(330 days)
The Instant-View® Multi-Drug Urine Test Cup (Home Use) and Instant-View® Multi-Drug Urine Test Panel (Home Use) are rapid, qualitative immunoassays for the detection in human urine of one or more of the cutoff concentrations listed below. These devices will detect up to 13 of the drugs below in any combination. The tests are not intended to distinguish prescription use or abuse of any drugs.
These devices provide only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.
Tests for prescription drugs will yield preliminary positive results when these drugs are ingested at or above therapeutic doses. There are no uniformly recognized drug levels for prescription drugs in urine. This multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level.
The Instant View® Multi-Drug Urine Test Cup (Home Use) and the Instant View® Multi-Drug Urine Test Panel (Home Use) are one-step lateral flow chromatographic immunoassays. Each device consists of any combination of one to thirteen individual test strip(s) for the analyte(s) being tested. Each test strip in the device consists of 1) a conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a burgundy-colored band during the test regardless of the presence of the drug.
This document describes the performance characteristics and a lay-user study for the Instant-View® Multi-Drug Urine Test Cup (Home Use) and Instant-View® Multi-Drug Urine Test Panel (Home Use).
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Acceptance Criteria and Device Performance
The acceptance criteria for this device appear to be tied to the agreement rate of lay users' interpretations compared to GC/MS confirmed results. The performance is reported as the percentage of correctly interpreted results. The implicit acceptance criterion can be inferred from the overall results being "higher than 96%" on average for both device types when considering all concentrations, and 100% agreement at concentrations 150% and above, as well as 50% and below the cutoff. This suggests a high accuracy requirement for lay user interpretation.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state pre-defined acceptance criteria values in the form of thresholds (e.g., "must achieve >95% accuracy"). Instead, it presents the results of the study and concludes that "the participants were able to read the results correctly at an average of higher than 96%." Therefore, the reported performance is the demonstrated acceptance of the device's accuracy for lay users.
Given the phrasing and the detailed results, a simplified representation of the demonstrated performance can be derived:
| Drug Test | Cutoff (ng/ml) | Overall Average % Correct Interpretation (Cup) | Overall Average % Correct Interpretation (Panel) |
|---|---|---|---|
| Amphetamine (AMP) | 1000 | 99.25% | 99.5% |
| Barbiturates (BAR) | 200 | 99.5% | 99.25% |
| Buprenorphine (BUP) | 10 | 96.25% | 96.75% |
| Benzodiazepine (BZD) | 300 | 99.5% | 99.5% |
| Cocaine (COC) | 300 | 99.25% | 99.5% |
| Methamphetamine (MET) | 1000 | 99.5% | 99.5% |
| Methadone (MTD) | 300 | 99.5% | 99.5% |
| Phencyclidine (PCP) | 25 | 99.75% | 99.75% |
| Tricyclic Antidepressants (TCA) | 1000 | 99.75% | 99.75% |
| Marijuana (THC) | 50 | 99.5% | 99.5% |
| MDMA | 500 | 99.75% | 99.75% |
| Morphine/Opiate (MOR) | 2000 | 99.5% | 99.75% |
| Oxycodone (OXY) | 300 | 99.5% | 99.5% |
Implicit Acceptance Criteria:
- Average correct interpretation rate for lay users > 96% across all drugs and tested concentrations.
- 100% correct interpretation at concentrations 150% above and 50% below the cutoff. (This was achieved in the study based on the summary).
2. Sample Size and Data Provenance
- Sample Size for Test Set: 400 lay persons.
- Data Provenance: The study was performed at "three intended user sites." The document does not specify the country of origin but implies a domestic (US) setting given the FDA submission context. The study design is prospective, as it involved participants actively testing the devices with prepared blinded samples.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable in the context of this specific lay-user study's ground truth.
- Qualifications of Experts: Not applicable. The ground truth for the test set was established by analytical methods, not human expert consensus for interpretation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" for the urine samples (presence/absence and concentration of drugs) was established by GC/MS, which is an objective chemical analysis method, not a subjective interpretation requiring adjudication. Lay users then interpreted the device results, and their interpretations were compared to the GC/MS ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, this was not an MRMC comparative effectiveness study in the typical sense of evaluating human readers' performance with and without AI assistance for image interpretation. This was a direct evaluation of lay user interpretation of a rapid diagnostic test.
- Effect Size of Human Reader Improvement: Not applicable, as it was not an AI-assisted interpretation study.
6. Standalone Performance
- Standalone Performance: The study evaluates the human-device interaction for lay users. While the document mentions "analytical test result" and "chemical method" for confirmation, this specific lay-user study's performance data (the tables) represent the accuracy of the lay users' interpretation of the device results compared to the objective ground truth. The device itself (the immunochromatographic test) inherently provides a visual result that humans (lay users) then interpret. Thus, the performance described is the "human-in-the-loop" performance for the intended OTC use. The underlying analytical performance of the immunoassay itself is stated to be "the same as the predicate device," but the detailed performance data provided in the tables are for lay-user interpretation.
7. Type of Ground Truth Used
- Ground Truth: For the test set, the ground truth was established by Chromatography/Mass Spectrometry (GC/MS). The urine samples were "spiked with drugs into drug free-pooled urine specimens" at specific concentrations, and these concentrations were "confirmed by GC/MS."
8. Sample Size for the Training Set
- Training Set Sample Size: The document does not provide information about a separate "training set" in the context of "training" an algorithm or AI. This is a traditional diagnostic device validation, not an AI/ML product. The "training" for the device's development (e.g., optimizing immunoassay reagents) is not detailed in this submission summary.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no specific "training set" described for an AI/ML algorithm. The "training" that occurs is for the device's internal chemistry and design, which is not elaborated upon as distinct data sets for ground truth establishment.
Summary of the Study Design and Findings:
The study aimed to assess how accurately lay users could interpret the results of the Instant-View® Multi-Drug Urine Test Cup and Panel.
- Participants: 400 lay persons (210 female, 190 male), diverse in education, professional background, and age (18 to >60), with no prior OTC drug test experience.
- Methodology: Participants received package inserts, one test cup, and one test panel. Each participant tested two different blinded urine samples. The samples were prepared at various concentrations (0%, +/- 25%, +/- 50%) relative to the cutoff, and their true concentrations were confirmed by GC/MS.
- Results: The lay users achieved an average correct interpretation rate higher than 96% for both device formats, and 100% accuracy at concentrations 150% above and 50% below the cutoff.
- Conclusion: The study demonstrated that lay users could correctly interpret the device results with high accuracy, supporting the device's suitability for over-the-counter (home) use. The findings indicate effective labelling and ease of use, further supported by participant survey comments that the devices were "very easy to operate" and there were "no difficulties in interpreting the results." The package inserts also had a Flesch-Kincaid reading grade level of 7, indicating appropriate readability for a general audience.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).