(107 days)
The UCP Drug Test Mini Cups are rapid, qualitative, competitive binding immunoassays for the following drugs and their metabolites in human urine:
| Test | Calibrator | Cut-off |
|---|---|---|
| Amphetamine | D-Amphetamine | 1000 ng/mL |
| Barbiturates | Secobarbital | 300 ng/mL |
| Benzodiazepines | Oxazepam | 300 ng/mL |
| Buprenorphine | Buprenorphine | 10 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | Delta-9-THC-COOH | 50 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Methamphetamine | D-Methamphetamine | 1000 ng/mL |
| MDMA | MDMA | 500 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Opiates | 2000 | 2000 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Phencyclidine | Phencyclidine | 25 ng/mL |
| Propoxyphene | Propoxyphene | 300 ng/mL |
| Tricyclic Antidepressant | Nortiptyline | 1000 ng/mL |
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 - the second step in the process, along with the materials for shipping the urine speciment 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, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Buprenorphine, 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.
UCP Drug Test Mini Cups is competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Buprenorphine, Cocaines, Marijuana, Methamphetamine, MDMA, Methadone, Opiates, Morphine, 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 provided document is a 510(k) summary for the UCP Drug Test Mini Cups, a rapid, qualitative, competitive binding immunoassay for detecting various drugs and their metabolites in human urine. It describes the device, its intended use, and performance characteristics compared to a predicate device.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in a table format with corresponding "reported device performance" in a manner typical for a standalone AI/device study. Instead, it states that the performance was established in a predicate submission and that verification studies were conducted for the modified device (smaller cup size). These verification studies are described as having "demonstrated that UCP Drug Test Mini Cups performs satisfactorily when used according to the package inserts."
However, we can infer the acceptance criteria from the nature of the device (a qualitative drug test) and the fact that its performance was deemed satisfactory by the FDA for substantial equivalence. The key performance characteristics for such a device typically revolve around accuracy (sensitivity and specificity relative to a gold standard like GC/MS at specific cut-off levels), precision, and reproducibility. While specific numerical criteria are not listed, the document states:
"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, Tricyclic Antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level."
| Performance Characteristic | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Accuracy | Detect presence/absence of drugs/metabolites at specified cut-off levels (e.g., 50% positive at cut-off, 50% above). Preliminary positive results for certain prescription drugs at therapeutic doses. | "UCP Drug Test Mini Cups performs satisfactorily when used according to the package inserts." |
| "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." | ||
| "The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level." | ||
| Precision | Consistent results across replicates and different levels of analyte. | Mentioned as a "precision study" conducted to support the modification, with satisfactory results. Specific quantitative results are not provided. |
| Reproducibility | Consistent results across different manufacturing lots. | Mentioned as an "inter lots reproducibility study" conducted to support the modification, with satisfactory results. Specific quantitative results are not provided. |
| Sensitivity | Ability to correctly identify positive samples at or above the cut-off. | Mentioned as a "sensitivity study" conducted to support the modification, with satisfactory results. Specific quantitative results are not provided. The device aims to detect drugs at the specified cut-off concentrations (e.g., Marijuana: 50 ng/mL, Cocaine: 300 ng/mL, etc.). |
| pH and Specific Gravity | Performance maintained across various pH and specific gravity levels of urine. | Mentioned as a "pH and specific gravity study" conducted to support the modification, with satisfactory results. Specific quantitative results are not provided. |
| Lay User Performance | Ability for OTC users to correctly perform the test and interpret results according to instructions. | Mentioned as a "lay users study" conducted; "satisfactory" results are implied by the overall conclusion of substantial equivalence for OTC use. The package insert provides information for consumers on the two-step process (initial screening, then confirmatory lab test). The summary emphasizes the preliminary nature of the results and the need for professional judgment. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "Analytical performance was established in the predicate submission. In addition, verification studies were conducted in support of the modification - a smaller size test cup, including the precision study, inter lots reproducibility study, sensitivity study, pH and specific gravity study, accuracy study and the lay users study."
- Test Set Sample Size: Not explicitly stated in this summary. The summary refers to the predicate submission (K130463) for the primary analytical performance data. For the verification studies related to the cup size modification, specific sample sizes are not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be laboratory-based analytical studies and a lay user study, which are typically prospective in nature for performance verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a drug test kit, not an imaging device typically requiring expert interpretation for ground truth.
- Number of Experts & Qualifications: Not applicable in the same way as an imaging study. The "ground truth" for drug detection is typically established through confirmatory laboratory 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 implies that GC/MS would be the reference method for determining the true presence or absence of drugs/metabolites at the cut-off levels in the urine samples used for validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable in the context of this device. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple human readers for an imaging study. For a diagnostic test like this, performance is typically assessed against a definitive laboratory reference method (GC/MS).
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
Not applicable. This is a standalone diagnostic test kit (an immunoassay), not an AI system intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this is essentially a standalone device. The UCP Drug Test Mini Cups is a qualitative, competitive binding immunoassay that provides a visual result (line appears or doesn't appear). While a human interprets the visual result, the device itself is a chemical assay, and its performance is evaluated based on its ability to produce correct results given a sample, independent of ongoing human intervention in the assay process. The "lay users study" assesses the human-in-the-loop aspect of over-the-counter use, but the analytical performance (sensitivity, specificity, precision) is intrinsic to the device's chemical reactions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth used for such drug tests is confirmatory laboratory methods, specifically 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 is the gold standard for drug detection in urine.
8. The sample size for the training set
This device is not an AI/machine learning algorithm, so there is no "training set" in the conventional sense of AI development. The device's design and parameters (e.g., antibodies, cut-off levels) are established through research and development, but not through an iterative learning process on a large training dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for an AI model. The parameters of the immunoassay are determined through biochemical principles and established analytical chemistry.
§ 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).