CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test

• K Number: K153741
• Device Name: CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
• Manufacturer: HANGZHOU CLONGENE BIOTECH CO., LTD.
• Date Cleared: 2016-03-18 ( 81 days)
• Product Code: LDJ DJC DJG
• Regulation Number: 862.3870

Intended Use

Clungene Methamphetamine Tests are immunochromatographic assays for the qualitative determination of dmethamphetamine in human urine at cut-off concentration of 1000 ng/mL. The calibrator is d-methamphetamine. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only. Clungene Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-△9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The calibrator is 11-Nor-△9-Tetrahydrocannabinol-9-COOH. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, is provided in the package labeling. For in vitro diagnostic use only. Clungene Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 300 ng/mL. The callbrator is Morphine. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. This test is intended for over the counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.

Device Description

The CLUNGENE Methamphetamine Tests, CLUNGENE Morphine Tests, and CLUNGENE Marijuana Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Methamphetamine, Morphine and 11-Nor-A9-Tetrahydrocannabinol-9-COOH (target analytes) in human urine. The tests are 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.

Predicate Devices

K052115

Reference Devices

K052115

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard immunochromatographic assay (lateral flow test) for qualitative drug detection. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML. The results are read visually based on the presence or absence of lines.

Therapeutic

No.
This device is an in vitro diagnostic (IVD) test intended for qualitative determination of drugs in human urine, providing only preliminary test results. It is explicitly stated as "For in vitro diagnostic use only", indicating it's used for diagnosis and not for direct treatment or therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only," indicating its purpose is to diagnose.

SaMD (Software as a Medical Device)

No

The device description and intended use clearly indicate that these are physical immunochromatographic assays (Cassette, Easy Cup, Split Key Cup, Dip Card formats) for testing urine samples. There is no mention of software being the primary or sole component of the device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The document explicitly states "For in vitro diagnostic use only" multiple times in the "Intended Use / Indications for Use" section for all three tests (Methamphetamine, Marijuana, and Morphine).

Furthermore, the description of the device and its intended use aligns with the definition of an IVD: it is an assay used to examine human specimens (urine) to provide information about a person's health (presence of drugs or their metabolites).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Clungene Methamphetamine Tests are immunochromatographic assays for the qualitative determination of dmethamphetamine in human urine at cut-off concentration of 1000 ng/mL. The calibrator is d-methamphetamine. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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.

This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.

Clungene Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-△9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The calibrator is 11-Nor-△9-Tetrahydrocannabinol-9-COOH. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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.

This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.

Clungene Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 300 ng/mL. The callbrator is Morphine. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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.

This test is intended for over the counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.

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

LDJ, DJC, DJG

Device Description

The CLUNGENE Methamphetamine Tests, CLUNGENE Morphine Tests, and CLUNGENE Marijuana Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Methamphetamine, Morphine and 11-Nor-A9-Tetrahydrocannabinol-9-COOH (target analytes) in human urine. The tests are 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

over-the-counter (OTC) consumer 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

Analytical Performance:
Precision studies: Samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blindly labeled. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order.
Cut-off: 150 samples equally distributed at concentrations of -50% Cut-Off; -25% Cut-Off; Cut-Off; +25% Cut-Off; +50% Cut-Off were tested using three different lots of each device by three different operators.
Interference: Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of each device.
Specificity: Drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device.
Effect of Urine Specific Gravity and Urine pH: Urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device.

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

1. Analytical Performance

• a. Precision: The precision studies for Clungene Methamphetamine Tests, Clungene Morphine Tests, and Clungene Marijuana Tests were conducted at various concentrations relative to the cut-off (-100%, -75%, -50%, -25%, Cut off, +25%, +50%, +75%, +100%). For each drug and device format (Cassette, Dip Card, Split-Key Cup, Easy Cup), 3 lots were tested. For each lot and concentration, 50 tests were performed (2 runs/day for 25 days).

