Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a standard lateral flow immunochromatographic assay, which relies on chemical reactions and visual interpretation, not AI/ML for analysis. There is no mention of any computational analysis or algorithms.

Therapeutic

No.
This device is an in vitro diagnostic device used to detect the presence of various drugs in human urine. It is not designed to treat or alleviate a disease or condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "It is for in vitro diagnostic use only." Additionally, the "Device Description" characterizes the devices as "rapid, single-use in vitro diagnostic devices."

SaMD (Software as a Medical Device)

No

The device is described as a "rapid, single-use in vitro diagnostic device" that contains a "test device in one pouch" including a "test T-Dip® panel". This indicates a physical, hardware component for performing the test, not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

Explicit Statement: The text explicitly states in the "Intended Use / Indications for Use" and "Device Description" sections: "It is for in vitro diagnostic use only."
Purpose: The device is designed to detect the presence of specific substances (drugs) in a biological sample (human urine) in vitro (outside of the body). This is a core characteristic of an IVD.
Qualitative Detection: It performs a qualitative test, indicating the presence or absence of the target substances above a certain cutoff level.
Intended Use: The intended use is for detecting drugs of abuse in human urine, which is a diagnostic purpose.
Regulatory Context: The description of performance studies, including method comparison with confirmatory methods like GC/MS or LC/MS, and lay user studies, are typical requirements for regulatory submission and approval of IVD devices. The mention of predicate devices (K numbers) further supports its classification as a medical device undergoing regulatory review, likely as an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Wondfo T-Dip® Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedoxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Cannabinoids (THC 50)	50 ng/mL

Wondfo T-Dip® Multi-Drug Urine Test Panel offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Wondfo T-Dip® Multi-Drug Urine Test Panel Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Cannabinoids (THC 50)	50 ng/mL

Wondfo T-Dip® Multi-Drug Urine Test Panel offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Product codes

NFT, NGL, PTH, NFV, NFY, PTG, NGG, LCM, QBF, QAW, NFW

Device Description

The Wondfo T-Dip® Multi-Drug Urine Test Panel and Wondfo T-Dip® Multi-Drug Urine Test Panel Rx are rapid, single-use in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test T-Dip® panel and two desiccants, and a package insert. The Wondfo T-Dip® Multi-Drug Urine Test Panel is intended for over-the-counter use and the Wondfo T-Dip® Multi-Drug Urine Test Panel Rx is intended for prescription use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

OTC use (Over-The-Counter Use) and Prescription Use

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

Not Found

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

Not Found

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

Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cutoff, +25% cut off, +50% cut off, +75% cut off and +100% cut off. Samples with concentration of -100% cutoff were drug-free urines samples. Other samples were prepared by spiking target drug in drug-free urine samples. Each drug concentration was confirmed by LC/MS or GC/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test panels.

Specificity was tested by spiking drug metabolites and other components into drug-free urine, which were then tested using three lots of each device.

The effect of urine specific gravity (1.000 to 1.035) and urine pH (4 to 9) on the test devices was investigated by spiking target drugs at +25% cutoff and -25% cutoff levels into urine samples with varying specific gravity and pH. Results were all positive for +25% cutoff and all negative for -25% cutoff, indicating no effect.

Method comparison studies were performed in-house with three operators. Operators tested 80 (40 negative and 40 positive) unaltered urine samples that were blind labeled and compared to LC/MS or GC/MS results. Discordant results tables are provided for each drug showing discrepancies between the T-Dip result and the LC/MS or GC/MS result.

A lay user study was performed with 280 participants (94 males and 46 females for Configuration 1; 88 males and 52 females for Configuration 2) recruited from three sites. Urine samples were prepared at -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug-free pooled urine specimens. Concentrations were confirmed by LC/MS or GC/MS. Each participant received one package insert, one blind-labeled test solution, and one test device. Lay-user study results show "Percentage of correct results" for various concentrations related to the cutoff for each drug. All participants indicated that instructions were easy to understand. Flesch-Kincaid reading analysis showed a reading Grade Level of 7 for the package insert.

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

Key metrics are presented as "Percentage of correct results" in the lay-user study tables, indicating the consistency of results at different concentrations relative to the cutoff. For precision studies, results are presented as "Positive/Negative" (e.g., 0-/50+, 10-/40+) for 50 tests at various concentrations. For discordant results in comparison studies, individual sample numbers, LC/MS or GC/MS results, and T-Dip results are listed. Specific metrics such as Sensitivity, Specificity, PPV, NPV are not explicitly calculated or presented for the comparison studies or precision studies in aggregated form.

Predicate Device(s)

K182701

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

September 25, 2020

Guangzhou Wondfo Biotech Co., Ltd. % Joe Shia Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877

Re: K202567

Trade/Device Name: Wondfo T-Dip® Multi-Drug Urine Test Panel Wondfo T-Dip® Multi-Drug Urine Test Panel Rx Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NGL, PTH, NFV, NFY, PTG, NGG, LCM, QBF, QAW, NFW Dated: September 2, 2020 Received: September 4, 2020

Dear Joe Shia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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.

1

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Marianela Perez- Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K202567

Device Name Wondfo T-Dip® Multi-Drug Urine Test Panel

Indications for Use (Describe)

Wondfo T-Dip® Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedoxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Cannabinoids (THC 50)	50 ng/mL

Wondfo T-Dip® Multi-Drug Urine Test Panel offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

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

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

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."

4

Indications for Use

510(k) Number (if known)

K202567

Device Name

Wondfo T-Dip® Multi-Drug Urine Test Panel Rx

Indications for Use (Describe)

Wondfo T-Dip® Multi-Drug Urine Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Cannabinoids (THC 50)	50 ng/mL

Wondfo T-Dip® Multi-Drug Urine Test Panel Rx offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

5

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."

6

510(k) SUMMARY K202567

September 22, 2020 l Date Guangzhou Wondfo Biotech Co., Ltd. Submitter 2 No. 8 Lizhishan Road, Science City, Luogang District Guangzhou, Guangdong, P.R. China 510641
3 Contact Person Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: 240-505-7880 Fax: 301-916-6213 Email: shiajl@yahoo.com
4 Device Name Wondfo T-Dip® Multi-Drug Urine Test Panel Wondfo T-Dip® Multi-Drug Urine Test Panel Rx
5 Classification

Class II
Product Code
Target Drug	Regulation Section	Panel
NFT
Amphetamine (AMP)	862.3100, Amphetamine Test System	Toxicology
NGL
Buprenorphine (BUP)	862.3650, Opiate Test System	Toxicology
PTH
Secobarbital (BAR)	862.3150, Barbiturate Test System	Toxicology
NFV
Oxazepam (BZO)	862.3170,
Benzodiazepine Test System	Toxicology
NFY
Cocaine (COC)	862.3250, Cocaine Test System	Toxicology
PTG
2-ethylidene-1,5-
dimethyl-3,3-
diphenylpyrrolidine
(EDDP)	862.3620, Methadone Test System	Toxicology
NGG
Methamphetamine
(MET)	862.3610,
Methamphetamine Test System	Toxicology
NGG
Methylenedioxymethamphetamine (MDMA)	862.3610,
Methamphetamine Test System	Toxicology
NGL	862.3650, Opiate Test System	Toxicology

