(52 days)
A home drug screening, and if needed, confirmation service. This kit provides a / chome arage coroening, and intion/presence of the following drugs of abuse in urine: Opiates.
Immunoassay for the qualitative detection of opiates in urine.
Here's an analysis of the provided text regarding the "At Home Drug Test (Model 9084)":
Acceptance Criteria and Device Performance Study for At Home Drug Test (Model 9084)
The "At Home Drug Test (Model 9084)" is an immunoassay for the qualitative detection of opiates in urine, intended for home use to assist in preventing drug abuse, with a mechanism for anonymous confirmation testing at a SAMHSA certified laboratory.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for sensitivity, specificity, or accuracy that the device had to meet. Instead, it describes performance relative to predicate devices and established laboratory methods. The reported performance suggests that the implied acceptance criteria were likely based on demonstrating high correlation and overall accuracy comparable to these established methods and devices.
| Metric | Acceptance Criteria (Implied/Relative) | Reported Device Performance |
|---|---|---|
| Opiates Cut-off | N/A (Defined as a test parameter) | 300 ng/ml |
| Correlation | Substantially equivalent to Behring EMIT II and GC/MS | >99% correlation when compared to Behring EMIT II and GC/MS methodology (using clinical specimens) |
| Overall Accuracy | Excellent, comparable to commercially available tests (professional use) | >98% overall accuracy (in the hands of professional users) |
| Overall Accuracy | Excellent (consumer use) | Excellent overall accuracy; 97.3% accuracy for cocaine (Note: This specific data point is for cocaine, not opiates, but cited as example of consumer study. General "excellent overall accuracy" implied for opiates in consumer use.) |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not explicitly state the exact sample size for the clinical sample correlation study or the blind-labeled spiked study. It mentions "clinical specimens" and "clinical studies." For the consumer study, it provides a specific number for a cocaine test: 943 (918/943 or 97.3%).
- Data Provenance: The studies were performed at "two independent laboratories" and involved "clinical specimens." The manufacturer is based in San Diego, California, USA, suggesting the studies likely took place in the USA, although this is not explicitly stated. The studies were retrospective or prospective is not specified.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number or qualifications of experts used to establish the ground truth. It mentions that clinical studies were performed at "two independent laboratories" and that expert methods like "Behring EMIT II" and "GC/MS methodology" were used as comparators for ground truth. These are established laboratory techniques, implying that the personnel operating them would be qualified laboratory professionals, but no specific details are provided.
4. Adjudication Method
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The ground truth appears to be established by comparison with standard laboratory methods (Behring EMIT II and GC/MS) rather than a consensus of human reviewers for each case.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. The studies focus on the standalone performance of the device against established laboratory methods and, in a separate consumer study, its accuracy when interpreted by lay users. There is no information about human readers improving with or without AI assistance, as this is a non-AI, immunoassay-based drug test.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
Yes, a standalone performance study was done. The "product performance characteristics... were evaluated in a clinical sample correlation study and a blind labeled spiked study." The results (e.g., >99% correlation and >98% accuracy) reflect the device's performance when used by professionals, likely in a controlled setting, and its direct comparison to "Behring EMIT II and GC/MS methodology"—these are all measures of standalone performance. The consumer study also measures standalone performance when interpreted by lay users.
7. Type of Ground Truth Used
The primary ground truth used was established laboratory methods:
- Behring EMIT II: A widely accepted immunoassay for drug screening.
- GC/MS (Gas Chromatography-Mass Spectrometry): Considered a gold standard for drug confirmation due to its high specificity and sensitivity.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of an algorithm or machine learning. This is a conventional immunoassay, not an AI or machine learning device. Therefore, a training set in that sense is not applicable. The "clinical specimens" and "spiked samples" used in the performance evaluation serve as the data for validating the device's accuracy.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" in the context of machine learning, this question is not directly applicable. For the performance evaluation, the ground truth was established by the established laboratory methods: Behring EMIT II and GC/MS methodology. These methods are themselves highly reliable and considered accurate for detecting opiates.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).