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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

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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