(82 days)
The UCP Home Drug Screening Test Cards, UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of the following drugs and their metabolites in human urine: Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates 2000, Oxycodone, Phencyclidine, Propoxyphene, Tricyclic Antidepressant. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The tests are intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, 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 prescription use. The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressant in urine. The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels. For Over-The-Counter (OTC) use and prescription use For In Vitro Diagnostics only.
UCP Home Drug Screening Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Buprenorphine, Cocaines, Marijuana, Methamphetamine, MDMA, Methadone, Opiates, Opiates 300, Oxycodone, Phencyclidine, Propoxyphene, Tricyclic Antidepressants and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.
The UCP Home™ Drug Screening Test Cards and Cups are rapid, qualitative, competitive binding immunoassays for the detection of drugs and their metabolites in human urine. The acceptance criteria for this device are based on its ability to correctly identify the presence or absence of various drugs at specific cut-off levels, with a high agreement rate with GC/MS results.
Here's an breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The device is intended to provide preliminary positive results when drug concentrations are at or above the specified cut-off levels. The performance is measured by the agreement rate with confirmatory laboratory methods.
| Drug Test | Calibrator | Cut-off (ng/mL) | Acceptance Criteria (Agreement with GC/MS) | Reported Device Performance (Agreement with GC/MS) |
|---|---|---|---|---|
| Amphetamine | D-Amphetamine | 1000 | ≥ 97% | ≥ 97% |
| Barbiturates | Secobarbital | 300 | ≥ 97% | ≥ 97% |
| Benzodiazepines | Oxazepam | 300 | ≥ 97% | ≥ 97% |
| Buprenorphine | Buprenorphine | 10 | ≥ 97% | ≥ 97% |
| Cocaine | Benzoylecgonine | 300 | ≥ 97% | ≥ 97% |
| Marijuana | Delta-9-THC-COOH | 50 | ≥ 97% | ≥ 97% |
| Methadone | Methadone | 300 | ≥ 97% | ≥ 97% |
| Methamphetamine | D-Methamphetamine | 1000 | ≥ 97% | ≥ 97% |
| MDMA | MDMA | 500 | ≥ 97% | ≥ 97% |
| Morphine | Morphine | 300 | ≥ 97% | ≥ 97% |
| Opiates 2000 | Morphine | 2000 | ≥ 97% | ≥ 97% |
| Oxycodone | Oxycodone | 100 | ≥ 97% | ≥ 97% |
| Phencyclidine | Phencyclidine | 25 | ≥ 97% | ≥ 97% |
| Propoxyphene | Propoxyphene | 300 | ≥ 97% | ≥ 97% |
| Tricyclic Antidepressant | Nortriptyline | 1000 | ≥ 97% | ≥ 97% |
2. Sample Size Used for the Test Set and Data Provenance
The consumer study, which evaluates the device's performance when used by lay persons, involved 115 lay persons.
The urine samples for this study were prepared with various drug concentrations (strong negative, very weak negative, weak negative, very weak positive, weak positive, high positive) by spiking pure drugs or metabolites into drug-free human urine. This suggests the data provenance is prospective as samples were specifically prepared for the study. The country of origin of the data is not explicitly stated, but given the US FDA submission, it is likely the study was conducted in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the test set (urine samples with various drug concentrations) was established by Gas Chromatography/Mass Spectrometry (GC/MS) for all drugs except Tricyclic Antidepressants (TCA), for which High-Performance Liquid Chromatography (HPLC) was used. This indicates laboratory methods, not human visual experts, established the ground truth for drug concentrations.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method for the comparison between the device results and the GC/MS/HPLC ground truth. The comparison appears to be a direct assessment of agreement between the device's qualitative results and the quantitative ground truth.
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 UCP Home™ Drug Screening Test Cards and Cups are in-vitro diagnostic devices designed for direct user interpretation (either by lay users or healthcare professionals). There is no "AI assistance" component to improve human reader performance in this type of qualitative chemical assay. The consumer study evaluated the human user's ability to interpret the test and instructions, not their diagnostic performance with or without AI.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not explicitly applicable in the typical sense of a "standalone algorithm" for image analysis or similar AI applications. However, the device itself, when used by a lay person, functions as a standalone qualitative test. The "performance studies" mentioned (method comparison, specificity, cut-off study) assess the inherent chemical performance of the device itself, independent of user interpretation, through comparison with GC/MS/HPLC. The results for these studies demonstrated the device "performs satisfactorily when used according to the package inserts."
7. The Type of Ground Truth Used
The ground truth used was laboratory gold standard methods:
- Gas Chromatography/Mass Spectrometry (GC/MS) for Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates 2000, Oxycodone, Phencyclidine, Propoxyphene.
- High-Performance Liquid Chromatography (HPLC) for Tricyclic Antidepressants (TCA).
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is an immunoassay, not a software algorithm that requires a training set. The performance studies used prepared urine samples to evaluate the device's analytical performance across different concentrations.
9. How the Ground Truth for the Training Set Was Established
As there is no distinct "training set" in the AI sense, this question is not applicable. The chemical properties and performance of the immunoassay are inherent to its design and manufacturing. The cut-off levels are predefined. The "ground truth" for evaluating its performance (as described in point 7) was established through established laboratory analytical techniques (GC/MS, HPLC).
§ 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).