CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup

• K Number: K252118
• Device Name: CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup
• Manufacturer: Hangzhou Clongene Biotech Co.,Ltd.
• Date Cleared: 2025-08-27 ( 51 days)
• Product Code: NFT , NFV , NFW , NFY , NGG , NGL , NGM , PTG , PTH , QAW , QBF
• Regulation Number: 862.3100
• Type: Traditional
• Panel: Toxicology
• Reference & Predicate Devices: K250727
• Predicate For: N/A

Intended Use

The CLUNGENE Multi-Drug Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations:

Drug	Calibrator	Cut-off (ng/mL)
Morphine (MOP/OPI300)	Morphine	300
Morphine (MOP/OPI2000)	Morphine	2,000
Methamphetamine (mAMP/MET1000)	D-Methamphetamine	1,000
Methamphetamine (mAMP/MET500)	D-Methamphetamine	500
Cocaine (COC300)	Benzoylecgonine	300
Cocaine (COC150)	Benzoylecgonine	150
Marijuana (THC)	11-nor-9-THC-9-COOH	50
Methylenedioxymethamphetamine (MDMA)	D,L-Methylenedioxymethamphetamine	500
Buprenorphine (BUP)	Buprenorphine	10
Propoxyphene (PPX)	D-Propoxyphene	300
Amphetamine (AMP1000)	D-Amphetamine	1,000
Amphetamine (AMP500)	D-Amphetamine	500
Phencyclidine (PCP)	Phencyclidine	25
Methadone metabolite (EDDP)	2-Ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine	300
Oxycodone (OXY)	Oxycodone	100
Oxazepam (BZO)	Oxazepam	300
Nortriptyline (TCA)	Nortriptyline	1,000
Secobarbital (BAR)	Secobarbital	300
Methadone (MTD)	Methadone	300
6-Monoacetylmorphine (6-MAM)	6-Monoacetylmorphine	10
Fentanyl (FYL)	Fentanyl	1

The single or multi-test cups can consist of any combination of the above listed drug analytes, but only one cut off concentration under same drug condition will be included per device.

This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The CLUNGENE Multi-Drug Home Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations:

Drug (Identifier)	Cut-off (ng/mL)
Morphine (MOP/OPI2000)	300 or 2000
Methamphetamine (mAMP/MET)	500 or 1,000
Cocaine (COC)	150 or 300
Marijuana (THC)	50
Methylenedioxymethamphetamine (MDMA)	500
Buprenorphine (BUP)	10
Propoxyphene (PPX)	300
Amphetamine (AMP)	500 or 1,000
Phencyclidine (PCP)	25
Methadone metabolite (EDDP)	300
Oxycodone (OXY)	100
Oxazepam (BZO)	300
Nortriptyline (TCA)	1,000
Secobarbital (BAR)	300
Methadone (MTD)	300
6-Monoacetylmorphine (6-MAM)	10
Fentanyl (FYL)	1
The single or multi-test cup offers any combination from above 1 to 17 drugs, but only one cut off concentration under same drug condition will be included per device.

The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC-MS/MS is the preferred confirmatory method.

It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

Device Description

CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

AI/ML Overview

This document provides details on the performance characteristics of the CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup. Since this is an in vitro diagnostic device (specifically, a drug screening test), the acceptance criteria and study design are typically focused on analytical performance (accuracy, precision, analytical specificity) rather than a multi-reader multi-case (MRMC) comparative effectiveness study, which is more common for imaging AI. Similarly, "human readers improving with AI vs without AI" is not applicable here as the device is the test, not an aid to human interpretation of another modality.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for qualitative drug screening tests like this is accurate detection around a specific cutoff concentration. The reported performance demonstrates the device's ability to correctly classify samples as positive or negative relative to these cutoffs.

Table of Acceptance Criteria and Reported Device Performance (Analytical Precision/Reproducibility)

The "Acceptance Criteria" column represents the desired performance for a qualitative assay around its cutoff. For positive results, this means detecting drug concentrations above the cutoff, and for negative results, it means not detecting concentrations below the cutoff. The provided precision data shows the number of positive (+) and negative (-) results out of 50 tests for various concentrations relative to the cutoff. An ideal performance would show 100% positive for concentrations above cutoff and 100% negative for concentrations below, with roughly 50/50 split at the cutoff itself (due to inherent variability).

Drug (Cut-off ng/mL)	Acceptance Criteria (Implicit for qualitative assay)	Reported Device Performance (Accuracy as evidenced by reproducibility at various concentrations) Number of negative/positive results out of 50 tests. Values are aggregated across 3 lots where available.
MOP300	All samples >cutoff should test positive; all samples <cutoff should test negative. Around cutoff, results vary.	+100% cutoff: 0-/50+ (100% positive)
		+75% cutoff: 0-/50+ (100% positive)
		+50% cutoff: 0-/50+ (100% positive)
		+25% cutoff: 1-2/48-49+ (96-98% positive)
		cutoff: 23-27-/23-27+ (46-54% positive)
		-25% cutoff: 49-50-/0-1+ (98-100% negative)
		-50% cutoff: 50-/0+ (100% negative)
		-75% cutoff: 50-/0+ (100% negative)
		-100% cutoff: 50-/0+ (100% negative)
MET1000	(Same as above)	+100% cutoff: 0-/50+ (100% positive)
		+75% cutoff: 0-/50+ (100% positive)
		+50% cutoff: 0-/50+ (100% positive)
		+25% cutoff: 0-1/49-50+ (98-100% positive)
		cutoff: 25-26-/24-25+ (48-52% positive)
		-25% cutoff: 49-50-/0-1+ (98-100% negative)
		-50% cutoff: 50-/0+ (100% negative)
		-75% cutoff: 50-/0+ (100% negative)
		-100% cutoff: 50-/0+ (100% negative)
COC300	(Same as above)	+100% cutoff: 0-/50+ (100% positive)
		+75% cutoff: 0-/50+ (100% positive)
		+50% cutoff: 0-/50+ (100% positive)
		+25% cutoff: 1/49+ (98% positive)
		cutoff: 23-25-/25-27+ (46-54% positive)
		-25% cutoff: 49-50-/0-1+ (98-100% negative)
		-50% cutoff: 50-/0+ (100% negative)
		-75% cutoff: 50-/0+ (100% negative)
		-100% cutoff: 50-/0+ (100% negative)
(Similar detailed tables for all 20 analytes and two configurations would follow the same pattern as the MOP300, MET1000, and COC300 examples shown above, demonstrating consistent reproducibility around the cutoffs.)

Note: The implicit acceptance criterion for a qualitative test like this is generally that samples significantly above the cutoff should consistently yield positive results, samples significantly below the cutoff should consistently yield negative results, and samples near the cutoff (e.g., +/- 25% or 50% of the cutoff) will show varying results due to inherent assay variability, which is considered acceptable.

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Analytical Performance (Precision/Reproducibility): For each drug and each concentration point (9 concentration levels per drug), 50 tests were performed (2 runs per day for 25 days). Given there are 20 analytes (including the alternative cutoffs), this amounts to 20 drugs * 9 concentrations * 50 tests/concentration = 9000 tests.
   • Analytical Specificity/Interference: Not explicitly stated as a "test set" size with a fixed number of samples, but "drug metabolites and other components" were "spiked into drug-free urine" and tested using three lots of the device. For compounds showing no interference, they were tested at a "concentration of 100µg/mL or specified concentrations" in both drug-free urine and urine containing target drugs at +/- 50% cutoff. Over 100 compounds were listed.
   • Method Comparison Study: For each drug, 80 "unaltered urine clinical samples" were used (40 negative and 40 positive). These were "blind labeled." With 20 analytes, this sums to 20 drugs * 80 samples/drug = 1600 clinical samples.
   • Lay Person Study: 280 lay persons participated. Urine samples were prepared at 7 concentration levels (-100%, +/-75%, +/-50%, +/-25% of cutoff). Each participant received 1 blind-labeled sample and 1 device. The tables suggest that for each configuration (1 and 2), for each drug, 20 samples were tested at each concentration level. Thus, for Configuration 1, there are 17 drugs, so 17 drugs * 7 concentrations * 20 samples/conc = 2380 samples. For Configuration 2, there are 17 drugs, so 17 drugs * 7 concentrations * 20 samples/conc = 2380 samples.
   • Data Provenance: The analytical and method comparison studies were performed "in-house." The lay user study was performed "at three intended user sites." The origin of the urine samples (e.g., country of origin) is not specified. It is implied these are prospective tests using prepared or collected samples for the purpose of the study.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Analytical Precision/Reproducibility, Analytical Specificity/Interference, and Method Comparison: The ground truth for these studies was established by LC-MS/MS or GC/MS (or LC-MS/MS), which are reference analytical methods, not human expert consensus. The text states:
     • "Each drug concentration was confirmed by LC-MS/MS" for precision studies.
     • "The samples were…compared to LC-MS/MS results" for the method comparison study.
     • "The concentrations of the samples were confirmed by LC-MS/MS" for the lay person study.
   • Therefore, human experts were not directly establishing the ground truth for classification.

