The WEBEST Multi-Drug Urine Cup is a rapid lateral flow immunoassays for the qualitative detection of D-Amphetamine, Butalbital, Buprenorphine, Oxazepam, Benzoylecgonine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Fentanyl, Methylenedioxymethamphetamine, D-Methamphetamine, Methadone, 6-Monoacetylmorphine, Norfentanyl, Morphine, Oxycodone, Phencyclidine, D-Propoxyphene, Nortriptyline, 11-nor-Δ9-THC-COOH and Tramadol in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

Test	Calibrator	Cut-off (ng/ml)
AMP	D-Amphetamine	1000 or 500
BAR	Butalbital	300
BUP	Buprenorphine	10
BZO	Oxazepam	300
COC	Benzoylecgonine	300 or 150
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300
FYL	Fentanyl	1
MDMA	Methylenedioxymethamphetamine	500
MET	D-Methamphetamine	1000 or 500
MTD	Methadone	300
6-MAM	6-Monoacetylmorphine	10
NFYL	Norfentanyl	5
MOP/OPI	Morphine	2000 or 300
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	D-Propoxyphene	300
TCA	Nortriptyline	1000
THC	11-nor-Δ9-THC-COOH	50
TML	Tramadol	100

The single or multi-test cup can consist of up to nineteen (19) of the above listed analytes in any combination with or without on-board adulteration/ specimen validity tests (SVT).

The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

The Webest Home Multi-Drug Urine Cup is lateral flow immunoassays for rapid detection of multiple commonly abused drugs in human urine. The detectable drugs and their cutoff concentrations are listed below:

CODE	SUBSTANCE	CUT-OFF (ng/ml)
AMP	D-Amphetamine	1000 or 500
BAR	Butalbital	300
BUP	Buprenorphine	10
BZO	Oxazepam	300
COC	Benzoylecgonine	300 or150
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300
FYL	Fentanyl	1
MDMA	Methylenedioxymethamphetamine	500
MET	D-Methamphetamine	1000 or 500
MTD	Methadone	300
6-MAM	6-Monoacetylmorphine	10
NFYL	Norfentanyl	5
MOP/OPI	Morphine	2000 or300
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	D-Propoxyphene	300
TCA	Nortriptyline	1000
THC	11-nor-Δ9-THC-COOH	50
TML	Tramadol	100

This is not a screening device to monitor prescription medication.

The single or multi-test cup can include any combination of the analytes listed above, with and without on-board adulteration tests. However, only one cut-off concentration can be included per analyte per device.

This device provides only a preliminary test result. A more specific alternate method shall be used in order to obtain a confirmed analytical test result. GC/MS or LC/MS is the preferred confirmatory method.

Device Description

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

The devices are a cup format. Each test device is sealed with 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

N/A

Summary

U.S. Food & Drug Administration 510(k) Clearance Letter

Page 1

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

Doc ID # 04017.06.09

March 9, 2026

WEBEST Biotech, LLC
℅ Jenny Xia
LSI International Inc
504 East Diamond Ave., Suite H
Gaithersburg, Maryland 20877

Re: K260355
Trade/Device Name: Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup
Regulation Number: 21 CFR 862.3100
Regulation Name: Amphetamine test system
Regulatory Class: Class II
Product Code: NFT PTH NGL NFY NFV PTG NGG NGM QBF QAW NFW
Dated: February 3, 2026
Received: February 3, 2026

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.

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).

Page 2

K260355- Jenny Shia Page 2

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.

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-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

Digitally signed by JOSEPH A. KOTAREK -S
Date: 2026.03.09 14:31:09 -04'00'

Page 3

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.

Submission Number (if known): K260355

Device Name: Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup

Indications for Use (Describe)

Test	Calibrator	Cut-off (ng/ml)
AMP	D-Amphetamine	1000 or 500
BAR	Butalbital	300
BUP	Buprenorphine	10
BZO	Oxazepam	300
COC	Benzoylecgonine	300 or 150
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300
FYL	Fentanyl	1
MDMA	Methylenedioxymethamphetamine	500
MET	D-Methamphetamine	1000 or 500
MTD	Methadone	300
6-MAM	6-Monoacetylmorphine	10
NFYL	Norfentanyl	5
MOP/OPI	Morphine	2000 or 300
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	D-Propoxyphene	300
TCA	Nortriptyline	1000
THC	11-nor-Δ9-THC-COOH	50
TML	Tramadol	100

The single or multi-test cup can consist of up to nineteen (19) of the above listed analytes in any combination with or without on-board adulteration/ specimen validity tests (SVT).

CODE	SUBSTANCE	CUT-OFF (ng/ml)
AMP	D-Amphetamine	1000 or 500
BAR	Butalbital	300

Page 4

BUP	Buprenorphine	10
BZO	Oxazepam	300
COC	Benzoylecgonine	300 or150
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300
FYL	Fentanyl	1
MDMA	Methylenedioxymethamphetamine	500
MET	D-Methamphetamine	1000 or 500
MTD	Methadone	300
6-MAM	6-Monoacetylmorphine	10
NFYL	Norfentanyl	5
MOP/OPI	Morphine	2000 or300
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	D-Propoxyphene	300
TCA	Nortriptyline	1000
THC	11-nor-Δ9-THC-COOH	50
TML	Tramadol	100

This is not a screening device to monitor prescription medication.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(k) SUMMARY

K260355

Date: March 6, 2026
Submitter: WEBEST Biotech, LLC.
535 Irwindale Ave.
Irwindale, CA 91706
Contact person: Jenny Xia
LSI International Inc.
504 East Diamond Ave., Suite H
Gaithersburg, MD 20877
Telephone: 301-525-6856
Email: jxia@lsi-consulting.org
Device Name: Webest Multi-Drug Urine Cup
Webest Home Multi-Drug Urine Cup
Classification: Class II

Product Code	Target Drug	Regulation Section	Panel
NFT	Amphetamine (AMP)	862.3100, Amphetamine Test System	Toxicology
PTH	Butalbital (BAR)	862.3150, Barbiturate Test System	Toxicology
NGL	Buprenorphine (BUP), Fentanyl (FYL), Morphine (MOP/OPI), Oxycodone (OXY), 6-Monoacetylmorphine(6-MAM), Norfentanyl (NFYL), Tramadol (TML)	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
QBF		862.3700 Propoxyphene test system.	Toxicology

Page 6

Propoxyphene(PPX)
NGM	Phencyclidine (PCP)	Unclassified	Toxicology
QAW	Nortriptyline (TCA)	862.3910 Tricyclic antidepressant drugs test system	Toxicology
NFW	Cannabinoids (THC)	862.3870, Cannabinoids Test System	Toxicology

Predicate Devices:
AllTest Multi-Drug Rapid Test Cup (K244043)
Intended Use

CODE	SUBSTANCE	CUT-OFF (ng/mL)
AMP	D-Amphetamine	1000 or 500
BAR	Butalbital	300
BUP	Buprenorphine	10
BZO	Oxazepam	300
COC	Benzoylecgonine	300 or150
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300
FYL	Fentanyl	1
MDMA	Methylenedioxymethamphetamine	500
MET	D-Methamphetamine	1000 or 500
MTD	Methadone	300
6-MAM	6-Monoacetylmorphine	10
NFYL	Norfentanyl	5
MOP/OPI	Morphine	2000 or300
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	D-Propoxyphene	300
TCA	Nortriptyline	1000
THC	11-nor-Δ9-THC-COOH	50
TML	Tramadol	100

This is not a screening device to monitor prescription medication.

