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The CLUNGENE Multi-Drug Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations:

The single or multi-test cups can consist of any combination of the above listed drug analytes, but only one cut off concentration under same drug condition will be included per device.

This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The CLUNGENE Multi-Drug Home Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations:

The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC-MS/MS is the preferred confirmatory method.

It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

This document provides details on the performance characteristics of the CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup. Since this is an in vitro diagnostic device (specifically, a drug screening test), the acceptance criteria and study design are typically focused on analytical performance (accuracy, precision, analytical specificity) rather than a multi-reader multi-case (MRMC) comparative effectiveness study, which is more common for imaging AI. Similarly, "human readers improving with AI vs without AI" is not applicable here as the device is the test, not an aid to human interpretation of another modality.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for qualitative drug screening tests like this is accurate detection around a specific cutoff concentration. The reported performance demonstrates the device's ability to correctly classify samples as positive or negative relative to these cutoffs.

Table of Acceptance Criteria and Reported Device Performance (Analytical Precision/Reproducibility)

The "Acceptance Criteria" column represents the desired performance for a qualitative assay around its cutoff. For positive results, this means detecting drug concentrations above the cutoff, and for negative results, it means not detecting concentrations below the cutoff. The provided precision data shows the number of positive (+) and negative (-) results out of 50 tests for various concentrations relative to the cutoff. An ideal performance would show 100% positive for concentrations above cutoff and 100% negative for concentrations below, with roughly 50/50 split at the cutoff itself (due to inherent variability).

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The CLUNGENE Fentanyl Home Test Cassette is competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentany] in human urine at the cut off concentration of 1.0 ng/mL. This test provides only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS) is the preferred confirmatory method. Evaluate preliminary positive results carefully. For in vitro diagnostic use only.

The CLUNGENE Fentanyl Test Cassette is competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl in human urine at the cut off concentration of 1.0 ng/mL.

This test provides only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS). Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. For in vitro diagnostic use only.

The CLUNGENE Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each CLUNGENE Fentanyl Test device consists of a Test Cassette, a Dropper and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.

Here's a breakdown of the acceptance criteria and study information for the CLUNGENE Fentanyl Home Test Cassette and CLUNGENE Fentanyl Test Cassette, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a structured table. However, based on the performance characteristics presented, we can infer the criteria considered for demonstrating substantial equivalence. The reported performance is presented in the context of these implied criteria.

For qualitative detection of Fentanyl in human urine at a cut-off concentration of 1.0 ng/mL, the key performance characteristics evaluated were:

Lot 2:
-100%, -75%, -50%, -25% cut off: 100% negative (60-/0+)
Cut off: 43.3% negative, 56.7% positive (26-/34+)
+25%, +50%, +75%, +100% cut off: 100% positive (60+/0-)

Lot 3:
-100%, -75%, -50% cut off: 100% negative (60-/0+)
-25% cut off: 96.7% negative (58-/2+)
Cut off: 53.3% negative, 46.7% positive (32-/28+)
+25%, +50%, +75%, +100% cut off: 100% positive (60+/0-) |
| Stability | Stable at 39-86º F for 24 months (based on accelerated stability study). |
| Interference (no impact from common substances) | No interference observed at 100µg/mL (or specified concentrations) for a wide range of physiological, pathological, and common drug substances listed. This includes substances like Acetone (1000 mg/dL), Ethanol (1%), Glucose (3000 mg/dL), Ibuprofen, Caffeine, etc. |
| Specificity (cross-reactivity with similar compounds) | Demonstrated defined cross-reactivity profiles for Fentanyl analogs and related substances (e.g., Acetyl fentanyl (100%), Isobutyryl fentanyl (40%), Carfentanil (2%), Sufentanil (4%)). No cross-reactivity for a list of 27 other opioid compounds tested at 100 µg/mL. |
| Effect of Urine Specific Gravity and pH (robustness to urine variability) | All samples at and above +50% Cut-Off were positive; all samples at and below -50% Cut-Off were negative for urine specific gravities from 1.000 to 1.035 and pH from 4 to 9. |
| Method Comparison (agreement with confirmatory method) | Overall agreement near cutoff: For samples near the cutoff (between -50% and +50% of cutoff), there were a few discordant results, indicating expected variability around the cutoff.