7

Morphine (MOP/OPI)	862.3620, Methadone Test System	Toxicology
PTG
Methadone (MTD)
NGL
Oxycodone (OXY)	862.3650, Opiate Test System	Toxicology
LCM
Phencyclidine (PCP)	Unclassified	Toxicology
QBF
Propoxyphene (PPX)	862.3700 Propoxyphene test system.	Toxicology
QAW
Nortriptyline (TCA)	862.3910 Tricyclic antidepressant drugs test system	Toxicology
NFW
Cannabinoids (THC 50)	862.3870, Cannabinoids Test System	Toxicology

6. Predicate Device K182701

Wondfo T-Cup® Multi-Drug Urine Test Cup

7. Intended Use

Wondfo T-Dip® Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL

8

Cannabinoids (THC 50)	50 ng/mL
-----------------------	----------

Wondfo T-Dip® Multi-Drug Urine Test Panel offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Wondfo T-Dip® Multi-Drug Urine Test Panel Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Cannabinoids (THC 50)	50 ng/mL

9

Wondfo T-Dip® Multi-Drug Urine Test Panel offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

1. Device Description
  The Wondfo T-Dip® Multi-Drug Urine Test Panel and Wondfo T-Dip® Multi-Drug Urine Test Panel Rx are rapid, single-use in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test T-Dip® panel and two desiccants, and a package insert. The Wondfo T-Dip® Multi-Drug Urine Test Panel is intended for over-the-counter use and the Wondfo T-Dip® Multi-Drug Urine Test Panel Rx is intended for prescription use.

| Item | Proposed Device | Predicate
(K182701) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Indication(s) for use | For the qualitative determination of Amphetamine,
Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-
1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine,
Methylenedioxymethamphetamine, Morphine, Methadone,
Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and
Cannabinoids in human urine. | 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 Drug | Cutoff (ng/mL) |
| | Amphetamine (AMP) | 1000 or 500 |
| | Buprenorphine (BUP) | 10 |
| | Secobarbital (BAR) | 300 |
| | Oxazepam (BZO) | 300 |
| | Cocaine (COC) | 300 or 150 |

9. Substantial Equivalence Information

10

| | 2-ethylidene-1,5-dimethyl-3,3-
diphenylpyrrolidine (EDDP) | 300 | |
|----------------|--------------------------------------------------------------|-----------------------------|--|
| | Methamphetamine (MET) | 1000 or 500 | |
| | Methylenedioxymethamphetamine (MDMA) | 500 | |
| | Morphine (MOP 300/OPI 2000) | 2000 or 300 | |
| | Methadone (MTD) | 300 | |
| | Oxycodone (OXY) | 100 | |
| | Phencyclidine (PCP) | 25 | |
| | Propoxyphene (PPX) | 300 | |
| | Nortriptyline (TCA) | 1000 | |
| | Cannabinoids (THC 50) | 50 | |
| Configurations | Test Panel | Cup | |
| Intended Use | Prescription Use and over-the-counter use | For over-the-counter
use | |

10. Test Principle

Wondfo T-Dip® Multi-Drug Urine Test Panel and Wondfo T-Dip® Multi-Drug Urine Test Panel Rx are rapid tests for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine,Methamphetamine,

Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in urine samples. They chromatographic immunoassay. When urine sample is added to the cup device, urine is absorbed into the test strip and migrates upwards by capillary action. If the concentration of target drug presented in the urine sample is below the cutoff level, the target drug will not saturate the binding sites of its specific monoclonal antibody-coated particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored band will be formed on the test line region. If the concentration of target is beyond the cutoff level, the target drug will saturate the binding sites of its specific monoclonal antibody-particles, thus the antibody-coated particles will not be captured by immobilized drug-conjugate hence no colored band will be formed on the test line region.

A band should be formed on the control line region regardless of the presence of target drug or metabolite in the sample to indicate that the tests have been performed properly.

11. Performance Characteristics

1. Analytical Performance
- a. Precision

Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cutoff, +25% cut off, +50% cut off, +75% cut off and +100% cut off. Samples with concentration of -100% cutoff were drug-free urines samples. Other samples were prepared by spiking target drug in drug-free urine samples. Each drug concentration was confirmed

11

by LC/MS or GC/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test panels. The results obtained are summarized in the following tables:

| Concentration by
LC/MS
(ng/mL)
Lot Number | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 19.68 | 17.69 | 14.89 | 12.81 | 10.69 | 8.29 | 5.27 | 2.58 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 9-/41+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

T-Dip® Multi-Drug Urine Test Panel BUP 10

T-Dip® Multi-Drug Urine Test Panel PCP 25

| Concentration by
LC/MS
(ng/mL)
Lot Number | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|--------|----------------|----------------|----------------|------------------|
| 50.74 | 43.64 | 36.98 | 30.85 | 24.43 | 18.49 | 12.29 | 6.63 | 0 | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 6-/44+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 6-/44+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 7-/43+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

T-Dip® Multi-Drug Urine Test Panel THC 50

| Concentration by | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| LC/MS
(ng/mL) | 99.50 | 88.57 | 75.41 | 62.39 | 50.04 | 38.04 | 25.70 | 12.18 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

T-Dip® Multi-Drug Urine Test Panel OXY 100

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)
Lot Number	198.93	178.79	149.47	122.29	103.53	75.69	48.78	24.68	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	8-/42+	50-/0+	50-/0+	50-/0+	50-/0+

12

Lot II	0-/50+	0-/50+	0-/50+	0-/50+	9-/41+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	9-/41+	50-/0+	50-/0+	50-/0+	50-/0+

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)
	599.00	525.62	455.65	374.74	297.26	217.7	142.50	74.48	0
Lot Number
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	8-/42+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	8-/42+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	7-/43+	50-/0+	50-/0+	50-/0+	50-/0+

T-Dip® Multi-Drug Urine Test Panel BZO 300

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)
Lot Number	602.91	516.94	448.36	378.24	296.80	216.82	149.66	73.34	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	8-/42+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	7-/43+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	8-/42+	50-/0+	50-/0+	50-/0+	50-/0+

T-Dip® Multi-Drug Urine Test Panel EDDP 300

| Concentration by
LC/MS
(ng/mL)
Lot Number | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|--------|----------------|----------------|----------------|------------------|
| 597.99 | 537.04 | 454.10 | 376.30 | 296.48 | 231.98 | 152.78 | 71.21 | 0 | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 9-/41+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 9-/41+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 8-/42+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

