(26 days)
The UCP Compact Drug Test Cards, UCP Compact Drug Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of 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 configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is 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 health care professional users.
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Here's an analysis of the provided text regarding the UCP Compact Drug Test Cards and Cups, focusing on the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) but rather defines the calibrator and cut-off levels for each drug the device is intended to detect. The "reported device performance" in this context refers to the device's design to detect these substances at or above the specified cut-off concentrations.
| Test | Calibrator | Cut-off (Acceptance Criteria) | Reported Device Performance (as per intended design) |
|---|---|---|---|
| Amphetamine | D-Amphetamine | 1000 ng/mL | Detects Amphetamine at or above 1000 ng/mL |
| Barbiturates | Secobarbital | 300 ng/mL | Detects Barbiturates at or above 300 ng/mL |
| Benzodiazepines | Oxazepam | 300 ng/mL | Detects Benzodiazepines at or above 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL | Detects Cocaine at or above 300 ng/mL |
| Marijuana | Delta-9-THC-COOH | 50 ng/mL | Detects Marijuana at or above 50 ng/mL |
| Methadone | Methadone | 300 ng/mL | Detects Methadone at or above 300 ng/mL |
| Methamphetamine | D-Methamphetamine | 1000 ng/mL | Detects Methamphetamine at or above 1000 ng/mL |
| MDMA | MDMA | 500 ng/mL | Detects MDMA at or above 500 ng/mL |
| Morphine | Morphine | 300 ng/mL | Detects Morphine at or above 300 ng/mL |
| Opiate 2000 | Morphine | 2000 ng/mL | Detects Opiates at or above 2000 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL | Detects Oxycodone at or above 100 ng/mL |
| Phencyclidine | Phencyclidine | 25 ng/mL | Detects Phencyclidine at or above 25 ng/mL |
| Tricyclic Antidepressant | Nortriptyline | 1000 ng/mL | Detects Tricyclic Antidepressants at or above 1000 ng/mL |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain any information about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not contain any information about the number of experts used or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
The provided text does not contain any information about the adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
The provided text does not indicate that an MRMC comparative effectiveness study was conducted. This device is a rapid qualitative immunoassay, not an AI or imaging device that would typically involve human readers for interpretation in the same way. The language specifies "preliminary positive results... should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS)," implying a two-step process, not an aided human reading.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
The device itself, being a rapid immunoassay card/cup, is inherently a standalone "algorithm" (in the sense of a chemical reaction interpreted visually). It is designed to provide a result without human interpretation of complex images or data. However, the text does not explicitly describe a "standalone study" in the context of a software algorithm in the way typically discussed for AI devices. Its performance is based on its chemical reactivity and visual output.
7. The Type of Ground Truth Used
The ground truth for this type of drug test is typically established by confirmatory methods such as Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS)." This indicates that GC/MS is the gold standard used for confirmation and, by extension, would be the ground truth for evaluating the device's accuracy.
8. The Sample Size for the Training Set
The provided text does not contain any information about the sample size for a training set. This is not an AI/machine learning device that would typically have a "training set."
9. How the Ground Truth for the Training Set Was Established
Since this is not an AI/machine learning device, there is no "training set" in that context, and therefore, no information on how ground truth for a training set was established.
§ 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).