(55 days)
A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of methamphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.
Immunoassay for the Qualitative Detection of Methamphetamine in Urine. The QuickScreenTM One Step Methamphetamine Test utilizes colloidal gold as the label like other commercially available immunoassays for drug of abuse (methamphetamine) test kits, to qualitatively measure the presence of methamphetamine by visual color sandwich one step immunoassay technology.
The provided document describes the "QuickScreen™ One Step Methamphetamine Test," an immunoassay for the qualitative detection of methamphetamine in urine.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity, specificity, and accuracy thresholds that the device must meet. Instead, it compares the device's performance to commercially available predicate devices.
| Performance Metric | Reported Device Performance (QuickScreen™) | Comparison to Predicate (Syva EMIT II) |
|---|---|---|
| Sensitivity | >95% | Substantially equivalent |
| Specificity | >99% | Substantially equivalent |
| Accuracy | >97% | Substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "Correlation studies, using clinical specimens, produced a sensitivity of >95%, specificity of >99% and accuracy >97%". While the exact total number of specimens isn't provided for these correlation studies, a subsequent statement notes: "Two clinical laboratory studies were performed, the Phamatech QuickScreen™ exhibited excellent sensitivity (84/86), specificity (39/39), and accuracy (123/125)." This indicates a total of 125 clinical specimens were collectively used across these two laboratory studies.
- Data Provenance: The studies used clinical specimens, implying a real-world, retrospective or prospective collection from individuals. The sites of clinical testing were Poison Laboratories, San Diego, CA, and Quest Diagnostics Incorporated, San Diego, CA, suggesting data from the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts used to establish the ground truth. It states the performance was compared to the Syva EMIT II, which served as the reference method or "ground truth" for the clinical correlation studies. The "excellent sensitivity (84/86), specificity (39/39), and accuracy (123/125) in the hands of professional laboratory technicians" suggests experienced laboratory personnel operated the QuickScreen test, but it doesn't describe who established the ground truth for those 125 samples independent of the predicate method.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. The comparison was made against a predicate device (Syva EMIT II), which implies the results from the predicate device constituted the ground truth for comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes a standalone performance evaluation against a predicate device and does not involve human readers as a variable or assessment of their improvement with AI assistance (as this is not an AI-assisted device).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The QuickScreen™ One Step Methamphetamine Test is a qualitative immunoassay, and its performance was evaluated by directly comparing its results to those of the predicate device (Syva EMIT II) using clinical specimens. The reported sensitivity, specificity, and accuracy refer to the device's performance directly.
7. The Type of Ground Truth Used
The primary ground truth used for the correlation studies was the results obtained from the Syva EMIT II, another commercially available immunoassay for methamphetamine detection, which served as the reference method.
8. The Sample Size for the Training Set
The document does not mention a separate "training set" or "training data." As this is a traditional immunoassay, not an AI/machine learning algorithm, the concept of a training set as understood in AI development is not applicable. The device's design and calibration would have been established during its development, but this information is not detailed here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/machine learning model. For traditional immunoassays, development typically involves optimizing reagents and conditions against known positive and negative samples, but this is not a "ground truth for a training set" in the context of AI.
§ 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).