Predicate Devices

Reference Devices

No Reference Device(s) were found in the text.

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is described as a lateral flow immunochromatographic assay, which is a traditional biochemical test method. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI/ML. The performance studies focus on analytical and lay-user performance of the biochemical reaction, not on the performance of a computational model.

Therapeutic

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

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is for in vitro diagnostic use only." The "Device Description" section also describes it as a "rapid, single-use in vitro diagnostic device."

SaMD (Software as a Medical Device)

No

The device is a physical test cup for in vitro diagnostic use, not a software-only medical device. The description details a physical product containing a test device, pouch, desiccants, and package insert.

IVD (In Vitro Diagnostic)

Yes, this device is 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."
Device Description: The "Device Description" section also states: "The Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Test Cup Rx are rapid, singleuse in vitro diagnostic devices."
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 characteristic function of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Wisdiag Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana 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
Marijuana (THC)	50 ng/mL

Wisdiag 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. It is intended for OTC use.

The tests may vield 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.

Wisdiag Multi-Drug Urine Test Cup Rx 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 ng/mL

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

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

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

Product codes

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

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

OTC use, prescription use.

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

Not Found

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

Performance studies were conducted for the device. Precision studies utilized samples with concentrations ranging from -100% cutoff to +100% cutoff, confirmed by LC/MS. Tests were performed in two runs per day for 25 days using three lots of test cups.
Method comparison studies were performed in-house by three operators using 80 unaltered urine samples (40 negative and 40 positive), which were blind-labeled and compared to LC/MS results.
A lay user study was conducted with 280 participants (66 males, 74 females for Configuration 1; 72 males, 68 females for Configuration 2) aged 20 years and older from three sites. Participants were given one package insert, one blind-labeled test solution, and one test device. Samples were prepared at -100%, +/-75%, +/-50%, and +/-25% of the cutoff by spiking drugs into drug-free pooled urine specimens, and concentrations were confirmed by LC/MS or LC/MS.

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

Analytical Performance (Precision):

Precision studies were carried out using samples at concentrations of -100%, -75%, -50%, -25%, cutoff, +25%, +50%, +75%, and +100% of the cutoff.
Samples were prepared by spiking target drugs in drug-free urine, and concentrations were confirmed by LC/MS.
For each concentration, tests were performed in two runs per day for 25 days using three lots of test cups.
Results for each drug (BUP 10, PCP 25, THC 50, OXY 100, BAR 300, BZO 300, EDDP 300, MTD 300, MOP 300, PPX 300, COC 150, MDMA 500, TCA 1000, AMP 500, MET 500, OPI 2000, COC 300, AMP 1000, MET 1000) showed consistent performance across the three lots, with positive results occurring beyond the cutoff and negative results below the cutoff, and a mix of positive and negative results at the cutoff and +/- 25% cutoff levels.
Analytical Performance (Interference and Specificity):
Potential interfering substances were added to drug-free urine samples with target drugs at -25% cutoff and +25% cutoff levels. A table of numerous compounds that showed no interference at 100µg/mL was provided.
Cros-sreactivity studies were performed by spiking drug metabolites and other components into drug-free urine and testing with three lots of each device. Percentage cross-reactivity was calculated as (cutoff concentration / concentration yielding positive result) * 100. Specificity tables for each drug (BUP 10, PCP, THC 50, OXY 100, COC 150, BAR 300, BZO 300, EDDP 300, MTD 300, MOP 300, PPX 300, MDMA 500, AMP, MET 500, TCA 1000, COC 300, AMP 1000, MET 1000, OPI 2000) were provided, showing varying levels of cross-reactivity with related compounds and no cross-reactivity (represented by '--' or '-') with many other substances at high concentrations.
Effect of Urine Specific Gravity and Urine pH:
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.
Three operators tested each sample using test devices from three different lots.
Results indicated that urine specific gravity between 1.000 and 1.035 and urine pH values 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.

Comparison Studies (Lab-Based):

Method comparison studies were performed in-house with three operators.
80 blind-labeled unaltered urine samples (40 negative, 40 positive) were compared to LC/MS results for each analyte.
Detailed tables show the results for each operator across different concentration ranges: Drug-Free, Low Negative (less than -50% LC/MS), Near Cutoff Negative (between -50% and cutoff LC/MS), Near Cutoff Positive (between cutoff and +50% LC/MS), and High Positive (greater than +50% LC/MS).
Discordant results were reported for each drug, indicating specific samples where the test cup result did not match the LC/MS result (e.g., test cup positive when LC/MS was below cutoff, or test cup negative when LC/MS was above cutoff).

