(15 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: THC
Immunoassay for the qualitative detection of THC in urine. The At Home Drug Test is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentration for this test is as follows: THC (or marijuana): 50 ng/ml. This assay is intended for use in the home to assist in the prevention of drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a certified laboratory. The At Home Drug Test, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology.
Here's a breakdown of the acceptance criteria and study information for the At Home Drug Test (Model 9078), based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Goal) | Reported Device Performance (THC) |
|---|---|
| Qualitative detection of THC in urine at 50 ng/ml cut-off. | 97.0% accuracy (consumer study) |
| Overall accuracy in hands of professional users (for target drugs) | >97% overall accuracy |
| Substantially equivalent to predicate devices | >98% correlation to Behring EMIT II and GC/MS (clinical correlation studies) |
Notes on Acceptance Criteria:
- The document implies that "substantial equivalence" to existing, legally marketed predicate devices in terms of performance (accuracy, correlation) is the primary acceptance criterion.
- Specific numerical thresholds for acceptance (e.g., "must achieve X% accuracy") are not explicitly stated, but are demonstrated through high correlation and accuracy figures.
2. Sample Sizes Used for the Test Set and Data Provenance:
- Clinical Sample Correlation Study: Not explicitly stated, but produced a >98% correlation.
- Clinical Studies (Professional Users): Not explicitly stated. Performed at two independent laboratories. Data provenance is not explicitly mentioned but implies clinical settings.
- Consumer Study:
- Overall Accuracy: 4715 total interpretations for all target drugs (4557 correct).
- THC Accuracy (Component of Consumer Study): 943 interpretations (915 correct).
- Data Provenance: Retrospective, as it describes a completed study. The country of origin isn't specified, but given the manufacturer's location (San Diego, California, USA) and FDA submission, it's highly likely to be the USA.
3. Number of Experts and Qualifications for Ground Truth for the Test Set:
- Clinical Sample Correlation Study: The "Behring EMIT II" and "GC/MS methodology" are considered the reference methods for establishing ground truth. These are laboratory-based, objective tests, not relying on human expert interpretation for individual results.
- Clinical Studies (Professional Users): "Professional users" are mentioned, but their exact qualifications or how many were involved in establishing ground truth (vs. performing the test) are not specified. Given the context of a drug test, qualified laboratory personnel or medical professionals would establish ground truth using reference methods.
- Consumer Study: The ground truth for this study would have been established by comparing the lay user's interpretation to results from a definitive lab method (like GC/MS or EMIT II) on the same urine samples. The number of experts involved in determining this ground truth for the consumer study is not provided, but it would involve laboratory technicians or chemists operating the reference methods.
4. Adjudication Method for the Test Set:
- Not explicitly stated as a separate process. The ground truth appears to be established by comparison to reference methods (Behring EMIT II and GC/MS), which are objective and do not typically require multi-expert adjudication in the same way, for example, image interpretation might. The results of the device are compared directly to these established reference results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study described. The document focuses on the standalone performance of the device and its correlation with laboratory methods. It does not evaluate how human readers (interpreting the device) improve with AI assistance, as this is a simple visual immunoassay test, not an AI-powered diagnostic.
6. Standalone (Algorithm Only) Performance:
- Yes, standalone performance was done. The entire study describes the performance of the "At Home Drug Test (Model 9078)" as a standalone device. Its results are compared to established reference methods (EMIT II, GC/MS) and its accuracy is reported independently.
7. Type of Ground Truth Used:
- Laboratory Reference Methods: The primary ground truth for the clinical studies was established using:
- Behring EMIT II: An immunoassay for drug detection.
- GC/MS (Gas Chromatography/Mass Spectrometry): A highly accurate and definitive method for identifying and quantifying substances in a sample, often considered the "gold standard" for drug testing.
8. Sample Size for the Training Set:
- Not explicitly mentioned. As this is an immunoassay device (visual color sandwich one-step technology) and not an AI/machine learning model that undergoes "training," the concept of a training set in that context does not apply. The device's performance is determined by its inherent chemical and biological properties, not by a trained algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8 above. Immunoassays are developed based on established biochemical principles and validated against known concentrations of analytes, rather than being "trained" with ground truth data in the way an AI algorithm would be.
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).