K Number

Device Name

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

Manufacturer

NANTONG EGENS BIOTECH CO., LTD.

Date Cleared

2015-11-02

(48 days)

Product Code

LDJ LAF

Regulation Number

862.3870

Intended Use

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.

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.

More Information

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Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K142580

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a standard immunochromatographic assay (lateral flow test) for qualitative detection, with no mention of AI or ML algorithms for analysis or interpretation.

Therapeutic

No.
The device is an in vitro diagnostic test for the qualitative detection of specific substances in human urine. It does not provide therapy or treatment.

Diagnostic

Yes
The text explicitly states "For in vitro diagnostic use only" in multiple sections describing the intended use of the devices.

SaMD (Software as a Medical Device)

The device is a physical test kit (lateral flow system) for detecting substances in urine, not a software application.

IVD (In Vitro Diagnostic)

Based on the provided text, the device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The text explicitly states "For in vitro diagnostic use only" multiple times for each described test format (Cup, DipCard, Cassette).
Intended Use: The intended use is the qualitative detection of substances (Cannabinoids and Methylenedioxymethamphetamine) in a human biological sample (urine). This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
Device Description: The device description details immunochromatographic assays and lateral flow systems, which are common technologies used in IVD tests.
Performance Studies: The performance studies described (analytical performance, comparison studies with GC/MS, lay-user study) are typical studies conducted to validate the performance of an IVD device.

Therefore, the device clearly falls under the category of an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

LDJ, LAF

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Comparison Studies Test Set:
Sample Size: 80 (40 negative and 40 positive) unaltered clinical samples for each device type (Cannabinoids and Methylenedioxymethamphetamine).
Data Source: Unaltered clinical samples.
Annotation protocol: Samples were masked and randomized. The obtained test results were compared to GC/MS results, which served as the reference method.

Lay-user study Test Set:
Sample Size: 700 lay persons (100 tested for drug-free samples only, 360 for Cannabinoids samples only, and 240 for Methylenedioxymethamphetamine samples only).
Data Source: Urine samples prepared by spiking drug into drug-free pooled urine specimens.
Annotation protocol: 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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

1. Analytical Performance

Precision:
- Study Design: 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 were tested. For each concentration, tests were performed two runs per day by three operators for 25 days, using three different lots of the devices.
- Sample Size: 50 tests per concentration per lot for each device.
- Key Results: Results are presented in tables showing positive/negative counts for each concentration and lot. For THC DipCard, Cup, and Cassette, samples at -50% cut-off and below were consistently negative (50-/0+ for -100%, -75%, -50%). At +50% cut-off and above, samples were consistently positive (50+/0- for +50%, +75%, +100%). At the cut-off, results varied (e.g., THC DipCard Lot 1: 32+/18-). Similar trends were observed for MDMA DipCard and Cup.
Linearity: Not applicable.
Stability: The devices are stable at 4-30°C for 24 months, determined by accelerated and real-time stability testing.
Cut-off:
- Study Design: 125 Cannabinoids samples and 125 Methylenedioxymethamphetamine samples were used, equally distributed at concentrations of -50%, -25%, at the cut-off, +25%, +50% of their respective cut-offs. Tested using three different lots by three different operators.
- Key Results: All samples were positive at +50% cut-off and all negative at -50% cut-off for both Cannabinoids and Methylenedioxymethamphetamine.
Interference:
- Study Design: Potential interfering substances (physiological or pathological conditions) were added to urine containing Cannabinoids/Methylenedioxymethamphetamine.
- Sample Size: Tested using three lots of the devices by three different operators.
- Key Results: No differences were observed for different device formats. Lists of compounds that showed no interference at 100µg/mL are provided for both Cannabinoids and Methylenedioxymethamphetamine.
Specificity (Cross-Reactivity):
- Study Design: Drug metabolites and related compounds were tested at different concentrations using three lots for each device format by three different operators.
- Key Results: Cross-reactivity percentages are calculated based on the lowest detectable concentration. For THC: 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH (100%), 11-Hydroxy-Δ9-Tetrahydrocannabinol (1%), 11-Nor-Δ8-Tetrahydrocannabinol-9-COOH (100%), Cannabinol (0.3%), Δ8-Tetrahydrocannabinol (0.5%), Δ9-Tetrahydrocannabinol (0.5%), Cannabidiol (0.3%), 11-Nor-Δ9-THC-carboxy glucuronide (2%), (-)-11-nor-9-carboxy-Δ 9-THC (2%). For MDMA: D,L-3,4-Methylenedioxymethamphetamine (100%), 3,4-Methylenedioxymethamphetamine HCl (16.7%), 3,4-Methylenedioxymethamphetamine (50%), d-methamphetamine (>50,000ng/mL), d-amphetamine (>50,000ng/mL), l-amphetamine (>50,000ng/mL), l-methamphetamine (>50,000ng/mL).
Effect of Specific Gravity and Urine pH:
- Study Design: Urine samples with normal, high, and low specific gravity (1.000 to 1.035) and pH (4.00 to 9.00) were spiked at 25% below and 25% above the cut-off level. Tested using three lots of each device format by three different operators.
- Key Results: Device performance was found to not be affected by varying specific gravity and pH. No differences observed for different formats.

