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 of lines, not AI/ML for analysis or interpretation. 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 does not provide any therapeutic intervention.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states, "It is for in vitro diagnostic use only," indicating that the device is used for diagnostic purposes outside of a living organism.

SaMD (Software as a Medical Device)

No

The device description clearly states that the device consists of a "test cup and a package insert," which are physical components, not software. The device is an immunochromatographic assay, a type of in vitro diagnostic test that relies on chemical reactions on a physical strip or cup.

IVD (In Vitro Diagnostic)

Based on the provided information, the Wondfo T-Cup® Multi-Drug Urine Test Cup is indeed an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "It is for in vitro diagnostic use only".
Nature of the Test: The device performs a test on a biological sample (human urine) to detect the presence of specific substances (drugs of abuse). This is a core characteristic of an in vitro diagnostic device.
Purpose: The test is intended to provide information about a person's health status (presence of drugs), even though it provides preliminary results and requires confirmation.

Therefore, the Wondfo T-Cup® Multi-Drug Urine Test Cup fits the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Wondfo T-Cup® Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-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-Cup® Multi-Drug Urine Test Cup 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,

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 (comma separated list FDA assigned to the subject device)

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

Device Description

Wondfo T-Cup® Multi-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine,Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine. Each T-Cup® Multi-Drug Urine Test Cup device consists of a test cup and a package insert. Each test cup is sealed with two sachets of desiccant in an aluminum pouch.

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

Over-The-Counter Use

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

Not Found

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

Analytical Performance (Precision Study):

Sample Size: For each concentration and lot, tests were performed two runs per day for 25 days.
Data Source: Samples with concentrations of -100% cutoff, -75% cutoff, -50% cutoff, -25% cutoff, +25% cutoff, +50% cutoff, +75% cutoff and +100% cutoff, confirmed by LC/MS.
Annotation Protocol: Not explicitly stated, but results are summarized as number of negative/positive results for 50 tests.

Specificity Study:

Data Source: Drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine.
Annotation Protocol: These urine samples were tested using three lots of each device.

Effect of Urine Specific Gravity and Urine pH:

Data Source: Urine samples with specific gravity from 1.000 to 1.035 and pH values from 4 to 9 were spiked with target drugs at +25% cutoff and -25% cutoff levels.
Annotation Protocol: Three viewers tested each sample using test devices from three different lots.

Comparison Studies:

Sample Size: 80 (40 negative and 40 positive) unaltered urine samples were used for each drug.
Data Source: Unaltered urine samples.
Annotation Protocol: Samples were blind labeled and compared to LC/MS or GC/MS results. The studies were performed in-house by three operators.

Lay-user study:

Sample Size: 89 males and 51 females for Configuration 1; 84 males and 56 females for Configuration 2.
Data Source: Urine samples prepared at -100%, +/-75%, +/-25% of the cutoff by spiking drug(s) into drug-free pooled urine specimens. Concentrations confirmed by LC/MS or GC/MS. Each sample aliquoted into individual containers and blind-labeled.
Annotation Protocol: Each participant was provided with the package insert, 1 blind labeled sample and a device. Participants were given surveys on the ease of understanding the instruction for use.

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

1. Analytical Performance - Precision:

Study Type: Analytical precision study.
Sample Size: 50 tests per concentration per lot for 3 lots (total 150 tests per concentration).
Key Results:
- For concentrations at -100%, -75%, -50%, +50%, +75%, and +100% of cutoff, all 50 tests per lot yielded either 50 negative or 50 positive results (100% agreement).
- For samples near the cutoff (e.g., -25% cutoff and +25% cutoff) and at the cutoff level (Cutoff), a small number of discordant results (false positives/negatives) were observed across the three lots. For example, for AMP 1000 at cutoff, 8-9 negative and 41-42 positive results were observed across the 3 lots, indicating some variability at the cutoff.

2. Specificity:

Study Type: Interference/Cross-reactivity study.
Key Results: Tables list minimum concentrations required to obtain a positive result and percentage cross-reactivity for various related compounds and metabolites. Many compounds showed low or no cross-reactivity, while some metabolites or structurally similar compounds showed significant cross-reactivity at certain concentrations (e.g., 6-Monoacetylmorphine (6-MAM) with MOP 300 showing 200% cross-reactivity for 150 ng/mL).

