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
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.

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.

AI/ML Overview

This document is a 510(k) Summary for the Wondfo T-Cup® Multi-Drug Urine Test Cup, a rapid diagnostic device for detecting various drugs of abuse in urine. It describes the device's performance characteristics and a "lay-user study" that can be interpreted as a clinical study for a consumer-facing device.

Here's an analysis of the acceptance criteria and study data based on the provided text, framed to address your questions for an AI/ML device where applicable (though this device is an in-vitro diagnostic, not an AI/ML system):

Acceptance Criteria and Device Performance for Wondfo T-Cup® Multi-Drug Urine Test Cup

Since this is an in-vitro diagnostic device and not an AI/ML system, the "acceptance criteria" are typically defined by precision, specificity, linearity (if applicable), stability, and method comparison studies against a gold standard (LC/MS or GC/MS). The study described for the "lay-user" simulates a real-world use case for intended over-the-counter (OTC) use and provides data on how lay users interpret the results around the device's cut-off.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a pass/fail form for the lay-user study. Instead, it presents the results as percentages of correct results at different concentrations relative to the cutoff. For in-vitro diagnostics like this, the implicit acceptance criteria for performance usually revolve around high agreement with confirmed analytical methods (LC/MS or GC/MS), particularly around the cutoff concentrations, and demonstrating usability for the intended user (lay-user in this case).

The performance data for the "lay-user study" is provided for various drugs at different concentrations relative to the cutoff. A "correct result" implies agreement with the LC/MS or GC/MS ground truth.

Drug (Cut-off)	Concentration	Negative Results	Positive Results	Total Samples	Percentage of Correct Results (%)
AMP 500	-100% cutoff	20	0	20	100%
	-75% cutoff	20	0	20	100%
	-50% cutoff	20	0	20	100%
	-25% cutoff	18	2	20	90%
	+25% cutoff	2	18	20	90%
	+50% cutoff	0	20	20	100%
	+75% cutoff	0	20	20	100%
BAR 300	-100% cutoff	20	0	20	100%
	-75% cutoff	20	0	20	100%
	-50% cutoff	20	0	20	100%
	-25% cutoff	18	2	20	90%
	+25% cutoff	2	18	20	90%
	+50% cutoff	0	20	20	100%
	+75% cutoff	0	20	20	100%
... (similarly for all drugs/cutoffs listed in the "Lay-User Study Results" tables)

The percentage of correct results at concentrations -100%, -75%, -50%, +50%, +75% demonstrated 100% accuracy in the lay-user study for most drugs. Performance around the cutoff (at +/- 25% of cutoff) showed some misclassifications, typically around 85-95% accuracy.

2. Sample Size Used for the Test Set and Data Provenance

The primary test set for the device's performance is referred to as "Precision studies," "Comparison Studies," and "Lay-user study."

Precision Studies: For each drug and each concentration (-100% cutoff, -75% cutoff, -50% cutoff, -25% cutoff, +25% cutoff, +50% cutoff, +75% cutoff, and +100% cutoff), tests were performed two runs per day for 25 days. This means a total of 50 tests per concentration per lot. With 3 lots, this is 150 tests per concentration level per drug. The total number of concentrations varied per drug, but on average there are roughly 8 concentrations, so 1200 individual tests per drug type.
Comparison Studies (In-House): 80 unaltered urine samples (40 negative and 40 positive) were used. The provenance of this data (e.g., country of origin) is not explicitly stated but implied to be from an internal study ("performed in-house"). The samples were retrospective as they were prepared with spiked drug concentrations and used as "unaltered urine samples."
Lay-User Study:
- Configuration 1 (AMP 500, MET 500, MOP 300, COC 150): 89 males and 51 females participated, totaling 140 participants.
- Configuration 2 (AMP 1000, MET 1000, MOP 2000 (OPI), COC 300): 84 males and 56 females participated, totaling 140 participants.
- Each participant was given 1 blind labeled sample. For each drug, sample concentrations were -100%, +/-75%, +/-25% of the cutoff. Given there are 7 concentrations listed for each drug in the lay-user study tables, and a total of 20 samples per concentration level, this indicates 140 samples per drug (7 concentrations x 20 samples/concentration).
- Data provenance: "Urine samples were prepared... by spiking drug(s) into drug free-pooled urine specimens." This indicates the samples were synthetic/controlled (spiked), not necessarily from real patients. The study was likely conducted in China, given the manufacturer's location (Guangzhou Wondfo Biotech Co., Ltd.). The study is prospective in the sense that participants were recruited to read the tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth for all studies (Precision, Comparison, and Lay-User) was established using LC/MS or GC/MS (Liquid Chromatography-Mass Spectrometry or Gas Chromatography-Mass Spectrometry). These are highly accurate and widely accepted analytical methods for chemical substance identification and quantification, considered the "gold standard" for drug testing. No human experts are explicitly mentioned as establishing the initial ground truth for the drug concentrations, as this is laboratory methodologically determined.

