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The UCP Multi-Drug Test Key Cups are rapid tests for preliminary detection of the following drugs 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 a 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 in a urine sample. The second step is to send preliminary positive samples for confirmation testing by GCMS. The test is not intended to distinguish between prescription use or abuse of the following drugs: Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants. There are no uniformly recognized cutoff concentration levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxyodone, Propxyphene, Tricyclic Antidepressant in urine. Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. For Over-The-Counter (OTC) use For In Vitro Diagnostics only

UCP Multi-Drug Test Key Cups 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 at the cut-off levels as indicated. The tests can be performed without the use of an instrument.

Here's a breakdown of the acceptance criteria and study information for the UCP Multi-Drug Test Key Cups, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the UCP Multi-Drug Test Key Cups are defined by the agreement rates with reference methods (GC/MS or HPLC) and the predicate device. The performance of the device is then measured against these criteria.

2. Sample Sizes and Data Provenance

• Test Set (Clinical Samples for Accuracy Studies):
  • Sample Size: Total 80 clinical urine samples per one drug test. (Since there are 15 distinct drug tests listed, the total number of clinical samples used across all drug types would be 15 * 80 = 1200 samples).
  • Data Provenance: The clinical samples were obtained from "reference laboratories." It is not explicitly stated which country, but it is implied to be relevant to the US regulatory context (given the FDA submission). The data is retrospective, as the samples were "obtained" and then tested.
• Test Set (Consumer Studies):
  • Sample Size: 115 lay persons participated. The number of urine samples used per person or per drug is not specified, but the samples were prepared to contain various drug concentrations (strong negative, weak negatives, weak positives, high positive).
  • Data Provenance: Not explicitly stated, but the study was conducted "among 115 lay persons in three geographic regions." This suggests a prospective study specifically designed for the consumer evaluation.

3. Number of Experts and Qualifications for Ground Truth

• Clinical Sample Ground Truth: The ground truth for the clinical samples was established by "reference laboratories." The text states that "all clinical urine samples including drug negative urine samples and drug positive urine samples were tested by the reference method GC/MS, except TCA. The TCA positive urine samples were tested by HPLC method." This indicates that GC/MS and HPLC are the expert-level reference methods providing the ground truth, rather than human experts adjudicating individual cases. The qualifications of the personnel performing these reference methods are not specified, but it's implied they are qualified laboratory professionals.
• Consumer Study Ground Truth: The ground truth for the urine samples used in the consumer study was also established by objective analytical methods: "the final drug concentrations in each urine sample were confirmed by GC/MS but TCA, TCA concentrations in the urine samples was confirmed by HPLC."

4. Adjudication Method for the Test Set

• Clinical Sample Studies: There was no human adjudication method described. The comparison was directly between the device's results and the objective results from the reference methods (GC/MS and HPLC).
• Consumer Studies: There was no human adjudication method described. The comparison was directly between the lay users' interpretations of the device's results and the objective results from the reference methods (GC/MS and HPLC).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not explicitly mentioned or described in the provided text. The studies focused on device accuracy against reference methods and lay user performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• Yes, a standalone performance study was conducted. The "Accuracy Studies" directly compare the UCP Multi-Drug Test Key Cups (device only, without human interpretation as part of the accuracy measure) against established reference methods. The "Consumer Studies" also have a standalone component, as the device itself is producing a result that the lay users then interpret. The reported agreement rates of the device with GC/MS/HPLC in both types of studies represent its standalone performance in terms of detecting the target substances.

7. Type of Ground Truth Used

• The primary type of ground truth used was objective analytical methods/pathology, specifically:
  • Gas Chromatography/Mass Spectrometry (GC/MS) for most drug classes.
  • High-Performance Liquid Chromatography (HPLC) for Tricyclic Antidepressants (TCA).

8. Sample Size for the Training Set

• The text does not explicitly state a sample size for a training set. This is common for lateral flow immunochromatographic assays like the UCP Multi-Drug Test Key Cups, which are typically developed and validated rather than "trained" in the machine learning sense. The performance characteristics were established through precision, sensitivity, specificity, cross-reactivity, interference, and stability studies, but these do not typically involve a "training set" in the same way an AI/ML model would.

9. How the Ground Truth for the Training Set Was Established

• As a training set is not explicitly referred to in the context of this device's development or the provided studies, the method for establishing its ground truth is not applicable from the given information. The ground truth for the test sets (clinical and consumer samples) was established using GC/MS and HPLC, as detailed in point 7.

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The UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection the following drugs and their metabolites in human urine: Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates 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. The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Oxycodone, 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 Home Drug Screening Test Cups are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Cocaines, Marijuana, Methamphetamine, MDMA, Methadone, Opiates, Opiates 300, Oxycodone, Phencyclidine, Tricyclic Antidepressants and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.

