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The DRI Ecstasy Enzyme Immunoassay is a homogeneous enzyme immunoassay intended for the qualitative or semiquantitative determination of ecstasy drugs in human urine. The assay provides a simple and rapid analytical screening procedure for detecting ecstasy drugs at a Cutoff level of 500 ng/mL.

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The DRI Ecstasy Assay is a liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies, which can detect ecstasy drugs in urine with minimal cross-reactivity to various amphetamine compounds. The assay is based on competition between a drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme, and free drug from the urine sample for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the specific antibody binds the drug labeled with G6PDH causing a decrease in enzyme activity. This phenomenon creates a direct relationship between drug concentration in urine and enzyme activity. The enzyme G6PDH activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

Here's a breakdown of the acceptance criteria and study information for the DRI® Ecstasy Enzyme Immunoassay, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a set of predefined thresholds that the device must meet to be approved. Instead, it presents the performance characteristics of the device without directly comparing them to a pre-stated pass/fail benchmark within the document. However, we can infer the reported performance that was deemed acceptable for substantial equivalence.

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