• Example: 1 positive result for a true negative sample (0.953 ng/mL) by Operator 1.
• Example: 2 negative results for true positive samples (1.073 ng/mL, 1.083 ng/mL) by Operator 1 and 2.
  Key finding: Generally high agreement for samples significantly below or above the cutoff. |
  | Lay-User Performance (ease of use and accuracy by target users) | - 100% correct results for -100%, -75%, -50%, +25%, +50%, +75% of cutoff concentrations.
• 95% correct results for -25% of cutoff (1 positive result out of 20 samples).
• All lay users indicated the instructions were easy to follow.
• Package insert has a Flesch-Kincaid reading grade level less than 7. |

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

• Precision Study: For each of 9 fentanyl concentrations (-100% to +100% cut off), 60 tests were performed per lot (2 tests/day/operator for 10 days, across 3 lots).
• Interference Study: Urine samples were prepared with various interfering substances, with target fentanyl at 50% below and 50% above Cut-Off levels. Tested using three batches of each device. Specific sample sizes per substance are not given, but refers to "compounds that showed no interference at a concentration of 100µg/mL or specified concentrations".
• Specificity Study: Drug metabolites and other components were tested. Not explicitly stated as "test set" samples, but these are part of the analytical validation.
• Effect of Urine Specific Gravity and pH: Urine samples with varying specific gravity and pH were spiked with fentanyl at 50% below and 50% above cut-off levels. Tested using three lots of devices.
• Method Comparison Studies (Clinical Samples): 80 unaltered clinical urine samples (40 negative and 40 positive) were used.
• Lay-user Study: 140 lay persons tested samples. 20 samples were prepared per concentration level spanning -100% to +75% of the cutoff.

Data Provenance:
The document does not explicitly state the country of origin for the clinical samples or for the samples used in the precision and lay-user studies. The method comparison study used "unaltered clinical samples." The precision and lay-user studies used "spiked fentanyl in negative samples" or "spiked fentanyl into drug free-pooled urine specimens," which implies these were lab-prepared samples. The overall study appears to be retrospective in terms of sample collection for clinical samples, but the testing itself would be prospective for evaluating the device.

3. Number of Experts and Qualifications for Ground Truth for Test Set

• Method Comparison Studies (Clinical Samples): The ground truth was established by LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly accurate analytical method and is stated as the "preferred confirmatory method" in the Indications for Use. No human experts are listed for establishing this ground truth, as it is an instrumental analysis.
• Precision Study, Lay-user Study, Interference, Specificity, Effect of Urine Specific Gravity and pH: The fentanyl concentrations in spiked samples were "confirmed by LC/MS". Again, LC/MS served as the ground truth.

4. Adjudication Method for the Test Set

• Method Comparison Studies (Clinical Samples): Samples were "blind labeled" and compared to LC/MS results. This suggests a direct comparison method. Discrepancies (discordant results) were noted, but there's no mention of an adjudication process by human experts to resolve these. The LC/MS result is considered the definitive truth.
• Precision, Interference, Specificity, Effect of Urine Specific Gravity and pH, Lay-user Study: The ground truth was based on the known spiked concentrations confirmed by LC/MS. No human adjudication method is described or necessary for these types of analytical validation studies.

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

No MRMC comparative effectiveness study was done. The study compares the device's performance against LC/MS (a gold standard analytical method) and evaluates lay-user performance, but not in a comparative effectiveness study with human readers with and without AI assistance. This device is a rapid diagnostic test cassette, not an AI-assisted diagnostic tool.

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

Yes, this is essentially a standalone (device-only) performance assessment. The "CLUNGENE Fentanyl Test Cassette" is a lateral flow immunoassay. Its performance is read visually from the lines on the cassette. While human interpretation is involved in reading the result, the core "performance" (sensitivity, specificity, precision, etc.) is inherent to the chemical reactions and design of the device itself. The lay-user study evaluates the human interpretation aspect too.

7. Type of Ground Truth Used

The ground truth used throughout the studies was analytical confirmation by LC/MS (Liquid Chromatography-Mass Spectrometry). This is considered a highly reliable and quantitative method for determining the presence and concentration of fentanyl.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. This is a traditional immunoassay device, which typically does not involve machine learning models that require training sets. The studies described are for analytical and clinical validation of the device's inherent performance characteristics.