For the Comparison Studies (In-House), "three operators" ran the samples. Their qualifications are not specified beyond being "operators," but they would be trained lab personnel capable of correctly performing the tests and interpreting the results.

4. Adjudication Method for the Test Set

Precision Studies: No explicit adjudication method is mentioned for individual readings within daily runs. The overall results are summarized by tallying positive/negative results across all runs and lots.
Comparison Studies (In-House): "Operators ran 80 (40 negative and 40 positive) unaltered urine samples." The results were then compared to LC/MS or GC/MS. The tables show results for Viewer A, Viewer B, and Viewer C, implying three independent readers/operators performed and reported the results. Discordant results are individually listed for each viewer against the LC/MS result, indicating that each viewer's interpretation was recorded, and there was no internal adjudication between the viewers before comparison to the ground truth.
Lay-User Study: "Each participant was provided with... 1 blind labeled sample and a device." This suggests no formal adjudication among lay-users. Each participant's reading was taken as their individual result and then compared against the LC/MS or GC/MS ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, a traditional MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. This device is an in-vitro diagnostic, not an AI-assisted diagnostic.

However, the "Comparison Studies" with three "Viewers" (human operators) against the LC/MS/GC/MS ground truth, and the "Lay-User Study" where multiple lay participants interpreted the results, do resemble aspects of MRMC studies in that they evaluate multiple readers (operators/lay users) across multiple cases (samples). The "effect size" here would be the agreement of the device, as interpreted by human readers, with the gold standard. The tables show detailed agreement and disagreement for various drugs and concentrations. For example, in the "Comparison Studies" for AMP 500, Viewer A had 2 false positives near cutoff negative and 30 true positives near cutoff positive, compared to LC/MS.

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

This question is not applicable as the device is not an algorithm or AI. It is a rapid diagnostic test that produces a visual result that must be interpreted by a human user. Its performance is inherently tied to human interpretation.

7. The Type of Ground Truth Used

The type of ground truth used for all performance evaluations (precision studies, in-house comparison studies, and lay-user studies) was confirmed analytical results from LC/MS or GC/MS (Liquid Chromatography-Mass Spectrometry or Gas Chromatography-Mass Spectrometry). This is a highly objective and quantitative chemical analysis, serving as the definitive measurement of drug concentration in the urine samples.

8. The Sample Size for the Training Set

This question is not applicable. This is an in-vitro diagnostic device (a chemical test) and does not involve AI/ML requiring a training set in the conventional sense. The "training" of the device is through its chemical formulation and manufacturing process, optimized through R&D, rather than data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of AI/ML for this device. The development of the test's performance characteristics (e.g., sensitivity, specificity, cutoff levels) would have been established during the research and development phase of the immunochromatographic assay, typically through extensive chemical and biological experimentation to optimize reagent concentrations and reaction conditions.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known)

Device Name

Wondfo T-Cup® Multi-Drug Urine Test Cup

Indications for Use (Describe)

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

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.

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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
NFTAmphetamine (AMP)	862.3100, Amphetamine Test System	Toxicology
NGLBuprenorphine (BUP)	862.3650, Opiate Test System	Toxicology
PTHSecobarbital (BAR)	862.3150, Barbiturate Test System	Toxicology
NFVOxazepam (BZO)	862.3170, Benzodiazepine Test System	Toxicology
NFYCocaine (COC)	862.3250, Cocaine Test System	Toxicology
PTG2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine(EDDP)	862.3620, Methadone Test System	Toxicology
NGGMethamphetamine(MET)	862.3610, Methamphetamine Test System	Toxicology
NGGMethylenedioxymethamphetamine (MDMA)	862.3610, Methamphetamine Test System	Toxicology
NGLMorphine (MOP/OPI)	862.3650, Opiate Test System	Toxicology

