(52 days)
A home drug screening, and if needed, confirmation service. This kit provides a rapid, qualitative immunoassay for the detection of any of the following drugs of abuse in urine: Methamphetamine, MDMA.
The At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for this test is as follows: Methamphetamine, MDMA; 500 ng/ml. This assay is intended for use in the home to assist in preventing drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the "At Home Drug Test (Model 9069)":
Acceptance Criteria and Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets. Instead, the document frames the device's performance in terms of "substantial equivalence" to existing commercially available tests and a high percentage of accuracy. The key performance indicators mentioned are:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices | Stated as "substantially equivalent to the reported performance characteristics of other commercially available tests". |
| High correlation with laboratory methods (EMIT II, GC/MS) | ">99% correlation when compared to the Behring EMIT II and GC/MS methodology." |
| High overall accuracy (professional users) | "excellent overall accuracy (>98%) in the hands of professional users." |
| High accuracy (consumer interpretation) | "Consumer interpretation of the methamphetamine test showed accuracy to be 428/444 or 96.4%." |
Study Details
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Sample Size and Data Provenance:
- Test Set Sample Size:
- Clinical sample correlation study: Not explicitly stated, but "clinical specimens" are mentioned.
- Blind labeled spiked study: Not explicitly stated.
- Clinical studies (professional users): Not explicitly stated, but "performed at two independent laboratories."
- Consumer study (methamphetamine accuracy): 444 samples.
- Data Provenance: Not explicitly stated as retrospective or prospective. It implies prospective data collection for the "clinical sample correlation study," "blind labeled spiked study," "clinical studies," and "consumer study." The countries of origin for the data are not specified beyond the locations of the manufacturers (San Diego, CA, USA for Phamatech; Cupertino, CA, USA for Behring EMIT II).
- Test Set Sample Size:
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Number of Experts and Qualifications:
- The document implies the use of "professional users" in the "clinical studies" and comparison to "SAMHSA certified laboratory" for confirmation. However, the specific number of experts involved in establishing ground truth for the test set and their qualifications are not explicitly stated.
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Adjudication Method:
- The document mentions "Correlation studies... when compared to the Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology." This suggests that the EMIT II and GC/MS results served as the reference or adjudicating methods, rather than a human consensus approach among the "professional users." No specific human adjudication method (e.g., 2+1, 3+1) is mentioned.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study is explicitly mentioned. The study focuses on comparing the device's performance to predicate devices and laboratory methods, and on consumer interpretation, not on how human readers' performance improves with or without AI assistance. The device itself is a qualitative immunoassay, not an AI-assisted diagnostic tool for human interpretation.
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Standalone Performance:
- Yes, a standalone performance was done. The entire performance section describes the results of the device (an immunoassay) detecting drugs/metabolites, both when compared to laboratory standards and when interpreted by consumers. This represents the algorithm's (immunoassay's) standalone performance.
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Type of Ground Truth Used:
- The ground truth for the "clinical sample correlation study" was established using Behring EMIT II and GC/MS methodology, which are highly regarded laboratory analytical methods.
- For the "blind labeled spiked study" and "clinical studies," the ground truth is implicitly the known spiked concentrations or the results from the EMIT II/GC/MS comparisons.
- For the "consumer study," the accuracy is reported against an assumed established ground truth, likely the EMIT II/GC/MS results or a confirmed positive/negative status.
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Training Set Sample Size:
- The document does not specify a separate "training set" sample size. As this is a rapid immunoassay, it typically doesn't involve a machine learning training phase in the same way an AI algorithm would. The development of such a test relies on chemical and biological design, optimization, and then validation studies (the "performance" section describes these validation studies, effectively the "test set" for regulatory purposes).
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Ground Truth for Training Set:
- Since a distinct "training set" for an AI algorithm is not applicable here, the concept of establishing ground truth for a training set in the AI sense is not relevant or described. The development of the immunoassay involves establishing its chemical and biological parameters to accurately detect the target analytes at the specified cut-off, which is a different process than "training" an AI model.
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