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

As there is no mention of a "training set" for a machine learning algorithm, this question is not applicable to the provided document.

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The CLUNGENE HCG Pregnancy Rapid Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.

The CLUNGENE HCG Pregnancy Rapid Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.

The CLUNGENE HCG Pregnancy Rapid Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.

Clungene HCG Pregnancy Rapid Test will be sold in three different formats: Cassette, Test Strip, and Midstream. The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and a package insert. The Cassette format contains one test device, a disposable plastic dropper, and a package insert.

The provided document describes the CLUNGENE HCG Pregnancy Rapid Test, a qualitative in vitro diagnostic device for early detection of pregnancy. The acceptance criteria and study details are primarily focused on the analytical performance and comparison with a predicate device, as this is a 510(k) submission for a Class II device.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" for each performance characteristic in a pass/fail format. However, based on the presented data, the implicit acceptance criterion for most analytical tests is 100% agreement/expected result at the defined concentrations. For the sensitivity, the acceptance criterion is implied to be 25 mIU/mL, as this is the claimed analytical detection limit, and the results show 100% positivity at 25 mIU/mL and above. For the method comparison and lay person studies, 100% concordance with the reference method (predicate device or professional testing) suggests an implicit acceptance criterion of 100% agreement.

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

• Analytical Performance (Precision/Reproducibility/Sensitivity, Hook Effect, Specificity, Interfering Substances): Urine samples were spiked with hCG standards and various interfering substances. The origin of the initial negative urine is not specified but is typically a controlled laboratory setting. The study design for these tests appears to be prospective laboratory testing.
  • Precision/Reproducibility/Sensitivity: 90 replicates per hCG concentration (3 lots * 30 replicates each) were tested for each of the three formats. Negative urine was spiked with hCG standard (Traceable to the 5th WHO).
  • Hook Effect: Negative urine samples were spiked with varying hCG concentrations.
  • Specificity and Cross-reactivity: Negative and positive urine samples (10 mIU/mL and 25 mIU/mL) were spiked with various concentrations of glycoprotein hormones and hCG ß-core fragment.
  • Interfering Substance: Urine samples containing 10 mIU/mL and 25 mIU/mL hCG were spiked with the interfering substances.
• Method Comparison Study:
  • Sample Size: 120 urine samples from women presenting to test for pregnancy. Approximately half were suspected to be pregnant and in early stages (less than 5 weeks).
  • Data Provenance: Not explicitly stated but implies prospective collection from "POC sites" (Point-of-Care). Country of origin is not mentioned.
• Lay Person Study:
  • Sample Size: 300 women.
  • Data Provenance: Not explicitly stated, but participants were recruited from "three sites" for self-testing. Implies prospective collection. Country of origin not mentioned.

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)

• Analytical Performance: The ground truth for analytical performance (e.g., hCG concentrations) was established by spiking known concentrations of hCG standard traceable to the 5th WHO, and preparing samples with known concentrations of interfering substances. This implies a laboratory setting with qualified personnel to perform and verify the spiking, but "experts" in the sense of clinical interpretation are not involved here.
• Method Comparison Study: The ground truth was established by testing all samples with the predicate device AND by "three different health professionals for each format at the 3 POC sites for a total of 12 POC operators." The qualifications of these "health professionals" or "POC operators" are not specified beyond being "health professionals."
• Lay Person Study: The ground truth was established by "professional testing" of the urine samples provided by the lay persons. The qualifications of these "professionals" are not specified.

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

• Analytical Performance: Not applicable for spiked samples with known concentrations. The results are quantitative (e.g., 30 positives out of 30, 0 negatives out of 30).
• Method Comparison Study: The study involved professional testing of each sample by "three different health professionals" and comparison to the predicate device. It's not explicitly stated if there was an adjudication process if these three professionals disagreed among themselves, or if the predicate device result was considered the definitive ground truth for comparison. The tables indicate a direct comparison between the candidate device and the predicate device.
• Lay Person Study: Each lay person's result was compared to "professional testing." It's not explicitly stated if there was an adjudication for professional testing if multiple professionals were involved or if it was a single professional's reading.