T-Dip® Multi-Drug Urine Test Panel MTD 300

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)
Lot Number	601.73	533.12	444.38	377.94	300.53	221.54	158.88	89.27	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	8-/42+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	9-/41+	50-/0+	50-/0+	50-/0+	50-/0+

13

Lot III	0-/50+	0-/50+	0-/50+	0-/50+	9-/41+	50-/0+	50-/0+	50-/0+	50-/0+
---------	--------	--------	--------	--------	--------	--------	--------	--------	--------

| Concentration by
LC/MS
(ng/mL)
Lot Number | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 603.15 | 514.08 | 444.29 | 366.05 | 297.98 | 237.05 | 158.56 | 87.33 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

T-Dip® Multi-Drug Urine Test Panel PPX 300

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)
Lot Number	602.35	510.96	445.25	373.09	301.81	238.40	151.24	77.94	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	10-/40+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	10-/40+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	11-/39+	50-/0+	50-/0+	50-/0+	50-/0+

T-Dip® Multi-Drug Urine Test Panel COC 150

| Concentration by
GC/MS
(ng/mL) | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 298.12 | 265.57 | 228.13 | 185.01 | 149.94 | 111.61 | 73.28 | 35.91 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

T-Dip® Multi-Drug Urine Test Panel MDMA 500

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)
	1005.82	874.87	746.39	620.36	496.21	377.55	245.14	120.41	0
Lot Number
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	10-/40+	50-/0+	50-/0+	50-/0+	50-/0+

14

Lot II	0-/50+	0-/50+	0-/50+	0-/50+	10-/40+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	11-/39+	50-/0+	50-/0+	50-/0+	50-/0+

T-Dip® Multi-Drug Urine Test Panel TCA 1000

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)
Lot Number	1994.55	1772.4
6	1489.6
1	1244.9
4	1029.95	764.86	493.08	283.95	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	11-/39+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	10-/40+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	11-/39+	50-/0+	50-/0+	50-/0+	50-/0+

T-Dip® Multi-Drug Urine Test Panel AMP 500

| Concentration
by GC/MS
(ng/mL)
Lot Number | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 998.23 | 880.545 | 750.15 | 630.77 | 500.18 | 372.34 | 256.24 | 125.78 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

T-Dip® Multi-Drug Urine Test Panel MET 500

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
GC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)	1006.21	862.45	744.97	620.39	497.11	374.32	246.02	123.98	0
Lot Number
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	10-/40+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	10-/40+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	10-/40+	50-/0+	50-/0+	50-/0+	50-/0+

T-Dip® Multi-Drug Urine Test Panel OPI 2000

Concentration by	+100%	+75%	+50%	+25%	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff	cutoff	cutoff	cutoff	cut-off
(ng/mL)
Lot Number	4008.48	3474.1
9	2990.6
7	2429.1
3	1971.46	1514.1
6	1051.1
6	494.48	0

15

Lot I	0-/50+	0-/50+	0-/50+	0-/50+	10-/40+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	11-/39+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	10-/40+	50-/0+	50-/0+	50-/0+	50-/0+

T-Dip® Multi-Drug Urine Test Panel COC 300

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)
Lot Number	599.44	528.54	450.89	370.66	299.9	224.66	149.77	78.09	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	10-/40+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	10-/40+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	11-/39+	50-/0+	50-/0+	50-/0+	50-/0+

T-Dip® Multi-Drug Urine Test Panel AMP 1000

| Concentration by
LC/MS
(ng/mL) | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 1978.82 | 1746.3 | 1508.6 | 1260.5 | 1026.56 | 758.64 | 505.69 | 258.23 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 7-/43+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 8-/42+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 7-/43+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

T-Dip® Multi-Drug Urine Test Panel MET 1000

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)
Lot Number	1978.55	1740.9	1506.5	1234.8	1037.23	751.60	491.85	245.71	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	8-/42+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	8-/42+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	7-/43+	50-/0+	50-/0+	50-/0+	50-/0+

The following cutoff values are verified:

Target Drug	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL

16

Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Cannabinoids (THC 50)	50 ng/mL

b. Linearity
Not applicable
c. Stability
The devices are stable at 4-30°C for 24 months based on real-time stability studies.
d. Interference
Potential interfering substances were added to drug-free urine samples with target drugs of -25% cutoff and +25% cutoff level.

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

Acetaminophen	Acetophenetidin	Acetylsalicylic Acid
Acyclovir	Amiodarone Hydrochloride	Apomorphine
Afrin	Albumin (100mg/dL)	Amlodipine Mesylate
Aminophylline	Amoxicillin	Aripiprazole
Aminopyrine	Ampicillin	Aspartame
Benzilic Acid	Atropine	Atomoxetine
Benzoic Acid	Carbamazepine	Atorvastatin Calcium
Bilirubin	Cefradine	Chloramphenicol
Bupropion	Cephalexin	Chlorothiazide
Captopril	Chloral Hydrate	Chloroquine
Ciprofloxacin Hydrochloride	Clonidine	Cholesterol
Citalopram	Clopidogrel Hydrogen Sulphate	(-) Cotinine
Clarithromycin	Clozapine	chlorpheniramine
Deoxy- corticosterone	D,L-Tyrosine	D,L-Octopamine
Dextromethorphan	Digoxin	D,L-Propranolol
Diclofenac	Diphenhydramine	D-Norpropoxy- phene
Diflunisal	Dirithromycin	Domperidone
D-Pseudo- ephedrine	Ecgonine Methyl Ester	Doxylamine
Duloxetine	Effexor	Epinephrine Hydrochloride
Dicyclomine	Enalapril Maleate	Erythromycin
β-Estradiol	Fentanyl Citrate	Esomeprazole Magnesium
Ethanol (1%)	Fluoxetine Hydrochloride	Furosemide
Fenofibrate	Fluvoxamine	Gabapentin
Fenoprofen	Glucose	Gentisic Acid
Glibenclamide	Haloperidol	3-Hydroxy- tyramine
Gliclazide	Hemoglobin	Isosorbide Dinitrate
Glipizide	Ketamine	Isoxsuprine
Ibuprofen	Kratom powder	Lamotrigine
Ketoconazole	Labetalol	Levofloxacin Hydrochloride
Ketoprofen	Liverite	Levonorgestrel
Lidocaine Hydrochloride	Loperamide	Levothyroxine Sodium
Lisinopril	Loratadine	Minocycline
Lithium Carbonate	Naproxen	Nalidixic Acid
Metoprolol Tartrate	Mifepristone	Niacinamide
Magnesium	Mirtazapine	Nifedipine
Meperidine	Montelukast Sodium	Nikethamide
Meprobamate	Phenelzine	Sulfamethazine
Mosapride Citrate	Pioglitazone Hydrochloride	Sulindac
Maprotiline	Piracetam	Tetrahydrocortisone 3 -acetate
Nimodipine	Pravastatin Sodium	Tetrahydrocortisone 3-(β-D-
glucuronide)
Norethindrone	Prednisone	Tetrahydrozoline
N-Acetylprocain-amide	Propylthiouracil	Tetracycline
O-Hydroxyhippu-ric Acid	Promethazine	Thiamine
Olanzapine	Quetiapine Fumarate	Thioridazine
Omeprazole	Quinine	Topiramate
Oxalic Acid	Ranitidine	Tramadol Hydrochloride
Oxolinic Acid	Rifampicin	Trazodone Hydrochloride
Oxymetazoline	Risperidone	Triamterene
Ondansetran	Salicylic Acid	Trifluoperazine
Paliperidone	Serotonin	Trimethoprim
Pantoprazole	Sertraline Hydrochloride	Uric Acid
Papaverine	Sildenafil Citrate	Valproate
Paroxetine Hydrochloride	Simvastatin	Verapamil
Penfluridol	Sodium Valproate	Vitamin B2
PenicillinV Potassium	Spironolactone	Vitamin C
Penicillin-G

17

18

e. Specificity
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 each device.

