(52 days)
A home drug screening, and if needed, confirmation service. This kit provides a rapid, qualitative immunoassay for the detection/presence of the following drugs of abuse in urine: Amphetamines.
Immunoassay for the qualitative detection of Amphetamines in urine. 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.
Here's an analysis of the provided text, outlining the acceptance criteria and the study that supports the device's performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Correlation to Predicate Device (Behring EMIT II) & GC/MS (Clinical Specimens) | >99% correlation | >99% correlation |
| Overall Accuracy (Professional Users, Clinical Studies) | >98% accuracy | >98% accuracy |
| Overall Accuracy (Consumer Users, Amphetamine Test Interpretation) | Not explicitly stated, but likely high accuracy. | 917/943 or 97.2% accuracy |
Note: The acceptance criteria are "implicit" because the document states that the device is "substantially equivalent to the reported performance characteristics of other commercially available tests," and then immediately provides the performed results as if they met this standard. The specific numerical targets for "acceptance" are not explicitly called out as such but are implied by the results presented.
2. Sample Sizes and Data Provenance
- Clinical Sample Correlation Study: The exact sample size is not specified, only referred to as "clinical specimens." The provenance is not explicitly stated, but the reference to "two independent laboratories" performing clinical studies suggests multiple sites, likely within the USA given the manufacturer's and FDA's location. The study was retrospective, comparing the device to established methods.
- Blind Labeled Spiked Study: Sample size and provenance are not specified.
- Consumer Study: The sample size for the Amphetamine test interpretation was 943 (917/943 accurate interpretations). Provenance is not stated but suggests a US consumer population.
3. Number of Experts and Qualifications for Ground Truth for the Test Set
- No specific number of experts is provided for the clinical sample correlation study or the blind labeled spiked study.
- The "professional users" in the clinical studies are implied to be experts, but their specific qualifications (e.g., medical technologists, toxicologists) are not detailed.
- For the consumer study, the "experts" were the analytical methods (Behring EMIT II and GC/MS) that established the true presence or absence of amphetamines, not human interpreters of the device itself.
4. Adjudication Method for the Test Set
- No specific adjudication method is mentioned. The comparison was made against a "gold standard" (Behring EMIT II and GC/MS), implying direct comparison rather than an adjudication process between conflicting device results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was explicitly described. The studies focused on device performance in isolation and consumer interpretation of results, not on how human readers' performance might improve with or without AI assistance. This device is not AI-driven; it's a qualitative immunoassay for home use.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was done. The entire performance section describes the device's (an immunoassay, not an algorithm) standalone performance, both in "clinical sample correlation" and "blind labeled spiked" studies. The "consumer study" also assessed the device's standalone performance in the hands of lay users.
7. Type of Ground Truth Used
- Analytical Gold Standards: For the clinical sample correlation study, the ground truth was established by:
- Behring EMIT II: A commercially available immunoassay considered a predicate device.
- GC/MS (Gas Chromatography/Mass Spectrometry): A highly accurate and sensitive laboratory confirmatory method, often considered a "gold standard" for drug testing.
- For the consumer study, the ground truth was also based on these analytical methods, against which consumer interpretations were compared.
8. Sample Size for the Training Set
- Not applicable / Not provided. As a rapid, qualitative immunoassay, this device does not utilize a "training set" in the context of machine learning or AI models. Its performance is based on the chemical and immunological properties of the test components, which are designed and validated through laboratory testing, not trained on data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not provided. As mentioned above, there is no "training set" for this type of immunoassay device. The "ground truth" for its development and validation would involve controlled laboratory experiments using known concentrations of analytes and interferents, established through certified reference materials and analytical chemistry techniques.
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