The Cocaine and Cocaine Metabolite Test System typically involves devices designed for the rapid detection of cocaine and its metabolites in biological samples, such as urine or saliva. These systems utilize immunoassay techniques, which can provide quick results and are often used in various settings, including law enforcement, sports, and workplace drug testing. They are valued for their efficiency, though confirmatory testing using methods like gas chromatography-mass spectrometry (GC-MS) may be required to validate initial positive results. The design and technology of these devices vary, but they all aim to be user-friendly and provide accurate readings in a timely manner.

Intended Use of Cocaine and Cocaine Metabolite Test system

A Cocaine and Cocaine Metabolite Test System is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Intended Use:

The EIA Cocaine Assay is an enzyme immunoassay designed for the preliminary qualitative detection of cocaine in human head and body hair. It uses a cocaine calibrator at a cutoff of 5 ng/10 mg hair to identify cocaine use. This product is exclusively for in-house professional use and not for sale. The EIA Cocaine Assay provides only a preliminary analytical test result, and to confirm positive results, a more specific alternate chemical method (e.g., LC/MS/MS) must be used. Clinical consideration and professional judgment should be applied to the interpretation of any drug-of-abuse test result. This product is intended for in-house professional use only and not for sale.

Device Description:

The homogeneous enzyme immunoassay (HEIA) test involves a pre-analytical hair treatment procedure to extract cocaine from a solid hair matrix and a screening assay called the Cocaine HEIA. The screening part involves competition for antibody binding sites between the drug and drug-labeled recombinant glucose-6-phosphate dehydrogenase (G6PDH). Enzyme activity decreases as the antibody binds G6PDH, but increases in proportion to drug concentration. The active enzyme reduces NAD to NADH in the presence of G6P, resulting in spectrophotometric absorbance changes.

Enzyme Immunoassay, Cocaine and Cocaine Metabolites

Intended Use:

The Cocaine assay is a homogeneous enzyme immunoassay used to determine benzoylecgonine (Cocaine Metabolite) in human urine at a cutoff concentration of 150 ng/mL or 300 ng/mL. It allows laboratories to determine an appropriate dilution for confirmation using methods like Liquid Chromatography/Tandem Mass Spectrometry (LCMS/MS) or quality control procedures. The assay provides only a preliminary analytical test result, and a more specific chemical method is required for a confirmed analytical result. It is important to apply clinical and professional judgment when using preliminary results, especially when used for in vitro diagnostic use only.

Device Description:

The Cocaine Assay is a homogeneous enzyme immunoassay that uses a specific antibody to detect benzoylecgonine in urine. It competes with an enzyme glucose- 6-phosphate dehydrogenase (G6PDH) labeled drug and the drug from the urine sample for specific antibody binding sites. In the presence of free drug, the free drug occupies these binding sites, allowing G6PDH to interact with the substrate. In the absence of drug, the specific antibody binds to the drug labeled with G6PDH, inhibiting enzyme activity. This relationship between drug concentration in urine and enzyme activity is determined spectrophotometrically at 340 nm by measuring G6PDH’s ability to convert nicotinamide adenine dinucleotide (NAD) to NADH. The assay consists of two reagents: Reagent A, which contains mouse monoclonal anti-benzoylecgonine antibody, and Reagent E, which contains benzoylecgonine analog labeled with G6PDH.

PERFORMANCE TESTING (Analytical) for Cocaine and Cocaine Metabolite Test System

• Precision/Reproducibility
• Linearity/assay reportable range
• Traceability (controls, calibrators, or method)
• Analytical specificity (cross reactivity)
• Accuracy(recovery)
• Interfering Substances

Clinical Testing:

No Guidance available for 510k submission