Page 7

Test	Calibrator	Cut-off (ng/mL)
AMP	D-Amphetamine	1000 or 500
BAR	Butalbital	300
BUP	Buprenorphine	10
BZO	Oxazepam	300
COC	Benzoylecgonine	300 or 150
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300
FYL	Fentanyl	1
MDMA	Methylenedioxymethamphetamine	500
MET	D-Methamphetamine	1000 or 500
MTD	Methadone	300
6-MAM	6-Monoacetylmorphine	10
NFYL	Norfentanyl	5
MOP/OPI	Morphine	2000 or 300
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	D-Propoxyphene	300
TCA	Nortriptyline	1000
THC	11-nor-Δ9-THC-COOH	50
TML	Tramadol	100

The single or multi-test cup can consist of up to nineteen (19) of the above listed analytes in any combination with or without on-board adulteration/ specimen validity tests (SVT).

Device Description

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

Substantial Equivalence Information

Similarities

Item	Device	Predicate (K244043)

Page 8

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 that no Norfentanyl
	Amphetamine(AMP) 1000 or 500
	Butalbital (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-AM) 10
	Fentanyl (FYL) 1
	Norfentanyl (NFYL) 5
	Tramadol (TML) 100
Configurations	Test cup	Same

Standard/Guidance Document Reference (if applicable)
None referenced.
Test Principle

The Webest Multi-Drug Urine Cup or The Webest Home Multi-Drug Urine 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 (mouse) conjugate binding sites.

Page 9

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.

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. Samples with concentration of -100% cutoff were drug-free urines samples. 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 with one operator per lot. The results obtained are summarized in the following tables.

Drug	Lot Number	+100% cutoff	+75% cutoff	+50% cutoff	+25% cutoff	Cutoff	-25% cutoff	-50% cutoff	-75% cutoff	-100% cut-off
6AM 10	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	27+/23-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	2-/48+	26+/24-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	24+/26-	50-/0+	50-/0+	50-/0+	50-/0+
AMP 500	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	27+/23-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	26+/24-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	25+/25-	49-/1+	50-/0+	50-/0+	50-/0+
BAR 300	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	27+/23-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	0-/50+	27+/23-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	0-/50+	26+/24-	48-/2+	50-/0+	50-/0+	50-/0+
BUP 10	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	26+/24-	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	26+/24-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	27+/23-	48-/2+	50-/0+	50-/0+	50-/0+
BZO 300	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	27+/23-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	0-/50+	25+/25-	50-/0+	50-/0+	50-/0+	50-/0+

Page 10

	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	26+/24-	50-/0+	50-/0+	50-/0+	50-/0+
COC 150	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	25+/25-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	2-/48+	27+/23-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	0-/50+	26+/24-	49-/1+	50-/0+	50-/0+	50-/0+
EDDP 300	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	27+/23-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	24+/26-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	25+/25-	49-/1+	50-/0+	50-/0+	50-/0+
FYL 1	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	26+/24-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	2-/48+	25+/25-	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	25+/25-	48-/2+	50-/0+	50-/0+	50-/0+
NFYL 5	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	24+/26-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	25+/25-	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	0-/50+	27+/23-	48-/2+	50-/0+	50-/0+	50-/0+
MDMA 500	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	24+/26-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	27+/23-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	23+/27-	49-/1+	50-/0+	50-/0+	50-/0+
MET 500	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	27+/23-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	26+/24-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	26+/24-	48-/2+	50-/0+	50-/0+	50-/0+
MOR 300	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	27+23-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	26+/24-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	0-/50+	24+/26-	50-/0+	50-/0+	50-/0+	50-/0+
MTD 300	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	25+/25-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	0-/50+	27+/23-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	24+/26-	50-/0+	50-/0+	50-/0+	50-/0+
OXY 100	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	26+/24-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	26+/24-	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	25+/25-	49-/1+	50-/0+	50-/0+	50-/0+
PCP 25	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	25+/25-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	26+/24-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	27+/23-	49-/1+	50-/0+	50-/0+	50-/0+
PPX 300	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	26+/24-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	0-/50+	25+/25-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	26+/24-	48-/2+	50-/0+	50-/0+	50-/0+
TCA 1000	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	27+/23-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	26+/24-	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	0-/50+	27+/23-	49-/1+	50-/0+	50-/0+	50-/0+
THC 50	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	25+/25-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	26+/24-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	26+/24-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	26+/24-	49-/1+	50-/0+	50-/0+	50-/0+

Page 11

TML 100	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	26+/24-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	0-/50+	24+/26-	50-/0+	50-/0+	50-/0+	50-/0+
AMP 1000	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	26+/24-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	0-/50+	26+/24-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	26+/24-	49-/1+	50-/0+	50-/0+	50-/0+
COC 300	Lot 1	0-/50+	0-/50+	0-/50+	1-/49+	27+/23-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	23+/27-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	0-/50+	25+/25-	48-/2+	50-/0+	50-/0+	50-/0+
MET 1000	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	25+/25-	49-/1+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	0-/50+	26+/24-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	27+/23-	49-/1+	50-/0+	50-/0+	50-/0+
OPI 2000	Lot 1	0-/50+	0-/50+	0-/50+	0-/50+	27+/23-	50-/0+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	23+/27-	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	1-/49+	26+/24-	50-/0+	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 36 months based on 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. The results obtained are summarized in the following table. 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.

