(52 days)
A home drug screening, and if needed, confirmation service. This kit provides a rapid, qualitative immunoassay for the detection of the following drugs of abuse in urine: Cocaine.
Immunoassay for the qualitative detection of benzoylecgonine in urine. 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: cocaine; 300 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. The At Home Drug Test, like many commercially available drug screening test kits, qualitatively measures the presence of target drug and metabolites by visual color sandwich one step immunoassay technology.
This document describes the regulatory submission for the At Home Drug Test (Model 9074) by Phamatech, an immunoassay for the qualitative detection of benzoylecgonine (cocaine metabolite) in urine.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "correlation" and "accuracy" thresholds achieved in the studies. Given the context of a 510(k) submission, the implicit acceptance criterion is "substantial equivalence" to a predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Professional Use | >95% Accuracy | >98% overall accuracy |
| Clinical Specimen Correlation | >95% Correlation | >99% correlation with Behring EMIT II and GC/MS |
| Consumer Use Accuracy | >95% Accuracy | 97.2% (917/943) |
2. Sample Sizes Used for the Test Set and Data Provenance
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Clinical Sample Correlation Study: The text does not explicitly state the sample size for this study. It mentions using "clinical specimens."
- Data Provenance: Not explicitly stated, but "clinical specimens" suggest a real-world origin, likely retrospective from patients. The study was performed at "two independent laboratories."
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Blind Labeled Spiked Study: The text does not explicitly state the sample size for this study.
- Data Provenance: This is a prospective study where samples are "spiked" with known concentrations of the analyte.
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Consumer Study:
- Sample Size: 943 cases (implied by 917/943 accurate interpretations).
- Data Provenance: Prospective, as it involved consumer interpretation of the test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
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Clinical Sample Correlation Study:
- Number of Experts: Not explicitly stated. The comparison was against "Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology." GC/MS is a highly accurate laboratory method, implying a high level of expertise in running and interpreting these sophisticated tests. The reference to "two independent laboratories" performing clinical studies suggests multiple professional users/experts were involved.
- Qualifications: "Professional users" are mentioned, implying trained laboratory personnel or clinical staff experienced with drug testing, GC/MS, and EMIT II assays. Specific qualifications (e.g., years of experience, specific certifications) are not provided.
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Blind Labeled Spiked Study:
- Number of Experts: Not explicitly stated, but the performance was evaluated in "professional users," similar to the clinical study.
- Qualifications: As above, "professional users" would be experienced laboratory personnel.
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Consumer Study: Ground truth for this study was likely established by the manufacturer, comparing consumer results to the expected result of the spiked or clinical samples. No "experts" were used to establish ground truth for the consumer interpretation itself, but rather to establish the "true" status of the samples given to consumers.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The performance is reported based on direct comparison with established methods (Behring EMIT II, GC/MS) for professional use, and consumer interpretation compared to a known result.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study for human readers with/without AI assistance was not done. This device is a standalone diagnostic test, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the primary performance studies ("Clinical sample correlation study" and "Blind labeled spiked study" for professional users) represent the standalone performance of the device when used by trained professionals. The consumer study evaluates its standalone performance in the hands of lay users.
7. The Type of Ground Truth Used
- Clinical Sample Correlation Study: The ground truth was established by comparison with a predicate device (Behring EMIT II) and a gold standard laboratory method (GC/MS methodology).
- Blind Labeled Spiked Study: The ground truth was established by known concentrations of the target analyte (cocaine) spiked into urine samples.
- Consumer Study: The ground truth was established by the known status of the samples provided to consumers (based on spiking or professional lab results).
8. The Sample Size for the Training Set
The document does not provide any information about a training set. This is an immunoassay (a chemical test), not a machine learning or AI-based device that typically requires a training set. The "studies" described are performance validation studies, not algorithm training.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set or an algorithm that requires training, this question is not applicable to the provided text.
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