  • Results for -100%, -75%, -50% cut off: All 50 tests showed negative results (50-/0+).
  • Results for +25%, +50%, +75%, +100% cut off: All 50 tests showed positive results (50+/0-).
  • Results at Cut off (variable performance for different lots and formats):
    • Methamphetamine Cassette: 22-29 negative, 21-28 positive out of 50.
    • Methamphetamine Dip Card: 21-23 negative, 27-29 positive out of 50.
    • Methamphetamine Split-Key Cup: 21-23 negative, 27-29 positive out of 50.
    • Methamphetamine Easy Cup: 17-25 negative, 25-33 positive out of 50.
    • Morphine Cassette: 22-27 negative, 23-28 positive out of 50.
    • Morphine Dip Card: 20-27 negative, 23-30 positive out of 50.
    • Morphine Split-Key Cup: 19-32 negative, 18-31 positive out of 50.
    • Morphine Easy Cup: 22-31 negative, 19-28 positive out of 50.
    • Marijuana Cassette: 21-26 negative, 24-29 positive out of 50.
    • Marijuana Dip Card: 19-25 negative, 25-31 positive out of 50.
    • Marijuana Split-Key Cup: 25-31 negative, 19-25 positive out of 50.
    • Marijuana Easy Cup: 24-30 negative, 20-26 positive out of 50.

• b. Linearity: Not applicable.

• c. Stability: The devices are stable at 4-30 ℃ for 24 months based on accelerated stability study at 45 °C and real time stability determination at both 4 °C and 30 °C.

• d. Cut-off: Verified cut-off values: d-Methamphetamine (1000 ng/mL), Morphine (300 ng/mL), 11-Nor-△9-Tetrahydrocannabinol-9-COOH (50 ng/mL). Results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off for Methamphetamine, Morphine, and Marijuana across three lots tested by three operators.

• e. Interference: Extensive list of compounds tested and showed no interference at a concentration of 100µg/mL.

• f. Specificity: Cross-reactivity was tested for various related compounds.

  • Methamphetamine: d-Methamphetamine (100%), (+/-)3,4-Methylenedioxy-n-ethylamphetamine (5%), D/L-Methamphetamine (33%), p-Hydroxymethamphetamine (3.3%), L-Methamphetamine (12.5%), (+/-)3,4-Methylenedioxyamphetamine (5%).
  • Morphine: Morphine (100%), O6-Acetylmorphine (100%), Codeine (100%), Hydromorphone (10%), Levorphanol (20%), Thebaine (5%). Lower cross-reactivity for EthylMorphine (5%), Hydrocodone (0.6%), Oxycodone (1%), Procaine (2%), Morphine-3-glucuronide (

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

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 18, 2016

HANGZHOU CLONGENE BIOTECH CO., LTD. C/O JOE SHIA MANAGER 504 E DIAMOND AVE., SUITE I GAITHERSBURG MD 20877

Re: K153741

Trade/Device Name: Clungene Methamphetamine Test, Clungene Morphine Test, Clungene Marijuana Test Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: II Product Code: LDJ, DJC, DJG Dated: December 19, 2015 Received: December 28, 2015

Dear Mr. 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/ResourcesforYou/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 H. Lias -S

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) K153741

Device Name Clungene Methamphetamine Tests Clungene Marijuana Tests Clungene Morphine Tests

Indications for Use (Describe)

Clungene Methamphetamine Tests are immunochromatographic assays for the qualitative determination of dmethamphetamine in human urine at cut-off concentration of 1000 ng/mL. The calibrator is d-methamphetamine. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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.

This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.

Clungene Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-△9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The calibrator is 11-Nor-△9-Tetrahydrocannabinol-9-COOH. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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.

This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.

Clungene Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 300 ng/mL. The callbrator is Morphine. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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.

This test is intended for over the counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.

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: February 22, 2016
• Hangzhou Clongene Biotech Co., Ltd. 2. Submitter: 20 Longquan Road Hangzhou 311121, China
• 3. Contact person: Zheng Shujian Hangzhou Clongene Biotech Co., Ltd. 20 Longquan Road Hangzhou 311121, China Telephone: [phone] Email: [e-mail].
• 4. Device Name: CLUNGENE Methamphetamine Tests CLUNGENE Morphine Tests CLUNGENE Marijuana Tests

Classification:

Product Code	CFR	Panel
DJC	21 CFR, 862.3610 Methamphetamine Test	Toxicology
LDJ	21 CFR, 862.3870 Cannabinoid Test System	Toxicology
DJG	21 CFR, 862.3650 Opiate Test System	Toxicology

5. Predicate Devices: K052115

The FIRST CHECK MULTI DRUG CUP Urine Test

• 6. Intended Use
     Clungene Methamphetamine Tests are immunochromatographic assays for the qualitative determination of d-methamphetamine in human urine at cut-off concentration of 1000 ng/mL. The calibrator is d-methamphetamine. The tests are available in a Cassette format, an Easy Cup format, a Split Key Cup format and a Dip Card format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.