3. Adjudication Method for the Test Set:

   • Not applicable as the ground truth was established by LC-MS/MS/GC/MS, a definitive chemical analysis method, not by human expert reading requiring adjudication. The device itself is an immunoassay, the results of which are compared to the LC-MS/MS gold standard.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This type of study design is not applicable to a lateral flow immunoassay drug test. The device is a diagnostic test itself, not an AI assisting human interpretation of another modality.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, implicitly. The precision, specificity, and method comparison studies evaluate the performance of the device itself (the immunoassay) against confirmed concentrations (LC-MS/MS), which represents its "standalone" analytical performance. However, there is a human element in reading the qualitative bands (positive/negative line), which is addressed in the lay-person study.

6. The Type of Ground Truth Used:

   • The primary ground truth used across all analytical studies (precision, specificity, method comparison, lay person study) was LC-MS/MS or GC/MS results. This is considered a highly accurate and definitive chemical confirmatory method for drug concentrations in urine.

7. The Sample Size for the Training Set:

   • This device is a lateral flow immunoassay, not a machine learning/AI algorithm that requires a "training set" in the computational sense. Its "training" is inherent in its chemical and biological design. Therefore, this question is not applicable.

8. How the Ground Truth for the Training Set was Established:

   • As this is not an AI/ML device relying on a training set, this question is not applicable. The device's performance is governed by its chemical design (antibodies, reagents) and manufacturing process, which are developed and validated through iterative biochemical and engineering studies, not by a data-driven training process in the AI sense.

Summary

FDA 510(k) Clearance Letter - CLUNGENE Multi-Drug Test Easy Cup

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 27, 2025

Hangzhou Clongene Biotech Co.,Ltd.
℅ Jenny Xia
Director
LSI International Inc
504 E Diamond Ave, Suite H
Gaithersburg, Maryland 20877

Re: K252118
Trade/Device Name: CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup
Regulation Number: 21 CFR 862.3100
Regulation Name: Amphetamine Test System
Regulatory Class: Class II
Product Code: NFT, PTH, NGL, NFV, NFY, PTG, NGG, QBF, NGM, QAW, NFW
Dated: July 4, 2025
Received: July 7, 2025

Dear Jenny Xia:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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K252118 - Jenny Xia Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K252118 - Jenny Xia Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Joseph A. Kotarek -S
Digitally signed by JOSEPH A. KOTAREK -S
Date: 2025.08.27 12:37:03 -04'00'

Joseph Kotarek, Ph.D.
Branch Chief
Division of Chemistry and Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

FORM FDA 3881 (8/23) Page 1 of 2

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K252118

Device Name:
CLUNGENE Multi-Drug Test Easy Cup
CLUNGENE Multi-Drug Home Test Easy Cup

Indications for Use (Describe)

The CLUNGENE Multi-Drug Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations:

Drug	Calibrator	Cut-off (ng/mL)
Morphine (MOP/OPI300)	Morphine	300
Morphine (MOP/OPI2000)	Morphine	2,000
Methamphetamine (mAMP/MET1000)	D-Methamphetamine	1,000
Methamphetamine (mAMP/MET500)	D-Methamphetamine	500
Cocaine (COC300)	Benzoylecgonine	300
Cocaine (COC150)	Benzoylecgonine	150
Marijuana (THC)	11-nor-9-THC-9-COOH	50
Methylenedioxymethamphetamine (MDMA)	D,L-Methylenedioxymethamphetamine	500
Buprenorphine (BUP)	Buprenorphine	10
Propoxyphene (PPX)	D-Propoxyphene	300
Amphetamine (AMP1000)	D-Amphetamine	1,000
Amphetamine (AMP500)	D-Amphetamine	500
Phencyclidine (PCP)	Phencyclidine	25
Methadone metabolite (EDDP)	2-Ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine	300
Oxycodone (OXY)	Oxycodone	100
Oxazepam (BZO)	Oxazepam	300
Nortriptyline (TCA)	Nortriptyline	1,000
Secobarbital (BAR)	Secobarbital	300
Methadone (MTD)	Methadone	300
6-Monoacetylmorphine (6-MAM)	6-Monoacetylmorphine	10
Fentanyl (FYL)	Fentanyl	1

The single or multi-test cups can consist of any combination of the above listed drug analytes, but only one cut off concentration under same drug condition will be included per device.

This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The CLUNGENE Multi-Drug Home Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations:

Drug (Identifier)	Cut-off (ng/mL)
Morphine (MOP/OPI2000)	300 or 2000
Methamphetamine (mAMP/MET)	500 or 1,000

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FORM FDA 3881 (8/23) Page 2 of 2

Drug	Cut-off (ng/mL)
Cocaine (COC)	150 or 300
Marijuana (THC)	50
Methylenedioxymethamphetamine (MDMA)	500
Buprenorphine (BUP)	10
Propoxyphene (PPX)	300
Amphetamine (AMP)	500 or 1,000
Phencyclidine (PCP)	25
Methadone metabolite (EDDP)	300
Oxycodone (OXY)	100
Oxazepam (BZO)	300
Nortriptyline (TCA)	1,000
Secobarbital (BAR)	300
Methadone (MTD)	300
6-Monoacetylmorphine (6-MAM)	10
Fentanyl (FYL)	1

The single or multi-test cup offers any combination from above 1 to 17 drugs, but only one cut off concentration under same drug condition will be included per device.

The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC-MS/MS is the preferred confirmatory method.

It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

Type of Use (Select one or both, as applicable)

☐ Prescription Use (Part 21 CFR 801 Subpart D)
☒ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

---

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510(k) SUMMARY

K252118

1. Date: August 3, 2025

2. Submitter: Hangzhou Clongene Biotech Co., Ltd.
   No.1 Yichuang Road, Yuhang District.
   Hongzhou, 311121
   China

3. Contact person: Jenny Xia
   LSI International Inc.
   504 East Diamond Ave., Suite H
   Gaithersburg, MD 20877
   Telephone: [phone]
   Email: [e-mail]

4. Device Name: CLUNGENE Multi-Drug Test Easy Cup
   CLUNGENE Multi-Drug Home Test Easy Cup

5. Classification: Class II

Product Code	Target Drug	Regulation Section	Panel
NFT	Amphetamine (AMP)	862.3100, Amphetamine Test System	Toxicology
PTH	Secobarbital (BAR)	862.3150, Barbiturate Test System	Toxicology
NGL	Buprenorphine (BUP)Morphine (MOP/OPI)Oxycodone (OXY)6-Monoacetylmorphine (6-MAM)Fentanyl (FYL)	862.3650, Opiate Test System	Toxicology
NFV	Oxazepam (BZO)	862.3170, Benzodiazepine Test System	Toxicology
NFY	Cocaine (COC)	862.3250, Cocaine and cocaine metabolite test system	Toxicology
PTG	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)Methadone (MTD)	862.3620, Methadone Test System	Toxicology
NGG	Methylenedioxymethamphetamine (MDMA)Methamphetamine (MET)	862.3610, Methamphetamine Test System	Toxicology
NGM	Phencyclidine (PCP)	Unclassified	Toxicology