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PTGMethadone (MTD)	862.3620, Methadone Test System	Toxicology

NGLOxycodone (OXY)	862.3650, Opiate Test System	Toxicology

LCMPhencyclidine (PCP)	Unclassified	Toxicology

QBFPropoxyphene (PPX)	862.3700 Propoxyphene testsystem.	Toxicology

QAWNortriptyline (TCA)	862.3910 Tricyclic antidepressantdrugs test system	Toxicology

NFWCannabinoids (THC 50)	862.3870, Cannabinoids TestSystem	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

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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.

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 andCut 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.

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	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 andover-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.

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Concentration byLC/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 byLC/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 byLC/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 byLC/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 byLC/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 byLC/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	1772.46	1489.61	1244.94	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

Concentrationby 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	3474.19	2990.67	2429.13	1971.46	1514.16	1051.16	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 concentrationrequired to obtain apositive 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 concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
4-Hydroxyphencyclidine	12500	0.2%

THC 50(11-nor-Δ9-THC-9-COOH,Cutoff=50 ng/mL)	Minimum concentrationrequired to obtain apositive 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 concentrationrequired to obtain apositive 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 concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
Cocaine	375	40%
Cocaethylene	6250	2.4%
Ecgonine	16000	<1%
Ecgonine methyl ester	>100,000	--
Norcocaine	>100,000	--

BAR 300(Secobarbital, Cutoff=300ng/mL)	Minimum concentrationrequired to obtain apositive 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 concentrationrequired to obtain apositive 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 concentrationrequired to obtain apositive 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 concentrationrequired to obtain apositive 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 concentrationrequired to obtain apositive 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 concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
d-Norpropoxyphene	300	100%

MDMA 500(3,4-Methylenedioxymethamphetamine HCl,Cutoff=500ng/mL)	Minimum concentrationrequired to obtain apositive 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 concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
1-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	--
(+/- ) 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%

{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 concentrationrequired to obtain apositive 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 concentrationrequired to obtain apositive 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 concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
Cocaine	750	40%
Cocaethylene	12500	2.4%
Ecgonine	32000	<1%
Ecgonine methyl Ester	>100000	--
Norcocaine	>100,000	--

AMP 1000(d-Amphetamine, Cutoff=1000ng/mL)	Minimum concentrationrequired to obtain apositive 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 concentrationrequired to obtain apositive 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 concentrationrequired to obtain apositive 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:

WondfoT-Cup®		Drug-Free	LowNegative byGC/MS (lessthan -50%)	Near CutoffNegative byGC/MS(Between -50%and the Cutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby 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}------------------------------------------------

WondfoT-Cup®		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby 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

WondfoT-Cup®		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby 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

WondfoT-Cup®		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby 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	LowNegative byGC/MS(less than -50%)	Near CutoffNegative byGC/MS(Between -50% and theCutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	HighPositive byGC/MS(greaterthan +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	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50% and theCutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby 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
WondfoT-Cup®	Drug-Free	LowNegative byGC/MS (lessthan -50%)	Near CutoffNegative byGC/MS(Between -50%and the Cutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby 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

WondfoT-Cup®		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby 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}------------------------------------------------

WondfoT-Cup®
	Drug-Free	LowNegative byGC/MS (lessthan -50%)	Near CutoffNegative byGC/MS(Between -50%and the Cutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby 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

WondfoT-Cup®		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby 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

WondfoT-Cup®	Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby 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

WondfoT-Cup®		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby 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

WondfoT-Cup®		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby 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}------------------------------------------------

WondfoT-Cup®		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby 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

WondfoT-Cup®
		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby 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

WondfoT-Cup®		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby 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

WondfoT-Cup®		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby 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

WondfoT-Cup®		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS	High Positiveby LC/MS(greater than+50%)
------------------	--	-----------	-------------------------------------------------	-------------------------------------------------------------------------	-------------------------------------	-----------------------------------------------------

{33}------------------------------------------------

					(Between thecutoff 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

WondfoQ-Cup		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and +50%)	High Positiveby 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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):

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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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect results (%)	100%	100%	100%	85%	90%	100%	100%

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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.

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).