6-MAM (6-Acetylmorphine)
(6-Acetylmorphine, Cutoff=10ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
Heroin	60	16.7%
Morphine	70,000	0.014%
Normorphine	100,000(Negative)	Not detected
NalorphineHCl	100,000(Negative)	Not detected
Hydrocodone	100,000(Negative)	Not detected
Hydromorphone	100,000(Negative)	Not detected
Chlordiazepoxide	100,000(Negative)	Not detected
Clobazam	100,000(Negative)	Not detected
D-Amphetamine	100,000(Negative)	Not detected
(±)-Amphetamine	100,000(Negative)	Not detected
Levorphanoltartrate	100,000(Negative)	Not detected
Codeine	100,000(Negative)	Not detected

Page 12

Ethylmorphine	100,000(Negative)	Not detected
Morphine3-β-D-glucuronide	100,000(Negative)	Not detected
Norcodeine	100,000(Negative)	Not detected
Oxycodone	100,000(Negative)	Not detected
Oxymorphone	100,000(Negative)	Not detected
Procainehydrochloride	100,000(Negative)	Not detected
Thebaine	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
Imipraminehydrochloride	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
Naloxonehydrochloride	100,000(Negative)	Not detected
Naltrexonehydrochloride	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
(+)-Norpropoxyphenemaleate	100,000(Negative)	Not detected
Oxymorphone-3β-D-glucuronide	100,000(Negative)	Not detected
TapentadolHCl	100,000(Negative)	Not detected
Tramadol	100,000(Negative)	Not detected

AMP(Amphetamine) (Amphetamine, Cutoff=500ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
Hydroxyamphetamine	4,000	12.5%
(+/-)-Methylenedioxyamphetamine(MDA)	200	250%
D,L-Amphetamine	500	100%
Diethylstilbestrol	2,500	20%
L-Amphetamine	60,000	0.8%
Phentermine	4,000	12.5%
β-Phenylethylamine	50,000	1%
Tyramine	5,000	10%
p-Hydroxynorephedrine	50,000	1%
D,L-Norephedrine	50,000	1%
(+/-)3,4-Methylenedioxy-n-	100,000	0.5%
d-Methamphetamine	100,000(Negative)	Not detected

Page 13

l-Methamphetamine	100,000(Negative)	Not detected
(+/-)3,4-Methylenedioxymethamphetamine (MDMA)	100,000(Negative)	Not detected
Ephedrine hydrochloride	100,000(Negative)	Not detected
Phenylpropanolamine	100,000(Negative)	Not detected
Benzphetamine	100,000(Negative)	Not detected
L-Ephedrine	100,000(Negative)	Not detected
L-Epinephrine	100,000(Negative)	Not detected
D,L-Epinephrine	100,000(Negative)	Not detected

AMP(Amphetamine) (Amphetamine, Cutoff=1000ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
Hydroxyamphetamine	8,000	13%
(+/-)-Methylenedioxyamphetamine(MDA)	1300	77%
D,L-Amphetamine	1,000	100%
Diethylstilbestrol	5,000	20%
L-Amphetamine	100,000	1%
Phentermine	100,000	1%
β-Phenylethylamine	100,000	1%
Tyramine	10,000	10%
p-Hydroxynorephedrine	100,000	1%
D,L-Norephedrine	100,000	1%
p-Hydroxyamphetamine	100,000(Negative)	Not detected
D-Methamphetamine	100,000(Negative)	Not detected
L-Methamphetamine	100,000(Negative)	Not detected
Ephedrine hydrochloride	100,000(Negative)	Not detected
(+/-)3,4- Methylenedioxymethamphetamine	100,000(Negative)	Not detected
Phenylpropanolamine	100,000(Negative)	Not detected
Benzphetamine	100,000(Negative)	Not detected
L-Ephedrine	100,000(Negative)	Not detected
L-Epinephrine	100,000(Negative)	Not detected
D,L-Epinephrine	100,000(Negative)	Not detected
(+/-)3,4-Methylenedioxyethylamphetamine (MDEA)	100,000(Negative)	Not detected

BAR(Butalbital) (Butalbital, Cutoff=300ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
Alphenal	250	120%
Amobarbital	3000	10%
Aprobarbital	200	150%
Butabarbital	1,000	30%

Page 14

Butethal	500	60%
Cyclopentobarbital	300	100%
Pentobarbital	1300	23%
Phenobarbital	1900	16%
Secobarbital	300	100%
Barbital

BUP(Buprenorphine) (Buprenorphine, Cutoff=10ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
Buprenorphine -3-D-Glucuronide	15	66.67%
Norbuprenorphine	40	25%
Norbuprenorphine-3-D-Glucuronide	500	2%
Morphine	100,000(Negative)	Not detected
Oxymorphone	100,000(Negative)	Not detected
Hydromorphone	100,000(Negative)	Not detected

BZO(Oxazepam) (Oxazepam, Cutoff=300ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
a-Hydroxyalprazolam	2,500	12%
Alprazolam	120	250%
Bromazepam	1,500	20%
Chlordiazepoxide	1,500	20%
Clobazam	60	500%
Clonazepam	10,000	3%
ClorazepateDipotassium	200	150%
Desalkylflurazepam	1,500	20%
Diazepam	100	300%
Estazolam	150	200%
Flunitrazepam	160	187.5%
D,L-Lorazepam	1,560	19.23%
Midazolam	6,000	5.00%
Nitrazepam	300	100%
Norchlordiazepoxide	250	120%
Nordiazepam	400	75%
Oxazepamglucuronide	500	60%
R,S-Lorazepamglucuronide	160	187.5%
Temazepam	100	300%
Triazolam	2,500	12%
Demoxepam	2,000	15%
Flurazepam	500	60%
Delorazepam	100,000(Negative)	Not detected

Page 15

COC(Benzoylecgonine) (Benzoylecgonine, Cutoff=150ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
Cocaethylene	100,000（Negative）	Not detected
Cocaine hydrochloride	3,000	5%
Ecgonine	100,000（Negative）	Not detected
Norcocaine	100,000（Negative）	Not detected
Ecgonine methyl Ester	100,000（Negative）	Not detected

COC(Benzoylecgonine) (Benzoylecgonine, Cutoff=300ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
Cocaethylene	100,000（negative）	Not detected
Cocaine hydrochloride	5,000	6%
Ecgonine	100,000（negative）	Not detected
Norcocaine	100,000	0.3%
Ecgonine methyl ester	100,000（negative）	Not detected

EDDP (EDDP, Cutoff=300ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
Methadone	100,000（negative）	Not detected
EMDP	100,000（negative）	Not detected
Doxylamine	100,000（negative）	Not detected
Disopyramide	100,000（negative）	Not detected
LAAM (Levo-alpha-acetylmethadol)	100,000（negative）	Not detected
Alpha Methadol	100,000（negative）	Not detected

FYL(Fentanyl) (Fentanyl, Cutoff=1ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
Norfentanyl	300	0.33%
Acetyl fentanyl	5	20%
Acetyl Norfentanyl	100,000	0.001%
(±)-β-Hydroxythiofentanyl HCl	5	20%
Acryl Fentanyl	5	20%
Butyryl Fentanyl	30	3.33%
Cis-d, I 3-Methylfentanyl	25,000	0.004%
Furanyl Fentanyl	10	10%
Para-fluorobutyrl Fentanyl (P-FBF)	25	4%
Para-fluoroFentanyl	25	4%
9-HydroxyRisperidone	10,000	0.01%
Alfentanil	100,000(Negative)	Not detected
Isobutyryl Fentanyl	5	20%