Page 7

Product Code	Target Drug	Regulation Section	Panel
QBF	Propoxyphene (PPX)	862.3700 Propoxyphene test system.	Toxicology
QAW	Nortriptyline (TCA)	862.3910 Tricyclic antidepressant drugs test system	Toxicology
NFW	Cannabinoids (THC)	862.3870, Cannabinoids Test System	Toxicology

6. Predicate Devices:
   AllTest Multi-Drug Urine Test Cup (K250727)

7. Intended Use

The CLUNGENE Multi-Drug Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations:

Drug	Calibrator	Cut-off (ng/mL)
Morphine (MOP/OPI300)	Morphine	300
Morphine (MOP/OPI2000)	Morphine	2,000
Methamphetamine (mAMP/MET1000)	D-Methamphetamine	1,000
Methamphetamine (mAMP/MET500)	D-Methamphetamine	500
Cocaine (COC300)	Benzoylecgonine	300
Cocaine (COC150)	Benzoylecgonine	150
Marijuana (THC)	11-nor-Δ9-THC-9-COOH	50
Methylenedioxymethamphetamine (MDMA)	D,L-Methylenedioxymethamphetamine	500
Buprenorphine (BUP)	Buprenorphine	10
Propoxyphene (PPX)	D-Propoxyphene	300
Amphetamine (AMP1000)	D-Amphetamine	1,000
Amphetamine (AMP500)	D-Amphetamine	500
Phencyclidine (PCP)	Phencyclidine	25
Methadone metabolite (EDDP)	2-Ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine	300
Oxycodone (OXY)	Oxycodone	100
Oxazepam (BZO)	Oxazepam	300
Nortriptyline (TCA)	Nortriptyline	1,000
Secobarbital (BAR)	Secobarbital	300
Methadone (MTD)	Methadone	300
6-Monoacetylmorphine (6-MAM)	6-Monoacetylmorphine	10
Fentanyl (FYL)	Fentanyl	1

The single or multi-test cups can consist of any combination of the above listed drug analytes, but only one cut off concentration under same drug condition will be included per device.

Page 8

This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The CLUNGENE Multi-Drug Home Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations:

Drug (Identifier)	Cut-off (ng/mL)
Morphine (MOP/OPI2000)	300 or 2000
Methamphetamine (mAMP/MET)	500 or 1,000
Cocaine (COC)	150 or 300
Marijuana (THC)	50
Methylenedioxymethamphetamine (MDMA)	500
Buprenorphine (BUP)	10
Propoxyphene (PPX)	300
Amphetamine (AMP)	500 or 1,000
Phencyclidine (PCP)	25
Methadone metabolite (EDDP)	300
Oxycodone (OXY)	100
Oxazepam (BZO)	300
Nortriptyline (TCA)	1,000
Secobarbital (BAR)	300
Methadone (MTD)	300
6-Monoacetylmorphine (6-MAM)	10
Fentanyl (FYL)	1

The single or multi-test cup offers any combination from above 1 to 17 drugs, but only one cut off concentration under same drug condition will be included per device.

The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC-MS/MS is the preferred confirmatory method.

It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only

8. Device Description

CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

Page 9

The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

9. Substantial Equivalence Information

Item	Device	Predicate (K250727)
Intended use	Qualitative detection of drugs of abuse in urine. For over-the-counter use.	Same
Methodology	Competitive binding, lateral flow immunochromatographic assay based on antigen-antibody reaction	Same
Type of Test	Qualitative	Same
Specimen Type	Human urine	Same
Target Drug and Cut Off Values	Target Drugs: Cutoff (ng/mL)	Same except for the
	Amphetamine(AMP): 1000 or 500	TRA
	Secobarbital (BAR): 300
	Buprenorphine (BUP): 10
	Oxazepam (BZO): 300
	Cocaine (COC): 150 or 300
	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP): 300
	Methylenedioxymethamphetamine (MDMA): 500
	Methamphetamine (MET): 1000 or 500
	Morphine (MOP300/OPI2000): 300 or 2000
	Methadone (MTD): 300
	Oxycodone (OXY): 100
	Phencyclidine (PCP): 25
	Propoxyphene(PPX): 300
	Nortriptyline (TCA): 1000
	Cannabinoids (THC): 50
	6-Monoacetylmorphine(6-MAM): 10
	Fentanyl (FYL): 1
Configurations	Test cup	Same

10. Standard/Guidance Document Reference (if applicable)

Page 10

None referenced.

11. Test Principle

CLUNGENE Multi-Drug Test Easy Cup or CLUNGENE Multi-Drug Home Test Easy Cup is a competitive immunoassay that is used to screen for the presence of various drugs and drug metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody conjugate binding sites.

When the test is activated, the urine is absorbed into each test strip by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test strip. This produces a colored Test line in the Test Region (T) of the strip, which, regardless of its intensity, indicates a negative test result.

When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.

To serve as a procedure control, a colored line will appear at the Control Region (C) of each strip, if the test has been performed properly.

12. Performance Characteristics

A. Analytical performance

a. Precision/Reproducibility:

Precision studies were carried out for samples with concentrations of +100% cutoff, +75% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Other samples were prepared by spiked target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups. The results obtained are summarized in the following tables:

Drug	Lot Number	+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
MOP300	Lot1	0-/50+	0-/50+	0-/50+	2-/48+	23-/27+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	1-/49+	27-/23+	49-/1+	50-/0+	50-/0+	50-/0+
MET1000	Lot1	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
COC300	Lot1	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+

Page 11

Drug	Lot Number	+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
	Lot3	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	49-/1+	50-/0+	50-/0+	50-/0+
THC	Lot1	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	2-/48+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
MDMA	Lot1	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	2-/48+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
BUP	Lot1	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	1-/49+	27-/23+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
PPX	Lot1	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
AMP1000	Lot1	0-/50+	0-/50+	0-/50+	2-/48+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	1-/49+	22-/28+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	48-/2+	50-/0+	50-/0+	50-/0+
PCP	Lot1	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	2-/48+	26-/24+	48-/2+	50-/0+	50-/0+	50-/0+
EDDP	Lot1	0-/50+	0-/50+	0-/50+	2-/48+	26-/24+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	1-/49+	22-/28+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
OXY	Lot1	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	48-/2+	50-/0+	50-/0+	50-/0+
BZO	Lot1	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	2-/48+	23-/27+	49-/1+	50-/0+	50-/0+	50-/0+
TCA	Lot1	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	1-/49+	21-/29+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
BAR	Lot1	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
MTD	Lot1	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	2-/48+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
6-MAM	Lot1	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	2-/48+	27-/23+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	1-/49+	22-/28+	49-/1+	50-/0+	50-/0+	50-/0+
FYL	Lot1	0-/50+	0-/50+	0-/50+	1-/49+	22-/28+	49-/1+	50-/0+	50-/0+	50-/0+

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Drug	Lot Number	+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
	Lot2	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
MET500	Lot1	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
COC150	Lot1	0-/50+	0-/50+	0-/50+	2-/48+	26-/24+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	2-/48+	22-/28+	48-/2+	50-/0+	50-/0+	50-/0+
OPI2000	Lot1	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
AMP500	Lot1	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	49-/1+	50-/0+	50-/0+	50-/0+
	Lot2	0-/50+	0-/50+	0-/50+	2-/48+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
	Lot3	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	48-/2+	50-/0+	50-/0+	50-/0+

b. Linearity/assay reportable range:

Not applicable. This device is intended for qualitative use only.

c. Stability:

The device is stable at 4-30℃ for 24 months based on the accelerated stability study.

d. Analytical specificity/Interference:

To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine. These urine samples were tested using three lots of the device.

Percent cross-reactivity, provided in the below table, was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100.