Percent cross-reactivity, provided in the below table, was calculated as the concentration of analyte tested that yielded a positive result, divided by the cutoff concentration, multiplied by 100; compounds that did not yield a positive result at the highest concentration tested have relative cross reactivity results represented by a dash in the table below:

| BUP 10 (Buprenorphine,
Cutoff=10 ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|--------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Buprenorphine -3-D-Glucuronide | 15 | 66.7% |
| Norbuprenorphine | 20 | 50% |
| Norbuprenorphine-3-D-Glucuronide | 200 | 5% |
| Morphine | >100,000 | -- |
| Oxymorphone | >100,000 | -- |
| Hydromorphone | >100,000 | -- |

| PCP (Phencyclidine)
(Phencyclidine,
Cutoff=25 ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 4-Hydroxyphencyclidine | 12500 | 0.2% |

| THC 50
(11-nor-Δ9-THC-9-COOH,
Cutoff=50 ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 11-nor-Δ8-THC 50-9-COOH | 30 | 167% |
| (-)-11-nor-9-carboxy-Δ 9-THC 50 | 50 | 100% |
| 11-nor-Δ9-THC 50-carboxy glucuronide | 100 | 50% |
| 11-hydroxy-Δ9-Tetrahydrocannabinol | 5000 | 1% |
| Δ8- Tetrahydrocannabinol | 1300 | 4% |
| Δ9- Tetrahydrocannabinol | 5000 | 1% |
| Cannabinol | 20000 | 0.25% |
| Cannabidiol | 100000 | 0.05% |

19

| OXY 100
(Oxycodone, Cutoff=100 ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Dihydrocodeine | 20000 | 0.5% |
| Hydrocodone | 10000 | 1% |
| Oxymorphone | 1000 | 10% |
| Codeine | 100000 | 0.1% |
| Hydromorphone | 32000 | 0.3125% |
| Morphine | >100,000 | -- |
| Acetylmorphine | >100,000 | -- |
| Buprenorphine | >100,000 | -- |
| Ethylmorphine | >100,000 | -- |
| Thebaine | >100,000 | -- |

| COC 150
(Benzoylecgonine, Cutoff=150 ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Cocaine | 375 | 40% |
| Cocaethylene | 6250 | 2.4% |
| Ecgonine | 16000 | 100,000 | -- |
| Norcocaine | >100,000 | -- |

| BAR 300
(Secobarbital, Cutoff=300ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|--------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Amobarbital | 10000 | 3% |
| Alphenol | 150 | 200% |
| Aprobarbital | 200 | 150% |
| Butabarbital | 75 | 400% |
| Butathal | 100 | 300% |
| Butalbital | 2500 | 12% |
| Cyclopentobarbital | 600 | 50% |
| Pentobarbital | 2500 | 12% |
| Phenobarbital | 10000 | 3% |

| BZO 300
(Oxazepam, Cutoff=300ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Alprazolam | 200 | 150% |
| a-Hydroxyalprazolam | 1500 | 20% |
| Bromazepam | 500 | 60% |

20

Chlordiazepoxide	1500	20%
Clobazam	100	300%
Clonazepam	800	37.5%
Clorazepate dipotassium	200	150%
Delorazepam	1500	20%
Desalkylflurazepam	400	75%
Diazepam	200	150%
Estazolam	1000	30%
Flunitrazepam	2500	12%
Midazolam	12500	2.4%
Nitrazepam	4000	7.5%
Norchlordiazepoxide	200	150%
Nordiazepam	500	60%
Temazepam	250	120%
Triazolam	1200	25%
Demoxepam	2000	15%
Flurazepam	500	60%
D,L-Lorazepam	1500	20%

| EDDP 300
(2-ethylidene-1,5-dimethyl-3,3-
diphenylpyrrolidine, Cutoff = 300 ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Methadone | 300000 | 0.1% |
| EMDP | 300000 | 0.1% |
| Doxylamine | >100,000 | -- |
| Disopyramide | >100,000 | -- |
| LAAM (Levo-alpha-acetylmethadol) HCl | >100,000 | -- |
| Alpha Methadol | >100,000 | -- |

| MTD 300
(Methadone, Cutoff=300ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Doxylamine | 50000 | 0.6% |
| EDDP | >100,000 | -- |
| EMDP | >100,000 | -- |
| LAAM | >100,000 | -- |
| Alpha Methadol | >100,000 | -- |

| MOP 300
(Morphine, Cutoff=300ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Normorphine | 300 | 100% |

21

Codeine	300	100%
s-Monoacetylmorphine	300	100%
Ethyl Morphine	100	300%
Heroin	300	100%
Hydrocodone	5000	6%
Hydromorphone	1000	30%
Morphinie-3-β-d-glucuronide	1000	30%
Oxycodone	>100000	--
Oxymorphone	100000	0.3%
Thebaine	3000	10%
Levorphanol	10000	3%
6-Monoacetylmorphine (6-MAM)	150	200%
Norcodeine	6250	4.8%
Procaine	150000	0.2%

| PPX 300
(Propoxyphene, Cutoff=300ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|--------------------------------------------|--------------------------------------------------------------------------|------------------------|
| d-Norpropoxyphene | 300 | 100% |

| MDMA 500
(3,4-Methylenedioxymethamphetamine HCl,
Cutoff=500ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 3,4-Methylenedioxyamphetamine HCl (MDA) | 3000 | 17% |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | 300 | 167% |
| d-methamphetamine | >100,000 | -- |
| d-amphetamine | >100,000 | -- |
| l-methamphetamine | 50000 | 1% |
| l-amphetamine | >100,000 | -- |

| AMP 500
(Amphetamine, Cutoff=500ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-------------------------------------------|--------------------------------------------------------------------------|------------------------|
| l-Amphetamine | 25000 | 2% |
| dl- Amphetamine | 1500 | 33% |
| (+/-) 3,4-Methylenedioxyamphetamine (MDA) | 2500 | 20% |
| Phentermine | 1500 | 33% |
| Hydroxyamphetamine | 8000 | 6.25% |
| d-Methamphetamine | >100,000 | -- |
| l-Methamphetamine | >100,000 | -- |

