(79 days)
Acro Rapid Phencyclidine Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Phencyclidine in human urine at a cutoff of 25 ng/mL. The test is used to obtain a visual qualitative result and is intended for central laboratory use only.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
Acro Rapid Phencyclidine Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Phencyclidine in human urine at a cutoff of 25 ng/mL.
This document describes the Acro Rapid Phencyclidine Urine Test, a lateral flow immunoassay for detecting Phencyclidine (PCP) in human urine.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance:
The document explicitly states the "cutoff of 25 ng/mL" for Phencyclidine detection. However, it does not contain a table of acceptance criteria or reported device performance metrics such as sensitivity, specificity, accuracy, or positive/negative predictive values. These are typically found in the clinical study section of a 510(k) submission, which is not included here. The document is primarily the FDA's clearance letter and the Indications for Use statement.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not provide any information about a test set sample size, data provenance, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
5. If a multi-reader multicase (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:
This device is an immunoassay for drug detection, not an AI-assisted diagnostic imaging tool. Therefore, an MRMC study or AI assistance is not applicable to its function, and no such study details are present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a lateral flow immunoassay that provides a visual qualitative result. It is not an algorithm, and its performance is inherently "standalone" in giving a preliminary result. However, the document emphasizes that "Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result" and that confirmation with GC/MS is needed. This implies a human interpretation step and subsequent confirmation. Therefore, while the initial test is standalone, it's not a fully automated diagnostic without human involvement in the overall clinical pathway. The document does not detail a study specifically on 'standalone' performance in the context of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document states, "In order to obtain a confirmed analytical result, a more specific alternate chemical is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred." This indicates that GC/MS analysis is the accepted "gold standard" or ground truth for confirming Phencyclidine presence.
8. The sample size for the training set:
The document does not provide any information about a training set sample size.
9. How the ground truth for the training set was established:
The document does not provide any information about a training set or how its ground truth was established. For an immunoassay, the "training" typically involves optimizing antibody-antigen reactions and cutoff concentrations, which would be validated against known concentrations (spiked samples) and confirmed clinical samples (with GC/MS as ground truth). However, these details are not in the provided text.
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