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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: cocaine and THC

Immunoassay for the qualitative detection of cocaine and THC in urine. The At Home Test, 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.

The provided text describes the "At Home Cocaine & THC Screening Test (Model 9170)", a qualitative immunoassay for the detection of cocaine and THC in urine, intended for home use to prevent drug abuse.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "clinical sample correlation study" and a "blind labeled spiked study" for performance evaluation. However, the specific sample sizes for these test sets are not provided.

The data provenance is not explicitly stated in terms of country of origin. The studies were described as "clinical sample correlation study" and "clinical studies, performed at two independent laboratories," implying real-world or simulated clinical data. The term "spiked study" suggests some samples were prepared with known concentrations of the target substances in a laboratory setting. The studies include both "clinical specimens" and presumably simulated samples for the "blind labeled spiked study." It is retrospective and/or prospective depending on the nature of the "clinical sample correlation study" and the "blind labeled spiked study" but the document doesn't specify.

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

The document doesn't explicitly state the number of experts used to establish ground truth. However, for "correlation studies, using clinical specimens," the comparison was made to "Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology." Thus, the ground truth was established by these established, presumably accurate, laboratory methods. The "clinical studies, performed at two independent laboratories" likely also relied on these expert-operated laboratory methods for confirmation. The professionals performing these tests would be qualified laboratory technicians or scientists.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method in the way medical imaging studies sometimes employ (e.g., 2+1, 3+1). The ground truth appears to be based on the results of established analytical methods (Behring EMIT II and GC/MS), which are considered definitive for drug detection. Discrepancies, if any, would likely be resolved through retesting or further analysis using these gold standard methods rather than through expert consensus of multiple human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not conducted or reported. The study focused on the device's performance against established laboratory methods and its accuracy in the hands of both professional and lay users, not on comparing human readers' performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Yes, a standalone performance evaluation was done. The device itself is a qualitative immunoassay, and its performance (correlation with established methods, accuracy with professional and lay users) was assessed. The "human-in-the-loop" here refers to the user interpreting the visual color change. The accuracy numbers (>97%) reflect the device's performance when interpreted by either professional or lay users, implying the device's inherent ability to detect the substances. The document distinguishes between professional and lay users, indicating that the device's standalone performance, when interpreted, was evaluated in both contexts.

7. Type of Ground Truth Used:

The primary ground truth used was comparative analysis with established laboratory methods, specifically:

• Behring EMIT II: An immunoassay widely used for drug screening.
• GC/MS (Gas Chromatography/Mass Spectrometry): Considered a gold standard confirmatory method for drug identification and quantification.

8. Sample Size for the Training Set:

The document does not mention a training set or its sample size. This is expected as the "At Home Cocaine & THC Screening Test" is an immunoassay (a chemical test), not a machine learning or AI-based device that would typically require a training set. Its principles are based on known chemical reactions and antibody-antigen binding.

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

Since there is no training set mentioned or implied for this type of device, the question of how its ground truth was established is not applicable.

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