22

| (+/-) 3,4-Methylenedioxyethylamphetamine

(MDE)	>100,000	--
(+/-)3,4-Methylenedioxymethamphetamine
(MDMA)	>100,000	--
Ephedrine	>100,000	--
β-Phenylethylamine	100000	0.5%
Tyramine	100000	0.5%
p-Hydroxynorephedrine	100000	0.5%
Phenylpropanolamine	>100,000	--
(±)Phenylpropanolamine	>100,000	--
p-Hydroxyamphetamine	100000	0.5%
d/l-Norephedrine	100000	0.5%
Benzphetamine	>100,000	--
l-Ephedrine	>100,000	--
l-Epinephrine	>100,000	--
d/l-Epinephrine	>100,000	--

| MET 500
(D(+)-Methamphetamine, Cutoff=500ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-----------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| D-Amphetamine | 25000 | 2% |
| L- Amphetamine | 37500 | 1.3% |
| Chloroquine | 10000 | 5% |
| (+/-)-Ephedrine | 25000 | 2% |
| D/L-Methamphetamine | 500 | 100% |
| L-Methamphetamine | 10000 | 5% |
| (+/-)3,4Methylenedioxy-n-ethylamphetamine
(MDEA) | 500 | 100% |
| (+/-)3,4- Methylenedioxyamphetamine(MDA) | 500 | 100% |
| (+/-)3,4- Methylenedioxymethamphetamine
(MDMA) | 2000 | 25% |
| β-Phenylethylamine | 25000 | 2% |
| Trimethobenzamide | 5000 | 10% |
| d/l-Amphetamine | 75000 | 0.7% |
| p-Hydroxymethamphetamine | 15000 | 3.3% |
| Mephentermine | 25000 | 2% |
| (1R,2S)-(-)-Ephedrine | 50000 | 1% |
| 1-Phenylephrine | 100000 | 0.5% |
| (-)-Methamphetamine | 12500 | 4% |

23

| TCA 1000
(Nortriptyline, Cutoff=1000ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-----------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Nordoxepine | 1000 | 100% |
| Trimipramine | 3000 | 33.3% |
| Amitriptyline | 1500 | 66.7% |
| Promazine | 1500 | 66.7% |
| Desipramine | 200 | 500% |
| Imipramine | 400 | 250% |
| Clomipramine | 12500 | 8% |
| Doxepine | 2000 | 50% |
| Maprotiline | 2000 | 50% |
| Promethazine | 25000 | 4% |
| Cyclobenzaprine | 800 | 125% |
| Norclomipramine | 12500 | 8% |

| COC 300
(Benzoylecgonine, Cutoff=300ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-----------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Cocaine | 750 | 40% |
| Cocaethylene | 12500 | 2.4% |
| Ecgonine | 32000 | 100000 | -- |
| Norcocaine | >100,000 | -- |

| AMP 1000
(d-Amphetamine, Cutoff=1000ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|---------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 1-Amphetamine | 50000 | 2% |
| d1-Amphetamine | 3000 | 33.3% |
| Phentermine | 3000 | 33.3% |
| (+/-) 3,4-Methylenedioxyamphetamine
(MDA) | 5000 | 20% |
| Hydroxyamphetamine | >100000 | -- |
| d-Methamphetamine | >100000 | -- |
| l-Methamphetamine | >100000 | -- |
| Ephedrine | >100000 | -- |
| (+/-)3,4- Methylenedioxymethamphetamine
(MDMA) | 100000 | 1% |
| β-Phenylethylamine | 100000 | 1% |
| Tyramine | 100000 | 1% |

24

p-Hydroxynorephedrine	100000	1%
Phenylpropanolamine	>100000	--
(±)Phenylpropanolamine	>100000	--
p-Hydroxyamphetamine	100000	1%
d/l-Norephedrine	100000	1%
Benzphetamine	>100000	--
l-Ephedrine	>100000	--
l-Epinephrine	>100000	--
d/l-Epinephrine	>100000	--
Hydroxyamphetamine	8000	12.5%

| MET 1000
(D(+)-Methamphetamine, Cutoff=1000ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine
(MDEA) | 1000 | 100% |
| D/L-Methamphetamine | 1000 | 100% |
| p-Hydroxymethamphetamine | 30000 | 3.3% |
| D-Amphetamine | >100000 | -- |
| L-Amphetamine | 75000 | 1.3% |
| Chloroquine | 50000 | 2% |
| (+/-)-Ephedrine | 50000 | 2% |
| (-)-Methamphetamine | 25000 | 4% |
| (+/-)3,4-Methylenedioxyamphetamine (MDA) | 1000 | 100% |
| (+/-)3,4-Methylenedioxymethamphetamine
(MDMA) | 4000 | 25% |
| β-Phenylethylamine | 50000 | 2% |
| Trimethobenzamide | 10000 | 10% |
| d,l-Amphetamine | 100000 | 1% |
| Mephetermine | 50000 | 2% |
| (1R,2S)-(-)-Ephedrine | >100000 | -- |
| l-phenylephrine | >100000 | -- |
| L-Methamphetamine | 25000 | 4% |

| OPI 2000
(Morphine, Cutoff=2000ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Codeine | 2000 | 100% |
| Ethyl Morphine | 1500 | 133% |
| Hydrocodone | 12500 | 16% |
| Hydromorphone | 3500 | 57% |

25

Levorphanol	75000	2.7%
6-Monoacetylmorphine (6-MAM)	1500	133%
Morphine 3-β-D-glucuronide	2000	100%
Norcodeine	12500	16%
Normorphine	50000	4%
Oxycodone	25000	8%
Oxymorphone	25000	8%
Procaine	150000	1.3%
Thebaine	5000	40%
Heroin	2000	100%
s-Monoacetylmorphine	2000	100%

f. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity, urine samples with specific gravity from 1.000 to 1.035 were spiked with target drugs at +25% cutoff and -25% cutoff levels. Three viewers tested each sample using test devices from three different lots. The results were all positive for samples at +25% cutoff and all negative for samples at -25% cutoff, indicating that urine specific gravity between 1.000 and 1.035 has no effect on the accuracy and precision of the test device.

To investigate the effect of urine pH, urine samples with pH value from 4 to 9 were spiked with target drugs at +25% cutoff and -25% cutoff levels. Three viewers tested each sample using test devices from three different lots. The results were all positive for samples at +25% cutoff and all negative for samples at -25% cutoff, indicating that urine pH value between 4.0 and 9.0 has no effect on the accuracy and precision of the test device.

1. Comparison Studies
  The method comparison studies for Wondfo T-Dip® Multi-Drug Urine Test Panel were performed in-house with three operators.

