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EGENS Urine Test Cup THC-MDMA is a rapid test for the qualitative detection of Cannabinoids and Methylenedioxymethamphetamine in human urine at a cutoff concentration of 50 ng/mL respectively. EGENS Urine Test Cup THC-MDMA test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. CCMS 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.

EGENS Urine Test DipCard THC-MDMA is a rapid test for the qualitative detection of Cannabinoids and Methylenedioxymethamphetamine in human urine at a cutoff concentration of 50 ng/mL and 500 ng/mL, respectively. EGENS Urine Test DipCard THC-MDMA 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. The tests are intended for over-the-counter and for prescription use.

EGENS Urine Test Cassette Marijuana is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

EGENS Urine Test Cassette Marijuana test provides only preliminary test results. A more specific alternative chemial method must be used in order to obtain a confirmed analytical result. CC/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. The tests are intended for over-the-counter and for prescription use.

EGENS Urine Test MDMA uses immunochromatographic assays for Methylenedioxymethamphetamine. These tests are lateral flow systems for the qualitative detection of Methylenedioxymethamphetamine in human urine. EGENS Urine Test Marijuana (THC) uses immunochromatographic assays for Cannabinoids. These tests are lateral flow systems for the qualitative detection of Cannabinoids in human urine. Each test is 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.

This document describes the performance of the EGENS Urine Test Marijuana (THC) and EGENS Urine Test MDMA devices. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are implicitly defined by their performance around the cutoff concentrations. For instance, samples significantly below the cutoff should test negative, and samples significantly above should test positive, with the most variability expected around the cutoff. The reported performance is based on precision studies and lay-user studies.

Precision Study Performance (Examples from THC DipCard and MDMA DipCard):

Lay-User Study Performance (Examples from THC Cassette and MDMA DipCard):

The acceptance criteria are generally that the device correctly identifies negative samples as negative and positive samples as positive, with some allowance for variability around the cutoff concentration. The high agreement percentages for samples significantly away from the cutoff (100% for -100%, -75%, -50% and +50%, +75%) demonstrate the device meets these criteria. The variability around the -25% and +25% cut-off points is expected for qualitative tests designed to provide a preliminary result.

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

• Precision Studies: For each concentration level (-100%, -75%, -50%, -25%, at cut-off, +25%, +75%, +100% cut-off) and for each of the three lots, tests were performed two runs per day by three operators for 25 days.
  • Total tests per concentration per lot: 2 runs/day * 3 operators = 6 tests per day. Over 25 days, this is 6 * 25 = 150 tests per concentration per lot. The results shown for each lot represent 50 tests (-/+) which implies 50 individual sample aliquots were tested (likely 1 aliquot per operator per day over some period, or 2 aliquots per day for 25 days by one operator per lot, etc., but the interpretation from the table is 50 results per lot per concentration).
  • Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing (in-house). The document does not specify the country of origin for the samples themselves. These samples were prepared by spiking known concentrations into urine.
• Method Comparison Studies (Clinical Samples):
  • Sample Size: 80 "unaltered clinical samples" for Cannabinoids (40 negative and 40 positive) for each format (DipCard, Cup, Cassette). 80 "unaltered clinical samples" for MDMA (40 negative and 40 positive) for each format (DipCard, Cup).
  • Data Provenance: "in-house" (presumably for testing execution). The origin of the "unaltered clinical samples" is not specified (e.g., country of origin, retrospective/prospective collection).
• Lay-user Study:
  • Sample Size: 700 lay persons in total.
    • 100 tested for drug-free samples only.
    • 360 for Cannabinoids samples only.
    • 240 for Methylenedioxymethamphetamine samples only.
  • Each participant was given 1 blind-labeled sample.
  • For each drug and concentration level shown in the tables (e.g., Cannabinoids -100%, -75% etc.), 20 samples were tested.
  • Data Provenance: Not explicitly stated beyond "performed at three intended user sites." The origin of the urine specimens (drug-free pooled urine spiked with drugs) is consistent with controlled laboratory preparation.

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

• For Precision, Cut-off, Interference, and Specificity Studies: The ground truth was established by preparing urine samples with known, spiked concentrations of the analytes. No human experts were used for this ground truth creation.
• For Method Comparison Studies (Clinical Samples): The ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a highly accurate and generally accepted confirmatory method for drug testing. No human experts were involved in establishing this ground truth, as it is an analytical chemical method.