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 device is a rapid diagnostic test (HCG Pregnancy Rapid Test), not an AI-powered image analysis tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed. The "multi-reader" aspect in the method comparison and lay person studies refers to different operators/professionals performing the assay, not interpreting complex images.

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

• This is a lateral flow immunoassay that produces a visual result, interpreted by a human user (either a professional or a lay person). There is no "algorithm only" component to evaluate in isolation. Its performance is its standalone performance when correctly used and interpreted.

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

• Analytical Performance: Ground truth was based on known, spiked concentrations of hCG (traceable to WHO International Standard) and other substances in urine. This is a highly controlled laboratory ground truth.
• Method Comparison Study: Ground truth was established by comparison to a legally marketed predicate device and readings by "health professionals." The predicate device results served as the reference standard.
• Lay Person Study: Ground truth was established by "professional testing" of the urine samples from the lay persons.

8. The sample size for the training set

• This document describes performance characteristics for a rapid diagnostic test. There is no mention of a "training set" as this is not an AI/machine learning model that requires training. The studies conducted are for analytical validation and clinical performance evaluation.

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

• As there is no training set mentioned or implied for this type of device, this question is not applicable.

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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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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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CLUNGENE Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

CLUNGENE Cocaine Tests are immunochromatographic assays for the qualitative determination of Cocaine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Dip Card format, and a Split Key Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

CLUNGENE Oxazepam Tests are immunochromatographic assays for the qualitative determination of Oxazepam in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Dip Card format, and a Split Key Cup format.

The test may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxazepam in urine. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

The CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, and CLUNGENE Oxazepam Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Cocaine and Oxazepam (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

Here's a breakdown of the acceptance criteria and the studies performed for the CLUNGENE drug tests, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a separate section with numerical thresholds for performance metrics. Instead, it presents various performance studies (Precision, Cut-off, Interference, Specificity, Method Comparison, and Lay-user studies) and concludes that the device's performance is "acceptable" and "substantially equivalent to the predicate."

However, we can infer the implied acceptance criteria from the reported results, particularly for the precision and comparison studies, which demonstrate high accuracy around the cutoff concentrations. Essentially, the criteria are met if the tests accurately identify negative samples as negative and positive samples as positive, especially around the cutoff values, with minimal false positives or negatives.

Implied Acceptance Criteria and Reported Performance Summary

Cocaine Tests (Cassette, Dip Card, Split-Key Cup, Easy Cup): Similar to Amphetamine, 100% correct results were consistently observed for concentrations at -100%, -75%, -50% cut-off (all negative) and +25%, +50%, +75%, +100% cut-off (all positive) across all lots and formats. Variability in positive/negative calls occurred at the exact cut-off.

