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A workplace 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: Methamphetamine, Amphetamine, THC, Cocaine and Opiates

Immunoassay for the qualitative detection Methamphetamine. THC. Cocaine and Opiates in urine

Here's an analysis of the provided text, outlining the acceptance criteria and the study used to demonstrate the device's performance:

QuickScreen Workplace Drug Screening Test (Model 9147 25C)

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary implicitly defines acceptance criteria through its performance claims. While explicit pass/fail thresholds are not stated, the reported high correlation and accuracy suggest the criteria.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The text mentions "clinical specimens" for the correlation studies and "clinical studies" for professional users. For lay users, a "consumer study" was performed, but no specific number of samples is given for any of these.
• Data Provenance: The studies used "clinical specimens," implying real-world samples. The clinical studies were performed at "two independent laboratories," suggesting multiple sites. The origin of the data (e.g., country) is not specified. The studies appear to be retrospective for the "clinical sample correlation study" (using existing clinical specimens) and potentially prospective for the "blind labeled spiked study" and the clinical studies performed at independent laboratories, though this is not explicitly stated.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: The text refers to "professional users" in the context of the clinical studies. Their specific qualifications (e.g., medical technologists, lab technicians) are not detailed.

4. Adjudication Method

• The text doesn't describe an explicit adjudication method for establishing ground truth from multiple expert readings. For the correlation studies, the device's results were compared against an established predicate device (Behring EMIT II) and a gold standard (GC/MS). This implies that GC/MS and EMIT II were considered definitive for their respective comparisons, rather than a process of adjudicating expert opinions.

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

• No MRMC comparative effectiveness study is described where human readers' performance with and without AI assistance is compared. The device itself is an immunoassay, not an AI-assisted diagnostic tool that aids human interpretation. The "consumer study" involved lay users but didn't assess an improvement in their performance due to AI.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The entire performance section describes the device's (algorithm-only, as it's an immunoassay) performance in detecting drugs/metabolites in urine. This includes:
  • Correlation studies using clinical specimens compared to the Behring EMIT II and GC/MS.
  • Clinical studies at two independent laboratories measuring overall accuracy with professional users.
  • A consumer study measuring overall accuracy with lay users (though this was for a related product with identical formulation).

7. Type of Ground Truth Used

• The primary ground truth used for the performance evaluation was a combination of:
  • Predicate Device Performance: Comparison against the Behring EMIT II, a commercially available and presumably validated immunoassay.
  • Confirmatory Gold Standard: Gas Chromatography/Mass Spectrometry (GC/MS), which is widely accepted as a definitive method for drug confirmation.
    Therefore, the ground truth is a combination of established reference method comparison and definitive analytical method (GC/MS).

8. Sample Size for the Training Set

• The provided document does not mention a training set for the device. The QuickScreen Workplace Drug Screening Test is an immunoassay, which typically does not involve machine learning or AI models requiring a distinct "training set." Its performance is based on the chemical reactions and physical design of the test strip rather than an algorithm trained on data.

9. How Ground Truth for the Training Set Was Established

• Since there is no mention of a training set or an AI/ML component, this question is not applicable to the described device.

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