(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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2015
NANTONG EGENS BIOTECH CO., LTD. C/O JOE SHIA BUSINESS DIRECTOR 504 EAST DIAMOND AVE. SUITE I GAITHERSBURG, MD 20877
Re: K152643
Trade/Device Name: EGENS Urine Test Marijuana (THC) EGENS Urine Test MDMA Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: II Product Code: LDJ, LAF Dated: September 9, 2015 Received: September 15, 2015
Dear Mr. Joe Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152643
Device Name EGENS Urine Test Cup THC-MDMA EGENS Urine Test DipCard THC-MDMA EGENS Urine Test Cassette Marijuana
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) SUMMARY
| 1. Date: | October 26, 2015 | |
|---|---|---|
| Submitter: | NANTONG EGENS BIOTECHNOLOGY, LTD.Building 15, 1692 Xinghu Avenue,Nantong 226010, China | |
| 2. Contact person: | Yan CaoNANTONG EGENS BIOTECHNOLOGY, LTD.Building 15, 1692 Xinghu Avenue,Nantong 226010, ChinaPhone: 86-0513-85920700Email: cyhfhjn@163.com | |
| 3. Device Name: | EGENS Urine Test Marijuana (THC) |
EGENS Urine Test MDMA
| Classification: | Class II | |
|---|---|---|
| Product Code | CFR # | Panel |
| LDJ | 21 CFR, 862.3870 Cannabinoids Test System | Toxicology |
| LAF | 21 CFR, 862.3610 MethylenedioxymethamphetamineTest System | Toxicology |
- Predicate Devices: K142580
Chemtrue Multi-Panel DOA DipCard Tests
5. Intended Use:
EGENS Urine Test Marijuana (THC) is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL. The tests are available in a Cassette format, a Cup format and a Dip Card format.
EGENS Urine Test Marijuana (THC) 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..
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EGENS Urine Test MDMA is is a rapid for the qualitative test detection of Methylenedioxymethamphetamine in human urine at a cutoff concentration of 500 ng/mL. The tests are available in a Cup format and a Dip Card format.
EGENS Urine Test 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.
6. Device Description:
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.
| Item | Candidate Device | Predicate - K142580 |
|---|---|---|
| EGENS Urine Test Marijuana(THC) | ||
| Indication(s)for use | For the qualitative determination ofCannabinoids in human urine | Same |
| Methodology | Competitive binding, lateral flowimmunochromatographic assaysbased on the principle of antigenantibody immunochemistry. | Same |
| Results | Qualitative | Same |
| SpecimenType | Human urine | Same |
| Cut Off Values | Cannabinoids: 50ng/ml | Same for Cannabinoids |
| Configurations | Cup, Cassette and Dipcard | Dipcard |
| Conditions forUse | Over-the-Counter & PrescriptionUse | Same |
-
- Substantial Equivalence Information
| Item | Candidate Device | Predicate - K142580 |
|---|---|---|
| EGENS Urine Test MDMA |
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| Indication(s)for use | For the qualitative determination ofMethylenedioxymethamphetaminein human urine | Same |
|---|---|---|
| Methodology | Competitive binding, lateral flowimmunochromatographic assaysbased on the principle of antigenantibody immunochemistry. | Same |
| Results | Qualitative | Same |
| SpecimenType | Human urine | Same |
| Cut Off Values | Methylenedioxymethamphetamine:500ng/ml | Same for MDMA |
| Configurations | Cup and Dipcard | Dipcard |
| Conditions forUse | Over-the-Counter & PrescriptionUse | Same |
8. Test Principle
The EGENS Urine Test MDMA is a rapid test for the qualitative detection of Methylenedioxymethamphetamine in urine samples. The EGENS Urine Test Marijuana (THC) is a rapid test for the qualitative detection of Cannabinoids in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.