4. Adjudication Method for the Test Set

• Precision, Cut-off, Interference, and Specificity Studies: Ground truth was based on spiked concentrations. Discrepancies between expected results and device results were noted and analyzed, but no adjudication by human experts was described as the samples had known concentrations.
• Method Comparison Studies (Clinical Samples): The device results were compared directly to the GC/MS results. Discordant results are presented, but there is no mention of an adjudication process (e.g., by experts) to resolve these discrepancies in the context of the study's conclusions. GC/MS results are generally considered the gold standard for confirmation.
• Lay-user Study: The ground truth was established by GC/MS for the spiked samples. The lay-users' interpretations of the device results were compared to these GC/MS confirmed concentrations.

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.
• These devices are qualitative urine drug screening tests for direct visual interpretation. They are not AI-assisted imaging or diagnostic devices that would typically involve human readers interpreting complex images with or without AI assistance. The "Viewers" mentioned in the method comparison study are likely laboratory assistants reading the test strips, and their role is to interpret the visual lines on the test, not to make complex diagnostic decisions.

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

• Yes, a standalone performance was done for the device itself. The device itself is a standalone, rapid immunoassay that produces a visual result inherently. There is no separate "algorithm" being evaluated beyond the chemical assay's performance.
• The "Precision" studies and "Cut-off" studies directly demonstrate the device's performance in detecting specific concentrations without human interpretation variability influencing the reported percentage agreements at extreme concentrations.
• The "Method Comparison Studies" compare the device's visual output (as interpreted by "Viewers") directly against GC/MS. This is a measure of the device's accuracy in producing a result that then is read.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Spiked Samples (for Precision, Cut-off, Interference, Specificity, and Lay-user Studies): Known concentrations of target analytes (Cannabinoids, MDMA) added to urine. This is a highly controlled laboratory method to establish ground truth.
• Gas Chromatography/Mass Spectrometry (GC/MS) (for Method Comparison Studies and confirmation for Lay-user Study samples): This is an advanced analytical chemical method, considered a gold standard for confirming the presence and concentration of drugs in urine.

8. The Sample Size for the Training Set

• Not applicable. These are lateral flow immunochromatographic assays, not machine learning or AI models with "training sets." The device's performance is based on its chemical and biological components, which are designed and manufactured, not "trained" in the computational sense.

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

• Not applicable, as there is no training set for this type of device.

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The EGENS Urine Test Cup Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively.

EGENS Urine Test Cup Morphine - Methamphetamine 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. The tests are intended for over-the-counter and for prescription use.

The EGENS Urine Test DipCard Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively.

EGENS Urine Test DipCard Morphine - Methamphetamine test provides only preliminary test results. A more specific alternative chemical 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. The tests are intended for over-the-counter and for prescription use.

EGENS Urine Test Morphine-Methamphetamine test uses immunochromatographic assays for Morphine and Methamphetamine. The test is a lateral flow system for the qualitative detection of Morphine and Methamphetamine in human urine. The test is 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.

The provided document describes the performance characteristics of the EGENS Urine Test Cup Morphine - Methamphetamine and EGENS Urine Test DipCard Morphine - Methamphetamine devices.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" but rather presents performance characteristics from various studies. For the purpose of this response, I infer the reported performance to be the intended criteria and thus list the results.

Morphine (MOP) and Methamphetamine (MET) Detection
Cut-off for Morphine: 300 ng/mL
Cut-off for Methamphetamine: 1000 ng/mL