Oxazepam Tests (Cassette, Dip Card, Split-Key Cup, Easy Cup): Consistently 100% correct results for concentrations at -100%, -75%, -50% cut-off (all negative) and +25%, +50%, +75%, +100% cut-off (all positive) across all lots and formats. Variability in positive/negative calls occurred at the exact cut-off. |
| Cut-off Verification | The device should correctly identify samples above the specified cut-off as positive and below as negative. | For Amphetamine, Cocaine, and Oxazepam, all results were positive at and above +25% Cut-off and all negative at and below -25% Cut-off. This confirms the functional cut-off. |
| Interference | No interference from common exogenous or endogenous substances that would lead to false positive or false negative results. | Numerous compounds (physiological and pathological conditions, common drugs) were tested at 100µg/mL. The document states, "Compounds that showed no interference at a concentration of 100µg/mL are summarized in the following tables. There were no differences observed for different devices." |
| Specificity (Cross-reactivity) | Limited or no cross-reactivity with structurally similar compounds or other common substances at concentrations below relevant clinical levels. | Detailed tables provided for Amphetamine, Cocaine, and Oxazepam showing concentrations that cause a positive result. For instance, L-Amphetamine showed 2% cross-reactivity at 50000 ng/mL compared to D-Amphetamine's 100% at 1000 ng/mL. Similarly, other drugs (e.g., Alprazolam, Clonazepam for Oxazepam) showed varying degrees of cross-reactivity at higher concentrations. The levels are generally much higher than the detection levels for the target drug, indicating reasonable specificity. |
| Effect of Urine Specific Gravity and pH | Accurate results are maintained across a physiological range of urine specific gravity (1.000-1.035) and pH (4-9). | For samples spiked at +/- 25% of Cut-Off levels, all results were positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off, regardless of specific gravity or pH. "No differences observed for different devices." |
| Method Comparison (Clinical) | High concordance with the GC/MS reference method, especially for samples clearly positive or negative, and reasonable performance around the cut-off. | Amphetamine, Cocaine, Oxazepam (all formats): High agreement with GC/MS. For "Negative", "Low Negative (-50%)" categories, all device results were negative for most viewers across all formats. For "High Positive (+50%)", all device results were positive. Discrepancies primarily occurred in the "Near Cutoff Negative" and "Near Cutoff Positive" ranges (e.g., a few false negatives or false positives just above/below the GC/MS cutoff). For example, Amphetamine Cassette Viewer A had 1 positive result in "Near Cutoff Negative" and 0 negative results in "Near Cutoff Positive", while Viewer B had 0 positive and 1 negative result respectively. This expected variability is seen across all drugs and device formats. |
| Lay-user Study | High percentage of correct results for clearly positive/negative samples when interpreted by lay users, and ease of understanding instructions. | Amphetamine, Cocaine, Oxazepam (all formats): All lay-user studies showed 100% correct results for -100%, -75%, -50% cut-off (negative) and +50%, +75% cut-off (positive). At -25% and +25% cut-off, accuracy ranged narrowly, typically between 90-95% (e.g., 1-2 incorrect results out of 20 samples), indicating high performance even at concentrations closest to the threshold. All lay users found the instructions easy to follow, and the package insert had a Flesch-Kincaid Grade Level of 7. |

2. Sample Sizes and Data Provenance

• Precision Study:

  • Test Set Sample Size: For each drug (Amphetamine, Cocaine, Oxazepam) and each device format (Cassette, Dip Card, Split-Key Cup, Easy Cup), 3 lots were tested. For each lot, 8 concentrations were tested (ranging from -100% cut off to +100% cut off). Each concentration was tested with 50 replicates (2 runs per day for 25 days).
  • Total (per drug per format): 3 lots * 8 concentrations * 50 replicates = 1200 tests.
  • Provenance: Samples were "prepared by spiking drug in negative samples." These were laboratory-prepared samples. The original "negative samples" are not specified as to country of origin, but the overall context of an FDA submission suggests the intent is for global marketability/regulatory compliance. This is a prospective lab study.

• Cut-off Verification Study:

  • Test Set Sample Size: 150 samples were used per drug/device type (equally distributed at -50%, -25%, Cut-Off, +25%, +50% Cut-Off).
  • Provenance: "prepared by spiking drug in negative samples." This is a prospective lab study.

• Interference Study:

  • Test Set Sample Size: Urine samples (drug-free and spiked with target drugs at -25% and +25% Cut-Off) were tested with 3 batches of each device for numerous potential interfering substances. Specific numbers per substance are not given, but refers to "summarized in the following tables" which list many compounds.
  • Provenance: Laboratory-prepared spiked urine samples. This is a prospective lab study.

• Specificity (Cross-reactivity) Study:

  • Test Set Sample Size: Not explicitly stated as a total number of samples, but "drug metabolites and other components" were tested using three batches of each device. Similar to interference, these were individual compounds tested for cross-reactivity.
  • Provenance: Laboratory-prepared samples. This is a prospective lab study.

• Effect of Urine Specific Gravity and pH Study:

  • Test Set Sample Size: Urine samples with varying specific gravity (1.000-1.035) or pH (4-9) were spiked with target drugs at -25% and +25% Cut-Off levels. These were tested using three lots of each device.
  • Provenance: Laboratory-prepared spiked urine samples. This is a prospective lab study.

• Method Comparison Studies (Clinical):

  • Test Set Sample Size: For each drug (Amphetamine, Cocaine, Oxazepam) and each device format, 80 unaltered clinical samples were used (40 negative and 40 positive).
  • Provenance: These were "unaltered clinical samples." The country of origin is not specified, but they are clearly retrospective samples (collected from a clinical setting).