Clungene Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-A9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The calibrator is 11-Nor-A9-Tetrahydrocannabinol-9-COOH. The tests are available in a Cassette format, an Easy Cup format, a Split Key Cup format and a Dip Card format.

The tests provide only preliminary test results. A more specific alternative chemical must

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be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.

Clungene Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 300 ng/mL. The calibrator is Morphine. The tests are available in a Cassette format, an Easy Cup format, a Split Key Cup format and a Dip Card format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.

• 7. Device Description
     The CLUNGENE Methamphetamine Tests, CLUNGENE Morphine Tests, and CLUNGENE Marijuana Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Methamphetamine, Morphine and 11-Nor-A9-Tetrahydrocannabinol-9-COOH (target analytes) in human urine. The tests are 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.
• 8. Substantial Equivalence Information
     A summary comparison of features of the CLUNGENE Methamphetamine Tests, CLUNGENE Morphine Tests and CLUNGENE Marijuana Tests and the predicate devices is provided in following tables.

Item	Device	Predicate - K052115
Indication(s)
for Use	For the qualitative determination of drugs of
abuse in human urine.	Same (but the number of
drugs detected is different)
Calibrator	d-Methamphetamine	Same
Methodology	Competitive binding, lateral flow
immunochromatographic assays based on the
principle of antigen antibody
immunochemistry.	Same

Table 1: Features Comparison of CLUNGENE Methamphetamine Tests and the Predicate Devices

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Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Cut-Off Values	1000 ng/mL	Same
Intended Use	For over-the-counter and prescription uses.	Same
Configurations	Cassette, Dip Card and Cups	Cup

Table 2: Features Comparison of CLUNGENE Morphine Tests and the Predicate Devices

Item	Device	Predicate - K052115
Indication(s)
for Use	For the qualitative determination of
drugs of abuse in human urine.	Same (but the number of
drugs detected is different)
Calibrator	Morphine	Same
Methodology	Competitive binding, lateral flow
immunochromatographic assays based on the
principle of antigen antibody
immunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Cut-Off Values	300 ng/mL	Same
Intended Use	For over-the-counter and prescription uses.	Same
Configurations	Cassette, Dip Card and Cups	Cup

Table 3: Features Comparison of CLUNGENE Marijuana Tests and the Predicate Devices

Item	Device	Predicate - K052115
Indication(s)
for Use	For the qualitative determination of
drugs of abuse in human urine.	Same (but the number of
drugs detected is different)
Calibrator	11-Nor-△9-Tetrahydrocannabinol-9-COOH	Same
Methodology	Competitive binding, lateral flow
immunochromatographic assays based on the
principle of antigen antibody
immunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Cut-Off Values	50 ng/mL	Same
Intended Use	For over-the-counter and prescription uses.	Same
Configurations	Cassette, Dip Card and Cups	Cup

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9. Test Principle

The CLUNGENE Methamphetamine Tests, CLUNGENE Morphine Tests, and CLUNGENE Marijuana Tests are rapid tests for the qualitative detection of d-Methamphetamine, Morphine and 11-Nor-A9-Tetrahydrocannabinol-9-COOH 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 are below the 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 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.

10. 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, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables.

Cassette
Lot
Number	-100%
cut off	-75%
cut off	-50%
cut off	-25%
cutoff	cut off	+25%
cut off	+50%
cut off	+75%
cut off	+100%
cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	29-/21+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	29-/21+	50+/0-	50+/0-	50+/0-	50+/0-
Dip Card
Lot
Number	-100%
cut off	-75%
cut off	-50%
cut off	-25%
cutoff	cut off	+25%
cut off	+50%
cut off	+75%
cut off	+100%
cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	21-/29+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-
Split-Key Cup
Lot
Number	-100%
cut off	-75%
cut off	-50%
cut off	-25%
cutoff	cut off	+25%
cut off	+50%
cut off	+75%
cut off	+100%
cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	21-/29+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-

