, competitive binding immunoassay for the determination of Cannabinoids and its metabolites in urine. The test provides only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. This test is not intended to be used in monitoring cannabinoid levels.

The sponsor Drug Detection Devices Ltd. (6620 Meadowridge Court, Suite A-7, Alpharetta, GA 30005) has had developed and tested under GMP/GLP guidelines a device for the qualitative testing of urine for the presence of Marijuana and its metabolites in a screening format. The Trade names of the device are SCREENERS Marijuana Test and DrugScreen Dip Marijuana Test, having a designated common name of Cannabinoid Test System and a classification as a class II device per 21 CFR 862.3870. This device is intended for medical/forensic screening of urine. Drug Detection Devices Marijuana test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a rose-pink color band when the detection level of 50 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a rose-pink color band, demonstrating that the reagents and device are functioning correctly.