3. Effect of Urine Specific Gravity and Urine pH:

Study Type: Interference study.
Key Results: Urine specific gravity between 1.000 and 1.035 and urine pH value between 4.0 and 9.0 had no effect on the accuracy and precision of the test device, as all samples at +25% cutoff were positive and all at -25% cutoff were negative.

4. Comparison Studies:

Study Type: Method comparison study with LC/MS or GC/MS.
Sample Size: 80 unaltered urine samples (40 negative, 40 positive) for each drug.
Key Results: Tables show the breakdown of Wondfo T-Cup® results (positive/negative) against LC/MS or GC/MS results across different concentration ranges (Drug-Free, Low Negative, Near Cutoff Negative, Near Cutoff Positive, High Positive) for three viewers. Discordant results are explicitly listed with their LC/MS results and T-Cup results. For example:
- AMP 500: A few samples near the cutoff (e.g., 479.507 ng/mL, 480.687 ng/mL) were read as positive by T-Cup by all viewers, which are below the 500 ng/mL cutoff, indicating some false positives near the cutoff.
- BUP 10: Samples at 10.039 ng/mL (at cutoff) were read as negative, and samples below the cutoff (8.071, 8.226, 9.000 ng/mL) were read as positive by T-Cup, showing discrepancies around the cutoff.
- Similar patterns of discordant results, particularly near the cutoff concentration, were observed across most drugs tested (BAR 300, BZO 300, COC 150, EDDP 300, MET 500, MDMA 500, MOP 300, MTD 300, OXY 100, PCP 25, PPX 300, TCA 1000, THC 50, AMP 1000, COC 300, MET 1000, OPI 2000).

5. Lay-user study:

Study Type: Usability and performance study with lay users.
Sample Size: 140 (Configuration 1) and 140 (Configuration 2) participants.
Key Results: Tables show percentages of correct results for different drug assays at various concentrations relative to the cutoff.
- For -100%, -75%, and -50% cutoff concentrations, assays generally showed 100% negative results.
- For +50% and +75% cutoff concentrations, assays generally showed 100% positive results.
- At -25% cutoff, the percentage of correct results ranged from 85% to 100%, with some false positives (e.g., AMP 500 had 18 negative and 2 positive for 20 samples at -25% cutoff).
- At +25% cutoff, the percentage of correct results ranged from 85% to 100%, with some false negatives (e.g., AMP 500 had 2 negative and 18 positive for 20 samples at +25% cutoff).
- Participants universally found the instructions easy to understand and follow, with a Flesch-Kincaid reading Grade Level of 7.

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

Not explicitly stated as Sensitivity, Specificity, PPV, NPV values but results are presented in a format that allows calculation of these metrics from the "Comparison Studies" and "Lay-user study" data. For example, the discordant results section for each drug provides counts of true positives, true negatives, false positives, and false negatives in relation to the LC/MS or GC/MS reference.

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

K122809

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

Not Found

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

Not Found

Regulation Number and Section

§ 862.3100 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.

July 16, 2019

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

Re: K182701

Trade/Device Name: Wondfo T-Cup ® Multi-Drug Urine Test Cup 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 24, 2018 Received: September 27, 2018

Dear Joe Shia:

This letter corrects our substantially equivalent letter of December 3, 2018.

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kellie B. Kelm, Ph.D. Acting 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)

Device Name

Wondfo T-Cup® Multi-Drug Urine Test Cup

Indications for Use (Describe)

Wondfo T-Cup® Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-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-Cup® Multi-Drug Urine Test Cup 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,

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

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4

K182701 510(k) SUMMARY

November 28, 2018 Date 1
Guangzhou Wondfo Biotech Co., Ltd. 2 Submitter No. 8 Lizhishan Road, Science City, Luogang District Guangzhou, Guangdong, P.R. China 510641
3 Contact Joe Shia
- Person LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: 240-505-7880 Fax: 301-916-6213 Email: shiajl@yahoo.com
Device Name Wondfo T-Cup® Multi-Drug Urine Test Cup 4
Classification 5 Class II

Product Code	Regulation Section	Panel
Target Drug
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
Morphine (MOP/OPI)	862.3650, Opiate Test System	Toxicology

5

| PTG

Methadone (MTD)	862.3620, Methadone Test System	Toxicology

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 K122809 Device Advin Biotech Multi-Drug Screen Tests

7. Intended Use

Wondfo T-Cup® Multi-Drug Urine Test Cup 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

6

Wondfo T-Cup® Multi-Drug Urine Test Cup 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.

