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CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Opiates, Oxycodone, Secobarbital, Methadone, Buprenorphine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene in human urine at the cutoff concentrations of:

Configuration of the CLUNGENE® Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GCMS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

CLUNGENE® Multi-Drug Test Easy Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Opiates, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene in human urine at the cutoff concentrations of:

Configuration of the CLUNGENE® Multi-Drug Test Easy Cup can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

The CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. The CLUNGENE Multi-Drug Test Dip Card kit contains a Dip Card device, a package insert and a urine cup for sample collection. The CLUNGENE Multi-Drug Test Easy Cup kit contains a Cup device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

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

The document does not explicitly state "acceptance criteria" as a single, consolidated table with pass/fail metrics. However, the "Performance Characteristics" section details various studies with implied performance targets. The key performance demonstrated is in the precision studies and lay-user studies for detecting drug analytes in urine at specific cut-off levels.

Implied Acceptance Criteria (based on presented data patterns):

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

• Test Set Sample Size:

  • Precision Studies: For EDDP, Opiates, and Propoxyphene, each concentration level (-100% to +100% cut-off) was tested with 50 samples for each of three lots, making a total of 450 tests per analyte per lot (50 samples * 9 concentrations) * 3 lots = 1350 tests per analyte. Since there are three analytes and two device types (Dip Card and Easy Cup), this would be 1350 tests * 3 analytes * 2 devices = 8100 individual tests for these three new analytes in the precision study.
  • Method Comparison Studies: For EDDP, Opiates, and Propoxyphene, 80 unaltered clinical samples (40 negative and 40 positive) were used for each drug. This means 80 samples * 3 drugs * 2 device types = 480 samples.
  • Lay-user Study: 310 lay persons were involved for each device format (Dip Card and Easy Cup). The total number of individual tests performed by lay users is not explicitly stated as a single number but would be 310 tests * 15 analytes * 2 device formats = 9300 tests (based on the "entire panel" evaluation). For each drug, a varying number of samples were prepared across different concentration levels, totaling 360 samples for Amphetamine, for example.
  • Interference and Specificity Studies: Samples were "spiked into negative urine" and tested using three lots of each device. Numerical sample sizes are not provided for these, but rather the list of compounds and their effects.
  • Effect of Urine Specific Gravity and pH: Urine samples were spiked with drugs at +/-25% Cut-Off levels and tested using three lots of each device. Numerical sample sizes are not provided.

• Data Provenance: The document does not explicitly state the country of origin of the data for the experimental studies. However, the submitter, Hangzhou Clongene Biotech Co.,Ltd., is located in China, which might suggest the studies were conducted there. The clinical samples for the method comparison were "unaltered clinical samples." The lay-user study was performed "at three intended user sites."

• Retrospective or Prospective: Not explicitly stated, but the precision, interference, specificity, and pH/specific gravity studies appear to be prospective, controlled laboratory studies. The method comparison using "unaltered clinical samples" suggests a prospective collection or at least a retrospective analysis of prospectively collected samples with LC/MS confirmation. The lay-user study appears to be prospective.

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)

• Number of Experts: For the method comparison studies, the "in-house" tests were performed by "three laboratory assistants for each device." Their qualifications are not specified beyond being "laboratory assistants."
• Qualifications of Experts: Not specified.

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

Not applicable. The ground truth for the test set for the method comparison studies was established by LC/MS results, not by human expert adjudication of the device results themselves. The "Viewer" results (Viewer A, B, C) in the method comparison tables refer to the readings by the three laboratory assistants using the multi-drug test devices, which were then compared against the LC/MS 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

• A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not explicitly stated as being performed in the context of comparing human readers with and without AI assistance.
• The document describes a "Comparison Studies" section comparing the device's performance to LC/MS results, with three "viewers" (laboratory assistants) reading the device results. This is a form of multi-reader study, but it is a standalone performance assessment against a gold standard (LC/MS), not a comparative effectiveness study of human readers with and without AI.
• Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not provided.

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

• The devices (CLUNGENE Multi-Drug Test Dip Card and Easy Cup) are described as "competitive binding, lateral flow immunochromatographic assay" and are read visually. These are not AI-driven devices, and their performance inherently involves "human-in-the-loop" visual interpretation.
• Therefore, a standalone (algorithm only) performance study was not done, as the device itself is not an algorithm.

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

• The ground truth for all performance studies (e.g., Precision, Specificity, Method Comparison, Lay-user study) was established using Liquid Chromatography-Mass Spectrometry (LC/MS). For the precision study, samples were "prepared by spiking drug in negative urine samples" and "confirmed by LC/MS." For the method comparison study, "unaltered clinical samples" were "compared to LC/MS results."

8. The sample size for the training set

• This information is not applicable. The CLUNGENE devices are immunoassay-based test kits, not machine learning or AI algorithms that require a "training set" in the computational sense. The "training" for the device refers to its manufacturing and validation processes, not data-driven algorithmic training.

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

• This information is not applicable as the device is not an AI/ML algorithm requiring a training set.

