(84 days)
The Redi-Test Methamphetamine is a qualitative, one step immunochromatographic competitive assay used to screen human urine for the presence of d, methamphetamine at a cutoff concentration of 1000ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
The Redi-Test Methamphelamine is an immunochromatographic based one step in vitro lest.
The provided text describes a 510(k) summary for the "Redi-Test Methamphetamine" device, comparing it to a predicate device, the "DRI Amphetamine Enzyme Immunoassay." The study is a comparative one to demonstrate substantial equivalence, rather than a standalone performance study against a predefined acceptance criterion.
Here's the information broken down:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and the desired level of agreement. The study does not explicitly state pre-defined acceptance criteria in terms of sensitivity or specificity independently. Instead, it aims for substantial equivalence, which is demonstrated by a high agreement percentage with the predicate device.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Redi-Test Methamphetamine vs. DRI Amphetamine EIA) |
|---|---|---|
| Overall Agreement | High agreement with predicate device (DRI Amphetamine Enzyme Immunoassay) | 94% |
| Discrepancy Analysis | Discrepancies to be understood and justifiable | 5 samples positive by DRI EIA, negative by Redi-Test, GC/MS between 300-800ng/mL. |
| 1 sample negative by DRI EIA, positive by Redi-Test, GC/MS at 1100ng/mL. | ||
| Cut-off Sensitivity | Equivalent to predicate device | 1000ng/mL (same as DRI EIA) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 102 specimens
- 45 negative for methamphetamine
- 57 positive for methamphetamine
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study involves "specimens" which typically refers to real-world samples, but the collection method (retrospective or prospective) is not defined.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for the discrepancies appears to have been established using an alternate methodology, GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold standard for confirming drug presence and concentration. This does not involve human experts in the sense of adjudication for interpretation, but rather a definitive analytical test.
4. Adjudication Method for the Test Set
Not applicable. The "adjudication" for discrepant samples was performed by an objective analytical method (GC/MS), rather than human expert consensus.
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
Not applicable. This study is for an in-vitro diagnostic (IVD) device (a chemical test kit) and does not involve human readers or AI in its diagnostic process.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a way, the study evaluates the "standalone" performance of the Redi-Test Methamphetamine device by comparing its results directly to another IVD device (DRI Amphetamine Enzyme Immunoassay) and then using GC/MS for validation of discrepant results. It's a "device-only" performance assessment.
7. The Type of Ground Truth Used
- For demonstrating substantial equivalence: The predicate device, the "DRI Amphetamine Enzyme Immunoassay," served as a primary reference for comparison.
- For resolving discrepancies/validation: GC/MS (Gas Chromatography/Mass Spectrometry) was used as the definitive analytical method to determine the actual methamphetamine levels in discrepant samples.
8. The Sample Size for the Training Set
Not applicable. This is an immunochromatographic test kit, which is a chemical assay, not a machine learning or AI-based device that requires a training set. The device itself is "trained" during its manufacturing and quality control processes.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The performance characteristics are inherent to the chemistry and design of the immunochromatographic assay.
§ 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).