2. Sample Size and Data Provenance

• Precision Studies: For each concentration level (-100%, -75%, -50%, -25%, cut-off, +25%, +50%, +75%, +100% cut-off), 50 tests were performed per lot. With 3 lots and 9 concentrations, this is 50 * 3 * 9 = 1350 tests per drug for each device format (Cup/DipCard).
  • Data Provenance: Not explicitly stated, but the studies were conducted in-house. This typically implies controlled lab conditions rather than real-world patient samples, but the samples themselves are referenced as "samples with concentrations."
• Cut-off Studies: A total of 125 morphine samples and 125 methamphetamine samples were used, equally distributed across 5 concentration levels (-50%, -25%, cut-off, +25%, +50%).
  • Data Provenance: Not explicitly stated, but implied to be controlled, spiked samples.
• Interference/Specificity Studies: Samples were prepared by adding potential interfering substances or drug metabolites to urine containing target drugs. The quantity of samples is not explicitly given but implied to be sufficient for testing (e.g., "These samples were tested using three batches...").
  • Data Provenance: Not explicitly stated, likely controlled lab conditions.
• Effect of Specific Gravity and Urine pH: 12 urine samples covering normal, high, and low specific gravity ranges, and urine pH adjusted to 4.00-9.00 in 1 pH unit increments. These were spiked samples.
  • Data Provenance: Not explicitly stated, likely controlled lab conditions.
• Laboratory Comparison Studies: 80 "unaltered clinical samples" (40 negative and 40 positive) for each drug (Morphine and Methamphetamine) per device format (DipCard, Cup). This means 80 * 2 (drugs) * 2 (formats) = 320 samples in total for this part of the study.
  • Data Provenance: "Clinical samples" are explicitly stated, implying these are from actual patients rather than purely synthetic or spiked lab samples. The country of origin is not specified but the study was performed "in-house."
• Lay-User Study: 560 lay persons. The study used 80 "drug-free samples", 240 "morphine samples", and 240 "methamphetamine samples". Within these, the document describes 20 samples per concentration level (-100%, -75%, -50%, -25%, +25%, +50%, +75% of cut-off) per drug.
  • Data Provenance: Urine samples were "spiked drugs into drug free-pooled urine specimens." So, these were controlled, spiked samples, not unalterted clinical samples.

3. Number of Experts and their Qualifications for Ground Truth

• Laboratory Comparison Studies: "Three laboratory assistants" were involved in running the tests. Their qualifications are not specified beyond being "laboratory assistants."
• Precision, Cut-off, Interference, Specific Gravity/pH Studies: "Three operators" repeatedly tested the samples. Their qualifications are not specified.
• Lay-User Study: The "lay persons" were the "users" in this study, not "experts" establishing ground truth. There were 560 lay users. Their qualifications were described as having "diverse educational and professional backgrounds and ranged in age from 21 to >50 years."

4. Adjudication Method for the Test Set

• Laboratory Comparison Studies: The collected results from the three viewers/operators were directly compared to the GC/MS results. There is no explicit mention of an adjudication process (e.g., 2+1, 3+1) among the viewers to establish a consensual device output. Each viewer's result was compared to GC/MS independently.
• Other Studies (Precision, Cut-off, Interference, etc.): The results were aggregated from multiple operators/lots, but the tables present aggregated counts (e.g., 50-/0+, 33+/17-), not individual operator adjudication.
• Lay-User Study: Each participant was given one blind-labeled sample and a device. Their individual results were recorded and compared to the GC/MS ground truth. No adjudication between lay users is mentioned.

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

There is no mention of a formal MRMC comparative effectiveness study or analysis of how much human readers improve with AI vs. without AI assistance. The study involves human readers (operators/lay users) interpreting the results of the device, but it does not compare their performance with and without an AI or advanced assistance system. It is a standalone device performance comparison against GC/MS.

6. Standalone Performance Study (Algorithm only without Human-in-the-loop)

The devices described (EGENS Urine Test Cup and DipCard) are rapid, qualitative immunoassay tests that rely on visual interpretation of results (presence or absence of colored lines). They are not "algorithms" in the computational sense, and there is no "algorithm only" or "standalone" performance without human-in-the-loop, as human interpretation of the visual result is integral to the device's function. The "laboratory comparison study" and "lay-user study" assess the device's performance when interpreted by humans.

7. Type of Ground Truth Used

• Analytical Performance Studies (Precision, Cut-off, Interference, Specificity, Specific Gravity/pH): The ground truth was established by precise spiking of known concentrations of the target drug or interfering substances into drug-free urine.
• Laboratory Comparison Studies: GC/MS (Gas Chromatography/Mass Spectrometry) was used as the preferred confirmatory method and thus, the primary ground truth reference.
• Lay-User Study: GC/MS was used to confirm the concentrations of the spiked samples, serving as the ground truth.

8. Sample Size for the Training Set

The document describes premarket notification (510(k)) studies to demonstrate substantial equivalence, not the development of a predictive model or algorithm that would typically involve a "training set." Therefore, no training set size is mentioned or applicable in the context of these device types and studies. The tests are immunoassays, not machine learning models.

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

As stated above, this document does not describe the development of a device requiring a "training set" for a machine learning algorithm. The "training set" concept is not applicable here.

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