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The RapidSense™ Drugs of Abuse Phencyclidine (PCP) 25 Device is a lateral flow competitive immunoassay intended for the qualitative detection for Phencyclidine in human urine at a cut-off concentration of 25 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For in vitro diagnostic use.

This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method. Tests for PCP cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with tests for PCP and cause false positive results.

The RapidSense™ Drugs of Abuse Phencyclidine (PCP) 25 Device is an immunoassay based on the principle of competitive binding. Phencyclidine which may be present in the urine specimen competes against its respective drug conjugate for binding sites on the specific antibody. The assay is a coloredlatex particle, monoclonal antibody-based rapid test for the qualitative detection of Phencyclidine at a cut-off of 25 ng/mL. The test utilizes the QuantRx patented, one step positive read, competitive immunoassay technology.

In the absence of the drug in the urine or if the amount of drug is below cut-off level, the visible test line zone (T) will show a clean negative (no signal on the test band). Drug positive specimens show a blue line in the visible test line zone (T). As an internal procedural control, a red control line appears in the control region (C) to verify that sufficient volume of sample was added and proper flow was obtained. The control line should always appear regardless of the presence of the drug if the assay has been performed properly.

The provided 510(k) summary describes the RapidSense™ Drugs of Abuse Phencyclidine (PCP) 25 Device and a study conducted to demonstrate its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance thresholds (e.g., "must achieve >90% sensitivity"). Instead, it presents the device's performance metrics (agreement rates with GC/MS) and implicitly suggests that these results demonstrated "substantial equivalence" to the predicate device and the reference method. For the purpose of this table, I will use the reported agreement rates as the "reported performance" and infer that demonstrating these high levels of agreement was the implicit "acceptance criteria" for substantial equivalence.

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

• Sample Size for the Test Set: 80 specimens.
• Data Provenance: The specimens were "previously collected from subjects presenting for drug testing by an external laboratory." This indicates the data is retrospective, and the country of origin is not specified, but given the manufacturer and consultant's addresses are in the US, it's highly likely to be from the United States.

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

• The ground truth was established by laboratory analysis using Gas chromatography/mass spectrometry (GC/MS). This is an analytical chemical method, not reliant on expert human interpretation in the same way as, for example, a radiologist reading an image. Therefore, the concept of "number of experts" and "qualifications of those experts" as typically applied to clinical image interpretation or diagnosis by multiple clinicians does not directly apply here. The "experts" would be the trained laboratory personnel operating the GC/MS equipment and interpreting the results according to established protocols. No specific number or qualifications are given in the document, which is typical for objective analytical methods.

4. Adjudication Method for the Test Set

• Not applicable in the conventional sense for this type of study. The ground truth was established by GC/MS, which is an objective chemical analysis. The RapidSense™ device results were directly compared to these GC/MS results. There was no mention of multiple readings of the RapidSense™ device that required adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This study is for an in vitro diagnostic (IVD) device (a lateral flow immunoassay), not an AI-based diagnostic tool that assists human readers.

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

• Yes, this study represents a standalone performance evaluation of the RapidSense™ device. The device itself (a test strip) generates a result (positive or negative read based on a colored line), and this result is directly compared to the GC/MS reference method. While healthcare professionals interpret the visual output, the study focuses on the accuracy of the device's output itself, independent of potential human interpretive errors influencing the device's intrinsic performance.

7. The Type of Ground Truth Used

• The ground truth used was Gas chromatography/mass spectrometry (GC/MS) results. This is considered a gold standard analytical method for confirming the presence and concentration of drugs in urine.

8. The Sample Size for the Training Set

• The document does not provide information regarding a training set. This is typical for traditional immunoassay devices, which are developed based on chemical and biological principles rather than machine learning models that require distinct training sets. The study described is entirely a performance validation on a "test set" or clinical sample set.

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

• As no training set is mentioned or implied for the development of this device, this question is not applicable. The device's mechanism (competitive immunoassay with colored-latex particles) is based on established biochemical principles, not on learned patterns from a training dataset.

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