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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 and Methadone 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 Oxazepam. Secobarbital 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. GC/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 and Methadone 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 Oxazepam. Secobarbital 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 alternical method must be used in order to obtain a confirmed analytical result. GC/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 and Methadone (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.

Based on the provided text, the device in question is the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup, which are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of various drugs in human urine.

Here's an analysis of the acceptance criteria and the studies performed:

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

The document does not explicitly state "acceptance criteria" as a separate, quantitative table with pass/fail thresholds before presenting the results. However, the performance data presented implies the criteria for "acceptable performance" for each test type. The precision study for concentrations near the cut-off would be a key indicator for quantitative acceptance. For the qualitative tests, the performance at concentrations above and below the cutoff demonstrates the criteria.

Implied Acceptance Criteria and Reported Performance from Precision Studies (for Secobarbital)

The precision study for Secobarbital demonstrates expected performance around the cut-off (300 ng/mL). A device is expected to consistently classify samples below the cut-off as negative and above as positive. At the exact cut-off, a roughly 50/50 split is typical, reflecting the analytical variation.

Similar tables and outcomes are provided for Methadone and Oxycodone, and referenced for other drugs (Amphetamine, Oxazepam, Cocaine, Methamphetamine, Morphine, Marijuana) in previous submissions (K153741 and K161251).

Lay-User Study Performance:

The lay-user study also demonstrates adherence to an implicit acceptance criterion that a high percentage of correct results should be obtained, especially for samples significantly above or below the cutoff. For samples at +/- 25% of the cutoff, a slight reduction in accuracy is observed and expected due to the nature of qualitative assays at the analytical threshold.

2. Sample size used for the test set and the data provenance

• Precision Study:

  • Sample Size: For each drug and concentration, "tests were performed two runs per day for 25 days per device," which equates to 50 individual tests per concentration per lot. With 9 concentrations tested and 3 lots, this is 50 * 9 * 3 = 1350 tests per drug type. This study was carried out for Secobarbital, Methadone, and Oxycodone. Data for other drugs were reported previously.
  • Data Provenance: Samples were "prepared by spiking drug in negative urine samples." This indicates controlled laboratory conditions. The text does not specify the country of origin of the urine samples themselves, but the manufacturer is Hangzhou Clongene Biotech Co.,Ltd. in China. The study is prospective in the sense that samples were prepared and then tested.

• Comparison Studies (Clinical Samples):

  • Sample Size: "Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug." This was done for Secobarbital, Methadone, and Oxycodone. Similar studies for the other drugs were referenced in previous submissions.
  • Data Provenance: "unaltered clinical samples." The origin (e.g., country) is not specified. The study design sounds retrospective, as samples were collected clinically and then processed for the study.

• Lay-user Study:

  • Sample Size: "A lay user study was performed at three intended user sites with 300 lay persons for each device format." Each participant tested one sample. The samples included negative and various levels around the cut-off. For each drug, the total number of samples tested with the device by lay users corresponds to the sum of samples across all concentrations (e.g., for AMP, 20+20+160+20+20+40+20 = 300 samples). This implies 300 samples per drug per device format. Given there are 9 drugs, this means 300 * 9 tests per device format.
  • Data Provenance: Urine samples were "prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens." This indicates controlled laboratory-prepared samples. The study was prospective in its execution. The "three intended user sites" are not specified geographically.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Precision Study: The ground truth for the prepared samples was established by LC/MS (Liquid Chromatography/Mass Spectrometry). This is a highly accurate analytical method, and no human experts are noted for establishing this specific ground truth.
• Comparison Studies (Clinical Samples): The ground truth for the clinical samples was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is explicitly stated as "The samples were blind labeled and compared to GC/MS results." No human experts are mentioned for establishing the ground truth, as GC/MS is an objective chemical analysis method.
• Lay-user Study: The ground truth for the prepared samples was established by LC/MS (Liquid Chromatography/Mass Spectrometry). No human experts are noted for establishing this specific ground truth.

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

• For the device's reading: In the comparison studies, "three laboratory assistants" for each device (Dip Card and Easy Cup) seem to have visually read the results. The document provides tables breaking down positive/negative calls by "Viewer A, Viewer B, Viewer C". There is no explicit mention of an adjudication process (like 2+1 or 3+1) if these viewers disagreed. The data shows individual viewer results, and discordant results are listed separately, implying that their individual interpretations were recorded.
• For the ground truth: As the ground truth for all studies was established by chemical analytical methods (LC/MS or GC/MS), no human adjudication method was needed for the ground truth itself.

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 performed in the context of AI assistance. This document describes the performance of a point-of-care, visually interpreted immunochromatographic device (dip card/easy cup drug test). The "viewers" are laboratory assistants reading the visual results, not radiologists interpreting medical images with or without AI.
• The study is a direct comparison of the device's results against a gold standard (GC/MS or LC/MS), and a lay-user study to assess comprehensibility and ease of use. There is no AI component or human-in-the-loop AI assistance involved.

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

• Not applicable. The device is a lateral flow immunoassay that produces a visual result inherently requiring human interpretation (either by a lay user or laboratory assistant). There is no "algorithm" in the sense of software interpreting results without human input described for this device.

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

• The ground truth for all studies (Precision, Comparison, Lay-user) was established using objective chemical analytical methods: LC/MS and GC/MS. These are considered gold standards for drug concentration determination. No expert consensus, pathology, or outcomes data were used as ground truth for this type of diagnostic device.

8. The sample size for the training set

• This information is not provided in the document. The document describes performance testing of the final device, not the development or training of a software algorithm. For an immunochromatographic assay, the "training set" would refer to the samples used during the assay development and optimization phase to establish the device's characteristics (e.g., antibody selection, membrane properties, cutoff optimization), which is distinct from the formal performance validation studies presented here.

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

• This information is not provided in the document, as it pertains to the device's development phase rather than its validation. However, it can be inferred that similar analytical methods (LC/MS/GC/MS) would have been used during development to characterize drug concentrations in samples used for internal optimization.

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