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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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Healgen THC One Step Marijuana Test is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a Cut-Off concentration of 50 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

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. 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. It is intended for over-the-counter and for prescription use.

Healgen mAMP One Step Methamphetamine Test is an immunochromatographic assay for the qualitative determination of methamphetamine in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

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. 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. It is intended for over-the-counter and for prescription use.

Immunochromatographic assays for Marijuana and Methamphetamine Urine Tests use a lateral flow, one step system for the qualitative detection of 11-nor-Δ9-THC-9-COOH and Methamphetamine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

The provided document describes the performance characteristics of the Healgen THC One Step Marijuana Test and the Healgen mAMP One Step Methamphetamine Test, and concludes that they are substantially equivalent to a predicate device.

Here's an analysis of the acceptance criteria and the studies that support it:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are implicitly defined by the results of the performance studies presented, primarily focused on their ability to correctly identify drug presence/absence at and around the specified cutoff concentrations. The studies demonstrate that for samples at or above +25% of the cutoff, the devices consistently show positive results, and for samples at or below -25% of the cutoff, they consistently show negative results. At the cutoff concentration, there is some variability, which is expected for qualitative tests.

Healgen THC One Step Marijuana Test (Cut-off: 50 ng/mL)

Healgen mAMP One Step Methamphetamine Test (Cut-off: 1000 ng/mL)

2. Sample Sizes and Data Provenance

• Precision Study: For each drug (THC and MET) and each format (Strip, Cassette, Cup, Dip Card), 8 concentrations (-100% cut off to +100% cut off) were tested. For each concentration, tests were performed two runs per day for 25 days. This implies 50 individual tests per concentration per lot, and 3 lots were used for each format.
  • Example for THC Strip: 8 concentrations x 50 tests/concentration x 3 lots = 1200 tests.
  • Data Provenance: The document does not explicitly state the country of origin but implies an in-house laboratory setting (referred to as "in-house" for comparison studies, and "prepared by spiking drug in negative samples" for precision, cut-off, and interference studies). The data is retrospective in the sense that samples were prepared and then tested. The urine samples were "negative samples" (for spiking) or "drug-free urine" (for interference), suggesting they were sourced specifically for testing purposes.
• Cut-off Verification Study: 150 samples were used, equally distributed at concentrations of -50%, -25%, Cut-Off, +25%, +50% Cut-Off. So, 30 samples per concentration.
  • Data Provenance: Similar to precision, prepared by spiking.
• Interference Study: Urine samples (drug-free and spiked with target drugs +/-25% Cut-Off) were used for testing various interfering substances. The number of samples per substance is not specified, but it was tested using three batches of each device for all formats.
  • Data Provenance: Assumed to be artificially created/spiked samples.
• Method Comparison Study: For each drug and each format, 80 unaltered clinical urine samples were used (40 negative, 40 positive).
  • Data Provenance: The samples are described as "clinical samples," suggesting real-world patient samples. The country of origin is not specified, but the study was performed "in-house." This is retrospective data.
• Lay-user Study: 140 lay persons participated. Urine samples were prepared at 7 different concentrations (negative, +/-75%, +/-50%, +25% of cutoff). For each concentration, 20 samples were prepared.
  • Data Provenance: Artificially prepared by spiking into drug-free pooled urine specimens.

3. Number of Experts and Qualifications for Ground Truth

• Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH:
  • The ground truth for these analytical performance studies was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and widely accepted gold standard method for quantifying drug concentrations in urine.
  • The document states that "Each drug concentration was confirmed by GC/MS" and that the "concentrations of the samples were confirmed by GC/MS." No human experts are explicitly mentioned for establishing ground truth from GC/MS results, as GC/MS is an objective analytical method.
• Method Comparison Study:
  • The ground truth for the 80 clinical samples was established by GC/MS results.
  • No specific number or qualifications of human experts are mentioned for interpreting the GC/MS results or establishing the ground truth from them.
• Lay-user Study:
  • Ground truth was established by GC/MS for the spiked urine samples.

4. Adjudication Method for the Test Set

• Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH: For these analytical studies, GC/MS was the objective reference. The testing was done by unspecified personnel; "sample aliquots were blinded labeled by the person who prepared the samples and won't take part in the sample testing" (precision study). This suggests a blinding mechanism but no explicit multi-reader adjudication process for the actual device results.
• Method Comparison Study: Three laboratory assistants were the "operators" who ran the devices and presumably interpreted the results. The comparison was against GC/MS. The individual results of each viewer are reported, and then discordant results are listed. There is no explicit mention of an adjudication method (e.g., 2+1, 3+1 consensus among the three viewers) to arrive at a single device result per sample if their interpretations differed. Each viewer's interpretation is compared independently to the GC/MS ground truth.
• Lay-user Study: The study involved "140 lay persons" each testing "1 blind labeled sample and a device." The "Lay person results" table shows aggregate counts of positive/negative results. It does not describe an adjudication process for discordant interpretations among lay users on a single sample, as each lay user tested a unique sample (or set of samples for the overall study) and their individual interpretation was the data point.

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

No MRMC comparative effectiveness study was described. The studies focused on the performance of the device itself, observed by laboratory assistants (method comparison) or lay users (lay-user study), against an objective ground truth (GC/MS). There is no comparison of "human readers improve with AI vs without AI assistance" because the device is a simple, qualitative immunochromatographic assay, not an AI-powered diagnostic system requiring human interpretation of complex AI outputs.

6. Standalone Performance Study (Algorithm Only)

The device itself is a standalone, qualitative diagnostic test (immunochromatographic assay). All the performance studies (precision, cut-off, interference, specificity, method comparison, lay-user study) assess the standalone performance of the device without human interpretation being the primary variable. The "human-in-the-loop" component is essentially the reading and interpretation of the colored lines on the test strip as positive or negative, which is intrinsic to this type of device. There isn't an "algorithm" in the sense of a sophisticated computational model that could be evaluated separately from the physical test.

7. Type of Ground Truth Used

The primary and consistently used ground truth for all analytical and comparative studies was GC/MS (Gas Chromatography/Mass Spectrometry). This is an objective, highly accurate analytical method for drug concentration determination.

8. Sample Size for the Training Set

The document does not describe the development of an "algorithm" or "AI" system that would typically require a training set. This is an immunochromatographic assay, which relies on chemical and biological reactions rather than machine learning algorithms. Therefore, there is no "training set" in the context of AI. The product validation data described (precision, cut-off, interference, specificity, method comparison) serves to demonstrate the device's performance, not to "train" it.

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

As there is no "training set" in the context of AI/algorithm development for this device, this question is not applicable. The device's inherent design and manufacturing processes are validated by the performance studies using GC/MS as the ground truth.

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