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A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of phencyclidine (PCP), a hallucinogenic compound in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of phencyclidine (PCP) use.

The QuickScreen TM One Step PCP Screening Test utilizes colloidal gold as the label like other commercially available immunoassays for drug of abuse test kits, to qualitatively measure for the presence of PCP by visual color sandwich one step immunoassay technology.

Please find the detailed analysis of the acceptance criteria and the study proving the device's performance below, based on the provided text.

Acceptance Criteria and Device Performance Study for QuickScreen™ One Step PCP Screening Test

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states the device exhibited "excellent performance" and "substantially equivalent" to predicate devices. The specific acceptance criteria are inferred from the reported performance results, as they met or exceeded "greater than 99%" across all three metrics. This high threshold is common for qualitative diagnostic tests for drugs of abuse to ensure reliable detection.

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

• Test Set Description: The performance was evaluated using "clinical sample correlation study" and a "blind labeled PCP study." correlation studies, using "clinical specimens."
• Sample Size for Test Set: Not explicitly stated. The document mentions "clinical specimens" and "blind labeled PCP study" but does not quantify the number of samples used in these studies.
• Data Provenance: The studies were conducted by "Two independent clinical laboratories." The country of origin for the data is not explicitly stated, but the manufacturer is based in San Diego, California, USA, and the FDA submission is to the US FDA, suggesting the studies were likely conducted within the USA. The studies were prospective as they involved testing the device on clinical samples and a blind labeled study, rather than re-analyzing existing data.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The ground truth was established by comparison with a predicate device, the "Syva EMIT II," which is a laboratory-based immunoassay. Therefore, the "experts" in this context would likely be the qualified laboratory personnel operating and interpreting the results of the predicate device.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. However, since the device's performance was compared to the "Syva EMIT II," a well-established immunoassay, the Syva EMIT II's results likely served as the reference standard without a separate adjudication process involving multiple human readers for conflict resolution on the ground truth.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. The study focused on the standalone performance of the QuickScreen™ device compared to a predicate immunoassay. The document does not mention human readers or AI assistance.

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

• Standalone Study: Yes, a standalone performance study was conducted. The QuickScreen™ One Step PCP Screening Test is an in-vitro diagnostic test that provides a visual color change for qualitative detection. Its performance metrics (sensitivity, specificity, accuracy) were directly compared to a predicate device (Syva EMIT II), representing its standalone capability without human interpretation being the primary variable. The phrasing "excellent performance in the hands of professional laboratory technicians" refers to the operation of the device rather than human-in-the-loop clinical decision-making.

7. Type of Ground Truth Used

• Ground Truth Type: The ground truth was established by comparison to a predicate device's results. Specifically, the "Syva EMIT II" (San Jose, CA 95161), another commercially available immunoassay for PCP, served as the reference standard for determining true positives, true negatives, false positives, and false negatives.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The QuickScreen™ One Step PCP Screening Test is a qualitative immunoassay kit, not an AI/ML algorithm. Therefore, it does not have a "training set" in the context of machine learning. Its "training" is inherent in its chemical and biological design established during its development.

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

• Training Set Ground Truth Establishment: Not applicable, as this device does not use a training set in the machine learning sense. The device's design and manufacturing are based on established immunochemical principles for drug-of-abuse testing, rather than being "trained" on a dataset.

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