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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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UCP Pregnancy Cassette Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Prescription Use Only including at point of care sites.

UCP Pregnancy Dip Card/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Prescription Use Only including at point of care sites.

UCP Home Pregnancy Cassette Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

UCP Home Pregnancy Midstream Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

UCP Home Pregnancy Dip Card/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

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Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The document describes several studies to demonstrate the safety and effectiveness of the UCP Home Pregnancy Tests/UCP Pregnancy Tests, thereby showing it meets the acceptance criteria (primarily by demonstrating substantial equivalence to the predicate device).

2. Sample Size and Data Provenance:

• Test Set Sample Size: 100 urine specimens.
• Data Provenance: The document does not explicitly state the country of origin. It indicates that the specimens were collected from "100 women who fit into the following categories: childbearing age, suspected pregnant women, women early in pregnancy, and the first trimester of pregnancy." The study appears to be prospective in the sense that the collection of specimens and testing were part of this specific comparison study.

3. Number and Qualifications of Experts for Ground Truth:

• Number of Experts: Not explicitly stated, but "lab professionals" are mentioned as performing testing for both the candidate and predicate devices. It is implied that these professionals are the "experts" in this context.
• Qualifications of Experts: "Lab professionals" are mentioned. No further specific qualifications (e.g., years of experience, specific certifications) are provided.

4. Adjudication Method for the Test Set:

• The document implies a direct comparison, stating "There was 100% agreement between UCP Home Pregnancy Test results by lay users and by the professionals. The results were also 100% in agreement between UCP Home Pregnancy Tests/UCP Pregnancy Tests and the predicate device results tested by the professionals." This suggests a direct comparison method rather than a formal adjudication process (like 2+1 or 3+1). The predicate device's results, as interpreted by lab professionals, served as the primary benchmark.

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

• No, an MRMC comparative effectiveness study was not done in the sense of evaluating how much human readers improve with AI assistance. This device is a rapid chromatographic immunoassay (a "stick test") for qualitative detection of hCG, not an AI-powered diagnostic imaging or analysis system that would typically be evaluated with MRMC studies.
• However, there was a comparison of "readers" – specifically, lay users versus lab professionals – to assess the ease of use and interpretation for the Over-The-Counter (OTC) versions of the device. This is a different type of "reader" evaluation.

6. Standalone (Algorithm Only) Performance Study:

• The concept of a "standalone (algorithm only)" study is not applicable here because the device is a physical, chemical immunoassay, not an algorithm. The device itself is the "standalone" component in its intended use. The performance characteristics (sensitivity, specificity, precision, etc.) were established for the device itself.

7. Type of Ground Truth Used:

• The primary ground truth appears to be expert consensus / established clinical practice as demonstrated by the predicate device's results when interpreted by "lab professionals."
• Implicitly, the presence of hCG in the urine specimens (from "suspected pregnant women, women early in pregnancy, and the first trimester of pregnancy") serves as the underlying clinical truth.

8. Sample Size for the Training Set:

• The concepts of "training set" and "test set" are typically used for machine learning algorithms. For this type of immunoassay, there isn't a "training set" in the machine learning sense. The "training" or development of the device would involve biochemical formulation and optimization, not data-driven algorithm training.
• The document describes "comparison studies" using 100 urine specimens as the "test set" for performance evaluation against the predicate.

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

• As there is no "training set" in the AI/ML context for this device, this question is not applicable. The development and calibration of the assay would rely on established biochemical principles and standards (e.g., WHO Fourth International Standard for hCG).

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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.

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.

1. 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.

2. 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.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.

4. 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.

5. 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.

6. 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.

7. 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."

8. How the ground truth for the training set was established: Not applicable for the same reason as above.

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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.

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).

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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.

Not Found

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.

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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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 Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection the following drugs and their metabolites in human urine:

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, 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 will yield preliminary positive results when the prescription drugs Barbiturates, 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 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.

The UCP Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection the following drugs and their metabolites in human urine:

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, 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 will yield preliminary positive results when the prescription drugs Barbiturates, 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 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.

The document is a 510(k) premarket notification approval letter for the UCP Drug Screening Test Cups. It provides information about the device's intended use and lists the drugs it screens for, along with their calibrators and cut-off levels. However, it does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in a study.

Therefore, I cannot provide the requested information from this document. The document is an FDA approval letter, not a study report.

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The UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests are rapid, qualitative, competitive binding immunoassays for the detection the following drug in human urine:

The tests contain three formats: 1) Test Card/Strip; 2) Test Device, 3) Test Cup. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use.