Page 16

4-Fluoro-isobutyryl Fentanyl	50	2%
Norcarfentail Oxalate	100,000(Negative)	Not detected
Remifentanil	100,000(Negative)	Not detected
Valeryl Fentanyl	5	20%
ThienylFentnayl	100	1%
Trans-d, I 3-Methylfentanyl	100	1%
Despropionylfentanyl (4-ANPP)	50,000	0.002%
MT-45	100,000(Negative)	Not detected
Ocfentanil	100	1%
Risperidone	50,000	0.002%
Sufentanil	50,000	0.002%
Carfentanil Oxalate	100,000(Negative)	Not detected
LabetalolHydrochloride	100,000(Negative)	Not detected
Trazodone	50,000	0.002%
U-47700	100,000(Negative)	Not detected
ω-1-Hydroxyfentanyl	50,000	0.002%
6-Acetylmorphine	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
Levorphanoltartrate	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 hydrochloride	100,000(Negative)	Not detected
Naltrexonehydrochloride	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
Normorphine	100,000(Negative)	Not detected
Noroxycodone	100,000(Negative)	Not detected

Page 17

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
Tapentadolhydrochloride	100,000(Negative)	Not detected
Thioridazine	100,000(Negative)	Not detected
Tilidine	100,000(Negative)	Not detected
Tramadol	100,000(Negative)	Not detected
Tramadol-O-Desmethyl	100,000(Negative)	Not detected
Tramadol-N-Desmethyl	100,000(Negative)	Not detected

NFYL(Norfentanyl) (Norfentanyl, Cutoff=5ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
Norfentanyl	5	100%
Fentanyl	1,000	0.5%
Acetyl fentanyl	500	1%
Acetyl Norfentanyl	50	10%
(±)-β-Hydroxythiofentanyl HCl	100	5%
Acryl Fentanyl	100	5%
Butyryl Fentanyl	500	1%
Cis-d, I 3-Methylfentanyl	300	1.67%
Furanyl Fentanyl	1,000	0.5%
Para-fluorobutyrl Fentanyl (P-FBF)	100	5%
Para-fluoroFentanyl	100	5%
9-HydroxyRisperidone	10,000	0.05%
Alfentanil	100,000(Negative)	Not detected
Isobutyryl Fentanyl	80	6.25%
4-Fluoro-isobutyryl Fentanyl	200	2.5%
Norcarfentail Oxalate	10,000	0.05%
Remifentanil	10,000	0.05%
Valeryl Fentanyl	500	1%
ThienylFentnayl	100	5%
Trans-d, I 3-Methylfentanyl	200	2.50%
Despropionylfentanyl (4-ANPP)	60,000	0.008%
MT-45	8,000	0.06%
Ocfentanil	5,000	0.1%
Risperidone	600	0.83%
Sufentanil	10,000	0.05%
Carfentanil Oxalate	10,000	0.05%
LabetalolHydrochloride	100,000(Negative)	Not detected
Trazodone	60,000	0.008%
U-47700	100,000(Negative)	Not detected

Page 18

ω-1-Hydroxyfentanyl	60,000	0.008%
6-Acetylmorphine	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
Levorphanoltartrate	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 hydrochloride	100,000(Negative)	Not detected
Naltrexonehydrochloride	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
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
Tapentadolhydrochloride	100,000(Negative)	Not detected
Thioridazine	100,000(Negative)	Not detected
Tilidine	100,000(Negative)	Not detected
Tramadol	100,000(Negative)	Not detected
Tramadol-O-Desmethyl	100,000(Negative)	Not detected
Tramadol-N-Desmethyl	100,000(Negative)	Not detected

MDMA(Ecstasy) (Ecstasy, Cutoff=500ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity

Page 19

(+/-)3,4-Methylenedioxy-nethylamphetamine(MDEA)	1,000	167%
(+/-)-Methylenedioxyamphetamine(MDA)	8,000	6.25%
L-Methamphetamine	100,000（Negative）	Not detected
7-Aminoclonazepam	100,000	0.5%
D-Methamphetamine	100,000（Negative）	Not detected
D-Amphetamine	100,000（Negative）	Not detected
L-amphetamine	100,000（Negative）	Not detected

MET(Methamphetamine) (Methamphetamine, Cutoff=500ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
(+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA)	20,000	2.5%
(±)-MDMA	2,000	25%
L-Methamphetamine	5,000	10%
Fenfluramine	40,000	1.25%
p-Hydroxymethamphetamine	16,000	10%
D,L-Methamphetamine	500	100%
β-Phenylethylamine	25,000	2%
Mephetermine	25,000	2%
Methoxyphenamine hydrochloride	25,000	2%
L-Amphetamine	60,000	0.8%
Ephedrine hydrochloride	100,000（Negative）	Not detected
(1R,2S)-(-)-Ephedrine	100,000	0.5%
D-Amphetamine	100,000（Negative）	Not detected
Chloroquine	100,000（Negative）	Not detected
(+/-)3,4- Methylenedioxyamphetamine(MDA)	100,000（Negative）	Not detected
L-Phenylephrine	100,000（Negative）	Not detected
Trimethobenzamide	100,000（Negative）	Not detected
Procainehydrochloride	100,000（Negative）	Not detected
d/l-Amphetamine	100,000（Negative）	Not detected

MET(Methamphetamine) (Methamphetamine, Cutoff=1000ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
(+/-)3,4-Methylenedioxy-n-	40,000	2.5%
(+/-)3,4-Methylenedioxymethamphetamine (MDMA)	8,000	12.5%
L-Methamphetamine	10,000	10%
Fenfluramine	100,000（Negative）	Not detected
p-Hydroxymethamphetamine	27,000	3.7%
D,L-Methamphetamine	1,000	100%

Page 20

β-Phenylethylamine	50,000	2%
Mephetermine	50,000	2%
Methoxyphenamine hydrochloride	50,000	2%
L-Amphetamine	100,000（Negative）	Not detected
D-Amphetamine	100,000（Negative）	Not detected
D,L-Amphetamine	100,000（Negative）	Not detected
Chloroquine	100,000（Negative）	Not detected
Ephedrine hydrochloride	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
(1R,2S)-(-)-Ephedrine	100,000（Negative）	Not detected
Procainehydrochloride	100,000（Negative）	Not detected

