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510(k) Data Aggregation
(30 days)
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
The UCP Compact Drug Test Cards and 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, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates 2000, Oxycodone, Phencyclidine, Propoxyphene, Tricyclic Antidepressants. 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. 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.
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The provided text describes the UCP Compact Drug Test Cards and Cups, rapid, qualitative, competitive binding immunoassays for detecting various drugs and their metabolites in human urine. The information relevant to acceptance criteria and supporting studies is extracted below.
Acceptance Criteria and Device Performance
The acceptance criteria for each drug are defined by their respective cut-off concentrations. The device's performance is demonstrated by its qualitative detection of these drugs at or above these cut-off levels. The document indicates that the tests will yield preliminary positive results when the prescription drugs [listed] are ingested, even at or above therapeutic doses. This implies the device is performing as intended when it detects the presence of the drug at or above the specified cut-off.
A table summarizing the acceptance criteria (Cut-off) for each drug is provided below. The "Reported Device Performance" column indicates the qualitative detection capabilities as implied by the "Indications for Use" statement.
| Test | Calibrator | Acceptance Criteria (Cut-off) | Reported Device Performance |
|---|---|---|---|
| Amphetamine | D-Amphetamine | 1000 ng/mL | Detects at or above cut-off |
| Barbiturates | Secobarbital | 300 ng/mL | Detects at or above cut-off |
| Benzodiazepines | Oxazepam | 300 ng/mL | Detects at or above cut-off |
| Buprenorphine | Buprenorphine | 10 ng/mL | Detects at or above cut-off |
| Cocaine | Benzoylecgonine | 300 ng/mL | Detects at or above cut-off |
| Marijuana | Delta-9-THC-COOH | 50 ng/mL | Detects at or above cut-off |
| Methadone | Methadone | 300 ng/mL | Detects at or above cut-off |
| Methamphetamine | D-Methamphetamine | 1000 ng/mL | Detects at or above cut-off |
| MDMA | MDMA | 500 ng/mL | Detects at or above cut-off |
| Morphine | Morphine | 300 ng/mL | Detects at or above cut-off |
| Opiates 2000 | Morphine | 2000 ng/mL | Detects at or above cut-off |
| Oxycodone | Oxycodone | 100 ng/mL | Detects at or above cut-off |
| Phencyclidine | Phencyclidine | 25 ng/mL | Detects at or above cut-off |
| Propoxyphene | Propoxyphene | 300 ng/mL | Detects at or above cut-off |
| Tricyclic Antidepressants | Nortiptyline | 1000 ng/mL | Detects at or above cut-off |
Study Information
The provided document is an FDA 510(k) clearance letter and an "Indications for Use" form. While it states that the device is "substantially equivalent" to legally marketed predicate devices, it does not include details of specific studies, test sets, or validation methodologies that demonstrate the device meets these acceptance criteria. The information below is not explicitly available in the provided text.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the provided text.
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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): Not specified. However, the document mentions that results "should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS)," implying that GC/MS would serve as a confirmatory ground truth method.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
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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 device is a rapid diagnostic test (immunoassay), not an AI-assisted diagnostic tool requiring human reader interpretation in an MRMC study context.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is designed for standalone performance, providing preliminary positive/negative results. However, the document states it's the "first step in a two step process" where confirmatory testing (e.g., GC/MS) is the second step. The performance statistics for this standalone step are not detailed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "Indications for Use" form states that "preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS)." This implies that GC/MS is the intended "gold standard" or ground truth for confirmation.
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The sample size for the training set: Not applicable, as this is an immunoassay device, not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established: Not applicable for the same reason as above.
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(26 days)
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
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.
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