9. Performance Characteristics
1. Analytical Performance
- a. Precision
Precision studies were carried out for samples with concentrations of -100% cut-off, -75% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +75% cut-off and +100% cut-off. For each concentration, tests were performed two runs per day by three operators for 25 days. All sample aliquots were masked and randomized. The results obtained are summarized in the following tables:
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| ResultTHC | -100%cut-off | -75%cut-off | -50%cut-off | -25%cut-off | cut-off | +25%cut-off | +50%cut-off | +75%cut-off | +100%' cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 46-/4+ | 32+/18- | 46+/4- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 46-/4+ | 31+/19- | 46+/4- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 46-/4+ | 33+/17- | 46+/4- | 50+/0- | 50+/0- | 50+/0- |
A. For Marijuana (THC) DipCard
B. For Methylenedioxymethamphetamine (MDMA) DipCard
| ResultMET | -100%cut-off | -75%cut-off | -50%cut-off | -25%cut-off | cut-off | +25%cut-off | +50%cut-off | +75%cut-off | +100%cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 30+/20- | 46+/4- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 30+/20- | 46+/4- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 30+/20- | 46+/4- | 50+/0- | 50+/0- | 50+/0- |
C. For Marijuana (THC) Cup
| ResultTHC | -100%cut-off | -75%cut-off | -50%cut-off | -25%cut-off | cut-off | +25%cut-off | +50%cut-off | +75%cut-off | +100%cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 46-/4+ | 30+/20- | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 46-/4+ | 33+/17- | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 46-/4+ | 33+/17- | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
D. For Methylenedioxymethamphetamine (MDMA) Cup
| ResultMET | -100%cut-off | -75%cut-off | -50%cut-off | -25%cut-off | cut-off | +25%cut-off | +50%cut-off | +75%cut-off | +100%cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 31+/19- | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 31+/19- | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 31+/19- | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
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| ResultTHC | -100%cut-off | -75%cut-off . | -50%cut-off | -25%cut-off | cut-off | +25%cut-off | +50%cut-off | +75%cut-off | +100%cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 33+/17- | 46+/4- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 31+/19- | 46+/4- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 31+/19- | 46+/4- | 50+/0- | 50+/0- | 50+/0- |
E. For Marijuana (THC) Cassette
b. Linearity
Not applicable.
c. Stability
The EGENS Urine Test MDMA and the EGENS Urine Test Marijuana (THC) are stable at 4-30°C for 24 months as determined by conducting accelerated and real-time stability testing.
Control materials are not provided with the device. The labeling provides information on how to obtain control materials.
- d. Cut-off
Cut-off studies were conducted using a total of 125 Cannabinoids samples and 125 Methylenedioxymethamphetamine samples equally distributed at concentrations of -50%, -25%, at the cut-off, +25%, +50% of their respective cut-offs. These samples were tested using three different lots by three different operators. Results were all positive at +50% cut-off and all negative at -50% cut-off for both Cannabinoids and Methylenedioxymethamphetamine. The following cut-off values for the test devices have been verified.
