(94 days)
The UCP Home Drug Screening Test Cards and UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the following drugs and their metabolites in human urine: Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiate 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressant. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users. The tests only provide 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 spectrometry (GC/MS) is the preferred confirmatory method for most drugs (HPLC is the preferred confirmatory method for Tri-cyclic Antidepressants). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.
UCP Home Drug Screening Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates. Benzodiapines. Cocaines. Marijuana. Methamphetamine. MDMA. Opiates, Morphine, Oxycodone, Phencyclic Antidepressants and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument. The tests contain two formats: 1) Test Card; 2) Test Cup. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to the agreement rate with confirmatory laboratory methods, as the device provides preliminary results. The reported performance focuses on the ability of lay users to obtain results that agree with these reference methods.
| Drug Type | Cut-off Level (ng/mL) | Acceptance Criteria (Implicit) | Reported Device Performance (Agreement Rate with GC/MS or HPLC) |
|---|---|---|---|
| Marijuana | 50 | High agreement with reference | 96.7% or above |
| Cocaine | 300 | High agreement with reference | 96.7% or above |
| Amphetamine | 1000 | High agreement with reference | 96.7% or above |
| Methamphetamine | 1000 | High agreement with reference | 96.7% or above |
| Opiates | 2000 | High agreement with reference | 96.7% or above |
| Morphine | 300 | High agreement with reference | 96.7% or above |
| Phencyclidine | 25 | High agreement with reference | 96.7% or above |
| Barbiturates | 300 | High agreement with reference | 96.7% or above |
| Benzodiazepines | 300 | High agreement with reference | 96.7% or above |
| Methadone | 300 | High agreement with reference | 96.7% or above |
| Oxycodone | 100 | High agreement with reference | 96.7% or above |
| MDMA | 500 | High agreement with reference | 96.7% or above |
| Tricyclic Antidepressants | 1000 pg/mL | High agreement with reference | 96.7% or above |
Note: The text states "96.7% or above agreement rate" for all tests, implying this is the acceptance level for lay user performance against the confirmed drug concentrations.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set (Consumer Study):
- Test Cards: 115 lay persons (58 females, 57 males)
- Test Cups: 110 lay persons (55 females, 55 males)
- The total number of urine samples tested is not explicitly stated in terms of unique samples per drug, but rather concentrations were prepared in samples. For each participant, various prepared urine samples were likely used.
- Data Provenance: The studies were conducted in three geographic regions: Texas, Pennsylvania, and California. The study appears to be prospective as lay persons were recruited to perform the tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the prepared urine samples was established by laboratory methods, specifically:
- GC/MS (Gas Chromatography/Mass Spectrometry): Used for confirming final drug concentrations in most urine samples.
- HPLC (High-Performance Liquid Chromatography): Used for confirming TCA (Tricyclic Antidepressant) concentrations in urine samples.
The text does not mention the use of human experts (e.g., toxicologists, lab technicians) in establishing the ground truth beyond the "confirmation by GC/MS" statement. It implies the methods themselves are the gold standard for confirmation. Therefore, the number of experts is not specified as being directly involved in the establishment of ground truth, but rather the accredited laboratory procedures.
4. Adjudication Method for the Test Set
The text does not describe an adjudication method involving multiple human readers comparing their interpretations. Instead, the "test results performed by the lay users" were compared to the "GC/MS results" (or HPLC for TCA). This implies a direct comparison rather than an adjudication process among different readers.
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
No, an MRMC comparative effectiveness study was not done. This device is a rapid, qualitative immunochromatographic assay intended for direct use by consumers (lay persons) and healthcare professionals, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical test kit that requires human interaction (collecting urine, performing the test, and visually interpreting the results). It does not involve an algorithm separate from human-in-the-loop performance. The "standalone" aspect in this context would be the test kit's inherent chemical reaction, which is then interpreted by a human. The consumer studies directly evaluate human users' ability to correctly interpret these reactions.
7. The Type of Ground Truth Used
The type of ground truth used for the test set was laboratory confirmation using established analytical methods:
- GC/MS (Gas Chromatography/Mass Spectrometry) for most drugs.
- HPLC (High-Performance Liquid Chromatography) for Tricyclic Antidepressants.
This is considered a highly objective and quantitative gold standard for drug concentration.
8. The Sample Size for the Training Set
The document does not specify a sample size for a training set. This is not an AI/machine learning device that typically involves distinct training and testing sets. The studies described are performance evaluation studies for a diagnostic device.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a "training set" in the context of an algorithm, this question is not applicable to the information provided. The performance studies used urine samples with known concentrations established by GC/MS or HPLC, effectively serving as the reference for evaluating user accuracy.
§ 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).