CLUNGENE Methamphetamine Tests

Easy Cup

Lot 1

Lot 2

Lot 3

50-/0+

50-/0+

50-/0+

50-/0+

50-10+

50-/0+

50-/0+

50-/0+

50-10+

50-/0+

50-/0+

50-/0+ 20-/30+ 50+/0-

17-/33+

21-/29+

50+/0-

50+/0-

50+/0-

50+/0-

50+/0-

50+/0-

50+/0-

50+/0-

50+/0-

50+/0-

50+/0-

8

Lot Number	-100% cut off	-75% cut off	-50% cut off	-25% cutoff	+25% cut off	+50% cut off	+75% cut off	+100% cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	17-/33+	50+/0-	50+/0-	50+/0-

CLUNGENE Morphine Tests

Cassette

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Dip Card

Lot Number	-100% cut off	-75% cut off	-50% cut off	-25% cutoff	cut off	+25% cut off	+50% cut off	+75% cut off	+100% cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	27-/23+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-

Split-Key Cup

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 19-/31+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 32-/18+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Easy Cup

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 31-/19+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- |

CLUNGENE Marijuana Tests

Cassette

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Dip Card

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 19-/31+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- |

Split-Key Cup

9

Lot	-100%	-75%	-50%	-25%		+25%	+50%	+75%	+100%
Number	cut off	cut off	cut off	cutoff	cut off	cut off	cut off	cut off	cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	31-/19+	50+/0-	50+/0-	50+/0-	50+/0-
Easy Cup
Lot	-100%	-75%	-50%	-25%		+25%	+50%	+75%	+100%
Number	cut off	cut off	cut off	cutoff	cut off	cut off	cut off	cut off	cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	30-/20+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	29-/21+	50+/0-	50+/0-	50+/0-	50+/0-

b. Linearity

Not applicable.

• c. Stability
  The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C and real time stability determination at both 4 °C and 30 °C.

d. Cut-off

A total of 150 samples equally distributed at concentrations of -50% Cut-Off; -25% Cut-Off; Cut-Off; +25% Cut-Off; +50% Cut-Off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off for Methamphetamine, Morphine and Marijuana.

The following cut-off values for the candidate devices have been verified.

Calibrator	Cut-off (ng/mL)
d-Methamphetamine	1000
Morphine	300
11-Nor-△9-Tetrahydrocannabinol-9-COOH	50

e. Interference

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100µg/mL are summarized in the following tables. There were no differences observed for different devices.

4-Acetamidophenol	(-) Y Ephedrine	Penicillin-G
Acetophenetidin	Erythromycin	Pentazocaine
N-Acetylprocainamide	ß-Estradiol	Pentobarbital
Acetylsalicylic acid	Estrone-3-sulfate	Perphenazine
Aminopyrine	Ethyl-p-aminobenzoate	Phencyclidine
Amitriptyline	Fenfluramine	Phenelzine
Amobarbital	Fenoprofen	Phendimetrazine
Amoxicillin	Furosemide	Phenobarbital
Ampicillin	Gentisic acid	Phetoin
Ascorbic acid	Hemoglobin	L-Phenylephrine
Apomorphine	Hydralazine	β-Phenylethlamine
Aspartame	Hydrochlorothiazide	Phenylpropanolamine
Atropine	Hydrocodone	Prednisolone
Benzilic acid	Hydrocortisone	Prednisone
Benzoic acid	O-Hydroxyhippuric acid	Procaine
Benzoylecgonine	3-Hydroxytyramine	Promazine
Bilirubin	Ibuprofen	Promethazine
Brompheniramine	Imipramine	D,L-Propranolol
Caffeine	(-) Isoproterenol	Propiomazine
Cannabidiol	Isoxsuprine	D-Propoxyphene
Cannabinol	Ketamine	Quinidine
Chloralhydrate	Ketoprofen	Quinine
Chloramphenicol	Labetalol	Ranitidine
Chlordiazepoxide	Levorphanol	Salicylic acid
Chlorothiazide	Loperamide	Secobarbital
(+) Chlorpheniramine	Maprotiline	Serotonin
Chlorpromazine	Meperidine	Sulfamethazine
Chlorquine	Meprobamate	Sulindac
Cholesterol	Methadone	Temazepam
Clomipramine	Methylphenidate	Tetracycline
Clonidine	Morphine-3-Dglucuronide	Tetrahydrocortisone
Cocaine hydrochloride	Nalidixic acid	Tetrahydrozoline
Codeine	Naloxone	Δ9-THC-COOH
Cortisone	Naltrexone	Thebaine
(-) Cotinine	Naproxen	Thiamine
Creatinine	Niacinamide	Thioridazine
Deoxycorticosterone	Nifedipine	D,L-Thyroxine
Dextromethorphan	Norcodein	Tolbutamine
Diazepam	Norethindrone	Triamterene
Diclofenac	D-Norpropoxyphene	Trifluoperazine
Diflunisal	Noscapine	Trimethoprim
Digoxin	D,L-Octopamine	Trimipramine
Diphenhydramine	Oxalic acid	Tryptamine
Doxylamine	Oxazepam	D, L-Tyrosine
Ecgonine hydrochloride	Oxolinic acid	Uric acid
Ecgonine methylester	Oxycodone	Verapamil
(IR,2S)-(-)-Ephedrine	Oxymetazoline	Zomepirac
L-Ephedrine	Papaverine