MOR(Morphine) (Morphine, Cutoff=300ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
Codeine	300	100%
Dihydrocodeine	1,000	30%
EthylMorphine	200	150%
Heroin	700	42.86%
Hydrocodone	2,000	15%
Hydromorphone	4,000	7.5%
Levorphanol tartrate	12,000	2.5%
Nalorphinehydrochloride	50,000	0.6%
Thebaine	90,000	0.33%
Morphine-3-β-d-glucuronide	1,000	30%
6-Monoacetylmorphine (6-MAM)	150	200%
Codeine-6-β-D-glucuronide	150	200%
Morphine-6-β-D-glucuronide	150	200%
6-Acetylcodeine	900	33.33%
Normorphine	100,000（negative）	Not detected
Oxycodone	100,000（negative）	Not detected
Oxymorphone	100,000（negative）	Not detected
Norcodeine	100,000（negative）	Not detected
Procaine	100,000（negative）	Not detected
Norpropoxyphene	100,000（negative）	Not detected

OPI(Morphine) (Morphine, Cutoff=2000ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
Codeine	1,000	200%
Dihydrocodeine	1,500	133.3%
EthylMorphine	500	400%

Page 21

Codeine-6-β-D-glucuronide	2,500	80%
Heroin	5,000	40%
Hydrocodone	5,000	40%
Hydromorphone	7,000	28.6%
Levorphanol tartrate	16,000	12.5%
Nalorphinehydrochloride	5,0000	4%
Norcodeine	100,000（Negative)	Not detected
Normorphine	100,000（Negative)	Not detected
Oxymorphone	100,000（Negative)	Not detected
s-Monoacetylmorphine	2,000	100%
Morphine-6-β-D-glucuronide	1,300	153.8%
Thebaine	100,000（Negative)	Not detected
Morphine 3-β-D-glucuronide	1,300	153.8%
6-Monoacetylmorphine (6-MAM)	1,000	200%
6-Acetylcodeine	10,000	20%
Oxycodone	100,000（Negative)	Not detected
Procaine	100,000（Negative)	Not detected
Norpropoxyphene	100,000（Negative)	Not detected

MTD(Methadone) (Methadone, Cutoff=300ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
EDDP	100,000（negative）	Not detected
EMDP	100,000（negative）	Not detected
LAAM	100,000（negative）	Not detected
Alpha Methadol	100,000（negative）	Not detected
Doxylamine	100,000（negative）	Not detected

OXY(Oxycodone) (Oxycodone, Cutoff=100ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
Ethyl Oxycodone	75,000	0.13%
Hydrocodone	10,000	1%
Hydromorphone	100,000（negative）	Not detected
Levorphanol tartrate	25,000	0.40%
Naloxone hydrochloride	10,000	1%
Naltrexone hydrochloride	50,000	0.2%
Oxymorphone	200	50%
Oxymorphone-3β-D-glucuronide	100,000（negative）	Not detected
Noroxycodone	1,500	6.67%
Noroxymorphone	3,000	3.33%
Dihydrocodeine	100,000（negative）	Not detected
Codeine	100,000（negative）	Not detected
Morphine	100,000（negative）	Not detected

Page 22

Buprenorphine	100,000（negative）	Not detected
Ethylmorphine	100,000（negative）	Not detected
Thebaine	100,000（negative）	Not detected
6-acetylmorphine	100,000（negative）	Not detected

PCP(Phencyclidine) (Phencyclidine, Cutoff=25ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
4-Hydroxyphencyclidine	12,500	0.2%

PPX(Propoxyphene) (Propoxyphene, Cutoff=300ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
Norpropoxyphene	1,500	20%

TCA(Nortriptyline) (Nortriptyline, Cutoff=1000ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
Amitriptyline	5,000	20%
Chlorpheniramine	50,000	2%
Clomipramine	10,000	10%
Cyclobenzaprine Hydrochloride	5,000	20%
Desipramine	1,000	100%
Doxepine	2,000	50%
Duloxetine	10,000	10%
Imipramine	1,000	100%
Norclomipramine	100,000（negative）	Not detected
Nordoxepine	1,000	100%
Promazine	50,000	2%
Trimipramine	10,000	10%
Maprotiline	100,000（negative）	Not detected
Promethazine	100,000（negative）	Not detected

THC(Marijuana) (Marijuana, Cutoff=50ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
11-nor-Δ8-THC -9-COOH	30	166.67%
(-)-11-nor-9-carboxy-Δ9-THC	50	100%
(±)-11-nor-9-Carboxy-Δ9-THC	50	100%
11-nor-Δ9-THC -carboxyglucuronide	100	50%
11-hydroxy-Δ9-Tetrahydrocannabinol	15,000	0.33%
Δ8- Tetrahydrocannabinol	8,000	0.63%
Δ9- Tetrahydrocannabinol	7,000	0.71%
Cannabinol	100,000（negative）	Not detected
Cannabidiol	100,000（negative）	Not detected

Page 23

(±)-11-Hydroxy-Δ9-THC	100,000（negative）	Not detected

TML(Tramadol) (Tramadol, Cutoff=100ng/mL)

	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
n-Desmethyl Tramadol	400	25%
o-Desmethyl Tramadol	1,000	10%
o-Desmethyl Venlafaxine	100,000（negative）	Not detected
Venlafaxine HCl	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.

11-nor-9 carboxy THC (except for THC)	Diphenylhydantoin	Norpropoxyphene (except for PPX)
3-Hydroxytyramine	Disopyramide	Norpseudoephedrine
4-Bromo2,5,Dimethoxyphenethylamine	DL-Tryptophan	Nortriptyline (except for TCA)
7-Aminoclonazepam (except for MDMA)	DL-Tyrosine	Noscapine
7-Aminoflunitrazepam	Dopamine	O-Hydroxyhippuric acid
7-Aminonitrazepam	Doxepin (except for TCA)	Octopamine
Acetaminophen	Doxylamine	Olanzapine
Acetone (1000 mg/dL)	Duloxetine (except for TCA)	Omeprazole
Acetophenetidin	Ecgonine methyl ester	Oxalic Acid (100mg/dL)
Acetylsalicylic Acid (500 μg/mL)	Ephedrine	Oxalinic acid
Acyclovir	Erythromycin	Oxazepam (except for BZO)
Albumin(100 mg/dL)	Esomeprazole Magnesium	Oxolinic acid
Albuterol	Estradiol	Oxymetazoline
Alpha Methadol	Estrone	Paliperidone
Aminophylline	Ethanol (1%)	Papaverine
Aminopyrine	Fenfluramine (except for MET 500)	Penicillin-G
Amitriptyline (except for TCA)	Fenofibrate	PenicillinV Potassium
Amlodipine besylate	Fenoprofen	Pentazocine
Amobarbital (except for TCA)	Fluoxetine Hydrochloride	Perphenazine
Amoxicillin	Fluphenazine	Phencyclidine (except for PCP)
Ampicillin	Fotemustine	Phenelzine
Apomorphine	Furosemide	Phenobarbital (except for BAR)
Aripiprazole	Gabapentin	Phentermine (except for AMP)
Ascorbic Acid	Galactose	Phenylethylamine (except for AMP, MET)
Aspartame	Gamma Globulin (500mg/dL)	Phenylpropanolamine
Aspirin	Gatifloxacin	Prednisone
Atomoxetine	Gemfibrozil	Pregablin
Atorvastatin Calcium	Gentisic acid	Procaine
Atropine	Glucose (3000 mg/dL)	Promazine (except for TCA)
Azithromycin	Guaiacolglyceryl ether	Promethazine
Baclofen	Hemoglobin	Propoxyphene (except for PPX)
Benzilic acid	Hexobarbital	Propranolol
Benzocaine	Hydralazine	Pseudoephedrine
Benzoic Acid	Hydrochlorothiazide	Pyridoxine
Benzoylecgonine (except for COC)	Hydrocortisone	Pyrilamine
Benzphetamine	Hydroxytyramine	Pyrogallol