2. Comparison Studies

Study Type: Method Comparison
Sample Size: 80 (40 negative and 40 positive) unaltered clinical samples for each drug (Cannabinoids, Methylenedioxymethamphetamine) for each format.
Key Results:
- Cannabinoids DipCard (80 samples):
  - Viewer A: 0 Positive, 14 Negative (Negative); 0 Positive, 12 Negative (Low Negative); 1 Positive, 13 Negative (Near Cutoff Negative); 14 Positive, 1 Negative (Near Cutoff Positive); 25 Positive, 0 Negative (High Positive).
  - Discordant samples listed with GC/MS result and view result (e.g., A1422 (GC/MS 48) - positive for Viewer A, A1440 (GC/MS 52) - negative for Viewer A).
- Cannabinoids Cup (80 samples):
  - Viewer A: 0 Positive, 14 Negative (Negative); 0 Positive, 12 Negative (Low Negative); 0 Positive, 14 Negative (Near Cutoff Negative); 13 Positive, 2 Negative (Near Cutoff Positive); 25 Positive, 0 Negative (High Positive).
  - Discordant samples listed (e.g., A1401 (GC/MS 53) - negative for Viewer A, A1418 (GC/MS 52) - negative for Viewer A).
- Cannabinoids Cassette (80 samples):
  - Viewer A: 0 Positive, 14 Negative (Negative); 0 Positive, 12 Negative (Low Negative); 1 Positive, 13 Negative (Near Cutoff Negative); 13 Positive, 2 Negative (Near Cutoff Positive); 25 Positive, 0 Negative (High Positive).
  - Discordant samples listed (e.g., A1452 (GC/MS 49) - positive for Viewer A, A1418 (GC/MS 52) - negative for Viewer A).
- Methylenedioxymethamphetamine DipCard (80 samples):
  - Viewer A: 0 Positive, 10 Negative (Negative); 0 Positive, 18 Negative (Low Negative); 0 Positive, 12 Negative (Near Cutoff Negative); 10 Positive, 4 Negative (Near Cutoff Positive); 26 Positive, 0 Negative (High Positive).
  - Discordant samples listed (e.g., A0918 (GC/MS 505) - negative for Viewer A, A0937 (GC/MS 510) - negative for Viewer A).
- Methylenedioxymethamphetamine Cup (80 samples):
  - Viewer A: 0 Positive, 10 Negative (Negative); 0 Positive, 18 Negative (Low Negative); 0 Positive, 12 Negative (Near Cutoff Negative); 10 Positive, 4 Negative (Near Cutoff Positive); 26 Positive, 0 Negative (High Positive).
  - Discordant samples listed (e.g., A0918 (GC/MS 505) - negative for Viewer A, A0937 (GC/MS 510) - negative for Viewer A).

3. Lay-user study

Study Type: Over-the-counter (OTC) user study.
Sample Size: 700 lay persons (100 drug-free, 360 Cannabinoids, 240 Methylenedioxymethamphetamine samples).
Key Results (Agreement with GC/MS):
- EGENS Marijuana Cassette: 100% (Drug-free, -75%, -50%), 90% (-25%), 85% (+25%), 100% (+50%, +75%).
- EGENS Marijuana DipCard: 100% (Drug-free, -75%, -50%), 90% (-25%), 85% (+25%), 100% (+50%, +75%).
- EGENS Marijuana Cup: 100% (Drug-free, -75%, -50%), 90% (-25%), 80% (+25%), 100% (+50%, +75%).
- EGENS MDMA DipCard: 100% (Drug-free, -75%, -50%), 90% (-25%), 80% (+25%), 100% (+50%, +75%).
- EGENS MDMA Cup: 100% (Drug-free, -75%, -50%), 85% (-25%), 85% (+25%), 100% (+50%, +75%).
- Lay-users indicated that device instructions were easily followed. Flesch-Kincaid reading analysis showed a reading grade level of less than 7 for the package insert.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not explicitly stated as Sensitivity, Specificity, PPV, NPV. The data is presented as agreement with GC/MS for each concentration level. For example, in the Lay-User study, the "Agreement With GC/MS" column represents the overall accuracy of the device when used by lay users at different drug concentrations. The precision study also provides results in terms of +/- counts relative to the cut-off concentrations, which are indicative of analytical sensitivity and specificity around the cutoff.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K142580

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.

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.

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

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)

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.

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)

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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 Cao
NANTONG EGENS BIOTECHNOLOGY, LTD.
Building 15, 1692 Xinghu Avenue,
Nantong 226010, China
Phone: 86-0513-85920700
Email: 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 Methylenedioxymethamphetamine
Test 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..

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:

Item	Candidate Device	Predicate - K142580
	EGENS Urine Test Marijuana
(THC)
Indication(s)
for use	For the qualitative determination of
Cannabinoids in human urine	Same
Methodology	Competitive binding, lateral flow
immunochromatographic assays
based on the principle of antigen
antibody immunochemistry.	Same
Results	Qualitative	Same
Specimen
Type	Human urine	Same
Cut Off Values	Cannabinoids: 50ng/ml	Same for Cannabinoids
Configurations	Cup, Cassette and Dipcard	Dipcard
Conditions for
Use	Over-the-Counter & Prescription
Use	Same

1. Substantial Equivalence Information

Item	Candidate Device	Predicate - K142580
	EGENS Urine Test MDMA

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

| Result
THC | -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

| Result
MET | -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

| Result
THC | -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

| Result
MET | -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- |

| Result
THC | -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:

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

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
glucuronide)
Chlorpromazine	Methoxyphenamine	Tetrahydrozoline

Methylenedioxymethamphetamine

| 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% |

| △9-Tetrahydrocannabinol | Positive at
10000 ng/mL | 0.5% |
|-----------------------------------|----------------------------|------|
| Cannabidiol | Positive at
20000 ng/mL | 0.3% |
| 11-Nor-Δ9-THC-carboxy glucuronide | Positive at
2500 ng/mL | 2% |
| (-)-11-nor-9-carboxy-Δ 9-THC | Positive at
2500 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- Methylenedioxymethamphetamine
HCl (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 | 50,000ng/mL | 50,000ng/mL | 50,000ng/mL | 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

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%

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.

1. 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.