(14 days)
A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: methamphetamine
Immunoassay for the qualitative detection of methamphetamine in urine
Here's an analysis of the provided text regarding the "At Home Drug Test (Model 9068)" and its acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Methamphetamine) |
|---|---|
| High correlation with laboratory methods (EMIT II, GC/MS) | >98% correlation |
| High overall accuracy with professional users | >97% overall accuracy |
| High overall accuracy with lay users (consumers) | 96.65% overall accuracy |
| High accuracy for methamphetamine detection with lay users | 96.4% accuracy |
Note: The document describes performance rather than explicit pre-defined "acceptance criteria" in a quantitative sense. The reported performance demonstrates that the device meets an implied standard of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Sample Correlation Study: The text mentions "Correlation studies, using clinical specimens," but does not specify the exact sample size for this part.
- Clinical Studies (Professional Users): "Clinical studies, performed at two independent laboratories," were conducted, but the sample size is not explicitly stated.
- Consumer Study (Lay Users):
- Total Samples (all drugs): 4715 samples (resulting in 4557 correct interpretations).
- Methamphetamine Specific Samples: 444 samples (resulting in 428 correct interpretations).
- Data Provenance: The studies used "clinical specimens," suggesting prospective or retrospective collection from a clinical setting. The country of origin is not explicitly stated, but Phamatech's location is San Diego, California, USA, implying the studies likely took place in the USA. The "blind labeled spiked study" also suggests controlled experimental conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Clinical Sample Correlation Study: Ground truth was established using "Behring EMIT II... and GC/MS methodology." These are laboratory-based, objective analytical methods, not human experts in the typical sense of interpretation.
- Clinical Studies (Professional Users): The phrase "professional users" implies these individuals were qualified to perform and interpret drug tests, likely laboratory technicians or other trained healthcare professionals. The number of such professionals is not specified.
- Consumer Study: The ground truth for this study was presumably established by the "professional users" or the laboratory methods before the consumer interpretation. No specific number of experts or their qualifications are provided for setting up the ground truth for the consumer comparisons.
4. Adjudication Method for the Test Set
- For the correlation studies and professional user studies, the "Behring EMIT II and GC/MS methodology" served as the reference standard, essentially acting as the "adjudicator."
- For the consumer study, the "correct" results against which consumers were compared would have been determined by the professional users or the laboratory methods. No explicit adjudication process between multiple human interpreters is described beyond the comparison to a gold standard.
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?
This document describes a diagnostic device (an immunoassay drug test), not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not applicable and was not conducted. The "consumer study" evaluates the lay user's ability to interpret the test independently, rather than their improvement with an AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The "At Home Drug Test" itself is a standalone device in that it produces a result without further human intervention during the chemical reaction. However, the interpretation of the visual color change does require human observation.
- The "correlation studies" using EMIT II and GC/MS essentially provide a "standalone" or objective performance measure of the test's chemical reactions against a gold standard.
- The "professional users" study also represents the device's performance in trained hands, akin to its standalone diagnostic capability when properly used.
7. The Type of Ground Truth Used
- Laboratory Reference Methods: Behring EMIT II (an immunoassay) and Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is widely considered the "gold standard" for confirmatory drug testing due to its high specificity and sensitivity.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. The device is an immunoassay, which relies on chemical principles, not a trained algorithm. The studies described are performance validation studies, not studies related to model training.
9. How the Ground Truth for the Training Set Was Established
As there's no mention of a "training set" for an algorithm, this question is not applicable. The underlying chemical principles of the immunoassay are inherent to its design, not learned from data.
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).