| Test | Calibrator | Cut-off (ng/ml) | |
|---|---|---|---|
| Marijuana (THC ) | Cannabinoids | રા | |
| Methylenedioxymethamphetamine (MDMA) | Methylenedioxymethamphetamine | 500 |
e. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to urine containing Cannabinoids. These urine samples were tested using three lots of the EGENS Urine Test Marijuana (THC) devices by three different operators. There were no differences observed for different formats of the device. Compounds that showed no interference at a concentration of 100µg/mL are summarized below:
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Cannabinoids
| 4-Acetamidophenol | Diphenhydramine | Oxalic acid |
|---|---|---|
| Acetophenetidin | Doxylamine | Oxazepam |
| N-Acetvprocainamide | Ecaonine dydrochloride | Oxolinic acid |
| Acetvsalicylic acid | Ecqonine methylester | Pentobarbital |
| Aminopvrine | Ephedrine | Perphenazine |
| Amityptvline | Fenoprofen | Phencyclidine |
| Amorbarbital | Furosemide | Phenelzine |
| Amoxicillin | Gentisic acid | Phenobarbital |
| Ampicillin | Hemoglobin | Phentermine |
| 1-Ascorbic Acid | Hydrocortisone | L-Phenylephrine |
| Amphetamine | O-Hydroxyhippuric acid | (+/-)Phenylethylamine |
| Aporpmorphine | p-Hydroxy-methamphetamine | Phenylpropanotamine |
| Aspartame | 3-Hydroxytyramine | Prednisone |
| Atropine | Ibuprofen | D.L-Propanolol |
| Benzillic acid | Imipramine | D-Propoxyphene |
| Benzoic acid | Iproniazid | D-Pseudoephedrine |
| Benzoylecaonine | (±)Isoproterenol | Quinine |
| Benzphetamine | Isoxsuprine | Ranitidine |
| Bilirubin | Ketamine | Salicylic acid |
| Caffeine | Ketoprofen | Secobarbital |
| Cannabidiol | Labetalol | Serotonin |
| (5-Hydroxytyramine) | ||
| Chloralhydrate | Loperamide | Sulfamethazine |
| Chloramphenicol | Maprotiline | Sulindac |
| Chlordiazepoxide | Meperidine | Temazepam |
| Chlorothiazide | Meprobamate | Tetrahydrocortisone,3 |
| Acetate | ||
| (±)Chlorpheniramine | Methadone | Tetrahydrocortisone,(ß-D |
| glucuronide) | ||
| Chlorpromazine | Methoxyphenamine | Tetrahydrozoline |
| Chloroquine | 3,4-Methylenedioxy-amphetamine | Thiamine |
| Cholesterol | Methylenedioxy- methamphetamine | Thioridazine |
| Clomipramine | Nalidixic acid | D.L-Tyrosine |
| Clonidine | Nalorphine | Tolbutamide |
| Cocaine hydrochloride | Naloxone | Triamterene |
| Cortisone | Naltrexone | Trifluoperazine |
| (-)cotinine | Naproxen | Trimethoprim |
| Creatinine | Niacinamide | Tryptamine |
| Dextromethorphan | Nifedipine | D.L-Tryptophan |
| Diazepam | Norethindrone | Yramine |
| Diclolrfenac | D-Norpropoxyphene | Uric acid |
| Diflunisal | Noscapine | Verapamil |
| Diaoxin | D.L-Octopamine | Zomepirac |
{10}------------------------------------------------
Potential interfering substances found in human urine of physiological or pathological conditions were added to urine containing Methylenedioxymethamphetamine. These urine samples were tested using three lots of the EGENS Urine Test MDMA devices by three different operators. There were no differences observed for different formats of the device. Compounds that showed no interference at a concentration of 100µg/mL are summarized below:
| Methylene dioxymethamphetamine | ||
|---|---|---|
| 4-Acetamidophenol | Diphenhydramine | Oxalic acid |
| Acetophenetidin | Doxylamine | Oxazepam |
| N-Acetvprocainamide | Ecaonine dydrochloride | Oxolinic acid |
| Acetvsalicylic acid | Ecqonine methylester | Pentobarbital |
| Aminopyrine | (-)-Ψ-Ephedrine | Perphenazine |
| Amitriptyline | Fenoprofen | Phencyclidine |
| Amorbarbital | Furosemide | Phenelzine |
| Amoxicillin | Gentisic acid | Phenobarbital |
| Ampicillin | Hemoglobin | Phentermine |
| 1-Ascorbic Acid | Hydrocortisone | L-Phenylephrine |
| Amphetamine | O-Hydroxyhippuric acid | Phenylethylamine |
| Aporphine | p-Hydroxy-methamphetamine | Phenylpropanotamine |
| Aspartame | 3-Hydroxytyramine | Prednisone |