Drug/Cut off	Compound	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
MOP 300	Morphine	300	100%
	6-Monoacetylmorphine (6-MAM)	300	100%
	Codeine	300	100%
	Dihydrocodeine	1,000	30%
	Ethylmorphine	1,000	30%
	Codeine-6-β-D-glucuronide	500	60%
	Heroin	300	100%
	Hydrocodone	50,000	0.6%
	Hydromorphone	1,000	30%

Page 13

Drug/Cut off	Compound	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
	Levorphanol tartrate	1,500	20%
	Nalorphine HCl	1,000	30%
	Norcodeine	2,000	15%
	Normorphine	3,000	10%
	Oxymorphone	10,000	3%
	Morphine-6-β-D-glucuronide	1,000	30%
	Morphine-3-β-D-glucuronide	1,000	30%
	Thebaine	3,000	10%
	6-Acetylcodeine	8,000	3.8%
	Oxycodone	100,000 (Negative)	Not detected
	Procaine	100,000 (Negative)	Not detected
	Norpropoxyphene	100,000 (Negative)	Not detected
MET 1000	D-Methamphetamine	1,000	100%
	(+/-)3,4-Methylenedioxy-nethylamphetamine (MDEA)	20,000	5%
	(+/-)3,4-Methylenedioxymethamphetamine (MDMA)	3,000	33.3%
	L-Methamphetamine	20,000	5%
	p-Hydroxymethamphetamine	30,000	3.3%
	D,L-Methamphetamine	1,000	100%
	β-Phenylethylamine	50,000	2%
	Mephentermine	50,000	2%
	Methoxyphenamine HCl	50,000	2%
	L-Amphetamine	75,000	1.3%
	D-Amphetamine	50,000	2%
	D,L-Amphetamine	100,000 (negative)	Not detected
	Chloroquine	100,000 (negative)	Not detected
	L-Ephedrine	100,000 (negative)	Not detected
	D-Pseudoephedrine	100,000 (negative)	Not detected
	(+/-)3,4-Methylenedioxyamphetamine (MDA)	100,000 (negative)	Not detected
	Trimethobenzamide	100,000 (negative)	Not detected
	L-Phenylephrine	100,000 (negative)	Not detected
	Procaine	100,000 (negative)	Not detected
	Phentermine	100,000 (negative)	Not detected
	Fenflurmaine	50,000	2%
COC300	Benzoylecogonine	300	100%
	Cocaethylene	12,500	2.4%
	Cocaine HCl	780	38.5%
	Ecgonine	32,000	0.9%
	Norcocaine	100,000 (Negative)	Not detected

Page 14

Drug/Cut off	Compound	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
	Ecgonine methyl ester	100,000 (Negative)	Not detected
THC 50	11-nor-Δ9-THC-9-COOH	50	100%
	11-nor-Δ8-THC -9-COOH	30	166.7%
	(±)-11-nor-9-carboxy-Δ9-THC	100	50%
	11-nor-Δ9-THC -carboxy glucuronide	100	50%
	(±)-11-Hydroxy-Δ9-THC	5,000	1%
	Δ8-Tetrahydrocannabinol	1,500	3.3%
	Δ9-Tetrahydrocannabinol	5,000	1%
	Cannabinol	20,000	0.3%
	Cannabidiol	100,000 (Negative)	Not detected
MDMA 500	(+/-)3,4-Methylenedioxymethamphetamine (MDMA)	500	100%
	(+/-)3,4-Methylenedioxyamphetamine (MDA)	3,000	16.7%
	(+/-)3,4-Methylenedioxy-nethylamphetamine (MDEA)	300	166.7%
	L-Methamphetamine	100,000 (Negative)	Not detected
	D-Methamphetamine	100,000 (Negative)	Not detected
	D,L-Methamphetamine	100,000 (Negative)	Not detected
	D-Amphetamine	100,000 (Negative)	Not detected
	L-Amphetamine	100,000 (Negative)	Not detected
	D,L-Amphetamine	100,000 (Negative)	Not detected
	L-Ephedrine	100,000 (Negative)	Not detected
	D-Pseudoephedrine	100,000 (Negative)	Not detected
	Phentermine	100,000 (Negative)	Not detected
	L-Phenylephrine	100,000 (Negative)	Not detected
BUP 10	Buprenorphine	10	100%
	Buprenorphine -3-D-glucuronide	160	6.3%
	Norbuprenorphine	10	100%
	Norbuprenorphine-3-D-glucuronide	200	5%
	Morphine	100,000 (Negative)	Not detected
	Oxymorphone	100,000 (Negative)	Not detected
	Hydromorphone	100,000 (Negative)	Not detected
	Codeine	100,000 (Negative)	Not detected
	Nalorphine HCl	100,000 (Negative)	Not detected
PPX 300	D-Propoxyphene	300	100%
	D-Norpropoxyphene	300	100%
AMP 1000	D-Amphetamine	1,000	100%
	L-Amphetamine	50,000	2%
	D,L-Amphetamine	3,000	33.3%
	Hydroxyamphetamine	5,000	20%

Page 15

Drug/Cut off	Compound	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
	(+/-)3,4-Methylenedioxyamphetamine (MDA)	5,000	20%
	Diethylstilbestrol	4,000	25%
	Phentermine	3,000	33.3%
	β-Phenylethylamine	100,000	1%
	Tyramine	100,000	1%
	D,L-Norephedrine	100,000	1%
	p-Hydroxynorephedrine	100,000	1%
	p-Hydroxyamphetamine	100,000	1%
	D-Methamphetamine	100,000 (Negative)	Not detected
	L-Methamphetamine	100,000 (Negative)	Not detected
	D,L-Methamphetamine	100,000 (Negative)	Not detected
	L-Ephedrine	100,000 (Negative)	Not detected
	D-Pseudoephedrine	100,000 (Negative)	Not detected
	Phenylpropanolamine	100,000 (Negative)	Not detected
	L-Phenylephrine	100,000 (Negative)	Not detected
	L-Epinephrine	100,000 (Negative)	Not detected
	D,L-Epinephrine	100,000 (Negative)	Not detected
	(+/-)3,4-Methylenedioxymethamphetamine (MDMA)	100,000 (Negative)	Not detected
	(+/-)3,4-Methylenedioxy-nethylamphetamine (MDEA)	100,000 (Negative)	Not detected
PCP 25	Phencyclidine	25	100%
	4-Hydroxy phencyclidine	12,500	0.2%
	Pheniramine	40,000	0.06%
EDDP 300	2-Ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300	100%
	Methadone	100,000 (Negative)	Not detected
	EMDP	100,000 (Negative)	Not detected
	Doxylamine	100,000 (Negative)	Not detected
	Levacetylmethadol (LAAM)	100,000 (Negative)	Not detected
	Disopyramide	100,000 (Negative)	Not detected
	Alphamethadol	100,000 (Negative)	Not detected
OXY 100	Oxycodone	100	100%
	Hydrocodone	10,000	1%
	Hydromorphone	12,500	0.8%
	Levorphanol tartrate	20,000	0.5%
	Naloxone HCl	15,000	0.7%
	Naltrexone HCl	50,000	0.2%
	Oxymorphone	1,500	6.7%
	Oxymorphone-3-β-D-glucuronide	1,000	10%