• Lay-user Study:

  • Test Set Sample Size: 1680 lay persons participated. Each participant tested 1 blind-labeled sample. For each drug and each device format, there were 7 concentration levels tested (0, 75, 150, 225, 375, 450, 525 ng/mL corresponding to percentages of cutoff) with 20 samples per concentration level. So, 7 concentrations * 20 samples = 140 samples tested by lay users for each drug/device format.
  • Provenance: Urine samples were "prepared at the following concentrations... by spiking drug(s) into drug free-pooled urine specimens." The concentrations were confirmed by GC/MS. This makes them laboratory-prepared samples for a prospective lay-user study.

3. Number of Experts and Qualifications for Ground Truth

• Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH, Lay-user Studies: The ground truth for these studies was established by Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is a highly accurate analytical chemistry technique considered the "gold standard" for confirming the presence and concentration of drugs in urine. It is an objective laboratory method and therefore does not rely on human experts for establishing ground truth in the same way imaging-based diagnostic tests might use radiologists.

• Method Comparison Studies: The ground truth for these studies was also established by GC/MS results. The document states, "The samples were blind labeled and compared to GC/MS results." For these studies, the device results were compared to the GC/MS results. The method comparison studies mention "three laboratory assistants" who ran the devices, but their role was to operate the device and record its output, not to establish the ground truth.

4. Adjudication Method for the Test Set

• Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH, Lay-user Studies: The ground truth was established by GC/MS, which is an objective chemical analysis. There was no human expert adjudication method (like 2+1, 3+1, etc.) needed or performed to establish the ground truth for these studies. The determination of positive/negative by the device was compared directly to the quantitative GC/MS value relative to the specified cut-off.

• Method Comparison Studies: The samples were "blind labeled and compared to GC/MS results." This implies a direct comparison, not an adjudication process involving multiple human readers of the ground truth. The "three laboratory assistants" were viewers of the device results.

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

• No MRMC comparative effectiveness study was done in the sense of human readers interpreting the raw urine samples with and without AI assistance (the device) to assess an effect size.
• The "Method Comparison Studies" involved "three laboratory assistants" (viewers) interpreting the results of the device and comparing these to GC/MS. This is a multi-reader study of the device's output, not a study of human readers' improvement with AI (the device) versus without it. The device itself is an "immunochromatographic assay," not an AI algorithm in the typical sense of machine learning in medical imaging.

6. Standalone (Algorithm Only) Performance Study

• Yes, the device's performance is inherently a standalone performance. The "CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, and CLUNGENE Oxazepam Tests are immunochromatographic assays..." which produce a visual result (a colored line or its absence). The studies detailed (Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH) all assess the performance of the device itself (the "algorithm" or immunoassay in this context) against a known standard (GC/MS concentrations). The method comparison and lay-user studies also evaluate how human operators read the device's standalone output.

7. Type of Ground Truth Used

• The primary ground truth used for all performance studies was Gas Chromatography/Mass Spectrometry (GC/MS) results. This is an objective, highly accurate analytical chemistry method used to determine the exact concentration of the target drugs in the urine samples.

8. Sample Size for the Training Set

• This document describes a 510(k) submission for an in vitro diagnostic (IVD) test, which is a immunoassay device, not a machine learning or AI algorithm in the common sense that requires a "training set" for model development. Therefore, there is no mention or requirement for a training set in this context. The device's "training" is inherent in its chemical design and manufacturing process.

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

• As stated in point 8, there is no "training set" for these immunochromatographic assays. The performance is determined by the specific reagents, antibodies, and manufacturing consistency.

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Clungene Methamphetamine Tests are immunochromatographic assays for the qualitative determination of dmethamphetamine in human urine at cut-off concentration of 1000 ng/mL. The calibrator is d-methamphetamine. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.

Clungene Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-△9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The calibrator is 11-Nor-△9-Tetrahydrocannabinol-9-COOH. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. This test is intended for over-the-counter (OTC) consumer use 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, is provided in the package labeling. For in vitro diagnostic use only.

Clungene Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 300 ng/mL. The callbrator is Morphine. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. This test is intended for over the counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.