| Atropine | Ibuprofen | D.L-Propanolol |
| Benzilic acid | Imipramine | D-Propoxyphene |
| Benzoic acid | Iproniazid | D-Pseudoephedrine |
| Benzoylecgonine | (±)Isoproterenol | Quinine |
| Benzphetamine | Isoxsuprine | Ranitidine |
| Bilirubin | Ketamine | Salicylic acid |
| Caffeine | Ketoprofen | Secobarbital |
| Cannabidiol | Labetalol | Serotonin (5-Hydroxytyramine) |
| Chloralhydrate | Loperamide | Sulfamethazine |
| Chloramphenicol | Maprotiline | Sulindac |
| Chlordiazepoxide | Meperidine | Temazepam |
| Chlorothiazide | Meprobamate | Tetrahydrocortisone,3 Acetate |
| (±)Chlorpheniramine | Methadone | Tetrahydrocortisone,(β-Dglucuronide) |
| Chlorpromazine | Methoxyphenamine | Tetrahydrozoline |
Methylenedioxymethamphetamine
{11}------------------------------------------------
| Chlorquine | 3,4-Methylenedioxy-amphetamine | Thiamine |
|---|---|---|
| Cholesterol | 3,4-Methylenedioxy-methamphetamine | Thioridazine |
| Clomipramine | Nalidixic acid | D.L-Tyrosine |
| Clonidine | Nalorphine | Tolbutamide |
| Cocaine hydrochloride | Naloxone | Triamterene |
| Cortisone | Naltrexone | Trifluoperazine |
| (-)cotinine | Naproxen | Trimethoprim |
| Creatinine | Niacinamide | Tryptamine |
| Dextromethlorphan | Nifedipine | D.L-Tryptophan |
| Diazepam | Norethindrone | Yyramine |
| DicloIrfenac | D-Norpropoxyphene | Uric acid |
| Diflunisal | Noscapine | Verapamil |
| Diaoxin | D.L-Octopamine | Zomepirac |
f. Specificity
To test the specificity, drug metabolites and other components that are likely to be present in urine samples were tested. The target drug Cannabinoids, its drug metabolites and the related compounds were tested using three lots of the EGENS Urine Test Marijuana (THC) for each format of the devices by three different operators. The target drug Methylenedioxymethamphetamine, its drug metabolites and the related compounds were tested using three lots of the EGENS Urine Test MDMA for each format of the devices by three different operators. These drug metabolites and components were tested at different concentrations. The obtained lowest detectable concentration was used to calculate the cross-reactivity. Results are shown in the following tables. There were no differences observed for different formats for each of the drug devices.
| THC(Cut-off=50 ng/mL) | Result | %Cross-Reactivity |
|---|---|---|
| 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH | Positive at 50 ng/mL | 100% |
| 11-Hydroxy-Δ9-Tetrahydrocannabinol | Positive at 5000 ng/mL | 1% |
| 11-Nor-Δ8-Tetrahydrocannabinol-9-COOH | Positive at 50 ng/mL | 100% |
| Cannabinol | Positive at 20000 ng/mL | 0.3% |
| Δ8-Tetrahydrocannabinol | Positive at 10000 ng/mL | 0.5% |
{12}------------------------------------------------
| △9-Tetrahydrocannabinol | Positive at10000 ng/mL | 0.5% |
|---|---|---|
| Cannabidiol | Positive at20000 ng/mL | 0.3% |
| 11-Nor-Δ9-THC-carboxy glucuronide | Positive at2500 ng/mL | 2% |
| (-)-11-nor-9-carboxy-Δ 9-THC | Positive at2500 ng/mL | 2% |
| MDMA(Cut-off=500 ng/mL) | Result | %Cross-Reactivity |
|---|---|---|
| D,L-3,4-Methylenedioxymethamphetamine(MDMA) | Positive at 500 ng/mL | 100% |
| 3,4- MethylenedioxymethamphetamineHCl (MDA) | Positive at 3,000 ng/mL | 16.7% |
| 3,4-Methylenedioxymethy-amphetamine(MDEA) | Positive at 1,000 ng/mL | 50% |
| d-methamphetamine | > 50,000ng/mL | <1% |
| d-amphetamine | > 50,000ng/mL | <1% |
| l-amphetamine | > 50,000ng/mL | <1% |
| l-methamphetamine | > 50,000ng/mL | <1% |
g. Effect of Specific Gravity and Urine pH
Twelve urine samples of normal, high, and low specific gravity ranges (1.000 to 1.035) were collected and spiked with Cannabinoids at 25% below and 25% above the THC cut-off level. These samples were tested using three lots of each of the EGENS Urine Test Marijuana (THC) devices (DipCard, Cup, and Cassette) by three different operators.