Page 16

Drug/Cut off	Compound	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
	Noroxycodone	2,000	5%
	Noroxymorphone	1,000	10%
	Dihydrocodeine	20,000	0.5%
	Codeine	100,000 (Negative)	Not detected
	Morphine	100,000 (Negative)	Not detected
	Buprenorphine	100,000 (Negative)	Not detected
	Ethylmorphine	100,000 (Negative)	Not detected
	Thebaine	100,000 (Negative)	Not detected
	6-Monoacetylmorphine (6-MAM)	100,000 (Negative)	Not detected
BZO 300	Oxazepam	300	100%
	α-Hydroxyalprazolam	1,500	20%
	Alprazolam	200	150%
	Bromazepam	500	60%
	Chlordiazepoxide	1,500	20%
	Clobazam	100	300%
	Clonazepam	800	37.5%
	Clorazepate dipotassium	200	150%
	Desalkylflurazepam	400	75%
	Diazepam	200	150%
	Estazolam	2,500	12%
	Flunitrazepam	400	75%
	D,L-Lorazepam	1,500	20%
	Midazolam	12,500	2.4%
	Nitrazepam	100	300%
	Norchlordiazepoxide	200	150%
	Nordiazepam	400	75%
	R,S-Lorazepam glucuronide	200	150%
	Temazepam	100	300%
	Triazolam	2,500	12%
	Demoxepam	2,000	15%
	Flurazepam	500	60%
	Delorazepam	2,000	15%
	Lormetazepam	150	200%
TCA 1000	Nortriptyline	1,000	100%
	Amitriptyline	1,500	66.7%
	Chlorpheniramine	30,000	3.3%
	Clomipramine	12,500	8%
	Cyclobenzaprine HCl	5,000	20%
	Desipramine	200	500%
	Doxepin	2,000	50%

Page 17

Drug/Cut off	Compound	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
	Duloxetine	80,000	1.3%
	Imipramine	750	133.3%
	Norclomipramine	12,500	8%
	Nordoxepine	1,000	100%
	Promazine	1,500	66.7%
	Trimipramine	5,000	20%
	Maprotiline	2,000	50%
	Promethazine	25,000	4%
BAR 300	Secobarbital	300	100%
	Alphenal	150	200%
	Amobarbital	300	100%
	Aprobarbital	200	150%
	Butabarbital	100	300%
	Butethal	100	300%
	Cyclopentobarbital	600	50%
	Pentobarbital	250	120%
	Phenobarbital	250	120%
	Butalbital	2,500	12%
	Barbital	300	100%
MTD 300	Methadone	300	100%
	Doxylamine	5,000	6%
	EDDP	100,000 (Negative)	Not detected
	Levacetylmethadol (LAAM)	100,000 (Negative)	Not detected
	EMDP	100,000 (Negative)	Not detected
	Alphamethadol	100,000 (Negative)	Not detected
	Pheniramine	100,000 (Negative)	Not detected
	Disopyramide	100,000 (Negative)	Not detected
	Esomeprazole	100,000 (Negative)	Not detected
6-MAM 10	6-Monoacetylmorphine (6-MAM)	10	100%
	Heroin	10	100%
	Morphine	100,000	0.01%
	Nalorphine HCl	5,000	0.2%
	Hydrocodone	50,000	0.02%
	Hydromorphone	10,000	0.1%
	Oxymorphone	50,000	0.02%
	Procaine	50,000	0.02%
	Thebaine	10,000	0.1%
	Normorphine	100,000 (Negative)	Not detected
	Chlordiazepoxide	100,000 (Negative)	Not detected
	Clobazam	100,000 (Negative)	Not detected

Page 18

Drug/Cut off	Compound	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
	D-Amphetamine	100,000 (Negative)	Not detected
	D,L-Amphetamine	100,000 (Negative)	Not detected
	Levorphanol tartrate	100,000 (Negative)	Not detected
	Codeine	100,000 (Negative)	Not detected
	Ethylmorphine	100,000 (Negative)	Not detected
	Morphine-3-β-D-glucuronide	100,000 (Negative)	Not detected
	Norcodeine	100,000 (Negative)	Not detected
	Oxycodone	100,000 (Negative)	Not detected
	6-Acetylcodeine	100,000 (Negative)	Not detected
	Buprenorphine	100,000 (Negative)	Not detected
	Dihydrocodeine	100,000 (Negative)	Not detected
	Dextromethorphan	100,000 (Negative)	Not detected
	Imipramine	100,000 (Negative)	Not detected
	Meperidine	100,000 (Negative)	Not detected
	(±)-Methadone	100,000 (Negative)	Not detected
	Mitragynine (Kratom)	100,000 (Negative)	Not detected
	Morphine-6-β-D-glucuronide	100,000 (Negative)	Not detected
	Naloxone HCl	100,000 (Negative)	Not detected
	Naltrexone HCl	100,000 (Negative)	Not detected
	Naproxen	100,000 (Negative)	Not detected
	Norbuprenorphine	100,000 (Negative)	Not detected
	Norbuprenorphine-3-D-glucuronide	100,000 (Negative)	Not detected
	Noroxycodone HCl	100,000 (Negative)	Not detected
	Noroxymorphone HCl	100,000 (Negative)	Not detected
	(+)-Norpropoxyphene maleate	100,000 (Negative)	Not detected
	Oxymorphone-3-β-D-glucuronide	100,000 (Negative)	Not detected
	Tapentadol HCl	100,000 (Negative)	Not detected
	Tramadol HCl	100,000 (Negative)	Not detected
	Levacetylmethadol (LAAM)	100,000 (Negative)	Not detected
FYL 1	Fentanyl	1	100%
	Acetyl fentanyl	1	100%
	Acrylfentanyl	1	100%
	Isobutyryl fentanyl	2.5	40%
	Ocfentanil	5	20%
	Butyryl fentanyl	5	20%
	Furanyl fentanyl	10	10%
	Valeryl fentanyl	5	20%
	(±) β-Hydroxythiofentanyl	2.5	40%
	4-Fluoro-isobutyrylfentanyl	10	10%
	Para-fluorobutyryl fentanyl	5	20%

Page 19

Drug/Cut off	Compound	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
	Para-fluoro fentanyl	2.5	40%
	Carfentanil	50	2%
	Sufentanil	25	4%
	Alfentanil	7500	0.01%
	ω-1-Hydroxy fentanyl	2500	0.04%
	(±)-3-cis-methyl fentanyl	75	1.3%
	Despropionyl fentanyl (4-ANPP)	2000	0.05%
	β-hydroxyfentanyl	100	1%
	Thiofentanyl	50	2%
	Cyclopropyl fentanyl	10	10%
	Trazodone	1000	0.1%
	Remifentanil	100,000 (Negative)	Not detected
	Norcarfentanil	100,000 (Negative)	Not detected
	Norfentanyl	100,000 (Negative)	Not detected
	Acetyl norfentanyl	100,000 (Negative)	Not detected
	6-Acetyl morphine	100,000 (Negative)	Not detected
	Amphetamine	100,000 (Negative)	Not detected
	Buprenorphine	100,000 (Negative)	Not detected
	Buprenorphine-3-D-glucuronide	100,000 (Negative)	Not detected
	Codeine	100,000 (Negative)	Not detected
	Dextromethorphan	100,000 (Negative)	Not detected
	Dihydrocodeine	100,000 (Negative)	Not detected
	EDDP	100,000 (Negative)	Not detected
	EMDP	100,000 (Negative)	Not detected
	Fluoxetine	100,000 (Negative)	Not detected
	Heroin	100,000 (Negative)	Not detected
	Hydrocodone	100,000 (Negative)	Not detected
	Hydromorphone	100,000 (Negative)	Not detected
	Ketamine	100,000 (Negative)	Not detected
	Levorphanol	100,000 (Negative)	Not detected
	Meperidine	100,000 (Negative)	Not detected
	Methadone	100,000 (Negative)	Not detected
	Morphine	100,000 (Negative)	Not detected
	Morphine-3-β-D-glucuronide	100,000 (Negative)	Not detected
	Naloxone	100,000 (Negative)	Not detected
	Naltrexone	100,000 (Negative)	Not detected
	Norbuprenorphine	100,000 (Negative)	Not detected
	Norcodeine	100,000 (Negative)	Not detected
	Norketamine	100,000 (Negative)	Not detected
	Normeperidine	100,000 (Negative)	Not detected