Operators ran 80 (40 negative and 40 positive) unaltered urine samples were blind labeled and compared to LC/MS or GC/MS results are presented in the table below:

For T-Dip® Multi-Drug Urine Test Panel:

| Wondfo
T-Dip® | | Drug-Free | Low
Negative by
GC/MS (less
than -50%) | Near Cutoff
Negative by
GC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
GC/MS
(Between the
cutoff and
+50%) | High Positive
by GC/MS
(greater than
+50%) |
|------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 2 | 30 | 10 |
| | Negative | 10 | 17 | 11 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 30 | 10 |

AMP 500

26

	Negative	10	17	12	0	0
Viewer C	Positive	0	0	1	30	10
	Negative	10	17	12	0	0

Discordant Results for AMP 500:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Dip Result
Viewer A	20327	479.507	+
Viewer B	20327	479.507	+
Viewer C	20716	480.687	+
Viewer A	20716	480.687	+

BUP 10

| Wondfo
T-Dip® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 2 | 28 | 10 |
| | Negative | 10 | 18 | 10 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 28 | 10 |
| | Negative | 10 | 18 | 10 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 28 | 10 |
| | Negative | 10 | 18 | 10 | 2 | 0 |

Discordant Results for BUP 10:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Dip Result
Viewer A	20181	10.039	-
Viewer B	20181	10.039	-
Viewer C	20181	10.039	-
Viewer A	20317	11.063	-
Viewer B	20317	11.063	-
Viewer C	20317	11.063	-
Viewer A	20644	8.226	+
Viewer B	20644	8.226	+
Viewer C	20644	8.226	+
Viewer A	20611	9.000	+
Viewer B	20611	9.000	+
Viewer C	20611	9.000	+

27

| Wondfo
T-Dip® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 29 | 11 |
| | Negative | 10 | 19 | 10 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 28 | 11 |
| | Negative | 10 | 19 | 10 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 28 | 11 |
| | Negative | 10 | 19 | 10 | 1 | 0 |

Discordant Results for BAR 300:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Dip Result
Viewer A	20564	247.29	+
Viewer B	20564	247.29	+
Viewer C	20564	247.29	+
Viewer B	20332	307.799	-
Viewer C	20012	307.127	-

BZO 300

| Wondfo
T-Dip® | | Drug-Free | Low Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|------------------|----------|-----------|----------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 2 | 29 | 10 |
| | Negative | 10 | 15 | 13 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 28 | 10 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 3 | 29 | 10 |
| | Negative | 10 | 15 | 12 | 1 | 0 |

Discordant Results for BZO 300:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Dip Result
Viewer A	20556	274.237	+
Viewer C	20556	274.237	+
Viewer C	20848	286.984	+
Viewer A	21006	289.534	+

28

Viewer C	21006	289.534	+
Viewer A	20605	307.387	-
Viewer B	20605	307.387	-
Viewer C	20605	307.387	-
Viewer B	20995	313.241	-

COC 150

| Wondfo T-
Dip® | | Drug-Free | Low
Negative by
GC/MS
(less than -
50%) | Near Cutoff
Negative by
GC/MS
(Between -
50% and the
Cutoff) | Near Cutoff
Positive by
GC/MS
(Between the
cutoff and
+50%) | High
Positive by
GC/MS
(greater
than +50%) |
|-------------------|----------|-----------|-----------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 2 | 31 | 9 |
| | Negative | 10 | 18 | 10 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 30 | 9 |
| | Negative | 10 | 18 | 11 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 30 | 9 |
| | Negative | 10 | 18 | 10 | 1 | 0 |

Discordant Results for COC 150:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Dip Result
Viewer A	21001	145.437	+
Viewer B	21001	145.437	+
Viewer C	20447	133.375	+
Viewer A	20261	146.311	+
Viewer C	20261	146.311	+
Viewer B	21126	162.825	-
Viewer C	21051	150.712	-

EDDP 300

| Wondfo T-
Dip® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -
50% and the
Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|-------------------|----------|-----------|-------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 32 | 8 |
| | Negative | 10 | 18 | 11 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 32 | 8 |

29

	Negative	10	18	11	0	0
Viewer C	Positive	0	0	1	32	8
	Negative	10	18	11	0	0

Discordant Results for EDDP 300:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Dip Result
Viewer A	21064	246.737	+
Viewer B	21064	246.737	+
Viewer C	21064	246.737	+

MET 500

| Wondfo
T-Dip® | | Drug-Free | Low
Negative by
GC/MS (less
than -50%) | Near Cutoff
Negative by
GC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
GC/MS
(Between the
cutoff and
+50%) | High Positive
by GC/MS
(greater than
+50%) |
|------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 2 | 20 | 20 |
| | Negative | 10 | 15 | 13 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 20 | 20 |
| | Negative | 10 | 15 | 13 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 3 | 20 | 20 |
| | Negative | 10 | 15 | 12 | 0 | 0 |

Discordant Results for MET 500:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Dip Result
Viewer A	20402	478.249	+
Viewer B	20402	478.249	+
Viewer C	20402	478.249	+
Viewer A	20731	499.295	+
Viewer B	20731	499.295	+
Viewer C	20731	499.295	+
Viewer C	20459	384.376	+

MDMA 500

------------------	-----------	-------------------------------------------------	-------------------------------------------------------------------------	----------------------------------------------------------------------------	-----------------------------------------------------

30

Viewer A	Positive	0	0	2	30	10
	Negative	10	18	10	0	0
Viewer B	Positive	0	0	2	30	10
	Negative	10	18	10	0	0
Viewer C	Positive	0	0	2	30	10
	Negative	10	18	10	0	0

Discordant Results for MDMA 500:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Dip Result
Viewer A	21109	409.82	+
Viewer B	21109	409.82	+
Viewer C	21109	409.82	+
Viewer A	20810	417.972	+
Viewer B	20810	417.972	+
Viewer C	20810	417.972	+

MOP 300

| | Wondfo
T-Dip® | Drug-Free | Low
Negative by
GC/MS (less
than -50%) | Near Cutoff
Negative by
GC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
GC/MS
(Between the
cutoff and
+50%) | High Positive
by GC/MS
(greater than
+50%) |
|----------|------------------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 29 | 10 |
| | Negative | 10 | 18 | 12 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 29 | 10 |
| | Negative | 10 | 18 | 12 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 29 | 10 |
| | Negative | 10 | 18 | 12 | 1 | 0 |

Discordant Results for MOP 300:

Viewer	Sample Number	GC/MS Result (ng/mL)	T-Dip Result
Viewer A	20893	304.731	-
Viewer B	20893	304.731	-
Viewer C	20893	304.731	-

MTD 300

------------------	-----------	-------------------------------------------------	-------------------------------------	-------------------------------------	-----------------------------------------------------