Twelve urine samples of normal, high, and low specific gravity ranges (1.000 to 1.035) were collected and spiked with Methylenedioxymethamphetamine at 25% below and 25% above the MDMA cut-off level. These samples were tested using three lots of each of the EGENS Urine Test MDMA devices (DipCard and Cup) by three different operators.
The pH of an aliquot negative urine pool was adjusted to pH ranges of 4.00 to 9.00 in 1 pH unit increments and spiked with Cannabinoids at 25% below and 25% above the THC cut-off level. These samples were tested using three lots of each of the EGENS Urine Test Marijuana (THC) devices (DipCard, Cup, and Cassette) by three different operators.
{13}------------------------------------------------
The pH of an aliquot negative urine pool was adjusted to pH ranges of 4.00 to 9.00 in 1 pH unit increments and spiked with Methylenedioxymethamphetamine at 25% below and 25% above the MDMA cut-off level. These samples were tested using three lots of each of the EGENS Urine Test MDMA devices (DipCard and Cup) by three different operators.
The device performance was found to not be affected by varying specific gravity and pH. There were no differences observed for different formats.
-
- Comparison Studies
The method comparison for the EGENS Urine Test Marijuana (THC) were performed in-house with three laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples were masked and randomized. The obtained test results were compared to GC/MS results. The results are presented in the table below:
- Comparison Studies
| GroupOperators | Negative | LowNegative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Betweenthe cutoffand +50%) | HighPositive byGC/MS(greaterthan +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 1 | 14 | 25 |
| Negative | 14 | 12 | 13 | 1 | 0 | |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 25 |
| Negative | 14 | 12 | 13 | 1 | 0 | |
| Viewer C | Positive | 0 | 0 | 1 | 14 | 25 |
| Negative | 14 | 12 | 13 | 1 | 0 |
Cannabinoids DipCard
Discordant table:
| Viewer | Sample number | GC/MS result | Chemical Entity by GC/MS | Viewer result |
|---|---|---|---|---|
| Viewer A | A1422 | 48 | positive | |
| Viewer A | A1440 | 52 | negative | |
| Viewer B | A1452 | 49 | positive | |
| Viewer B | A1440 | 52 | 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH | negative |
| Viewer C | A1452 | 49 | positive | |
| Viewer C | A1418 | 52 | negative |
{14}------------------------------------------------
Cannabinoids Cup
| GroupOperators | Negative | LowNegative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Betweenthe cutoffand +50%) | HighPositive byGC/MS(greaterthan +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 0 | 13 | ਨਵ |
| Negative | 14 | 12 | 14 | 2 | 0 | |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 25 |
| Negative | 14 | 12 | 13 | 1 | 0 | |
| Viewer C | Positive | 0 | 0 | 1 | 14 | 25 |
| Negative | 14 | 12 | 13 | 1 | 0 |
Discordant table:
| Viewer | Sample number | GC/MS result | Chemical Entity by GC/MS | Viewer result |
|---|---|---|---|---|
| Viewer A | A1401 | 53 | negative | |
| Viewer A | A1418 | 52 | negative | |
| Viewer B | A1422 | 48 | 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH | positive |
| Viewer B | A1461 | 52 | negative | |
| Viewer C | A1452 | 49 | positive | |
| Viewer C | A1440 | 52 | negative |
Cannabinoids Cassette