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.

Device Description 8.

Wondfo T-Cup® Multi-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine,Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine. Each T-Cup® Multi-Drug Urine Test Cup device consists of a test cup and a package insert. Each test cup is sealed with two sachets of desiccant in an aluminum pouch.

| Item | Proposed Device | Predicate
(K122809) |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| 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 (but the number of drugs detected is different) |
| 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 | Same |
| | Cutoff (ng/mL) | |
| | Amphetamine (AMP) | 1000 or 500 |
| | Buprenorphine (BUP) | 10 |
| | Secobarbital (BAR) | 300 |
| | Oxazepam (BZO) | 300 |
| | Cocaine (COC) | 300 or 150 |

Substantial Equivalence Information 9.

7

| | 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 cup | | Same |
| Intended Use | For over-the-counter use | | Prescription Use and
over-the-counter use |

10. Test Principle

Wondfo T-Cup® Multi-Drug Urine Test Cup is a rapid test 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 are lateral flow 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, +25%cut off, +50%cut off, +75%cut off and +100%cut off. For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following table.

8

| 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+ | 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+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

T-Cup® Multi-Drug Urine Test Cup PCP 25

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	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+	7-/43+	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-Cup® Multi-Drug Urine Test Cup THC 50

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	99.50	88.57	75.41	62.39	50.04	38.04	25.70	12.18	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-Cup® Multi-Drug Urine Test Cup OXY 100

| 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 |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|--------|----------------|----------------|----------------|------------------|
| | 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+ | 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+ | 9-/41+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

T-Cup® Multi-Drug Urine Test Cup BAR 300

| حمد التعليق التقليمي التي التي تعلق التي التي تعلق التي التي التي تقييم التي التي التي تقييم التي التي التي تعلق التي التي تقييم التي تعلق التي تعلق التقييم التي التي تعلق ا | +100% | +75% | +50% | +25% | Cutoff | 25%
-6JI | -50% | -75% | -100% |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|------|------|------|--------|-------------|------|------|-------|
| | | | | | | | | | |

9

| LC/MS

(ng/mL)	cutoff	cutoff	cutoff	cutoff	cutoff	cutoff	cutoff	cutoff	cut-off
	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+	8-/42+	50-/0+	50-/0+	50-/0+	50-/0+

T-Cup® Multi-Drug Urine Test Cup BZO 300

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS
(ng/mL)
Lot Number	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
	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+	7-/43+	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-Cup® Multi-Drug Urine Test Cup EDDP 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	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+	8-/42+	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-Cup® Multi-Drug Urine Test Cup MTD 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 |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|--------|----------------|----------------|----------------|------------------|
| | 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+ | 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-Cup® Multi-Drug Urine Test Cup MOP 300

10

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	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+	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-Cup® Multi-Drug Urine Test Cup PPX 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 |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| 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+ | 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-Cup® Multi-Drug Urine Test Cup COC 150

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
GC/MS
(ng/mL)	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	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+	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-Cup® Multi-Drug Urine Test Cup MDMA 500

| 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 |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 1005.82 | 874.87 | 746.39 | 620.36 | 496.21 | 377.55 | 245.14 | 120.41 | 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+ |

11

| 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 |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 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+ | 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-Cup® Multi-Drug Urine Test Cup 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 |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | Lot I | 998.23 | 880.545 | 750.15 | 630.77 | 500.18 | 372.34 | 256.24 | 125.78 |
| 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-Cup® Multi-Drug Urine Test Cup 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)
Lot Number	1006.21	862.45	744.97	620.39	497.11	374.32	246.02	123.98	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+	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+