The CLUNGENE Methamphetamine Tests, CLUNGENE Morphine Tests, and CLUNGENE Marijuana Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Methamphetamine, Morphine and 11-Nor-A9-Tetrahydrocannabinol-9-COOH (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

Here's a breakdown of the acceptance criteria and study information for the Clungene Methamphetamine, Morphine, and Marijuana Tests, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for accuracy, sensitivity, or specificity that the device must meet for approval. Instead, it describes performance characteristics and then presents the results of those studies. The implicit acceptance criteria appear to be the demonstrated performance of the device showing appropriate qualitative detection relative to the cut-off concentrations when compared to GC/MS, and user readability for OTC use.

Performance Characteristics Summary (Implicit Acceptance Criteria and Reported Performance)

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

• Professional User (Method Comparison) Test Set:
  • Sample Size: 80 unaltered clinical urine samples per drug (40 negative, 40 positive).
  • Data Provenance: Retrospective, described as "in-house" studies using "unaltered clinical samples." The country of origin is not explicitly stated, but the manufacturer is based in China.
• Lay-user Study Test Set:
  • Sample Size:
    • Participants: 1680 lay persons.
    • Samples: 1 device per participant, with one blind-labeled urine sample.
    • For each drug (Methamphetamine, Morphine, Marijuana) and each device format (Cassette, Dip Card, Split-Key Cup, Easy Cup), there were a total of 7 concentrations tested. For each concentration, 20 samples were used.
    • Total samples per drug (e.g., Methamphetamine): 7 concentrations * 20 samples/concentration = 140 samples.
    • Total samples for all 3 drugs across all 4 device formats: 3 drugs * 4 device formats * (7 concentrations * 20 samples/concentration) = 3 * 4 * 140 = 1680 samples. This matches the number of lay persons, implying each lay person tested one sample with one device.
  • Data Provenance: Prospective, as it involved lay persons testing samples. The study was performed "at three intended user sites," but the country of origin for these sites is not specified. Samples were prepared by spiking known drug concentrations into drug-free pooled urine.

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

• Professional User (Method Comparison) Test Set:
  • Number of "Experts": Three "laboratory assistants" were involved in running the visual tests for comparison. Their qualifications are not specified beyond being "laboratory assistants."
  • Ground Truth: The ground truth for the clinical samples was established by Gas Chromatography/Mass Spectrometry (GC/MS) results. This is considered the gold standard for drug quantification.
• Lay-user Study Test Set:
  • Number of Experts: No explicit "experts" were used to establish the ground truth for reading the device results in this specific study, as the lay users were the test subjects. The ground truth for the sample concentrations was established by GC/MS.

4. Adjudication Method for the Test Set

• Professional User (Method Comparison) Test Set: No formal adjudication method (like 2+1 or 3+1) is described for the visual interpretation by the three laboratory assistants. Each assistant's interpretation was recorded and compared to the GC/MS ground truth. Discordant results between the device and GC/MS were tabulated for each viewer individually.
• Lay-user Study Test Set: No adjudication. Each lay user read their own device result.

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 such MRMC comparative effectiveness study was done. The device is a qualitative immunochromatographic assay for drug detection, not an AI interpretation system.

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

This is not applicable as the device is a manual, visually interpreted immunochromatographic assay, not an algorithm or AI system. Its performance is inherently "standalone" in that it produces a visual result without external algorithm assistance for interpretation, but it always requires human observation and interpretation.

7. The Type of Ground Truth Used

• For all studies (Precision, Cut-off, Specificity, Interference, Method Comparison, Lay-user): The primary ground truth for the presence and concentration of drugs in urine samples was Gas Chromatography/Mass Spectrometry (GC/MS). This is considered a highly accurate and quantitative analytical method.

8. The Sample Size for the Training Set

This information is not provided. The document describes performance testing of the finished device. For immunochromatographic assays, there isn't typically a "training set" in the machine learning sense. Instead, development involves R&D to optimize reagents, membrane materials, and assay parameters. The performance studies described serve to validate the finalized design.

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

Not applicable, as a "training set" in the AI sense is not relevant for this type of device. During the development and optimization of the assay, standard reference materials of known drug concentrations (confirmed by methods like GC/MS) would be used to evaluate and refine the test's linearity, sensitivity, and specificity.

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