Page 24

Benzylpiperiazine	I-Cotinine	Quetiapine
Bilirubin	I-Erythromycin	Quinidine
Boric Acid (1%)	Ibuprofen	Quinine
Bupropion	Imipramine (except for TCA)	Quinolinic Acid
Caffeine (500 μg/mL)	Isoproterenol	r-Globulin
Cannabidiol	Isoxsuprine	Ranitidine
Captopril	Ketamine	Riboflavin
Carbamazepine	Ketoprofen	Rifampicin
Carfentanil (except for NFYL)	L-Epinephrine	Salicylic Acid
Carisoprodol	L-phenylephrine	Secobarbital (except for BAR)
Cefradine	L-thyroxine	Serotonin(5-Hydroxytyramine)
Cephalexin	LAAM HCl	Sertraline
Cetirizine	Labetalol	Sildenafil Citrate
Chloral hydrate	Lamotrigine	Simvastatin
Chloramphenicol	Levofloxacin Hydrochloride	Sodium Azide
Chlordiazepoxide (except for BZO)	Levonorgestrel	Sufentanil Citrate (except for FYL, NFYL)
Chloroquine	Levothyroxine Sodium	Sulfamethazine
Chlorothiazide	Lidocaine	Sulindac
Chlorpheniramine (except for TCA)	Lisinopril	Telmisartan
Chlorpromazine	Loperamide	Tetracycline
Cholesterol	Loratadine	Tetrahydrocortisone 3-acetate
Ciprofloxacin Hydrochloride	Loratidine	Tetrahydrocortisone3-(βDglucuronide)
Citalopram	Lorazepam (except for BZO)	Tetrahydrozoline
Clarithromycin	LSD	THC (except for THC)
Clofibrate	Magnesium	Theophylline
Clomipramine (except for TCA)	Maprotiline	Thiamine
Clonidine	Meperidine	Thioridazine
Clozapine	Meprobamate	Trazodone Hydrochloride (except for FYL, NFYL)
Conjugated Estrogens	Metformin	Triamterene
Cortisone	Methapyrilene	Trifluoperazine
Cotinine	Methaqualone	Trifluoromethylphenyl- piperazine
Creatine Hydrate	Methoxyphenamine (except for MET)	Trimethobenzamide
Creatinine	Methylphenidate	Trimethoprim
Cyclobenzaprine (except for TCA)	Metoprolol	Tryptamine
Cyclodextrin-r	Metronidazole (300 ug/mL)	Tyramine (except for AMP)
Cyproheptadine	Mifepristone	Urea (2000 mg/dL)
D,L-Epinephrine	N-Acetylprocainamide	Uric Acid
d,l-Isoproterenol	N-desmethyl Tapentadol	Valproic acid (250 ug/mL)
Delorazepam	NaCl (40000 ug/mL)	Venlafaxine
Demoxepam (except for BZO)	Nalidixic Acid	Verapamil
Deoxycorticosterone	Naloxone (except for OXY)	Vitamin B2
Desipramine (except for TCA)	Naltrexone (except for OXY)	Zaleplon
Desloratadine	Naproxen	Zolpidem
Dextromethorphan	Niacinamide	Zolpidem Tartrate
Diclofenac	Nicotine	Zomepirac
Diflunisal	Nicotinic Acid	β-Estradiol
Digoxin	Nifedipine	β-Hydroxybutyric Acid
Dimethyl-aminoantipyrine	Nitroglycerin
Diphenhydramine	Norethindrone

Interference by pH and specific gravity were also evaluated using pooled urine specimens with concentrations of 0 (drug-free), 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

Page 25

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.

Drug test	Test Cup Result	Drug Free	Low Negative by LC-MS/MS (less than -50%)	Near Cutoff Negative by LC-MS/MS (Between -50% and the Cutoff)	Near Cutoff Positive by LC-MS/MS (Between the cutoff and +50%)	High Positive by LCMS/MS (greater than +50%)
6-MAM10	Operator A	- 10	16	13	2	0
		+ 0	0	1	19	19
	Operator B	- 10	16	13	1	0
		+ 0	0	1	20	19
	Operator C	- 10	16	14	2	0
		+ 0	0	0	19	19
AMP500	Operator A	- 10	18	11	1	0
		+ 0	0	1	15	24
	Operator B	- 10	18	11	1	0
		+ 0	0	1	15	24
	Operator C	- 10	18	11	1	0
		+ 0	0	1	15	24
AMP1000	Operator A	- 10	14	14	1	0
		+ 0	0	2	17	22
	Operator B	- 10	14	15	1	0
		+ 0	0	1	17	22
	Operator C	- 10	14	14	0	0
		+ 0	0	2	18	22
BAR300	Operator A	- 10	16	14	2	0
		+ 0	0	0	17	21
	Operator B	- 10	16	13	1	0
		+ 0	0	1	18	21
	Operator C	- 10	16	14	2	0
		+ 0	0	0	17	21
BUP10	Operator A	- 10	16	14	2	0
		+ 0	0	0	14	24
	Operator B	- 10	16	13	1	0
		+ 0	0	1	15	24
	Operator C	- 10	16	13	1	0
		+ 0	0	1	15	24
BZO300	Operator	- 10	19	10	1	0

