(230 days)
Instant-View Methamphetamine Urine Dip Strip 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) recommen 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. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.
This test is a one-step lateral flow chromatographic immunoassay.
Here's a breakdown of the acceptance criteria and study information for the Instant-View™ Methamphetamine Urine Dip Strip Test, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Threshold) | Reported Device Performance |
|---|---|---|
| Correlation with Predicate Device | Not explicitly stated as a numerical 'acceptance criteria', but implied to be high for regulatory approval. | > 97.9% correlation with the legally marketed predicate device (QuikStrip One Step Methamphetamine Test). |
| Agreement across POL Sites | Not explicitly stated as a numerical 'acceptance criteria', but implied to be high for regulatory approval. | 99.2% agreement among the three Physician's Office Laboratory (POL) sites. |
| Accuracy (Clinical Laboratory & POL) | Not explicitly stated as a numerical 'acceptance criteria', but implied to be high for regulatory approval. | 95.2% agreement with expected results from the Clinical Laboratory and three Physician's Offices. |
Note on "Acceptance Criteria": The document doesn't explicitly list numerical acceptance criteria in the format "The device must achieve X%." Instead, it presents the reported performance directly, implying that these results were deemed acceptable for regulatory clearance.
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated in the provided text. The document mentions "results from the Instant-View™ Methamphetamine Urine Dip Strip Test" and "results from the three POL sites" and "Accuracy evaluation results from Clinical Laboratory and the three Physician's Offices," but the number of actual samples tested is not given.
- Data Provenance: The study was conducted for regulatory purposes in the USA implicitly, as it's a 510(k) submission to the FDA. It appears to be a prospective study as it involves evaluation of a new device against a predicate and "expected results."
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not explicitly stated. The document mentions "persons with diverse educational backgrounds and working experience" for the Accuracy evaluation, but it doesn't specify how many individuals contributed to establishing the ground truth reference values for the samples used in the study.
- Qualifications of Experts: Described generally as "persons with diverse educational backgrounds and working experience." No specific qualifications like "radiologist with 10 years of experience" are provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It discusses "agreement" between sites and with "expected results," suggesting that a reference method or pre-determined values were used as a comparative standard rather than a consensus among multiple human readers of the test results themselves.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study typically assesses the improvement in human reader performance (e.g., diagnostic accuracy) when assisted by an AI device compared to without AI assistance. The Instant-View™ Methamphetamine Urine Dip Strip Test is a diagnostic test kit itself, not an AI-powered image analysis tool or decision support system for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, a standalone performance evaluation was conducted. The product itself, the "Instant-View™ Methamphetamine Urine Dip Strip Test," is a standalone diagnostic device. Its performance metrics (correlation, agreement, accuracy) were assessed directly, without an explicit "human-in-the-loop" component for interpreting the test's visual results in the context of the study's performance evaluation (though the test is intended for use by healthcare professionals who will read the visual result). The "accuracy" and "correlation" figures reported directly relate to the device's output.
7. Type of Ground Truth Used
The ground truth appears to be established by comparison with:
- Legally marketed predicate device: "QuikStrip One Step Methamphetamine Test" for the correlation study.
- "Expected results": For the Accuracy evaluation from the Clinical Laboratory and Physician's Offices, implying either a gold standard laboratory method (like GC/MS, which is mentioned as the preferred confirmatory method) or pre-determined reference values were used to define the true positive/negative status of samples.
8. Sample Size for the Training Set
The document does not mention a "training set" or its sample size. This is a point-of-care immunoassay device, not a machine learning or AI-driven system that typically requires a training set. The development process would likely involve various stages of assay optimization and internal validation rather than a distinct "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set was Established
As no training set is discussed or implied for an AI/ML context, this question is not applicable based on the provided text. The "training" of such a device is through biochemical and engineering design, not data-driven machine learning.
§ 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).