Methamphetamine:

10

Morphine

11

Acebutolol	(-) Y Ephedrine	Hydroxymethamphetamine
Acetopromazine - d6	Erythromycin	Papaverine
4-Acetamidophenol	β-Estradiol	Penicillin-G
Acetophenetidin	Estrone-3-sulfate	Pentazocaine
N-Acetylprocainamide	Ethyl-p-aminobenzoate	Pentobarbital
Acetylsalicylic acid	Fenoprofen	Perphenazine
D,L-Amphetamine	Furosemide	Phencyclidine
L-Amphetamine	Gentisic acid	Phenelzine
Aminopyrine	Hemoglobin	Phenobarbital
Amitryptyline	Hydralazine	Phentermine
Amobarbital	Hydrochlorothiazide	β-Phenylethylamine
Amoxicillin	Hydrocortisone	L-Phenylephrine
Ampicillin	O-Hydroxyhippuric acid	β-Phenylethlamine
Ascorbic acid	3-Hydroxytyramine	Phenylpropanolamine
Apomorphine	Ibuprofen	Prednisolone
Aspartame	Imipramine	Prednisone
Atropine	Iproniazid	Promazine
Benzilic acid	(-) Isoproterenol	Promethazine
Benzoic acid	Isoxsuprine	D,L-Propanolol
Benzoylecgonine	Ketamine	D-Propoxyphene
Benzphetamine	Ketoprofen	D-Pseudoephedrine
Bilirubin	Labetalol	Quinidine
Brompheniramine	Loperamide	Quinine
Caffeine	Maprotiline	Salicylic acid
Chloramphenicol	Meprobamate	Secobarbital
Chlordiazepoxide	Methoxyphenamine	Serotonin
Chlorothiazide	Methylenedioxyamphetamine	Sulfamethazine
(±) Chlorpheniramine	Methylenedioxymethamphetamine	Sulindac
Chlorpromazine	Methadone	Temazepam
Chlorquine	Methylphenidate	Tetracycline
Cholesterol	Methyprylon	Tetrahydrozoline
Clomipramine	Nalorphine	Tetrahydrocortisone
Clonidine	Nalidixic acid	Tetrahydrocortisone-(5-Dglucuronide)
Cocaine hydrochloride	Naloxone	Thiamine
Cortisone	Naltrexone	Thioridazine
(-) Cotinine	Naproxen	D,L-Thyroxine
Creatinine	Niacinamide	Tolbutamine
Deoxycorticosterone	Nifedipine	Triamterene
Dextromethorphan	Norcodein	Trifluoperazine

12

Diazepam	Norethindrone	Trimethoprim
Diclofenac	D-Norpropoxyphene	Trimipramine
Diflunisal	Noscapine	Tryptamine
Digoxin	D,L-Octopamine	D,L-Tyrosine
Diphenhydramine	Oxalic acid	Uric acid
Doxylamine	Oxazepam	Verapamil
Ecgonine	Oxolinic acid	Zomepirac
Ecgonine methylester	Oxymetazoline