Page 26

A	+	0	0	1	15	24
Operator B	-	10	19	10	1	0
	+	0	0	1	15	24
Operator C	-	10	19	10	1	0
	+	0	0	1	15	24
COC150	Operator A	-	10	15	14	2
	+	0	0	1	15	23
Operator B	-	10	15	14	1	0
	+	0	0	1	16	23
Operator C	-	10	15	14	1	0
	+	0	0	1	16	23
COC300	Operator A	-	10	16	13	1
	+	0	0	1	21	18
Operator B	-	10	16	13	2	0
	+	0	0	1	20	18
Operator C	-	10	16	12	0	0
	+	0	0	2	22	18
EDDP300	Operator A	-	10	13	16	1
	+	0	0	1	15	24
Operator B	-	10	13	16	1	0
	+	0	0	1	15	24
Operator C	-	10	13	17	1	0
	+	0	0	0	15	24
FYL1	Operator A	-	10	14	14	0
	+	0	0	2	18	22
Operator B	-	10	14	14	1	0
	+	0	0	2	17	22
Operator C	-	10	14	14	1	0
	+	0	0	2	17	22
NFYL5	Operator A	-	10	16	13	2
	+	0	0	1	14	24
Operator B	-	10	16	12	1	0
	+	0	0	2	15	24
Operator C	-	10	16	12	1	0
	+	0	0	2	15	24
MDMA500	Operator A	-	10	16	13	1
	+	0	0	1	18	21
Operator B	-	10	16	13	1	0
	+	0	0	1	18	21
Operator C	-	10	16	13	1	0
	+	0	0	1	18	21
MET500	Operator	-	10	16	13	1

Page 27

A	+	0	0	1	15	24
Operator B	-	10	16	12	1	0
	+	0	0	2	15	24
Operator C	-	10	16	13	1	0
	+	0	0	1	15	24
MET1000	Operator A	-	10	16	13	1
	+	0	0	1	18	21
Operator B	-	10	16	13	2	0
	+	0	0	1	17	21
Operator C	-	10	16	13	1	0
	+	0	0	1	18	21
MTD300	Operator A	-	10	16	13	1
	+	0	0	1	18	21
Operator B	-	10	16	13	1	0
	+	0	0	1	18	21
Operator C	-	10	16	14	3	0
	+	0	0	0	16	21
MOP300	Operator A	-	10	13	17	1
	+	0	0	0	20	19
Operator B	-	10	13	16	2	0
	+	0	0	1	19	19
Operator C	-	10	13	16	0	0
	+	0	0	1	21	19
OPI2000	Operator A	-	10	16	11	0
	+	0	0	3	21	19
Operator B	-	10	16	13	1	0
	+	0	0	1	20	19
Operator C	-	10	16	13	1	0
	+	0	0	1	20	19
OXY100	Operator A	-	10	15	15	1
	+	0	0	0	17	22
Operator B	-	10	15	13	1	0
	+	0	0	2	17	22
Operator C	-	10	15	14	0	0
	+	0	0	1	18	22
PCP25	Operator A	-	10	16	14	2
	+	0	0	0	16	22
Operator B	-	10	16	14	1	0
	+	0	0	0	17	22
Operator C	-	10	16	13	0	0
	+	0	0	1	18	22
PPX300	Operator	-	10	17	13	2

Page 28

A	+	0	0	0	17	21
Operator B	-	10	17	13	1	0
	+	0	0	0	18	21
Operator C	-	10	17	12	1	0
	+	0	0	1	18	21
TCA1000	Operator A	-	10	17	12	1
	+	0	0	1	16	23
Operator B	-	10	17	12	2	0
	+	0	0	1	15	23
Operator C	-	10	17	13	2	0
	+	0	0	0	15	23
THC50	Operator A	-	10	15	14	1
	+	0	0	1	20	19
Operator B	-	10	15	14	1	0
	+	0	0	1	20	19
Operator C	-	10	15	15	2	0
	+	0	0	0	19	19
TML100	Operator A	-	10	16	13	2
	+	0	0	1	16	22
Operator B	-	10	16	13	0	0
	+	0	0	1	18	22
Operator C	-	10	16	13	1	0
	+	0	0	1	17	22

Discordant Results are summarized below.

Drug	Operator	Sample Number	LC/MS/MS Result (ng/mL)	Accurate Result
6AM	Operator A	2025021225	11.69	-
	Operator C	2024112928	10.03	-
	Operator A, C	2025010829	10.37	-
	Operator B	2025022819	10.14	-
	Operator A, B	2024121928	9.62	+
AMP500	Operator A	2024072222	520.38	-
	Operator B	2024092628	506.41	-
	Operator C	2024081607	512.57	-
	Operator A	2024120516	494.96	+
	Operator B	2024073117	473.49	+
	Operator C	2025011427	443.03	+
AMP1000	Operator A	2025022406	1018.68	-
	Operator B	2024082723	1029.82	-
	Operator B, C	2024082624	984.60	+
	Operator A	2024071704	989.98	+

Page 29

Operator A, C	2025021122	875.36	+
BAR300	Operator A	2024071518	311.29
	Operator A	2025012211	333.75
	Operator B	2024092411	344.57
	Operator C	2024112222	323.25
	Operator C	2025012217	325.28
	Operator B	2024070127	294.61
BUP10	Operator A	2024072327	12.38
	Operator A	2024102420	10.17
	Operator B	2025022828	10.15
	Operator C	2025011721	10.01
	Operator B	2024110828	9.85
	Operator C	2024081216	9.36
BZO300	Operator A	2025012103	305.56
	Operator B	2024110729	301.66
	Operator C	2024070128	311.53
	Operator A, C	2024110118	264.48
	Operator B	2024093005	278.91
COC150	Operator A	2024112124	152.97
	Operator B	2024123126	151.87
	Operator A, C	2024071513	150.11
	Operator A, B	2024093011	149.17
	Operator C	2025021221	147.39
COC300	Operator A,B	2024101021	300.47
	Operator B	2024082311	304.87
	Operator C	2025010603	296.21
	Operator A,B,C	2024082222	299.37
EDDP300	Operator A	2025012323	303.33
	Operator B, C	2024071623	308.15
	Operator A	2025010618	290.68
	Operator B	2024103023	298.10
FYL1	Operator B	2024092630	1.03
	Operator C	2024111411	1.01
	Operator A, C	2025010803	0.99
	Operator A	2024111501	0.94
	Operator B, C	2024070914	0.89
	Operator B	2024080509	0.99
NFYL5	Operator A	2024082121	5.93
	Operator B,C	2024090221	5.24
	Operator A	2024120311	5.09
	Operator C	2024071209	4.12
	Operator C	2024071216	3.99
	Operator B	2025022821	4.11

