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TCPI's One Step™ Urine Drug of Abuse: Phencyclidine (PCP) Test is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine at the cutoff level of 25 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. TCPI's One Step™ Urine Drug of Abuse: Phencyclidine (PCP) Test is not intended to monitor drug levels, but only to screen urines for the presence of Phencyclidine (PCP) and its metabolites.

TCPI's One Step Urine Drug of Abuse Phencyclidine™ (PCP) Test Strip is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine. The One Step Urine Drug of Abuse Phencyclidine™ (PCP) Test Strip is a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for a limited number of antibody binding sites. As a test sample flows up through the absorbent device, labeled antibody-dye conjugate binds to free drug in the specimen, forming an antibody-antigen complex. This complex with immobilized antigen conjugate in the Test Zone of the strip, and will not produce a magenta color band when the drug concentration in the specimen is above the detection level of 25 ng/ml. Unbound dye conjugate birds to the reagent in the Control Zone of the strip, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A negative specimen produces two distinct color bands, one in the Test Zone and one in the Control Zone A positive specimen produces only one color band in the Control Zone.

This submission describes the "One Step Urine Drug of Abuse: Phencyclidine™ (PCP) Test" by Technical Chemicals and Products, Inc. (TCPI).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the comparison to the Emit® II assay, which is a legally marketed predicate device, and the subsequent confirmation by GC/MS. The goal is 100% agreement with Emit® II.

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

• Sample Size: 286 individual urine samples for the clinical trial, in addition to 227 in-house tested samples, for a total of 513 samples.
• Data Provenance: The 286 clinical trial samples were submitted to a "NDA certified laboratory," implying external, potentially real-world, clinical samples. The country of origin is not explicitly stated but can be inferred as the US based on the FDA submission. The study is retrospective in the sense that the samples were already collected and tested by the NDA certified laboratory using Emit® II before being re-tested with the new device.

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

• Experts: Not explicitly stated as "experts" in the traditional sense of clinicians establishing a diagnosis. The ground truth for the preliminary comparison was the Emit® II Phencyclidine (PCP) assay.
• Qualifications: The Emit® II assay was performed by an "NDA certified laboratory." The personnel performing these tests would be qualified laboratory technicians or clinical scientists.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the traditional sense for diagnostic test evaluation against a gold standard or predicate.
  • The initial comparison was directly against the Emit® II assay as the predicate.
  • For samples that tested positive by either the Emit® II or the new device (223 samples), all were confirmed by GC/MS. This acts as a confirmatory "adjudication" against the true (analytical) ground truth.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is an in vitro diagnostic device, not an imaging or interpretation device that would typically involve multiple human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

• Yes, this study represents a standalone performance evaluation of the immunoassay device itself. The interpretation of the color bands (positive/negative) is inherent to the device's design, and while a human observes the result, the "performance" is based on the chemical reaction within the device.

7. The Type of Ground Truth Used

• Primary Ground Truth for Comparison: Emit® II Phencyclidine (PCP) assay results (predicate device).
• Confirmatory Ground Truth: Gas Chromatography/Mass Spectrometry (GC/MS). This is considered the analytical gold standard for confirming drug presence and concentration.

8. The Sample Size for the Training Set

• The document does not explicitly mention a separate "training set" in the context of machine learning or AI. This is an immunoassay device, which typically does not involve a training phase in the same way an AI algorithm would. The 227 "in-house" tested samples could be considered an internal validation/development set, but not a training set for an algorithm.

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

• As there is no explicit "training set" for an AI algorithm mentioned, this question is not directly applicable. For the in-house testing, the ground truth would have been established through controlled spiking of samples or comparison to established methods like Emit® II or GC/MS, similar to the test set. The document states "In both studies, the laboratories used Emit® II Phencyclidine (PCP) as their screening procedure, with a cutoff of 25 ng/ml."

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