(74 days)
Simultaneous qualitative visual tests for five (5) drugs of abuse: Cocaine, Morphine, Cannabinoids, Methamphetamine and Phencyclidine and their metabolites in urine sample.
The Visualine® V Drugs of Abuse Dipstrip Panel test is based on the principle of antigen-antibody complexation and is used for the analysis of Cocaine, Cannabinoids, Morphine, Methamphetamine, and Phencyclidine and their corresponding metabolites in human urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered through a wicking action as the panel (holding the porous membrane) is dipped into the urine sample. The drug in the sample compeics for the limited antibody sites on the colored microspheres. When an adequate amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored microspheres to the probe site on the membrane. Therefore, a positive urine sample will inhibit the formation of precipitin at the probe site.
The information discusses the Visualine®V Drugs of Abuse Dipstrip Panel for qualitative determination of several drugs and their metabolites in human urine.
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1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a target value set before the study. Instead, it presents the results of a correlation study with a legally marketed predicate device (Hitachi 717) as evidence of performance. The performance metrics presented are Sensitivity, Specificity, and Efficiency.
| Drug / Performance Metric | Reported Device Performance (Visualine®V Dipstrip Panel) |
|---|---|
| Cocaine: | |
| Sensitivity | 98 % (49 / 50) |
| Specificity | >99 % (247 / 247) |
| Efficiency | >99 % (296 / 297) |
| Cannabinoids: | |
| Sensitivity | >99 % (50 / 50) |
| Specificity | >99 % (253 / 253) |
| Efficiency | >99 % (303 / 303) |
| Morphine: | |
| Sensitivity | >99 % (50 / 50) |
| Specificity | >99 % (257 / 257) |
| Efficiency | >99 % (307 / 307) |
| Methamphetamine: | |
| Sensitivity | >99 % (50 / 50) |
| Specificity | >99 % (255 / 255) |
| Efficiency | >99 % (305 / 305) |
| Phencyclidine: | |
| Sensitivity | >99 % (50 / 50) |
| Specificity | >99 % (255 / 255) |
| Efficiency | >99 % (305 / 305) |
Reproducibility (Precision) studies also reported:
- Within run and run to run: > 99 %
- Within day and day to day: > 99 %
- Within lot and lot to lot: > 99 %
2. Sample Size Used for the Test Set and Data Provenance
The test set consisted of:
- Presumptive positive samples: 50 for each drug (Cocaine, Cannabinoids, Morphine, Methamphetamine, Phencyclidine). These were initially tested on the Hitachi 717.
- Negative samples:
- Cocaine: 247
- Cannabinoids: 253
- Morphine: 257
- Methamphetamine: 255
- Phencyclidine: 255
These negative samples came from UTAK Laboratories Drug Free Urine pool, Lot# 2647, and in-house negative urines (tested with Sun Biomedical's Visualine® II product).
Data Provenance: The correlation studies were conducted at Redwood Toxicology Laboratory, Santa Rosa, California, and Sun Biomedical Laboratories. The samples used were a mix of presumptive positive samples provided by Redwood (implying patient samples) and defined negative urine pools. This suggests a retrospective collection of samples for the positive cases and a controlled source for the negative cases. The country of origin is implicitly the USA (California).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the number or qualifications of experts used to establish a ground truth.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method with multiple readers. The "ground truth" for the correlation study relies on the results from the Hitachi 717 instrument using Diagnostic Reagents, Inc. material, which is treated as the reference method.
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 is not applicable. The device is a "Dipstrip Panel" presenting a visual color comparison. It is an in-vitro diagnostic device, not an AI-powered image analysis tool or decision support system that would involve human readers making interpretations of complex data with or without AI assistance. The performance is based on the device's ability to detect substances, not on human interpretation of its results changing with AI.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, this was a standalone performance evaluation. The Visualine®V Dipstrip Panel is described as a "visual color precipitin formation" detection method. The study involved "blinded studies" where the Visualine®V panel results were compared to the reference Hitachi 717 results. This implies the dipstrip panel was read and its results were correlated directly with the established results without human intervention or interpretation that would alter the device's inherent performance.
7. The Type of Ground Truth Used
The ground truth used for the correlation study was based on the results from the Hitachi 717 instrument using Diagnostic Reagents, Inc. EIA (Enzyme Immunoassay) individual assays. This legally marketed predicate device served as the reference standard. For negative samples, established drug-free urine pools were used.
8. The Sample Size for the Training Set
The document does not specify a training set sample size. This is common for in-vitro diagnostic devices built on established chemical or immunological principles, where "training" in the machine learning sense is not applicable. The device's performance is determined by its design and chemical reactions, not by being "trained" on data.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned (see point 8), this question is not applicable. The device operates based on a competitive immunochromatographic technique.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).