Page 30

Operator A,B	2025021826	4.62	+
MDMA500	Operator A	2024122504	512.65
	Operator B	2024082902	505.45
	Operator C	2024091212	501.55
	Operator A	2025012429	498.12
	Operator B	2024080521	488.93
	Operator C	2024122412	469.24
MET500	OperatorA	2024121328	516.28
	Operator B	2024111330	500.12
	Operator C	2024081506	506.10
	Operator A, B	2024120413	496.93
	Operator B	2025012023	485.93
	Operator C	2024070214	463.37
MET1000	Operator B, C	2024072201	1142.94
	Operator A	2024072421	1000.87
	Operator B	2024111414	1014.70
	Operator C	2024070803	980.34
	Operator B	2024071613	998.49
	Operator A	2024092417	998.48
MTD300	Operator A	2024070110	312.01
	Operator C	2024090327	338.62
	Operator B, C	2024110616	302.80
	Operator C	2025010714	308.66
	Operator B	2024101503	241.25
	Operator A	2024121005	298.81
MOP300	Operator A, B	2024083003	306.99
	Operator B	2024090405	359.23
	Operator C	2024120925	241.77
	Operator B	2025011722	298.07
OPI2000	Operator B,C	2024092621	2032.06
	Operator A	2024081411	1946.49
	Operator A,C	2025022118	1992.26
	Operator A,B	2024071702	1890.60
OXY100	Operator B	2025021017	118.39
	Operator A	2024112817	101.02
	Operator B	2024112917	93.38
	Operator B,C	2025010903	98.65
PCP25	Operator A, B	2024082203	25.61
	Operator A	2024122009	26.88
	Operator C	2024091909	24.51
PPX300	Operator A	2024102227	319.65
	Operator B,C	2024082228	306.89
	Operator A	2024103108	305.09

Page 31

Operator C	2024091310	298.22	+
TCA100	Operator B, C	2024081328	1166.52
	Operator B	2024092023	1005.22
	Operator A	2024071625	1020.54
	Operator C	2024111822	1023.53
	Operator B	2024090426	986.95
	Operator A	2024070321	991.10
THC50	Operator C	2024081928	50.10
	Operator A	2025010223	50.75
	Operator B,C	2024070223	51.39
	Operator A	2024070929	48.00
	Operator B	2024111523	49.29
TML100	Operator A	2024080113	100.64
	Operator C	2024073110	101.15
	Operator A	2025021106	113.40
	Operator A	2024081423	95.20
	Operator C	2024071816	99.76
	Operator B	2024112002	99.32

C. Lay person study

A lay user study was performed at three intended user sites with 280 lay persons. 158 male and 122 female tested the Webest Multi-Drug Urine Cup. They had diverse educational and professional backgrounds and their age range from 20 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 The Webest Multi-Drug Urine Cup: Configuration 1

| Drug | Cutoff (ng/mL) | Results | Concentration |||||||
|------|----------------|---------|---------------|
| | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| AMP 500 | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% |
| BAR 300 | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% |
| BUP 10 | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |

Page 32

	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95%	95%	100%	100%
BZO 300	Positive	0	0	0	0	18	20	20
	Negative	20	20	20	20	2	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	100%	90%	100%	100%
COC 150	Positive	0	0	0	2	19	20	20
	Negative	20	20	20	18	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	90%	95%	100%	100%
EDDP 300	Positive	0	0	0	1	19	20	20
	Negative	20	20	20	19	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95%	95%	100%	100%
FYL 1	Positive	0	0	0	1	19	20	20
	Negative	20	20	20	19	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95%	95%	100%	100%
MDMA 500	Positive	0	0	0	2	20	20	20
	Negative	20	20	20	18	0	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	90%	100%	100%	100%
MET 500	Positive	0	0	0	2	19	20	20
	Negative	20	20	20	18	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	90%	95%	100%	100%
MTD 300	Positive	0	0	0	2	19	20	20
	Negative	20	20	20	18	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	90%	95%	100%	100%
6-MAM 10	Positive	0	0	0	2	19	20	20
	Negative	20	20	20	18	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	90%	95%	100%	100%
NFYL 5	Positive	0	0	0	2	20	20	20
	Negative	20	20	20	18	0	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	90%	100%	100%	100%
MOP 300	Positive	0	0	0	2	19	20	20
	Negative	20	20	20	18	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	90%	95%	100%	100%
OXY 100	Positive	0	0	0	2	19	20	20

Page 33

	Negative	20	20	20	18	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	90%	95%	100%	100%
PCP 25	Positive	0	0	0	2	19	20	20
	Negative	20	20	20	18	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	90%	95%	100%	100%
PPX 300	Positive	0	0	0	2	19	20	20
	Negative	20	20	20	18	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	90%	95%	100%	100%
TCA 1000	Positive	0	0	0	0	18	20	20
	Negative	20	20	20	20	2	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	100%	90%	100%	100%
THC 50	Positive	0	0	0	1	18	20	20
	Negative	20	20	20	19	2	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95%	90%	100%	100%
TML 100	Positive	0	0	0	2	19	20	20
	Negative	20	20	20	18	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	90%	95%	100%	100%

Result of the Webest Multi-Drug Urine Cup: Configuration 2

| Drug | Cutoff (ng/mL) | Results | Concentration |||||||
|------|----------------|---------|---------------|
| | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| AMP 1000 | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| BAR 300 | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| BUP 10 | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| BZO 300 | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |

Page 34

	Agreement (%)	100%	100%	100%	100%	95%	100%	100%
COC 300	Positive	0	0	0	1	19	20	20
	Negative	20	20	20	19	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95%	95%	100%	100%
EDDP 300	Positive	0	0	0	1	20	20	20
	Negative	20	20	20	19	0	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95%	100%	100%	100%
FYL 1	Positive	0	0	0	1	19	20	20
	Negative	20	20	20	19	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95%	95%	100%	100%
MDMA 500	Positive	0	0	0	2	19	20	20
	Negative	20	20	20	18	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	90%	95%	100%	100%
MET 1000	Positive	0	0	0	1	19	20	20
	Negative	20	20	20	19	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95%	95%	100%	100%
MTD 300	Positive	0	0	0	0	19	20	20
	Negative	20	20	20	20	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	100%	95%	100%	100%
6-MAM 10	Positive	0	0	0	1	19	20	20
	Negative	20	20	20	19	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95%	95%	100%	100%
NFYL 5	Positive	0	0	0	1	18	20	20
	Negative	20	20	20	19	2	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95%	90%	100%	100%
OPI 2000	Positive	0	0	0	1	19	20	20
	Negative	20	20	20	19	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95%	95%	100%	100%
OXY 100	Positive	0	0	0	1	18	20	20
	Negative	20	20	20	19	2	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95%	90%	100%	100%
PCP 25	Positive	0	0	0	1	19	20	20
	Negative	20	20	20	19	1	0	0

Page 35

	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95%	95%	100%	100%
PPX 300	Positive	0	0	0	2	19	20	20
	Negative	20	20	20	18	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	90%	95%	100%	100%
TCA 1000	Positive	0	0	0	1	19	20	20
	Negative	20	20	20	19	1	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95%	95%	100%	100%
THC 50	Positive	0	0	0	1	20	20	20
	Negative	20	20	20	19	0	0	0
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95%	100%	100%	100%
TML 100	Positive	0	0	0	1	19	20	20
	Negative	20	20	20	19	1	0	0
	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 7.

Clinical Studies:
Not applicable.

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 The Webest Multi-Drug Urine Cup and The Webest Home Multi-Drug Urine Cup are substantially equivalent to the predicate device.

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).