T-Cup® Multi-Drug Urine Test Cup OPI 2000

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	4008.48	3474.1
9	2990.6
7	2429.1
3	1971.46	1514.1
6	1051.1
6	494.48	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+	10-/40+	50-/0+	50-/0+	50-/0+	50-/0+

12

| Concentration by | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|--------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| LC/MS
(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+ | 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-Cup® Multi-Drug Urine Test Cup AMP 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)	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+	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-Cup® Multi-Drug Urine Test Cup MET 1000

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
	LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff
(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+	7-/43+	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+

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
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

13

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℃ for 24 months based on real-time stability studies.

d. Interference
Potential interfering substances were added to drug-free urine sample and samples with target drugs of -25% cutoff and +25% cutoff level.

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

Acetaminophen	Acetophenetidin	Acetylsalicylic Acid
Acyclovir	Amiodarone Hydrochloride	Apomorphine
Afrin	Albumin	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	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

14

e. Specificity

15

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.

Compounds that produced positive results are listed 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% |

| 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 | -- |

16

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% |
| 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% |

17

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% |
| s-Monoacetylmorphine | 300 | 100% |
| Codeine | 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% |

18

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) required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|--------------------- | 1-Amphetamine | dl- Amphetamine | ( +/- ) 3,4-Methylen | Phentermine | Hydroxyamphetamine | d-Methamphetamine | l-Methamphetamine | (+/- ) 3,4-Methylene (MDE) | >100,000 | (+/-)3,4-Methylenedi (MDMA) | >100,000 | Ephedrine | β-Phenylethylamine | Tyramine | p-Hydroxynorephedrine | Phenylpropanolamine | (±)Phenylpropanolamine | p-Hydroxyamphetamine | Minimum concentration
-------------------------------|--------------------------------------------------------------------------|------------------------|
| 25000 | 2% |
| 1500 | 33% |
edioxyamphetamine (MDA) | 2500 | 20% |
| 1500 | 33% |
| 8000 | 6.25% |
| >100,000 | -- |
| >100,000 | -- |
dioxyethylamphetamine
| -- |
oxymethamphetamine
| -- |
| >100,000 | -- |
| 100000 | 0.5% |
| 100000 | 0.5% |
| 100000 | 0.5% |
| >100,000 | -- |
| >100,000 | -- |
| 100000 | 0.5% |

19

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% |

| 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% |

20

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% |
| 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% |

21

| 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% |
| 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% |

22

Effect of Urine Specific Gravity and Urine pH f.

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-Cup® Multi-Drug Urine Test cup were performed inhouse with three operators.

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

For T-Cup® Multi-Drug Urine Test Cup:

| Wondfo
T-Cup® | | 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 |
| | Negative | 10 | 17 | 12 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 30 | 10 |
| | Negative | 10 | 17 | 11 | 0 | 0 |

AMP 500

Discordant Results for AMP 500:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Cup Result
Viewer A	10062	479.507	+
Viewer B	10062	479.507	+
Viewer C	10062	479.507	+
Viewer A	10021	480.687	+
Viewer C	10021	480.687	+

23

| Wondfo
T-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 | 3 | 29 | 10 |
| | Negative | 10 | 18 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 3 | 29 | 10 |
| | Negative | 10 | 18 | 9 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 3 | 29 | 10 |
| | Negative | 10 | 18 | 9 | 1 | 0 |

Discordant Results for BUP 10:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Cup Result
Viewer A	10140	10.039	-
Viewer B	10140	10.039	-
Viewer C	10140	10.039	-
Viewer A	10099	8.071	+
Viewer B	10099	8.071	+
Viewer C	10099	8.071	+
Viewer A	10090	8.226	+
Viewer B	10090	8.226	+
Viewer C	10090	8.226	+
Viewer A	10101	9.000	+
Viewer B	10101	9.000	+
Viewer C	10101	9.000	+

BAR 300

| Wondfo
T-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 | 0 | 28 | 11 |
| | Negative | 10 | 19 | 11 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 28 | 11 |
| | Negative | 10 | 19 | 11 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 28 | 11 |
| | Negative | 10 | 19 | 11 | 1 | 0 |

24

Discordant Results for BAR 300:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Cup Result
Viewer A	100177	306.032	-
Viewer B	100177	306.032	-
Viewer C	100177	306.032	-