| GroupOperators | Negative | LowNegative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Betweenthe cutoffand +50%) | HighPositive byGC/MS(greaterthan +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 1 | 13 | 25 |
| Negative | 14 | 12 | 13 | 2 | 0 | |
| Viewer B | Positive | 0 | 0 | 1 | 13 | 25 |
| Negative | 14 | 12 | 13 | 2 | 0 | |
| Viewer C | Positive | 0 | 0 | 1 | 14 | 25 |
| Negative | 14 | 12 | 13 | 1 | 0 |
Discordant table:
| Viewer | Sample number | GC/MS result | Chemical Entity by GC/MS | Viewer result |
|---|---|---|---|---|
| Viewer A | A1452 | 49 | 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH | positive |
| Viewer A | A1418 | 52 | negative |
{15}------------------------------------------------
| Viewer A | A1461 | 52 | negative |
|---|---|---|---|
| Viewer B | A1422 | 48 | positive |
| Viewer B | A1440 | 52 | negative |
| Viewer B | A1461 | 52 | negative |
| Viewer C | A1422 | 48 | positive |
| Viewer C | A1418 | 52 | negative |
The method comparison for the EGENS Urine Test MDMA were performed in-house with three laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were masked and randomized. The obtained test results were compared to GC/MS results. The results are presented in the table below:
Methylenedioxymethamphetamine DipCard
| GroupOperators | Negative | LowNegative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Betweenthe cutoffand +50%) | HighPositive byGC/MS(greaterthan +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 0 | 10 | 26 |
| Negative | 10 | 18 | 12 | 4 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 9 | 26 |
| Negative | 10 | 18 | 12 | 5 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 10 | 26 |
| Negative | 10 | 18 | 12 | 4 | 0 |
Discordant table:
| Viewer | Sample number | GC/MS result | Chemical Entity by GC/MS | viewer results |
|---|---|---|---|---|
| Viewer A | A0918 | 505 | negative | |
| Viewer A | A0937 | 510 | negative | |
| Viewer A | A0953 | 513 | negative | |
| Viewer A | A0979 | 506 | negative | |
| Viewer B | A0916 | 520 | negative | |
| Viewer B | A0918 | 505 | negative | |
| Viewer B | A0937 | 510 | D,L-3,4-Methylenedioxymethamphetamine | negative |
| Viewer B | A0953 | 513 | negative | |
| Viewer B | A0979 | 506 | negative | |
| Viewer C | A0918 | 505 | negative | |
| Viewer C | A0937 | 510 | negative | |
| Viewer C | A0953 | 513 | negative | |
| Viewer C | A0979 | 506 | negative |
{16}------------------------------------------------
Methylenedioxymethamphetamine Cup
| GroupOperators | Negative | Low Negative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Betweenthe cutoffand +50%) | HighPositive byGC/MS(greaterthan +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 0 | 10 | 26 |
| Negative | 10 | 18 | 12 | 4 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 10 | 26 |
| Negative | 10 | 18 | 12 | 4 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 10 | 26 |
| Negative | 10 | 18 | 12 | 4 | 0 |
Discordant table:
| Viewer | Sample number | GC/MS result | Chemical Entity by GC/MS | viewer results |
|---|---|---|---|---|
| Viewer A | A0918 | 505 | negative | |
| Viewer A | A0937 | 510 | negative | |
| Viewer A | A0953 | 513 | negative | |
| Viewer A | A0979 | 506 | negative | |
| Viewer B | A0918 | 505 | negative | |
| Viewer B | A0937 | 510 | D,L-3,4- | negative |
| Viewer B | A0953 | 513 | Methylenedioxymethamphetamine | negative |
| Viewer B | A0979 | 506 | negative | |
| Viewer C | A0918 | 505 | negative | |
