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A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: Amphetamine, MDA, Methamphetamine, MDMA , THC, Cocaine and Opiates.

The At Home Drug Cup is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentration for this test is as follows: amphetamine and MDA; 1000 ng/ml, methamphetamine and MDMA; 500 ng/ml, THC (or marijuana); 50 ng/ml, cocaine; 300 ng/ml, opiates; 300 ng/ml. This assay is intended for use in the home to assist in the prevention of drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory. The At Home Drug Cup, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / complexes.

The At Home Drug Cup (Model 9150X) is an immunoassay for the qualitative detection of amphetamine, MDA, methamphetamine, MDMA, THC, cocaine, and opiates in urine. The device's performance was evaluated through a clinical sample correlation study and a blind labeled spiked study.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "excellent overall accuracy" claims and correlation percentage. Specific, explicit acceptance criteria (e.g., "must achieve >95% accuracy") are not provided in the document.

2. Sample Sizes Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • For the "Correlations studies, using clinical specimens," the specific sample size is not provided, only the resulting correlation percentage.
  • For the "Clinical studies, performed at two independent laboratories" (professional user study), the specific sample size is not provided.
  • For the "consumer study," the sample size was 400 cases (resulting in 388 correct interpretations).
• Data Provenance: The document does not explicitly state the country of origin for the clinical specimens or the location of the independent laboratories. The studies appear to be prospective as they are described as performance evaluation studies for the device.

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

• Correlation Study: The ground truth was established by two methods:
  • Behring EMIT II: This is another commercially available drug screening test. While it's a device, its results are considered a form of established truth in this context.
  • GC/MS methodology: Gas Chromatography-Mass Spectrometry (GC/MS) is a highly accurate analytical method often used as a gold standard for drug detection and quantification.
• Clinical Studies (Professional Users): The document doesn't explicitly state the number or qualifications of "professional users," but implies they are trained personnel in laboratory settings.
• Consumer Study (Lay Users): The ground truth against which lay users' interpretations were compared is not explicitly detailed but would presumably have been established by laboratory methods (like GC/MS or EMIT II) on the same samples.

4. Adjudication Method for the Test Set

The document does not describe a particular adjudication method (like 2+1, 3+1) for resolving discrepancies in the ground truth establishment. For the correlation study, the comparison was made against established laboratory methods (EMIT II and GC/MS), which inherently provide a single result. For the consumer study, the "correct" result was presumably pre-determined.

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

• No evidence of MRMC study: The document does not describe a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study to assess how human readers improve with AI vs. without AI assistance. The device is a standalone immunoassay kit, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance

• Yes, standalone performance was done: The entire evaluation focuses on the standalone performance of the "At Home Drug Cup." Both the clinical sample correlation study and the consumer study assess the device's ability to detect target drugs independently. The clinical studies with professional users also represent standalone performance.

7. Type of Ground Truth Used

• Expert Consensus/Reference Method:
  • For the correlation studies, the ground truth was established using reference laboratory methods, specifically the Behring EMIT II and Gas Chromatography-Mass Spectrometry (GC/MS). GC/MS is widely considered a gold standard in toxicology.
  • For the clinical and consumer studies, the "correct" result against which the device's accuracy was measured would have been derived from these or similar established laboratory methods.

8. Sample Size for the Training Set

• The document does not mention a "training set" or "training data." As an immunoassay device, it is not an AI/ML algorithm that undergoes a training phase with a distinct dataset. Its performance is inherent to its biochemical design.

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

• Not applicable, as there is no "training set" for this type of device.

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