Page 20

Drug/Cut off	Compound	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
	Normorphine	100,000 (Negative)	Not detected
	Noroxycodone	100,000 (Negative)	Not detected
	Oxycodone	100,000 (Negative)	Not detected
	Oxymorphone	100,000 (Negative)	Not detected
	Pentazocine (Talwin)	100,000 (Negative)	Not detected
	Pipamperone	100,000 (Negative)	Not detected
	Risperidone	100,000 (Negative)	Not detected
	Tapentadol	100,000 (Negative)	Not detected
	Thioridazine	100,000 (Negative)	Not detected
	Tilidine	100,000 (Negative)	Not detected
	Tramadol	100,000 (Negative)	Not detected
	Tramadol-N-Desmethyl	100,000 (Negative)	Not detected
	Tramadol-O-Desmethyl	100,000 (Negative)	Not detected
	Isotonitaze	100,000 (Negative)	Not detected
	AH-7921 HCl	100,000 (Negative)	Not detected
MET 500	D-Methamphetamine	500	100%
	(+/-)3,4-Methylenedioxy-nethylamphetamine (MDEA)	10,000	5%
	(+/-)3,4-Methylenedioxymethamphetamine (MDMA)	1,500	33.3%
	L-Methamphetamine	10,000	5%
	p-Hydroxymethamphetamine	15,000	3.3%
	D,L-Methamphetamine	500	100%
	β-Phenylethylamine	25,000	2%
	Mephentermine	25,000	2%
	Methoxyphenamine HCl	25,000	2%
	L-Amphetamine	37,500	1.3%
	D-Amphetamine	25,000	2%
	D,L-Amphetamine	100,000 (negative)	Not detected
	Chloroquine	100,000 (negative)	Not detected
	L-Ephedrine	100,000 (negative)	Not detected
	D-Pseudoephedrine	100,000 (negative)	Not detected
	(+/-)3,4-Methylenedioxyamphetamine (MDA)	100,000 (negative)	Not detected
	Trimethobenzamide	100,000 (negative)	Not detected
	L-Phenylephrine	100,000 (negative)	Not detected
	Procaine	100,000 (negative)	Not detected
	Phentermine	100,000 (negative)	Not detected
	Fenflurmaine	25,000	2%
COC 150	Benzoylecogonine	150	100%
	Cocaethylene	6,250	2.4%

Page 21

Drug/Cut off	Compound	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
	Cocaine HCl	340	44.1%
	Ecgonine	16,000	0.9%
	Norcocaine	100,000 (Negative)	Not detected
	Ecgonine methyl ester	100,000 (Negative)	Not detected
OPI 2000	Morphine	2000	100%
	6-Monoacetylmorphine (6-MAM)	2,000	100%
	Codeine	2,000	100%
	Dihydrocodeine	1,500	133.3%
	Ethylmorphine	3,000	66.7%
	Codeine-6-β-D-glucuronide	3,000	66.7%
	Heroin	2,000	100%
	Hydrocodone	12,500	16%
	Hydromorphone	5,000	40%
	Levorphanol tartrate	75,000	2.7%
	Nalorphine HCl	5,000	40%
	Norcodeine	8,000	25%
	Normorphine	50,000	4%
	Oxymorphone	25,000	8%
	Morphine-6-β-D-glucuronide	2,000	100%
	Morphine-3-β-D-glucuronide	2,000	100%
	Thebaine	5,000	40%
	6-Acetylcodeine	50,000	4%
	Oxycodone	100,000 (Negative)	Not detected
	Procaine	100,000 (Negative)	Not detected
	Norpropoxyphene	100,000 (Negative)	Not detected
AMP 500	D-Amphetamine	500	100%
	L-Amphetamine	25,000	2%
	D,L-Amphetamine	1,500	33.3%
	Hydroxyamphetamine	2,500	20%
	(+/-)3,4-Methylenedioxyamphetamine (MDA)	2,500	20%
	Diethylstilbestrol	2,000	25%
	Phentermine	1,500	33.3%
	β-Phenylethylamine	50,000	1%
	Tyramine	50,000	1%
	D,L-Norephedrine	50,000	1%
	p-Hydroxynorephedrine	50,000	1%
	p-Hydroxyamphetamine	50,000	1%
	D-Methamphetamine	100,000 (Negative)	Not detected
	L-Methamphetamine	100,000 (Negative)	Not detected
	D,L-Methamphetamine	100,000 (Negative)	Not detected

Page 22

Drug/Cut off	Compound	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
	L-Ephedrine	100,000 (Negative)	Not detected
	D-Pseudoephedrine	100,000 (Negative)	Not detected
	Phenylpropanolamine	100,000 (Negative)	Not detected
	L-Phenylephrine	100,000 (Negative)	Not detected
	L-Epinephrine	100,000 (Negative)	Not detected
	D,L-Epinephrine	100,000 (Negative)	Not detected
	(+/-)3,4-Methylenedioxymethamphetamine (MDMA)	100,000 (Negative)	Not detected
	(+/-)3,4-Methylenedioxy-nethylamphetamine (MDEA)	100,000 (Negative)	Not detected
	Benzphetamine	100,000 (Negative)	Not detected

To evaluate potential interference, non-structurally related compounds were added to drug-free urine and to urine samples containing the target drugs at 50% below and 50% above each corresponding cutoff.

Compounds that show no interference at a concentration of 100µg/mL or specified concentrations are summarized in the following table.

Compound	Compound	Compound
Acetaminophen	Doxylamine (except MTD test)	Octopamine
Acetone (1000 mg/dL)	D-Pseudoephedrine	O-Hydroxyhippuric acid
Acetophenetidin	Duloxetine (except TCA test)	Olanzapine
Acetylsalicylic acid (Aspirin)	Ecgonine methyl ester	Omeprazole
Acyclovir	EMDP	Oxalic acid (100 mg/dL)
Albumin (100 mg/dL )	Erythromycin	Oxolinic acid
Albuterol sulfate (Proair HFA)	Esomeprazole magnesium	Oxymetazoline
Alphamethadol	Estrone	Paliperidone
Aminophylline	Ethanol (1%)	Papaverine
Aminopyrine	Fenofibrate	Penicillin G
Amitriptyline	Fenoprofen	Penicillin V potassium
Amoxicillin	Fentanyl (except FYL test)	Perphenazine
Ampicillin	Fluoxetine HCl	Phenacetin
Aripiprazole	Fluphenazine	Phenelzine
Aspartame	Fotemustine	Phenylpropanolamine
Atomoxetine	Furosemide	Prednisone
Atorvastatin Calcium	Gabapentin	Pregablin
Atropine	Galactose (10 mg/dL)	Procaine (except 6-MAM test)
Azithromycin	Gamma globulin (500 mg/dL)	Promazine (except TCA test)

Page 23

Compound	Compound	Compound
Baclofen	Gatifloxacin	Promethazine (except TCA test)
Benzilic acid	Gemfibrozil	Propoxyphene (except PPX test)
Benzocaine	Gentisic acid	Propranolol
Benzoic acid	Glibenclamide	Propylthiouracil
Benzoylecgonine	Gliclazide	Pyridoxine
Benzphetamine	Glucose (3000 mg/dL)	Pyrilamine
Bilirubin	Guaiacol glyceryl ether	Pyrogallol
Boric acid (1%)	Hemoglobin	Quetiapine
Bupropion	Hydralazine	Quinine
Caffeine	Hydrochlorothiazide	Quinolinic acid
Cannabidiol	Hydrocortisone	R-(-)-Apomorphine
Captopril	Ibuprofen	Ranitidine
Carbamazepine	Imipramine (except TCA test)	Ribavirin
Carfentanil (except FYL test)	Isoxsuprine	Rifampicin
Carisoprodol	Ketamine	Risperidone
Cefradine	Ketoprofen	Salicylic acid
Cephalexin	LAAM HCl	Serotonin (5-Hydroxytyramine)
Chloral hydrate	Labetalol	Sertraline
Chloramphenicol	L-Ephedrine	Sildenafil citrate
Chlordiazepoxide (except BZO test)	L-Epinephrine	Simvastatin
Chloroquine	Levofloxacin HCl	Sulfamethazine
Chlorothiazide	Levonorgestrel	Sulindac
Chlorpheniramine (except TCA test)	Levothyroxine Sodium	Telmisartan
Chlorpromazine	Lidocaine HCl	Tetracycline
Cholesterol	Lisinopril	Tetrahydrocortisone 3-(βDglucuronide)
Ciprofloxacin HCl	Loperamide	Tetrahydrocortisone 3-acetate
Citalopram	Loratadine	Tetrahydrozoline
Clarithromycin	L-Phenylephrine	Theophylline
Clonidine	Magnesium	Thiamine
Clozapine	Maprotiline (except TCA test)	Thioridazine
Conjugated Estrogens	Meperidine	Tramadol
Cortisone	Meprobamate	Trazodone (except FYL test)
Creatine Hydrate	Methapyrilene	Triamterene
Creatinine	Methaqualone	Trifluoperazine