Acceptance Criteria and Study Summary for UCP Home™ Drug Screening Test Cups

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the UCP Home™ Drug Screening Test Cups are implicitly defined by the agreement rates obtained in the consumer study against GC/MS (or HPLC for TCA) reference method. While explicit numerical acceptance criteria (e.g., "must achieve >95% agreement") are not stated, the reported performance of "97% or above agreement rate with GC/MS results" indicates that this level of performance was deemed acceptable for market clearance.

Note: An "Accuracy Study" comparing the device to predicate devices and reference methods (GC/MS/HPLC) also demonstrated "100% agreements between the candidate device and the predicate device" and "over 97.5% agreement between the candidate devices and the reference method GC/MS." This suggests that the internal accuracy criteria were met for healthcare professional use. However, for OTC clearance, the consumer study is the primary focus for usability and interpretability by lay users.

2. Sample Size and Data Provenance

Test Set (Consumer Study):

• Sample Size: 115 lay persons participated.
• Data Provenance: The study was conducted in "three geographic regions" within the United States. The data is prospective as participants performed the tests during the study.

Test Set (Accuracy Study):

• Sample Size: "Total 120 clinical urine samples per one drug test were included." (e.g., 120 samples for Marijuana, 120 for Cocaine, etc., implying multiple sets of 120 samples for each drug tested).
• Data Provenance: Clinical urine samples were obtained from "reference laboratories." The document does not specify the country of origin of these laboratories or whether the collection was retrospective or prospective, but the context of a 510(k) submission generally implies samples are relevant to the US population.

3. Number of Experts and Qualifications for Ground Truth

• Accuracy Study (Reference Method Confirmation): The reference method for confirming drug concentrations was GC/MS (Gas Chromatography/Mass Spectrometry), except for TCA which used HPLC (High-Performance Liquid Chromatography). These are instrumental methods that do not rely on human "experts" in the traditional sense of clinical interpretations. The "experts" would be the skilled technicians or analysts operating and interpreting the results from these analytical instruments. No specific number or qualification of these individuals is provided.
• Consumer Study (Reference Method Confirmation): Similar to the accuracy study, GC/MS (or HPLC for TCA) was used to confirm the final drug concentrations in the prepared urine samples.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for reconciling discrepancies between interpretations by multiple human readers (e.g., 2+1, 3+1). Instead:

• Accuracy Study: The device's results were directly compared against the objective reference methods (GC/MS/HPLC).
• Consumer Study: The lay users' interpretations of the device results were compared against the confirmed GC/MS/HPLC concentrations of the spiked urine samples.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The study mainly focused on:

1. The device's accuracy against a gold standard (GC/MS/HPLC), simulating healthcare professional use.
2. Lay user's ability to correctly perform and interpret the test according to instructions (consumer study).
   There is no mention of human readers improving with or without AI assistance, as this is a qualitative immunoassay device, not an AI-powered diagnostic tool requiring human interpretation of complex images or data.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device itself.

• Accuracy Study: This study directly assessed the device's performance (results from the test cups as interpreted by trained professionals or objectively read) against the reference methods (GC/MS/HPLC). This represents the algorithm's (or device's intrinsic chemistry's) performance.
• Consumer Study: While involving lay users, the core assessment was whether the device's output could be correctly interpreted by them, thereby confirming the standalone performance as read by its intended (lay) user.

7. Type of Ground Truth Used for the Test Set

The ground truth used for both the accuracy study and the consumer study was objective chemical analysis:

• Gas Chromatography/Mass Spectrometry (GC/MS) for most drugs.
• High-Performance Liquid Chromatography (HPLC) for Tricyclic Antidepressants (TCA).
  This provides a highly accurate and quantifiable measure of the drug and metabolite concentrations in the urine samples.

8. Sample Size for the Training Set

The document does not provide information on a specific "training set" or sample size for training. This type of immunoassay device typically relies on established chemical and biological principles, and its performance characteristics are determined through analytical validation rather than machine learning training. The "training" in this context refers to the development and optimization of the assay components and parameters, which is not usually quantified by a "training set sample size" in regulatory submissions for such devices.

9. How Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" in the context of machine learning is not applicable here. The ground truth for the development and validation of the assay (analogous to how a training set informs an algorithm) would have been established through well-controlled laboratory experiments using known concentrations of drugs and their metabolites, confirmed by highly accurate analytical methods like GC/MS or HPLC. This iterative development and refinement process ensures the device's antibodies and reagents react appropriately to the target analytes at specified cut-off levels.

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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.

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.

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