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) or Liguid chromatography/mass spectrometry (LC/MS) is the preferred confirmatory method. 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 Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Buprenorphine, Amphetamine, Methamphetamine, Cocaine and their metabolites 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 details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical or percentage format beyond the overarching statement regarding performance. However, based on the accuracy study, the implied acceptance criterion for accuracy against both a legally marketed device and GC/MS or LC/MS is essentially that the device performs at a high level.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 80 clinical urine specimens per drug (Buprenorphine, Amphetamine, Methamphetamine, Cocaine), totaling 320 specimens (80 specimens * 4 drugs).
  • Approximately 10% (8 specimens per drug) were at concentrations between -50% cutoff and cutoff ranges.
  • Approximately 10% (8 specimens per drug) were at concentrations between cutoff and +50% cutoff ranges.
• Data Provenance: Clinical urine specimens. The country of origin is not specified, but the study was conducted at "point of care sites." The data is retrospective in the sense that these were "clinical urine specimens," implying they were collected prior to this specific study for testing. However, the study itself is designed to prospectively test the new device against established methods.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not specify the "number of experts" or their qualifications for establishing ground truth. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) analysis, which are analytical laboratory methods considered the gold standard for confirmatory drug testing. These methods are performed by trained laboratory personnel, rather than medical "experts" in the clinical sense (e.g., radiologists).

4. Adjudication Method for the Test Set

The document describes a comparison study where the UCP device's results were compared to both GC/MS or LC/MS results and the predicate devices. It doesn't detail a specific "adjudication method" involving human consensus for discrepancies. The GC/MS or LC/MS results are considered the definitive ground truth, and device performance is measured against them.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. The study focuses on the device's accuracy against laboratory gold standards and predicate devices, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the study described is a standalone performance study of the device (UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests). These are rapid, qualitative, competitive binding immunoassays that can be performed "without the use of an instrument," implying visual interpretation of results. While human observation is part of reading the test, the performance being evaluated is that of the assay itself in detecting the target analytes in urine, not for an algorithm in an AI system.

7. The Type of Ground Truth Used

The type of ground truth used was confirmatory analytical methods: Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS).

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This type of device (rapid, qualitative immunoassay) typically does not involve machine learning or AI models that require specific training sets in the same way. The "training" for such devices is usually in the manufacturing process and quality control to ensure consistent chemical reactivity.

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

Since no training set is mentioned for this type of immunoassay device, the information on how its ground truth was established is not applicable or provided in the document.

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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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The UCP Multiple Drug Screen Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of Amphetamine, Barbiturates, Bezodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiate 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine at the following cutoff levels:

The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). The test configuration comes with any combination of multiple drug screen tests. 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.

Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C)

The UCP Multiple Drug Screen Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of Amphetamine, Barbiturates, Bezodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiate 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine.

The provided text describes a 510(k) premarket notification for the "UCP Multiple Drug Screen Test Cups," which is an in vitro diagnostic device. The document issues a substantial equivalence determination for this device, meaning it is considered equivalent to legally marketed predicate devices.

However, the provided text does not contain detailed information about the specific acceptance criteria, a standalone study to prove the device meets these criteria, sample sizes for test or training sets, ground truth establishment methods, or the qualifications of experts. The document is an FDA clearance letter and an "Indication for Use" statement, not a scientific study report.

The "Indication for Use" section lists the drugs detected and their respective cutoff levels (calibrator and cutoff concentration), which could be interpreted as part of the performance specification. However, it does not explicitly state "acceptance criteria" and "reported device performance" in the format of a typical scientific or validation study. It describes what the device is designed to do.

Therefore, I cannot fulfill most of your request using the provided text.

Here's what I can extract or infer:

1. A table of acceptance criteria and the reported device performance:

The document describes the intended performance specifications (detection of specific drugs at specific cutoff levels). It does not provide a table of acceptance criteria (e.g., sensitivity, specificity thresholds) alongside reported device performance (actual experimental results against those thresholds).

The table below shows the inherent performance specification from the "Indication for Use" section:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Information Not Found. The document does not provide details of specific studies, including sample size or data provenance.

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):

• Information Not Found. The document does not describe the establishment of ground truth or the involvement of experts for validation studies. The ground truth for drug tests like these is typically established through analytical chemistry methods, not expert consensus in the same way as medical imaging.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Information Not Found. This concept is generally not applicable to a chemical immunoassay, which provides a direct quantitative or qualitative result based on chemical reaction, not human interpretation requiring adjudication.

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:

• Information Not Found. This device is an in vitro diagnostic test (immunoassay), not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Information Not Found (but implied by device type). The device itself is a standalone test that produces a result (positive/negative based on cutoff levels). Its performance is inherently "standalone" in this context. However, the document does not describe such a study or its results. It simply states the device's function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Inferred: For drug screen tests, the ground truth for validation is typically established by definitive analytical methods, most commonly 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 strongly implies GC/MS is the reference standard for confirmatory results and, therefore, the likely "ground truth" for validation studies.

8. The sample size for the training set:

• Information Not Found. The document refers to a commercial product, not an AI model that requires a training set.

9. How the ground truth for the training set was established:

• Information Not Found. See point 8.

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