Marijuana

Marijuana
4-Acetamidophenol	Estrone-3-sulfate	Penicillin-G
Acetophenetidin	Ethyl-p-aminobenzoate	Pentazocine
N-Acetylprocainamide	Fenoprofen	Pentobarbital
Acetylsalicylic acid	Furosemide	Perphenazine
Aminopyrine	Gentisic acid	Phencyclidine
Amitryptyline	Hemoglobin	Phenelzine
Amobarbital	Hydralazine	Phenobarbital
Amoxicillin	Hydrochlorothiazide	Phentermine
Ampicillin	Hydrocodone	L-Phenylephrine
Ascorbic acid	Hydrocortisone	β-Phenylethlamine
D,L-Amphetamine	O-Hydroxyhippuric acid	β-Phenyllethylamine
L-Amphetamine	3-Hydroxytyramine	Phenylpropanolamine
Apomorphine	Ibuprofen	Prednisolone
Aspartame	Imipramine	Prednisone
Atropine	Iproniazid	Procaine
Benzilic acid	(-) Isoproterenol	Promazine
Benzoic acid	Isoxsuprine	Promethazine
Benzoylecgonine	Ketamine	D,L-Propanolol
Benzphetamine	Ketoprofen	D-Propoxyphene
Bilirubin	Labetalol	D-Pseudoephedrine
Brompheniramine	Levorphanol	Quinidine
Caffeine	Loperamide	Quinine
Chloralhydrate	Maprotiline	Ranitidine
Chloramphenicol	Meprobamate	Salicylic acid
Chlordiazepoxide	Methadone	Secobarbital
Chlorothiazide	Methoxyphenamine	Serotonin (5-
(±) Chlorpheniramine	(+)3,4-	Sulfamethazine
Chlorpromazine	(+)3,4-	Sulindac
Chlorquine	Methylphenidate	Temazepam
Cholesterol	Methyprylon	Tetracycline
Clomipramine	Morphine-3-β-Dglucuronide	Tetrahydrocortisone,3

13

| Clonidine | Nalorphine | Tetrahydrocortisone3 (5-
Dglucuronide) |
|------------------------|--------------------------|-------------------------------------------|
| Cocaine hydrochloride | Naloxone | Tetrahydrozoline |
| Codeine | Nalidixic acid | Thebaine |
| Cortisone | Naltrexone | Thiamine |
| (-) Cotinine | Naproxen | Thioridazine |
| Creatinine | Niacinamide | D, L-Thyroxine |
| Deoxycorticosterone | Nifedipine | Tolbutamine |
| Dextromethorphan | Norcodein | Triamterene |
| Diazepam | Norethindrone | Trifluoperazine |
| Diclofenac | D-Norpropoxyphene | Trimethoprim |
| Diflunisal | Noscapine | Trimipramine |
| Digoxin | D,L-Octopamine | Tryptamine |
| Diphenhydramine | Oxalic acid | D, L-Tryptophan |
| Doxylamine | Oxazepam | Tyramine |
| Ecgonine hydrochloride | Oxolinic acid | D, L-Tyrosine |
| Ecgonine methylester | Oxycodone | Uric acid |
| (-) Y Ephedrine | Oxymetazoline | Verapamil |
| Erythromycin | p-Hydroxymethamphetamine | Zomepirac |
| β-Estradiol | Papaverine | |

f. Specificity

To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below. There were no differences observed for different devices.

Methamphetamine	Result	% Cross-
(Cut-off=1000 ng/mL)	Positive at (ng/mL)	Reactivity
D - Methamphetamine	1000	100%
(+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA)	20000	5%
D/L-Methamphetamine	3000	33%
p-Hydroxymethamphetamine	30000	3.3%
L-Methamphetamine	8000	12.5%
(+/-)3,4-Methylenedioxyamphetamine(MDA)	20000	5%
(+/-)3,4-methylenedioxymethamphetamine(MDMA)	Negative at 100000	100000

Comparison between GC/MS and Lay Person Results for Methamphetamine Cassette

	Lay person results	The

21

| % of Cutoff | Number
of
samples | d-Methamphetamine
Concentration by GC/MS
(ng/mL) | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
|--------------|-------------------------|--------------------------------------------------------|--------------------|--------------------|-----------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 750 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1,250 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 1,500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1,750 | 20 | 0 | 100 |

Comparison between GC/MS and Lay Person Results for Methamphetamine Dip Card

| % of Cutoff | Number
of
samples | d-Methamphetamine
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|--------------------------------------------------------|--------------------|----|------------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 750 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1,250 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 1,500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1,750 | 20 | 0 | 100 |