Lay-User Study:

A total of 280 participants (diverse educational and professional backgrounds, aged 20+) were recruited from three sites.
Two configurations of the test cup were evaluated:
- Configuration 1 (AMP 500, MET 500, MOP 300, COC 150) was tested by 66 males and 74 females.
- Configuration 2 (AMP 1000, MET 1000, MOP 2000 (OPI), COC 300) was tested by 72 males and 68 females.
Each participant received a package insert, a blind-labeled test solution, and a test device.
Samples were prepared at -100%, -75%, -50%, -25%, +25%, +50%, and +75% of the cutoff.
For Configuration 1, the percentage of correct results for most assays was 100% at -100%, -75%, -50%, +50%, and +75% cutoff concentrations. At -25% and +25% cutoff, percentages ranged from 90% to 100%.
For Configuration 2, the percentage of correct results for most assays was 100% at -100%, -75%, -50%, +50%, and +75% cutoff concentrations. At -25% and +25% cutoff, percentages ranged from 90% to 100%.
All participants indicated that the device instructions were easy to understand and follow. The Flesch-Kincaid reading analysis showed a Grade Level of 7 for the package inserts.

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

Key metrics in the performance studies are presented as the counts of positive/negative results at different concentrations relative to the cutoff, and percentage of correct results in the lay-user study.
For laboratory comparison:

Discordant results are explicitly listed, showing specific inconsistencies between the Wisdiag Cup results and LC/MS results (e.g., samples with LC/MS results near but below cutoff showing positive, or LC/MS results near but above cutoff showing negative).

For lay-user study (Percentage of correct results):

AMP 500: 100% (-100%, -75%, -50%, +25%, +50%, +75% cutoff), 95% (-25% cutoff)
BAR 300: 100% (-100%, -75%, -50%, -25%, +50%, +75% cutoff), 95% (+25% cutoff)
BZO 300: 100% (-100%, -75%, -50%, -25%, +50%, +75% cutoff), 95% (+25% cutoff)
BUP 10: 100% (-100%, -75%, -50%, +50%, +75% cutoff), 95% (-25% cutoff), 90% (+25% cutoff)
COC 150: 100% (-100%, -75%, -50%, +50%, +75% cutoff), 90% (-25% cutoff), 95% (+25% cutoff)
EDDP 300: 100% for all tested concentrations
MDMA 500: 100% (-100%, -75%, -50%, -25%, +50%, +75% cutoff), 95% (+25% cutoff)
MET 500: 100% (-100%, -75%, -50%, +50%, +75% cutoff), 95% (-25%, +25% cutoff)
MOP 300: 100% (-100%, -75%, -50%, +25%, +50%, +75% cutoff), 95% (-25% cutoff)
MTD 300: 100% (-100%, -75%, -50%, -25%, +50%, +75% cutoff), 95% (+25% cutoff)
OXY 100: 100% (-100%, -75%, -50%, +25%, +50%, +75% cutoff), 95% (-25% cutoff)
PCP 25: 100% (-100%, -75%, -50%, -25%, +50%, +75% cutoff), 95% (+25% cutoff)
PPX 300: 100% (-100%, -75%, -50%, -25%, +50%, +75% cutoff), 95% (+25% cutoff)
TCA 1000: 100% (-100%, -75%, -50%, +25%, +50%, +75% cutoff), 95% (-25% cutoff)
THC 50: 100% (-100%, -75%, -50%, +50%, +75% cutoff), 90% (-25% cutoff), 95% (+25% cutoff)
AMP 1000: 100% (-100%, -75%, -50%, +25%, +50%, +75% cutoff), 95% (-25% cutoff)
COC 300: 100% (-100%, -75%, -50%, +50%, +75% cutoff), 95% (+25% cutoff), 100% (-25% cutoff)
MET 1000: 100% (-100%, -75%, -50%, +25%, +50%, +75% cutoff), 95% (-25% cutoff)
OPI 2000: 100% (-100%, -75%, -50%, +25%, +50%, +75% cutoff), 95% (-25% cutoff)

Predicate Device(s)

K182701

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 10, 2022

Vivachek Biotech (Hangzhou) Co., Ltd % Joe Shia Director LSI International 540 E Diamond Avenue, Suite I Gaithersburg, MD 20877

Re: K222667

Trade/Device Name: Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NGL, PTH, NFV, NFY, PTG, NGG, OBF, QAW, NFW, LCM Dated: September 2, 2022 Received: September 6, 2022

Dear Joe Shia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Paula
Digitally signed by
Paula Caposino -S
Caposino -S Date: 2022.11.10
14:59:10 -05'00'

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

Enclosure

2

Indications for Use

510(k) Number (if known) K222667

Device Name

Wisdiag Multi-Drug Urine Test Cup

Indications for Use (Describe)

Wisdiag Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana 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
Marijuana (THC)	50 ng/mL

Wisdiag 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. It is intended for OTC use.