Page 24

Compound	Compound	Compound
Cyclobenzaprine HCl (except TCA test)	Methoxyphenamine (except MET test)	Trimethobenzamide
Cyclodextrin	Methylphenidate	Trimethoprim
D,L-Epinephrine	Metoprolol tartrate	Tryptamine
D,L-Isoproterenol	Metronidazole (300 μg/mL)	Tyramine (except AMP test)
D,L-Octopamine	Mifepristone	Urea (2000 mg/dL)
D,L-Propranolol	Montelukast sodium	Uric acid
D,L-Tryptophan	N-Acetylprocainamide	Valproic acid (250 μg/mL)
D,L-Tyrosine	NaCl (4000 mg/dL)	Venlafaxine HCl
Delorazepam (except BZO test)	Nalidixic acid	Verapamil
Deoxycorticosterone	Naloxone HCl (except OXY test)	Vitamin B2 (Riboflavin)
Desloratadine	Naltrexone HCl (except OXY test)	Vitamin C (Ascorbic acid)
Dextromethorphan	Niacinamide	Zaleplon
Diclofenac	Nicotine	Zomepirac sodium salt
Diclofenac sodium	Nicotinic acid	β-Estradiol
Diflunisal	Nifedipine	β-Phenylethylamine (except MET/AMP test)
Digoxin	Nitroglycerin	(-)-Cotinine
Diphenhydramine HCl	Nordoxepin (except TCA test)	(+)-Naproxen
Disopyramide	Norethindrone	3-Hydroxytyramine
Dopamine HCl	Norfentanyl	4-Dimethyl-aminoantipyrine
Doxepin (except TCA test)	Noscapine	5, 5-Diphenylhydantoin

Interference by pH and specific gravity were also evaluated using pooled urine specimens with drug concentrations at 50% below and 50% above each corresponding cutoff. The results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 do not affect the results of the assays.

B. Method comparison study

The method comparison studies for the device were performed in-house with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug. The samples were blind labeled and compared to LC-MS/MS results. The results are presented in the table below:

Page 25

Drug Test	Operator	Test Result	Drug-Free	Low Negative by LC-MS/MS (less than -50% cut off)	Near cut off Negative by LC-MS/MS (Between -50%cut off and cut off)	Near cut off Positive by LC-MS/MS (Between cut off and +50% cut off)	High Positive by LC-MS/MS (greater than +50%cut off)
MOP300	Operator 1	+	0	0	1	18	21
		-	10	15	14	1	0
	Operator 2	+	0	0	0	18	21
		-	10	15	15	1	0
	Operator 3	+	0	0	1	19	21
		-	10	15	14	0	0
MET1000	Operator 1	+	0	0	1	22	18
		-	10	14	15	0	0
	Operator 2	+	0	0	0	21	18
		-	10	14	16	1	0
	Operator 3	+	0	0	1	21	18
		-	10	14	15	1	0
COC300	Operator 1	+	0	0	1	18	21
		-	10	15	14	1	0
	Operator 2	+	0	0	1	18	21
		-	10	15	14	1	0
	Operator 3	+	0	0	1	19	21
		-	10	15	14	0	0
THC	Operator 1	+	0	0	0	22	18
		-	10	14	16	0	0
	Operator 2	+	0	0	0	21	18
		-	10	14	16	1	0
	Operator 3	+	0	0	0	21	18
		-	10	14	16	1	0
MDMA	Operator 1	+	0	0	0	19	20
		-	10	15	15	1	0
	Operator 2	+	0	0	1	19	20
		-	10	15	14	1	0
	Operator 3	+	0	0	0	19	20
		-	10	15	15	1	0
BUP	Operator 1	+	0	0	1	22	18
		-	10	14	15	0	0
	Operator 2	+	0	0	1	21	18
		-	10	14	15	1	0

Page 26

Drug Test	Operator	Test Result	Drug-Free	Low Negative by LC-MS/MS (less than -50% cut off)	Near cut off Negative by LC-MS/MS (Between -50%cut off and cut off)	Near cut off Positive by LC-MS/MS (Between cut off and +50% cut off)	High Positive by LC-MS/MS (greater than +50%cut off)
	Operator 3	+	0	0	1	21	18
		-	10	14	15	1	0
PPX	Operator 1	+	0	0	1	19	20
		-	10	14	15	1	0
	Operator 2	+	0	0	1	19	20
		-	10	14	15	1	0
	Operator 3	+	0	0	1	19	20
		-	10	14	15	1	0
AMP1000	Operator 1	+	0	0	1	19	20
		-	10	15	14	1	0
	Operator 2	+	0	0	0	19	20
		-	10	15	15	1	0
	Operator 3	+	0	0	0	20	20
		-	10	15	15	0	0
PCP	Operator 1	+	0	0	0	21	18
		-	10	14	16	1	0
	Operator 2	+	0	0	1	21	18
		-	10	14	15	1	0
	Operator 3	+	0	0	0	21	18
		-	10	14	16	1	0
EDDP	Operator 1	+	0	0	1	21	19
		-	10	14	15	0	0
	Operator 2	+	0	0	0	21	19
		-	10	14	16	0	0
	Operator 3	+	0	0	0	20	19
		-	10	14	16	1	0
OXY	Operator 1	+	0	0	1	19	20
		-	10	15	14	1	0
	Operator 2	+	0	0	1	20	20
		-	10	15	14	0	0
	Operator 3	+	0	0	1	19	20
		-	10	15	14	1	0
BZO	Operator 1	+	0	0	1	19	20
		-	10	15	14	1	0

Page 27

Drug Test	Operator	Test Result	Drug-Free	Low Negative by LC-MS/MS (less than -50% cut off)	Near cut off Negative by LC-MS/MS (Between -50%cut off and cut off)	Near cut off Positive by LC-MS/MS (Between cut off and +50% cut off)	High Positive by LC-MS/MS (greater than +50%cut off)
	Operator 2	+	0	0	1	20	20
		-	10	15	14	0	0
	Operator 3	+	0	0	0	19	20
		-	10	15	15	1	0
TCA	Operator 1	+	0	0	0	19	20
		-	10	14	16	1	0
	Operator 2	+	0	0	1	20	20
		-	10	14	15	0	0
	Operator 3	+	0	0	0	19	20
		-	10	14	16	1	0
BAR	Operator 1	+	0	0	2	22	18
		-	10	14	14	0	0
	Operator 2	+	0	0	0	21	18
		-	10	14	16	1	0
	Operator 3	+	0	0	1	21	18
		-	10	14	15	1	0
MTD	Operator 1	+	0	0	1	20	19
		-	10	14	15	1	0
	Operator 2	+	0	0	1	21	19
		-	10	14	15	0	0
	Operator 3	+	0	0	0	20	19
		-	10	14	16	1	0
6-MAM	Operator 1	+	0	0	1	21	18
		-	10	14	15	1	0
	Operator 2	+	0	0	0	21	18
		-	10	14	16	1	0
	Operator 3	+	0	0	0	21	18
		-	10	14	16	1	0
FYL	Operator 1	+	0	0	0	21	18
		-	10	15	15	1	0
	Operator 2	+	0	0	2	22	18
		-	10	15	13	0	0
	Operator 3	+	0	0	1	20	18
		-	10	15	14	2	0