BZO 300

| Wondfo
T-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 | 29 | 10 |
| | Negative | 10 | 15 | 13 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 29 | 10 |
| | Negative | 10 | 15 | 13 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 29 | 10 |
| | Negative | 10 | 15 | 13 | 1 | 0 |

Discordant Results for BZO 300:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Cup Result
Viewer A	10279	289.534	+
Viewer B	10279	289.534	+
Viewer C	10279	289.534	+
Viewer A	10293	307.387	-
Viewer B	10293	307.387	-
Viewer C	10293	307.387	-
Viewer A	10310	274.237	+
Viewer B	10310	274.237	+
Viewer C	10310	274.237	+

COC 150

| Wondfo T-
Cup® | | 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 |

25

	Negative	10	18	10	0	0
Viewer B	Positive	0	0	1	31	9
	Negative	10	18	11	0	0
Viewer C	Positive	0	0	2	31	9
	Negative	10	18	10	0	0

Discordant Results for COC 150:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Cup Result
Viewer A	11397	146.311	+
Viewer C	11397	146.311	+
Viewer A	11414	145.437	+
Viewer B	11414	145.437	+
Viewer C	11414	145.437	+

EDDP 300

| Wondfo T-
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 | 1 | 32 | 8 |
| | Negative | 10 | 18 | 11 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 32 | 8 |
| | 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-Cup Result
Viewer A	10359	246.613	+
Viewer B	10359	246.613	+
Viewer C	10359	246.613	+

MET 500
Wondfo
T-Cup®	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%)

26

Viewer A
	Positive	0	0	2	20	20
	Negative	10	15	13	0	0
Viewer B
	Positive	0	0	1	20	20
	Negative	10	15	14	0	0
Viewer C
	Positive	0	0	2	20	20
	Negative	10	15	13	0	0

Discordant Results for MET 500:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Cup Result
Viewer B	11491	378.483	+
Viewer C	11491	378.483	+
Viewer A	11452	384.376	+
Viewer C	11452	384.376	+

MDMA 500

| Wondfo
T-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 | 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-Cup Result
Viewer A	10477	409.82	+
Viewer B	10477	409.82	+
Viewer C	10477	409.82	+
Viewer A	10456	417.972	+
Viewer B	10456	417.972	+
Viewer C	10456	417.972	+

27

| Wondfo

T-Cup®
	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	28	10
	Negative	10	18	12	2	0
Viewer B	Positive	0	0	0	28	10
	Negative	10	18	12	2	0
Viewer C	Positive	0	0	0	28	10
	Negative	10	18	12	2	0

Discordant Results for MOP 300:

Viewer	Sample Number	GC/MS Result (ng/mL)	T-Cup Result
Viewer A	10541	303.693	-
Viewer B	10541	303.693	-
Viewer C	10541	303.693	-
Viewer A	10514	307.303	-
Viewer B	10514	307.303	-
Viewer C	10514	307.303	-

MTD 300

| Wondfo
T-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 | 27 | 12 |
| | Negative | 10 | 18 | 10 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 27 | 12 |
| | Negative | 10 | 18 | 10 | 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-Cup Result
Viewer A	10566	282.733	+
Viewer B	10566	282.733	+
Viewer C	10566	282.733	+

28

Viewer A	10635	285.038	+
Viewer B	10635	285.038	+
Viewer C	10635	285.038	+
Viewer A	10634	309.555	-
Viewer B	10634	309.555	-
Viewer C	10634	309.555	-

OXY 100

| Wondfo
T-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 | 0 | 29 | 10 |
| Viewer A Negative | 10 | 18 | 12 | 1 | 0 |
| Viewer B Positive | 0 | 0 | 0 | 29 | 10 |
| Viewer B Negative | 10 | 18 | 12 | 1 | 0 |
| Viewer C Positive | 0 | 0 | 0 | 29 | 10 |
| Viewer C Negative | 10 | 18 | 12 | 1 | 0 |

Discordant Results for OXY 100:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Cup Result
Viewer A	10688	113.792	-
Viewer B	10688	113.792	-
Viewer C	10688	113.792	-