Comparison between GC/MS and Lay Person Results for Methamphetamine Split-Key Cup

| | Number
of
samples | d-Methamphetamine
Concentration by GC/MS
(ng/mL) | Lay person results | | The |
|-------------|-------------------------|--------------------------------------------------------|--------------------|--------------------|-----------------------------------------|
| % of Cutoff | | | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75%Cutoff | 20 | 25 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 750 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1,250 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 1,500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1,750 | 20 | 0 | 100 |

Comparison between GC/MS and Lay Person Results for Methamphetamine Easy Cup

| % of Cutoff | Number
of
samples | d-Methamphetamine
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|--------------------------------------------------------|--------------------|--------------------|------------------------------------------------|
| -100% Cutoff | 20 | 0 | No. of
Positive | No. of
Negative | 100 |
| -75% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 750 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 1,250 | 19 | 1 | 95 |

22

+50% Cutoff	20	1,500	20	0	100
+75% Cutoff	20	1,750	20	0	100

| % of Cutoff | Number
of
samples | Morphine Concentration
by GC/MS (ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|--------------------------------------------|--------------------|----|------------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |

Comparison between GC/MS and Lay Person Results for Morphine Cassette

Comparison between GC/MS and Lay Person Results for Morphine Dip Card

| % of Cutoff | Number of
samples | Morphine Concentration
by GC/MS (ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|----------------------|--------------------------------------------|--------------------|----|------------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |

Comparison between GC/MS and Lay Person Results for Morphine Split-Key Cup

| % of Cutoff | Number
of
samples | Morphine Concentration
by GC/MS (ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|--------------------------------------------|--------------------|--------------------|------------------------------------------------|
| -100% Cutoff | 20 | 0 | No. of
Positive | No. of
Negative | 100 |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 375 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |

Comparison between GC/MS and Lay Person Results for Morphine Easy Cup

		Lay person results	The
--	--	--------------------	-----

23

| % of Cutoff | Number
of
samples | Morphine Concentration
by GC/MS (ng/mL) | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
|--------------|-------------------------|--------------------------------------------|--------------------|--------------------|-----------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |

Comparison between GC/MS and Lay Person Results for Marijuana Cassette

% of Cutoff	Number of samples	Marijuana Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	12.5	0	20	100
-50% Cutoff	20	25	0	20	100
-25% Cutoff	20	37.5	1	19	95
+25% Cutoff	20	62.5	19	1	95
+50% Cutoff	20	75	20	0	100
+75% Cutoff	20	87.5	20	0	100

Comparison between GC/MS and Lay Person Results for Marijuana Dip Card

% of Cutoff	Number of samples	Marijuana Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
-100% Cutoff	20	0	No. of Positive	No. of Negative	100
-75% Cutoff	20	12.5	0	20	100
-50% Cutoff	20	25	0	20	100
-25% Cutoff	20	37.5	0	20	10
+25% Cutoff	20	62.5	18	2	90
+50% Cutoff	20	75	20	0	100
+75% Cutoff	20	87.5	20	0	100

Comparison between GC/MS and Lay Person Results for Marijuana Split-Key Cup

| % of Cutoff | Number
of
samples | Marijuana Concentration
by GC/MS (ng/mL) | Lay person results | | The |
|-------------|-------------------------|---------------------------------------------|--------------------|--------------------|-----------------------------------------|
| | | | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100 |

24

-75% Cutoff	20	12.5	0	20	100
-50% Cutoff	20	25	0	20	100
-25% Cutoff	20	37.5	1	19	95
+25% Cutoff	20	62.5	19	1	95
+50% Cutoff	20	75	20	0	100
+75% Cutoff	20	87.5	20	0	100

Comparison between GC/MS and Lay Person Results for Marijuana Easy Cup

% of Cutoff	Number of samples	Marijuana Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	12.5	0	20	100
-50% Cutoff	20	25	0	20	100
-25% Cutoff	20	37.5	1	19	95
+25% Cutoff	20	62.5	20	0	100
+50% Cutoff	20	75	20	0	100
+75% Cutoff	20	87.5	20	0	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 each package insert and the scores revealed a reading Grade Level of 7.

• 3. Clinical Studies
     Not applicable.

11. Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the devices, it's concluded that the CLUNGENE Methamphetamine Tests, CLUNGENE Morphine Tests and CLUNGENE Marijuana Tests are substantially equivalent to the predicate.