EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana

K152643 · Nantong Egens Biotech Co., Ltd. · LDJ · Nov 2, 2015 · Clinical Toxicology

Device Facts

• Record ID: K152643
• Device Name: EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana
• Applicant: Nantong Egens Biotech Co., Ltd.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Nov 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

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. EGENS Urine Test MDMA 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.

Device Story

Lateral flow immunochromatographic assay for qualitative detection of THC and MDMA in human urine; competitive binding principle using monoclonal mouse antibodies. Urine sample migrates via capillary action; target drug competes with drug-conjugate for antibody binding sites. Visible colored line indicates negative result (drug below cutoff); absence of line indicates positive result (drug above cutoff). Used in point-of-care or home settings by lay users or clinicians. Provides preliminary screening results; positive results require confirmatory testing via GC/MS. Assists healthcare providers in identifying potential substance use, necessitating clinical judgment for final decision-making.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical performance (precision, interference, specificity, pH/specific gravity effects) and a lay-user study (n=700). Lay-user study demonstrated high agreement with GC/MS results across various concentrations (-75% to +75% of cutoff). Analytical testing confirmed performance across three lots and three operators.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: Cup, Cassette, DipCard. Analyte-specific monoclonal mouse antibodies. No electronic components; non-powered. Stability: 4-30°C for 24 months.

Indications for Use

Indicated for qualitative detection of Cannabinoids (50 ng/mL) and Methylenedioxymethamphetamine (500 ng/mL) in human urine. Intended for over-the-counter and prescription use in individuals requiring drug screening. Preliminary results only; requires confirmation by GC/MS.

Regulatory Classification

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 include delta-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.

Special Controls

*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).

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.<br>Building 15, 1692 Xinghu Avenue,<br>Nantong 226010, China | |
| 2. Contact person: | Yan Cao<br>NANTONG EGENS BIOTECHNOLOGY, LTD.<br>Building 15, 1692 Xinghu Avenue,<br>Nantong 226010, China<br>Phone: [phone]<br>Email: [e-mail] | |
| 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 Methylenedioxymethamphetamine<br>Test System | Toxicology |

4. 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<br>(THC) | |
| Indication(s)<br>for use | For the qualitative determination of<br>Cannabinoids in human urine | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays<br>based on the principle of antigen<br>antibody immunochemistry. | Same |
| Results | Qualitative | Same |
| Specimen<br>Type | Human urine | Same |
| Cut Off Values | Cannabinoids: 50ng/ml | Same for Cannabinoids |
| Configurations | Cup, Cassette and Dipcard | Dipcard |
| Conditions for<br>Use | Over-the-Counter & Prescription<br>Use | Same |

- 7. Substantial Equivalence Information

| Item | Candidate Device | Predicate - K142580 |
|------|-----------------------|---------------------|
| | EGENS Urine Test MDMA | |

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| Indication(s)<br>for use | For the qualitative determination of<br>Methylenedioxymethamphetamine<br>in human urine | Same |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays<br>based on the principle of antigen<br>antibody immunochemistry. | Same |
| Results | Qualitative | Same |
| Specimen<br>Type | Human urine | Same |
| Cut Off Values | Methylenedioxymethamphetamine:<br>500ng/ml | Same for MDMA |
| Configurations | Cup and Dipcard | Dipcard |
| Conditions for<br>Use | Over-the-Counter & Prescription<br>Use | 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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| Result<br>THC | -100%<br>cut-off | -75%<br>cut-off | -50%<br>cut-off | -25%<br>cut-off | cut-off | +25%<br>cut-off | +50%<br>cut-off | +75%<br>cut-off | +100%<br>' 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

| Result<br>MET | -100%<br>cut-off | -75%<br>cut-off | -50%<br>cut-off | -25%<br>cut-off | cut-off | +25%<br>cut-off | +50%<br>cut-off | +75%<br>cut-off | +100%<br>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

| Result<br>THC | -100%<br>cut-off | -75%<br>cut-off | -50%<br>cut-off | -25%<br>cut-off | cut-off | +25%<br>cut-off | +50%<br>cut-off | +75%<br>cut-off | +100%<br>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

| Result<br>MET | -100%<br>cut-off | -75%<br>cut-off | -50%<br>cut-off | -25%<br>cut-off | cut-off | +25%<br>cut-off | +50%<br>cut-off | +75%<br>cut-off | +100%<br>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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| Result<br>THC | -100%<br>cut-off | -75%<br>cut-off . | -50%<br>cut-off | -25%<br>cut-off | cut-off | +25%<br>cut-off | +50%<br>cut-off | +75%<br>cut-off | +100%<br>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 |

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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-D<br>glucuronide) |
| Chlorpromazine | Methoxyphenamine | Tetrahydrozoline |

#### Methylenedioxymethamphetamine

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| Chlorquine | 3,4-Methylenedioxy-<br>amphetamine | Thiamine |
|-----------------------|----------------------------------------|-----------------|
| Cholesterol | 3,4-Methylenedioxy-<br>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<br>(Cut-off=50 ng/mL) | Result | %<br>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 at<br>10000 ng/mL | 0.5% |
|-----------------------------------|----------------------------|------|
| Cannabidiol | Positive at<br>20000 ng/mL | 0.3% |
| 11-Nor-Δ9-THC-carboxy glucuronide | Positive at<br>2500 ng/mL | 2% |
| (-)-11-nor-9-carboxy-Δ 9-THC | Positive at<br>2500 ng/mL | 2% |

| MDMA<br>(Cut-off=500 ng/mL) | Result | %<br>Cross-Reactivity |
|-----------------------------------------------------|-------------------------|-----------------------|
| D,L-3,4-<br>Methylenedioxymethamphetamine<br>(MDMA) | Positive at 500 ng/mL | 100% |
| 3,4- Methylenedioxymethamphetamine<br>HCl (MDA) | Positive at 3,000 ng/mL | 16.7% |
| 3,4-<br>Methylenedioxymethy-amphetamine(<br>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.

- 2. 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:

| Group<br>Operators | | Negative | Low<br>Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cutoff<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than +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

| Group<br>Operators | | Negative | Low<br>Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cutoff<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than +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

| Group<br>Operators | | Negative | Low<br>Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cutoff<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than +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

| Group<br>Operators | | Negative | Low<br>Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cutoff<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than +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-<br>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

| Group<br>Operators | | Negative | Low Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cutoff<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than +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.

- 10. 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.