PCP 25

| Wondfo
T-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 | 1 | 28 | 10 |
| | Negative | 10 | 20 | 9 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 28 | 10 |
| | Negative | 10 | 20 | 9 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 28 | 10 |
| | Negative | 10 | 20 | 9 | 2 | 0 |

29

Discordant Results for PCP 25:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Cup Result
Viewer A	10797	20.203	+
Viewer B	10797	20.203	+
Viewer C	10797	20.203	+
Viewer A	10736	25.049	-
Viewer B	10736	25.049	-
Viewer C	10736	25.049	-
Viewer A	10725	25.105	-
Viewer B	10725	25.105	-
Viewer C	10725	25.105	-

PPX 300

| Wondfo
T-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 | 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-Cup Result
Viewer A	10802	241.706	+
Viewer B	10802	241.706	+
Viewer C	10802	241.706	+
Viewer A	10820	252.045	+
Viewer B	10820	252.045	+
Viewer C	10820	252.045	+
Viewer A	10863	314.373	-
Viewer B	10863	314.373	-
Viewer C	10863	314.373	-

30

| Wondfo
T-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 | 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-Cup Result
Viewer A	10917	796.893	+
Viewer B	10917	796.893	+
Viewer C	10917	796.893	+
Viewer A	10951	812.065	+
Viewer B	10951	812.065	+
Viewer C	10951	812.065	+
Viewer A	10893	1007.857	-
Viewer B	10893	1007.857	-
Viewer C	10893	1007.857	-

THC 50

| Wondfo

T-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	3	28	10
	Negative	10	19	8	2	0
Viewer B	Positive	0	0	3	28	10
	Negative	10	19	8	2	0
Viewer C	Positive	0	0	3	28	10
	Negative	10	19	8	2	0

Discordant Results for THC 50:

31

Viewer A	11020	40.238	+
Viewer B	11020	40.238	+
Viewer C	11020	40.238	+
Viewer A	11011	43.304	+
Viewer B	11011	43.304	+
Viewer C	11011	43.304	+
Viewer A	10971	45.118	+
Viewer B	10971	45.118	+
Viewer C	10971	45.118	+
Viewer A	11001	51.112	-
Viewer B	11001	51.112	-
Viewer C	11001	51.112	-
Viewer A	10975	50.639	-
Viewer B	10975	50.639	-
Viewer C	10975	50.639	-

AMP 1000

| Wondfo
T-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 | 28 | 10 |
| | Negative | 10 | 16 | 12 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 28 | 10 |
| | Negative | 10 | 16 | 12 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 28 | 10 |
| | Negative | 10 | 16 | 12 | 2 | 0 |

Discordant Results for AMP 1000:

Viewer	Sample Number	LC/MS Result (ng/mL)	T-Cup Result
Viewer A	11077	739.221	+
Viewer B	11077	739.221	+
Viewer C	11077	739.221	+
Viewer A	11092	797.646	+
Viewer B	11092	797.646	+
Viewer C	11092	797.646	+
Viewer A	11057	1025.544	-
Viewer B	11057	1025.544	-
Viewer C	11057	1025.544	-

32

Viewer A	11112	1017.953	-
Viewer B	11112	1017.953	-
Viewer C	11112	1017.953	-

COC 300

| Wondfo
T-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 | 3 | 27 | 11 |
| | Negative | 10 | 13 | 14 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 3 | 27 | 11 |
| | Negative | 10 | 13 | 14 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 3 | 27 | 11 |
| | Negative | 10 | 13 | 14 | 2 | 0 |

Discordant Results for COC 300:

Viewer	Sample Number	LC/MS Result	T-Cup Result
Viewer A	11143	283.934	+
Viewer B	11143	283.934	+
Viewer C	11143	283.934	+
Viewer A	11126	292.623	+
Viewer B	11126	292.623	+
Viewer C	11126	292.623	+
Viewer A	11147	293.871	+
Viewer B	11147	293.871	+
Viewer C	11147	293.871	+
Viewer A	11160	309.73	-
Viewer B	11160	309.73	-
Viewer C	11160	309.73	-
Viewer A	11182	320.007	-
Viewer B	11182	320.007	-
Viewer C	11182	320.007	-

