(220 days)
Instant-View Methamphetamine Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect methamphetamine in human urine at a cutoff level of 500 ng/ml. It is intended for health care professional use only.
The US Substance Abuse and Mental Health Services Administration (SAMHSA) recommends the screening levels for Methamphetamine to be at a concentration of 1000 ng/ml.
This test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Professional judgment should be applied to any drug of abuse, consideration and positive results are used.
This test is a one-step lateral flow chromatographic immunoassay.
Here's an analysis of the provided information regarding the Instant-View™ Methamphetamine Urine Cassette Test, structured to address your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to a legally marketed predicate device (QuikStrip One Step Methamphetamine Test, K970395). The summary does not explicitly state pre-defined acceptance criteria values in a formal table; instead, it reports performance findings that are deemed sufficient to establish substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| High correlation with analytical results (likely referring to the predicate or a confirmatory method like GC/MS) | "The correlation of results from the Instant-View™ Methamphetamine Urine Cassette Test, is higher than 97.5 %." |
| High agreement across different testing sites (e.g., POLs) | "The results from all three POL sites agreed 98.3 %." |
| High accuracy in clinical laboratory settings (with diverse users) | "The Accuracy Evaluation results from the Clinical Laboratory conducted by persons with diverse educational background and working experiences agreed 95.2% with the expected results." |
| Substantial equivalence to the predicate device for intended use and technological characteristics | Concluded as "substantially equivalent to the existing legally marketed device." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the total number of samples used in the "correlation of results," "POL sites agreement," or "Accuracy Evaluation" studies.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It mentions "all three POL sites" (Physician Office Laboratories) and a "Clinical Laboratory," suggesting clinical data, but further details are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: The document mentions the "Clinical Laboratory conducted by persons with diverse educational background and working experiences." This is a general statement and does not specify the qualifications of experts establishing ground truth or interpreting results, beyond indicating that varying levels of expertise were involved in using the device. For establishing ground truth, it implies the expected results were determined by a reliable method, but the personnel involved are not detailed.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set results. The agreement percentages suggest comparisons to an expected result or between different readers/sites, but the method of resolving discrepancies is not detailed.
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 device is an immunoassay test kit, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted. There is no AI component.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Again, this is a diagnostic test kit, not an algorithm. The "standalone" performance would typically refer to the device's ability to produce a result without human interpretation of complex images or data. In this context, the device itself provides a visual result (line appearance), which is then interpreted by a human. The "correlation of results," "POL sites agreement," and "Accuracy Evaluation" could be considered indicators of its "standalone" performance in terms of generating the correct biochemical signal.
7. The Type of Ground Truth Used
The document implies the use of an "expected result" for the "Accuracy Evaluation" and a reference method for "correlation of results" and "POL sites agreement." Given the nature of a drug test, the ground truth would likely be established by a highly sensitive and specific confirmatory method, such as Gas Chromatography/Mass Spectrophotometry (GC/MS), which is explicitly mentioned as the "preferred confirmatory method" in the Indications for Use section (though not explicitly stated as the ground truth for the studies themselves, it's highly implied for drug testing validation).
8. The Sample Size for the Training Set
This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It's a lateral flow immunoassay. Its development would involve chemical optimization and validation, not algorithmic training on a dataset. Therefore, the concept of a training set sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" for this type of device. The ground truth for the validation or performance evaluation of the immunoassay, if it involved external comparison, would likely be established via a gold standard laboratory method like GC/MS.
§ 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).