(48 days)
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):
| Concentration Range | Expected Result | EGENS Urine Test Marijuana (THC) DipCard (Lot 1) - Reported Performance | EGENS Urine Test MDMA DipCard (Lot 1) - Reported Performance |
|---|---|---|---|
| -100% cut-off | Negative | 50-/0+ (100% Negative) | 50-/0+ (100% Negative) |
| -75% cut-off | Negative | 50-/0+ (100% Negative) | 50-/0+ (100% Negative) |
| -50% cut-off | Negative | 50-/0+ (100% Negative) | 50-/0+ (100% Negative) |
| -25% cut-off | Negative | 46-/4+ (92% Negative) | 47-/3+ (94% Negative) |
| cut-off | Variable | 32+/18- (64% Positive, 36% Negative) | 30+/20- (60% Positive, 40% Negative) |
| +25% cut-off | Positive | 46+/4- (92% Positive) | 46+/4- (92% Positive) |
| +50% cut-off | Positive | 50+/0- (100% Positive) | 50+/0- (100% Positive) |
| +75% cut-off | Positive | 50+/0- (100% Positive) | 50+/0- (100% Positive) |
| +100% cut-off | Positive | 50+/0- (100% Positive) | 50+/0- (100% Positive) |
Lay-User Study Performance (Examples from THC Cassette and MDMA DipCard):
| Drug | Concentration | Expected Result | EGENS Marijuana Cassette - Reported % Agreement with GC/MS | EGENS MDMA DipCard - Reported % Agreement with GC/MS |
|---|---|---|---|---|
| Drug -free | -100% | Negative | 100% | 100% |
| Cannabinoids | -75% | Negative | 100% | N/A |
| -50% | Negative | 100% | N/A | |
| -25% | Negative | 90% | N/A | |
| +25% | Positive | 85% | N/A | |
| +50% | Positive | 100% | N/A | |
| +75% | Positive | 100% | N/A | |
| MDMA | -75% | Negative | N/A | 100% |
| -50% | Negative | N/A | 100% | |
| -25% | Negative | N/A | 90% | |
| +25% | Positive | N/A | 80% | |
| +50% | Positive | N/A | 100% | |
| +75% | Positive | N/A | 100% |
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.
- Sample Size: 700 lay persons in total.
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.
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).