The CD Barbiturates Screen Test Card and Test Strip devices are rapid, in vitro diagnostic (IVD), qualitative, lateral flow, immunochromatographic urinary assays for the detection of barbiturate drugs (e.g., secobarbital, pentobarbital, phenobarbital, etc., their analogs and their metabolites (collectively termed: BAR) in human urine at the Substance Abuse and Mental Health Services Administration (SAMHSA) cut-off level of 300 ng/mL. The tests are designed to obtain a visual, qualitative result and are intended for professional use only. They are not intended for quantitative analysis, or for over-the-counter sale. The CD Barbiturates Screen Test provides only preliminary analytical data. A more specific, alternative method is required to obtain a confirmed analytical result. SAMHSA has established gas chromatography/mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.