MET 1000

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

33

| | | | | | (Between the
cutoff and
+50%) | |
|----------|----------|----|----|---|-------------------------------------|----|
| Viewer A | Positive | 0 | 0 | 3 | 23 | 15 |
| | Negative | 10 | 18 | 9 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 3 | 23 | 15 |
| | Negative | 10 | 18 | 9 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 3 | 23 | 15 |
| | Negative | 10 | 18 | 9 | 2 | 0 |

Discordant Results for MET 1000:

Viewer	Sample Number	LC/MS Result	T-Cup Result
Viewer A	11216	873.409	+
Viewer B	11216	873.409	+
Viewer C	11216	873.409	+
Viewer A	11250	888.241	+
Viewer B	11250	888.241	+
Viewer C	11250	888.241	+
Viewer A	11213	890.705	+
Viewer B	11213	890.705	+
Viewer C	11213	890.705	+
Viewer A	11215	1036.001	-
Viewer B	11215	1036.001	-
Viewer C	11215	1036.001	-
Viewer A	11240	1022.392	-
Viewer B	11240	1022.392	-
Viewer C	11240	1022.392	-

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 | 3 | 29 | 10 |
| | Negative | 10 | 18 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 3 | 29 | 10 |
| | Negative | 10 | 18 | 9 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 3 | 30 | 10 |
| | Negative | 10 | 18 | 9 | 0 | 0 |

34

Discordant Results for OPI 2000:

Viewer	Sample Number	LC/MS Result	T-Cup Result
Viewer A	11354	1830.086	+
Viewer B	11354	1830.086	+
Viewer C	11354	1830.086	+
Viewer A	11335	1882.994	+
Viewer B	11335	1882.994	+
Viewer C	11335	1882.994	+
Viewer A	11297	1947.150	+
Viewer B	11297	1947.150	+
Viewer C	11297	1947.150	+
Viewer A	11295	2015.745	-
Viewer B	11295	2015.745	-
Viewer C	11295	2015.745	-

Lay-user study:

89 males and 51 females tested T-Cup® Multi-Drug Urine Test Cup Configuration 1 (including AMP 500, MET 500, MOP 300, COC 150) ; 84 male and 56 females tested T-Cup® Multi-Drug Urine Test Cup Configuration 2 (including AMP 1000, MET 1000, MOP 2000 (OPI), COC 300). They had diverse educational and professional backgrounds and their age range from 20 to over 50. Urine samples were prepared at the following concentrations; -100%, +/-75%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS or GC/MS. Each sample was aliquoted into individual containers and blindlabeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.

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

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

35

36

Lay-User Study Results for T-Cup® Multi-Drug Urine Test Cup 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
AMP 1000	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	95%	100%	100%	100%
	BAR 300	Negative	20	20	20	18	2	0
Positive		0	0	0	2	18	20	20
Total		20	20	20	20	20	20	20
Percentage of
correct results (%)		100%	100%	100%	90%	90%	100%	100%
BZO 300		Negative	20	20	20	18	2	0
	Positive	0	0	0	2	18	20	20
	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
	Positive	0	0	0	2	19	20	20
BUP 10	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	90%	95%	100%	100%
	Negative	20	20	20	17	2	0	0
	Positive	0	0	0	3	18	20	20
COC 300	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
EDDP 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	1	0	0
	Positive	0	0	0	2	19	20	20
MDMA 500	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	90%	95%	100%	100%
	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
MET 1000	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	100%	95%	100%	100%
	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
OPI 2000	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	100%	95%	100%	100%
	Negative	20	20	20	18	2	0	0
	Positive	0	0	0	2	18	20	20
MTD 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	1	0	0
OXY 100	Positive	0	0	0	3	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	85%	95%	100%	100%
PCP 25	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%
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
correct results (%)	100%	100%	100%	95%	90%	100%	100%
TCA 1000	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	100%	95%	100%	100%
THC 50	Negative	20	20	20	17	2	0	0
	Positive	0	0	0	3	18	20	20
	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	85%	90%	100%	100%

37

38

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 T-Cup® Multi-Drug Urine Test Cup are substantially equivalent to the predicate devices.