31

| | | | | (Between -50%
and the Cutoff) | (Between the
cutoff and
+50%) | |
|----------|----------|----|----|----------------------------------|-------------------------------------|----|
| Viewer A | Positive | 0 | 0 | 2 | 28 | 12 |
| | Negative | 10 | 18 | 10 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 27 | 12 |
| | Negative | 10 | 18 | 11 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 27 | 12 |
| | Negative | 10 | 18 | 10 | 1 | 0 |

Discordant Results for MTD 300:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Dip Result
Viewer A	20646	282.733	+
Viewer B	20646	282.733	+
Viewer C	20646	282.733	+
Viewer A	20404	285.038	+
Viewer C	20404	285.038	+
Viewer B	20572	309.555	-
Viewer C	20572	309.555	-

OXY 100

| Wondfo
T-Dip® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 30 | 10 |
| | Negative | 10 | 18 | 11 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 29 | 10 |
| | Negative | 10 | 18 | 11 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 29 | 10 |
| | Negative | 10 | 18 | 12 | 1 | 0 |

Discordant Results for OXY 100:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Dip Result
Viewer A	20008	75.7	+
Viewer B	20008	75.7	+
Viewer B	20840	113.792	-
Viewer C	20840	113.792	-

32

PCP 25

| Wondfo
T-Dip® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 28 | 10 |
| | Negative | 10 | 20 | 9 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 29 | 10 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 29 | 10 |
| | Negative | 10 | 20 | 9 | 1 | 0 |

Discordant Results for PCP 25:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Dip Result
Viewer A	21197	20.203	+
Viewer B	21197	20.203	+
Viewer C	21197	20.203	+
Viewer A	20041	25.049	-
Viewer B	20041	25.049	-
Viewer C	20065	25.105	-
Viewer A	20065	25.105	-

PPX 300

| Wondfo
T-Dip® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 2 | 31 | 8 |
| | Negative | 10 | 17 | 11 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 31 | 8 |
| | Negative | 10 | 17 | 11 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 31 | 8 |
| | Negative | 10 | 17 | 11 | 1 | 0 |

Discordant Results for PPX 300:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Dip Result
Viewer A	20831	245.38	+

33

Viewer B	20831	245.38	+
Viewer C	20831	245.38	+
Viewer A	20108	252.045	+
Viewer B	20108	252.045	+
Viewer C	20108	252.045	+
Viewer A	20805	314.373	-
Viewer B	20805	314.373	-
Viewer C	20805	314.373	-

TCA 1000

| Wondfo

T-Dip®
	Drug-Free	Low
Negative by
LC/MS (less
than -50%)	Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff)	Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%)	High Positive
by LC/MS
(greater than
+50%)
Viewer A	Positive	0	0	2	29	10
	Negative	10	18	10	1	0
Viewer B	Positive	0	0	2	29	10
	Negative	10	18	10	1	0
Viewer C	Positive	0	0	2	29	10
	Negative	10	18	10	1	0

Discordant Results for TCA 1000:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Dip Result
Viewer A	20720	806.195	+
Viewer B	20720	806.195	+
Viewer C	20720	806.195	+
Viewer A	20937	812.065	+
Viewer B	20937	812.065	+
Viewer C	20937	812.065	+
Viewer A	20534	1007.857	-
Viewer B	20534	1007.857	-
Viewer C	20534	1007.857	-

THC 50

------------------	--	-----------	-------------------------------------------------	-------------------------------------------------------------------------	-------------------------------------	-----------------------------------------------------

34

| | | | | | (Between the
cutoff and
+50%) | |
|----------|----------|----|----|---|-------------------------------------|----|
| Viewer A | Positive | 0 | 0 | 2 | 30 | 10 |
| | Negative | 10 | 19 | 9 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 30 | 10 |
| | Negative | 10 | 19 | 9 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 30 | 10 |
| | Negative | 10 | 19 | 9 | 0 | 0 |

Discordant Results for THC 50:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Dip Result
Viewer A	20822	45.118	+
Viewer B	20822	45.118	+
Viewer C	20822	45.118	+
Viewer A	20385	43.304	+
Viewer B	20385	43.304	+
Viewer C	20385	43.304	+

AMP 1000

| Wondfo
T-Dip® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 30 | 10 |
| | Negative | 10 | 16 | 13 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 28 | 10 |
| | Negative | 10 | 16 | 13 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 28 | 10 |
| | Negative | 10 | 16 | 13 | 2 | 0 |

Discordant Results for AMP 1000:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Dip Result
Viewer A	21354	797.646	+
Viewer B	21354	797.646	+
Viewer C	21354	797.646	+
Viewer B	21426	1012.27	-
Viewer C	21426	1012.27	-
Viewer B	21240	1014.805	-

35

Viewer C	21240	1014.805	-
----------	-------	----------	---

COC 300

| Wondfo
T-Dip® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 3 | 28 | 11 |
| | Negative | 10 | 13 | 14 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 3 | 28 | 11 |
| | Negative | 10 | 13 | 14 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 3 | 28 | 11 |
| | Negative | 10 | 13 | 14 | 1 | 0 |

Discordant Results for COC 300:

Viewer	Sample Number	LC/MS Result	T-Dip Result
Viewer A	21495	283.934	+
Viewer B	21495	283.934	+
Viewer C	21495	283.934	+
Viewer A	21503	292.623	+
Viewer B	21503	292.623	+
Viewer C	21503	292.623	+
Viewer A	21368	293.871	+
Viewer B	21368	293.871	+
Viewer C	21368	293.871	+
Viewer A	21467	309.73	-
Viewer B	21467	309.73	-
Viewer C	21467	309.73	-

MET 1000

| Wondfo
T-Dip® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 2 | 24 | 15 |
| | Negative | 10 | 18 | 10 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 24 | 15 |
| | Negative | 10 | 18 | 10 | 1 | 0 |

36

| Y T "

Viewer C	Positive		J	ﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
	Negative

Discordant Results for MET 1000:

Viewer	Sample Number	LC/MS Result	T-Dip Result
Viewer A	21253	888.241	+
Viewer B	21253	888.241	+
Viewer C	21253	888.241	+
Viewer A	21334	890.705	+
Viewer B	21334	890.705	+
Viewer C	21334	890.705	+
Viewer A	21375	1036.001	-
Viewer B	21375	1036.001	-
Viewer C	21375	1036.001	-

OPI 2000

| Wondfo
Q-Cup | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and +50%) | High Positive
by LC/MS
(greater than
+50%) |
|-----------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 2 | 30 | 10 |
| | Negative | 10 | 18 | 10 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 3 | 30 | 10 |
| | Negative | 10 | 18 | 9 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 30 | 10 |
| | Negative | 10 | 18 | 11 | 0 | 0 |

Discordant Results for OPI 2000:

Viewer	Sample Number	LC/MS Result	T-Dip Result
Viewer A	21270	1830.086	+
Viewer B	21270	1830.086	+
Viewer C	21270	1830.086	+
Viewer B	21453	1882.994	+
Viewer A	21429	1947.150	+
Viewer B	21429	1947.150	+

Lay-user study:

A lay user study was performed using urine samples prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The

37

concentrations of the samples were confirmed by LC/MS or GC/MS. Each sample was aliquoted into individual containers and blind-labeled. A total of 280 participants with diverse educational and professional backgrounds aged 20 years and older were recruited from three sites. Ninety-four males and 46 females tested T-Dip® Multi-Drug Urine Test Panel Configuration 1 (including AMP 500, MET 500, MOP 300, COC 150); 88 male and 52 females tested T-Dip® Multi-Drug Urine Test Panel Configuration 2 (including AMP 1000, MET 1000, MOP 2000 (OPI), COC 300). Each participant was provided one package insert, one blind labeled test solution, and one test device. The results are summarized below:

Lay-User Study Results for T-Dip® Multi-Drug Urine Test Panel Configuration 1 (including AMP 500, MET 500, MOP 300, COC 150):

Assay	Results	Concentration
		-100%	-75%	-50%	-25%	+25%	+50%	+75%
		cutoff	cutoff	cutoff	cutoff	cutoff	cutoff	cutoff
	Negative	20	20	20	19	2	0	0
	Positive	0	0	0	1	18	20	20
AMP 500	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	95%	90%	100%	100%
	Negative	20	20	20	18	2	0	0
	Positive	0	0	0	2	18	20	20
BAR 300	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	90%	90%	100%	100%
	Negative	20	20	20	18	2	0	0
	Positive	0	0	0	2	18	20	20
BZO 300	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	90%	90%	100%	100%
	Negative	20	20	20	17	2	0	0
	Positive	0	0	0	3	18	20	20
BUP 10	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	85%	90%	100%	100%
	Negative	20	20	20	18	2	0	0
	Positive	0	0	0	2	18	20	20
COC 150	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	90%	90%	100%	100%
	Negative	20	20	20	18	1	0	0
EDDP 300	Positive	0	0	0	2	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	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
MET 500	Percentage of
correct results (%)	100%	100%	100%	90%	95%	100%	100%
	Negative	20	20	20	18	2	0	0
	Positive	0	0	0	2	18	20	20
Total	20	20	20	20	20	20	20
MOP 300	Percentage of
correct results (%)	100%	100%	100%	90%	90%	100%	100%
	Negative	20	20	20	18	2	0	0
	Positive	0	0	0	2	18	20	20
Total	20	20	20	20	20	20	20
MTD 300	Percentage of
correct results (%)	100%	100%	100%	90%	90%	100%	100%
	Negative	20	20	20	18	3	0	0
	Positive	0	0	0	2	17	20	20
Total	20	20	20	20	20	20	20
OXY 100	Percentage of
correct results (%)	100%	100%	100%	90%	85%	100%	100%
	Negative	20	20	20	18	2	0	0
	Positive	0	0	0	2	18	20	20
Total	20	20	20	20	20	20	20
PCP 25	Percentage of
correct results (%)	100%	100%	100%	90%	90%	100%	100%
	Negative	20	20	20	17	2	0	0
	Positive	0	0	0	3	18	20	20
Total	20	20	20	20	20	20	20
PPX 300	Percentage of
correct results (%)	100%	100%	100%	85%	90%	100%	100%
	Negative	20	20	20	18	3	0	0
	Positive	0	0	0	2	17	20	20
Total	20	20	20	20	20	20	20
TCA 1000	Percentage of
correct results (%)	100%	100%	100%	90%	85%	100%	100%
	Negative	20	20	20	19	2	0	0
	Positive	0	0	0	1	18	20	20
Total	20	20	20	20	20	20	20
Percentage of
correct results (%)	100%	100%	100%	95%	90%	100%	100%
THC 50	Negative	20	20	20	18	1	0	0
	Positive	0	0	0	2	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	90%	95%	100%	100%

38

39

Lay-User Study Results for T-Dip® Multi-Drug Urine Test Panel Configuration 2 (AMP 1000, MET 1000, MOP 2000 (OPI), COC 300):

Assay	Results	Concentration
		-100%
cutoff	-75%
cutoff	-50%
cutoff	-25%
cutoff	+25%
cutoff	+50%
cutoff	+75%
cutoff
	Negative	20	20	20	19	1	0	0
	Positive	0	0	0	1	19	20	20
AMP 1000	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	95%	95%	100%	100%
	Negative	20	20	20	19	2	0	0
	Positive	0	0	0	1	18	20	20
BAR 300	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	95%	90%	100%	100%
	Negative	20	20	20	18	2	0	0
	Positive	0	0	0	2	18	20	20
BZO 300	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	90%	90%	100%	100%
	Negative	20	20	20	18	3	0	0
	Positive	0	0	0	2	17	20	20
BUP 10	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	90%	85%	100%	100%
	Negative	20	20	20	19	2	0	0
	Positive	0	0	0	1	18	20	20
COC 300	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	95%	90%	100%	100%
	Negative	20	20	20	18	2	0	0
	Positive	0	0	0	2	18	20	20
EDDP 300	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	90%	90%	100%	100%

MDMA 500	Negative	20	20	20	18	2	0	0
	Positive	0	0	0	2	18	20	20
	Total	20	20	20	20	20	20	20
	Percentage of	100%	100%	100%	90%	90%	100%	100%
	correct results (%)
MET 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
	Percentage of	100%	100%	100%	95%	95%	100%	100%
	correct results (%)
OPI 2000	Negative	20	20	20	20	0	0	0
	Positive	0	0	0	0	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage of	100%	100%	100%	100%	100%	100%	100%
	correct results (%)
MTD 300	Negative	20	20	20	18	2	0	0
	Positive	0	0	0	2	18	20	20
	Total	20	20	20	20	20	20	20
	Percentage of	100%	100%	100%	90%	90%	100%	100%
	correct results (%)
OXY 100	Negative	20	20	20	18	1	0	0
	Positive	0	0	0	2	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of	100%	100%	100%	90%	95%	100%	100%
	correct results (%)
PCP 25	Negative	20	20	20	18	2	0	0
	Positive	0	0	0	2	18	20	20
	Total	20	20	20	20	20	20	20
	Percentage of	100%	100%	100%	90%	90%	100%	100%
	correct results (%)
PPX 300	Negative	20	20	20	19	2	0	0
	Positive	0	0	0	1	18	20	20
	Total	20	20	20	20	20	20	20
	Percentage of	100%	100%	100%	95%	90%	100%	100%
	correct results (%)
TCA 1000	Negative	20	20	20	20	0	0	0
	Positive	0	0	0	0	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage of	100%	100%	100%	100%	100%	100%	100%
	correct results (%)
Total	20	20	20	20	20	20	20
Percentage of
correct results (%)	100%	100%	100%	90%	90%	100%	100%

40

41

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.

12. 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 WondfoT-Dip® Multi-Drug Urine Test Panel and Wondfo T-Dip® Multi-Drug Urine Test Panel Rx are substantially equivalent to the predicate devices.