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CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Ampletamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Methylenedioxymethamphetamine and Tricyclic Antidepressants in human urine at the cutoff concentrations of:

Configuration of the CLUNGENE® Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GCMS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

CLUNGENE® Multi-Drug Test Easy Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine and Tricyclic Antidepressants in human urine at the cutoff concentrations of:

Configuration of the CLUNGENE® Multi-Drug Test Easy Cup can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GCMS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

The CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine and Tricyclic Antidepressants (target analytes) in human urine. The products are single-use in vitro diagnostic devices. The CLUNGENE Multi-Drug Test Dip Card kit contains a Dip Card device, a package insert and a urine cup for sample collection. The CLUNGENE Multi-Drug Test Easy Cup kit contains a Cup device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

This document describes the validation study for the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup, which are in vitro diagnostic devices for the qualitative detection of various drugs in human urine.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the precision studies and the comparison studies. For the precision studies, the acceptance criterion is that samples significantly below the cutoff should test negative, samples significantly above the cutoff should test positive, and samples very close to the cutoff (e.g., +/- 25% of the cutoff) should show a mix of positive and negative results, reflecting the inherent variability at the decision point. For the comparison studies and lay-user studies, the implicit acceptance criterion is a high percentage of agreement with the reference method (LC/MS) or expected results, especially for samples far from the cutoff.

Here is a summary table, focusing on the precision study and lay-user study data as they most directly reflect performance against concentration levels:

Table of Acceptance Criteria and Reported Device Performance

The study performed to prove the device meets acceptance criteria involved several components:

1. Sample Sizes and Data Provenance:

• Test Set (Analytical Performance - Precision): For precision studies, for each drug and each concentration (-100% to +100% cut-off), 50 individual tests were performed across two runs per day for 25 days, for a total of 50 tests per concentration level per drug for each device type (Dip Card and Easy Cup). This was repeated for three different manufacturing lots.
• Test Set (Comparison Studies): 80 unaltered clinical samples (40 negative and 40 positive) were used for each drug. Data provenance is "in-house" suggesting the tests were conducted at the manufacturer's facility. The samples were "clinical samples," implying human origin, but specific country of origin or whether they were retrospectively collected or prospectively collected is not explicitly stated. They were "unaltered."
• Test Set (Lay-User Study): 300 lay persons were involved for each device format (Dip Card and Easy Cup). Urine samples prepared at various concentrations (-100%, -75%, -50%, -25%, +25%, +50%, +75% of cutoff) by spiking drugs into drug-free pooled urine specimens. The distribution of samples given to each participant is not explicitly detailed beyond "1 blind labeled sample and a device." The total number of individual tests performed in the lay-user study appears to be substantial given the breakdown of samples across concentrations for each drug and the 300 participants.
• Data Provenance (General): While "in-house" is mentioned for comparison studies, specific origin countries or retrospective/prospective nature of the broader data (e.g., interference, specificity) are not explicitly stated, although given the manufacturer is based in China, it is likely data collection occurred there.

2. Number of Experts and Qualifications for Ground Truth - Test Set:

• Experts: For the analytical (precision) and comparison studies, the ground truth for drug concentrations was established by LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly sensitive and specific analytical chemistry method considered to be the "gold standard" for confirming drug concentrations in biological samples. Therefore, the "experts" in this context are the analytical chemists and laboratory personnel who performed and interpreted the LC/MS results. Their specific qualifications (e.g., number of years' experience, specific certifications) are not detailed in this document, but LC/MS analysis requires specialized training and expertise.
• For the lay-user study, the ground truth for the spiked samples was also established by LC/MS.

3. Adjudication Method for the Test Set:

• For the analytical (precision) studies, the samples were "blindly labeled by the person who prepared the samples and didn't take part in the sample testing." This indicates blinding, but no formal adjudication method (like 2+1 or 3+1 consensus) among different readers of the device results is mentioned, as the device results are qualitative (positive/negative) and read directly. The consistency across multiple lots and runs serves as a robustness check.
• For the comparison studies, "three laboratory assistants" for each device ran the samples. Their individual results are reported in detail, showing where discrepancies from the LC/MS ground truth occurred for each viewer and sample. There is no explicit mention of an adjudication process among these three laboratory assistants for their readings of the device results; their individual performance is reported.
• For the lay-user study, each of the 300 participants read their own single device. There was no reader adjudication among the lay users for their interpretation of the device results.

4. MRMC Comparative Effectiveness Study:

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was explicitly done in the typical sense of human readers with and without AI assistance. This device is a rapid, lateral flow immunochromatographic assay, not an AI-powered diagnostic imaging or algorithm. The "human readers" (laboratory assistants and lay users) are interpreting the visual lines on the test card/cup directly, not using "AI assistance."
• Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not applicable to this type of device and study.

5. Standalone Performance:

• Yes, a standalone performance study was done for the device itself. The precision studies directly evaluate the device's ability to correctly classify samples based on their concentration relative to the cutoff, independent of human interpretation variability (as the readings are a simple visual presence/absence of a line). The comparison studies similarly assess the device's performance against the gold standard (LC/MS) when read by trained laboratory professionals.

6. Type of Ground Truth Used:

• The primary ground truth used for both analytical performance (precision, interference, specificity) and comparison studies was LC/MS (Liquid Chromatography-Mass Spectrometry). This is an objective chemical method that provides precise quantitative measurements of drug concentrations, which are then used to define positive or negative status relative to the established cutoff concentrations.
• For the lay-user study, the ground truth for the spiked samples was also confirmed by LC/MS.

7. Sample Size for the Training Set:

• This information is not provided in the document. As this is a rapid in vitro diagnostic device (immunochromatographic assay) and not an AI/machine learning algorithm, there isn't a "training set" in the computational sense. The device's performance relies on its biochemical design and manufacturing consistency rather than a trained model.

8. How Ground Truth for Training Set was Established:

• As there is no "training set" for an AI model, this question is not applicable in the context of this device. The development of such devices typically involves extensive R&D, antibody selection, and optimization of chemical components, rather than data-driven training with a ground truth dataset in the way an AI algorithm would be.

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