Search Results

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.

Ask a specific question about this device