| Viewer C | A0937 | 510 | negative | |
| Viewer C | A0953 | 513 | negative | |
| Viewer C | A0979 | 506 | negative |
Lay-user study
A lay user study was performed at three intended user sites with 700 lay persons, of which, 100 tested for drug-free samples only, 360 for Cannabinoids samples only, and 240 for Methylenediox ymethamphetamine samples only. They had diverse educational and professional backgrounds and ranged in age from 21 to >50 years. Urine samples were prepared at the following concentrations; -100%, -- 75%, +/- 50%, +/- 25% of the cut-off by spiking each drug into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers, blind-labeled and randomized. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below:
| EGENS Marijuana Cassette format | OTC user | % Agreement | |||
|---|---|---|---|---|---|
| Drug | Concentration | Number of samples | Negative | Positive | With GC/MS |
{17}------------------------------------------------
| Drug -free | -100% | 20 | 20 | 0 | 100% |
|---|---|---|---|---|---|
| Cannabinoids | -75% | 20 | 20 | 0 | 100% |
| -50% | 20 | 20 | 0 | 100% | |
| -25% | 20 | 18 | 2 | 90% | |
| +25% | 20 | 3 | 17 | 85% | |
| +50% | 20 | 0 | 20 | 100% | |
| +75% | 20 | 0 | 20 | 100% |
| EGENS Marijuana DipCard format | OTC user | % Agreement | |||
|---|---|---|---|---|---|
| Drug | Concentration | Number of samples | Negative | Positive | With GC/MS |
| Drug -free | -100% | 20 | 20 | 0 | 100% |
| Cannabinoids | -75% | 20 | 20 | 0 | 100% |
| -50% | 20 | 20 | 0 | 100% | |
| -25% | 20 | 18 | 2 | 90% | |
| +25% | 20 | 3 | 17 | 85% | |
| +50% | 20 | 0 | 20 | 100% | |
| +75% | 20 | 0 | 20 | 100% |
| EGENS Marijuana Cup format | OTC user | % Agreement | |||
|---|---|---|---|---|---|
| Drug | Concentration | Number of samples | Negative | Positive | With GC/MS |
| Drug -free | -100% | 20 | 20 | 0 | 100% |
| Cannabinoids | -75% | 20 | 20 | 0 | 100% |
| -50% | 20 | 20 | 0 | 100% | |
| -25% | 20 | 18 | 2 | 90% | |
| +25% | 20 | 4 | 16 | 80% | |
| +50% | 20 | 0 | 20 | 100% | |
| +75% | 20 | 0 | 20 | 100% |
| EGENS MDMA DipCard format | OTC user | % Agreement | |||
|---|---|---|---|---|---|
| Drug | Concentration | Number of samples | Negative | Positive | With GC/MS |
| Drug -free | -100% | 20 | 20 | 0 | 100% |
| MDMA | -75% | 20 | 20 | 0 | 100% |
| -50% | 20 | 20 | 0 | 100% | |
| -25% | 20 | 18 | 2 | 90% | |
| +25% | 20 | 4 | 16 | 80% | |
| +50% | 20 | 0 | 20 | 100% | |
| +75% | 20 | 0 | 20 | 100% |
{18}------------------------------------------------
| EGENS MDMA Cup format | OTC user | % Agreement | |||
|---|---|---|---|---|---|
| Drug | Concentration | Number of samples | Negative | Positive | With GC/MS |
| Drug -free | -100% | 20 | 20 | 0 | 100% |
| MDMA | -75% | 20 | 20 | 0 | 100% |
| -50% | 20 | 20 | 0 | 100% | |
| -25% | 20 | 17 | 3 | 85% | |
| +25% | 20 | 3 | 17 | 85% | |
| +50% | 20 | 0 | 20 | 100% | |
| +75% | 20 | 0 | 20 | 100% |
Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed A Flesch-Kincaid reading analysis was performed on the package insert and the score revealed a reading grade level of less than 7.
3. Clinical Studies
Not applicable.
-
- Conclusion
Based on the test principle and performance characteristics of the device, it's concluded that EGENS Urine Test Marijuana (THC) and EGENS Urine Test MDMA devices are substantially equivalent to the predicate.
- Conclusion
§ 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).