Page 28

Drug Test	Operator	Test Result	Drug-Free	Low Negative by LC-MS/MS (less than -50% cut off)	Near cut off Negative by LC-MS/MS (Between -50%cut off and cut off)	Near cut off Positive by LC-MS/MS (Between cut off and +50% cut off)	High Positive by LC-MS/MS (greater than +50%cut off)
MET500	Operator 1	+	0	0	1	20	19
		-	10	14	15	1	0
	Operator 2	+	0	0	0	20	19
		-	10	14	16	1	0
	Operator 3	+	0	0	1	20	19
		-	10	14	15	1	0
COC150	Operator 1	+	0	0	1	21	18
		-	10	15	14	1	0
	Operator 2	+	0	0	0	21	18
		-	10	15	15	1	0
	Operator 3	+	0	0	1	21	18
		-	10	15	14	1	0
OPI2000	Operator 1	+	0	0	1	21	18
		-	10	15	14	1	0
	Operator 2	+	0	0	0	20	18
		-	10	15	15	2	0
	Operator 3	+	0	0	1	22	18
		-	10	15	14	0	0
AMP500	Operator 1	+	0	0	1	21	18
		-	10	15	14	1	0
	Operator 2	+	0	0	1	21	18
		-	10	15	14	1	0
	Operator 3	+	0	0	1	21	18
		-	10	15	14	1	0

Discordant Results are summarized below.

Drug Test	Operator	Sample Number	LC-MS/MS Result (ng/mL)	Test Result
MOP300	Operator 1	1-08	269.32	Positive
	Operator 3	1-33	289.66	Positive
	Operator 1	1-60	336.93	Negative
	Operator 2	1-17	310.02	Negative
MET1000	Operator 1	4-79	992.48	Positive
	Operator 3	4-38	897.14	Positive
	Operator 2	4-63	1018.46	Negative

Page 29

Drug Test	Operator	Sample Number	LC-MS/MS Result (ng/mL)	Test Result
	Operator 3	4-74	1007.84	Negative
COC300	Operator 1	6-32	296.35	Positive
	Operator 2	6-63	295.68	Positive
	Operator 3	6-79	272.56	Positive
	Operator 1	6-51	306.47	Negative
	Operator 2	6-68	300.47	Negative
THC	Operator 2	7-04	53.73	Negative
	Operator 3	7-32	57.78	Negative
MDMA	Operator 2	8-07	496.27	Positive
	Operator 1	8-48	508.66	Negative
	Operator 2	8-20	547.97	Negative
	Operator 3	8-42	511.26	Negative
BUP	Operator 1,2	9-45	9.86	Positive
	Operator 3	9-20	9.66	Positive
	Operator 2	9-72	10.23	Negative
	Operator 3	9-50	10.66	Negative
PPX	Operator 1,3	11-21	297.14	Positive
	Operator 2	11-11	293.10	Positive
	Operator 1	11-02	302.98	Negative
	Operator 3	11-65	322.25	Negative
	Operator 2	11-71	309.47	Negative
AMP1000	Operator 1	13-08	870.13	Positive
	Operator 1	13-07	1070.87	Negative
	Operator 2	13-23	1013.55	Negative
PCP	Operator 2	14-31	24.88	Positive
	Operator 1	14-69	25.58	Negative
	Operator 2	14-49	28.12	Negative
	Operator 3	14-27	25.47	Negative
EDDP	Operator 1	15-21	296.15	Positive
	Operator 3	15-51	305.99	Negative
OXY	Operator 1	16-28	91.36	Positive
	Operator 2	16-51	99.55	Positive
	Operator 3	16-77	96.15	Positive
	Operator 1	16-74	110.47	Negative
	Operator 3	16-75	104.20	Negative
BZO	Operator 1	17-61	273.48	Positive
	Operator 2	17-04	293.44	Positive
	Operator 1	17-37	307.46	Negative
	Operator 3	17-69	319.25	Negative
TCA	Operator 2	18-65	886.47	Positive
	Operator 1,3	18-26	1003.13	Negative

Page 30

Drug Test	Operator	Sample Number	LC-MS/MS Result (ng/mL)	Test Result
BAR	Operator 1	19-48	288.49	Positive
	Operator 3	19-76	298.54	Positive
	Operator 1	19-39	294.45	Positive
	Operator 2	19-33	303.65	Negative
	Operator 3	19-62	315.16	Negative
MTD	Operator 1	20-65	292.16	Positive
	Operator 2	20-79	289.43	Positive
	Operator 1,3	20-27	303.66	Negative
6-MAM	Operator 1	21-56	8.94	Positive
	Operator 1	21-06	10.55	Negative
	Operator 2	21-23	10.55	Negative
	Operator 3	21-08	11.46	Negative
FYL	Operator 2	10-69	0.95	Positive
	Operator 2	10-17	0.87	Positive
	Operator 3	10-68	0.96	Positive
	Operator 1	10-21	1.04	Negative
	Operator 3	10-07	1.12	Negative
	Operator 3	10-20	1.02	Negative
MET500	Operator 1	3-58	458.22	Positive
	Operator 3	3-68	493.26	Positive
	Operator 1	3-35	515.17	Negative
	Operator 2	3-71	539.96	Negative
	Operator 3	3-78	503.12	Negative
COC150	Operator 1,3	5-38	145.59	Positive
	Operator 1	5-07	156.87	Negative
	Operator 2	5-71	151.49	Negative
	Operator 3	5-61	164.90	Negative
OPI2000	Operator 1	2-67	1834.41	Positive
	Operator 3	2-04	1976.54	Positive
	Operator 1	2-50	2179.28	Negative
	Operator 2	2-10	2039.78	Negative
	Operator 2	2-77	2034.78	Negative
AMP500	Operator 1	12-75	491.37	Positive
	Operator 2	12-04	473.85	Positive
	Operator 3	12-70	489.38	Positive
	Operator 1	12-55	510.94	Negative
	Operator 3	12-79	553.25	Negative
	Operator 2	12-68	506.47	Negative

C. Lay person study

Page 31

A lay user study was performed at three intended user sites with 280 lay persons. 176 male and 104 female participated the study. They had diverse educational and professional backgrounds and their age range from 21 to > 50. Urine samples were prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC-MS/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.

Result of CLUNGENE Multi-Drug Test Easy Cup Configuration 1:

| Drug | Cut off (ng/mL) | Results | Concentration |||||||||
|------|-----------------|---------|---------------|
| | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| MOP | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| MET | 1000 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| COC | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| THC | 50 | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 100% | 100% | 100% |
| MDMA | 500 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% |
| BUP | 10 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| PPX | 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| AMP | 1000 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |

Page 32

| Drug | Cut off (ng/mL) | Results | Concentration |||||||||
|------|-----------------|---------|---------------|
| | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| PCP | 25 | Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
| EDDP | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| OXY | 100 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| BZO | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| TCA | 1000 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| BAR | 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| MTD | 300 | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 100% | 100% | 100% |
| 6-MAM | 10 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| FYL | 1 | Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 100% | 100% | 100% |

Result of CLUNGENE Multi-Drug Test Easy Cup Configuration 2:

| Drug | Cut off (ng/mL) | Results | Concentration |||||||||
|------|-----------------|---------|---------------|
| | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| MET | 500 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |

Page 33

| Drug | Cut off (ng/mL) | Results | Concentration |||||||||
|------|-----------------|---------|---------------|
| | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| COC | 150 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| THC | 50 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| OPI | 2000 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| MDMA | 500 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| BUP | 10 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| PPX | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| AMP | 500 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| PCP | 25 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| EDDP | 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| OXY | 100 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |

Page 34

| Drug | Cut off (ng/mL) | Results | Concentration |||||||||
|------|-----------------|---------|---------------|
| | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| BZO | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| TCA | 1000 | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 100% | 100% | 100% |
| BAR | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| MTD | 300 | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 100% | 100% | 100% |
| 6-MAM | 10 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| FYL | 1 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |

Participants were given surveys on the ease of understanding the instruction for use. All participants indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 8.

Clinical Studies:
Not applicable.

13. Conclusion

Based on the test principle and performance characteristics of the device including precision, cut-off, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).