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The First Check® Home Drug Test for MDMA (Ecstasy) is a screening test for the rapid detection of MDMA and its metabolites in human urine at a cut-off level of 500 ng/ml. The test is intended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of MDMA or its metabolites in a urine sample. Such information is beneficial to consumer efforts to comply with applicable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.

The First Check® Home Drug Test for MDMA (Ecstasy), like other commercially available drug screening tests, qualitatively measures the presence or absence of MDMA and its metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drug/antibody complexes.

The document describes the First Check® Home Drug Test for MDMA (Ecstasy), an immunoassay for the qualitative detection of drugs of abuse in urine.

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for the consumer study, but it implies that the test should perform "excellently" in the hands of lay users and that consumers should be able to interpret the results effectively. The performance is compared to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated for the consumer study.
• Data Provenance: The consumer study was conducted using the First Check® Home Drug Test for MDMA (Ecstasy). It is implied to be prospective, as it's a "consumer study." The country of origin is not specified but is implicitly the country where Worldwide Medical Corporation operates or markets its products, likely the USA given the FDA 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The document describes a home drug test for lay users; the ground truth for consumer performance would not typically be established by experts interpreting the test results but rather by the ability of consumers to correctly use and interpret results (which may be verified against a reference method or expert interpretation of the reference method's results). The specificity testing against related compounds (d-amphetamine, l-amphetamine, etc.) would likely involve laboratory analysis overseen by qualified personnel, but the number and qualifications of those individuals are not mentioned.

4. Adjudication Method for the Test Set:

Not applicable for the consumer study as described. The focus is on consumer use and interpretation, not expert adjudication of multiple readings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study is not mentioned. The study described focuses on standalone performance by consumers. The effectiveness is implied by the "excellent overall performance in the hands of lay users" and their ability to obtain preliminary information.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone performance is described. The "consumer study" focuses on the device's performance when used by lay users without expert assistance or further intervention at the point of initial use and interpretation. The analytical studies of the identical Applied Biotech SureStep™ MDMA (Ecstasy) Drug Screen Test (K011133) on specificity also represent standalone performance in a laboratory setting.

7. Type of Ground Truth Used:

• For Specificity: Laboratory reference methods testing for MDMA and its metabolites versus structurally related compounds at specified concentrations.
• For Consumer Study: The ground truth for the "excellent overall performance in the hands of lay users" and effective use/interpretation would likely be established by comparing consumer results to a definitive reference method (e.g., GC/MS) performed on the actual urine samples. The document states the test provides "preliminary information," implying further confirmatory testing is the ultimate ground truth.

8. Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI-based device that would require a "training set" in the traditional sense. It's an immunoassay. The development and validation of such immunoassay devices involve extensive laboratory testing and optimization, but not typically a training set in the context of AI.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set mentioned for this immunoassay device.

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