The tests may vield 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.

3

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.

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

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

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

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

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

FORM FDA 3881 (6/20)

Page 1 of 1

EF PSC Publishing Services (301) 443-6740

4

Indications for Use

510(k) Number (if known) K222667

Device Name

Wisdiag Multi-Drug Urine Test Cup Rx

Indications for Use (Describe)

Wisdiag Multi-Drug Urine Test Cup Rx 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 ng/mL

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

The tests may vield 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.

5

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

× Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

FORM FDA 3881 (6/20)

Page 1 of 1

EF PSC Publishing Services (301) 443-6740

6

510(k) SUMMARY

	510(k) Number	K222667
1	Date	November 7, 2022
2	Submitter	VivaChek Biotech (Hangzhou) Co., Ltd.
		Level 2, Block 2, 146 East Chaofeng Rd.
		Hangzhou, China
3	Contact Person	Joe Shia
		LSI International Inc.
		504 East Diamond Ave., Suite I
		Gaithersburg, MD 20877
		Telephone: 240-505-7880
		Fax: 301-916-6213
		Email: shiajl@yahoo.com

4 Device Name Wisdiag Multi-Drug Urine Test Cup Wisdiag Multi-Drug Urine Test Cup Rx
5 Classification

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

7

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

Predicate Device 6. K182701

Wondfo T-Cup® Multi-Drug Urine Test Cup

7. Intended Use

Wisdiag 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, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana 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
Marijuana (THC)	50 ng/mL

8

Wisdiag 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. It is intended for OTC use.

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

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

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

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

9

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

The tests may yield positive results for the prescription drugs Buprenorphine, 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.

8. Device Description

The Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Test Cup Rx are rapid, singleuse in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test Wisdiag Cup and two desiccants, and a package insert. The Wisdiag Multi-Drug Urine Test Cup is intended for over-the-counter use and the Wisdiag Multi-Drug Urine Test Cup Rx is intended for prescription use.

| Item | Proposed Device | Predicate
(K182701) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Indication(s) for use | For the qualitative determination of Amphetamine,
Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-
1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine,
Methylenedioxymethamphetamine, Morphine, Methadone,
Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and
Cannabinoids in human urine. | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assay
based on antigen-antibody reaction | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Target Drug and
Cut Off Values | Target Drug | Cutoff (ng/mL) |
| | Amphetamine (AMP) | 1000 or 500 |
| | Buprenorphine (BUP) | 10 |
| | Secobarbital (BAR) | 300 |
| | Oxazepam (BZO) | 300 |
| | Cocaine (COC) | 300 or 150 |

9. Substantial Equivalence Information

10

| 2-ethylidene-1,5-dimethyl-3,3-

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

10. Test Principle

Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Test Cup Rx are rapid tests for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in urine samples. They 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 target drug or metabolite in the sample to indicate that the tests have been performed properly.

11. Performance Characteristics

1. Analytical Performance

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

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 |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| 20.0 | 17.1 | 13.6 | 11.8 | 10.2 | 6.9 | 5.4 | 2.7 | 0 | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

Wisdiag Multi-Drug Urine Test Cup BUP 10

Wisdiag 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	52.1	43.1	37.3	29.4	25.2	17.7	12.2	6.5	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	22-/28+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup THC 50

| 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 |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 96.5 | 84.3 | 75.7 | 60.1 | 52.5 | 35.9 | 24.1 | 12.1 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

Wisdiag 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 |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 200.3 | 177.1 | 158.9 | 131.7 | 108.5 | 78.0 | 51.6 | 27.6 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

12

Wisdiag Multi-Drug Urine Test Cup BAR 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 |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 588.4 | 525.8 | 457.6 | 383.8 | 301.6 | 228.3 | 157.1 | 80.2 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

Wisdiag Multi-Drug Urine Test Cup BZO 300

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff	cutoff	cutoff	cutoff	cutoff	cut-off
(ng/mL)
Lot Number	596.1	536.5	470.4	370.3	290.4	219.8	157.3	78.5	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	27-/23+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup EDDP 300

| Concentration by
LC/MS
(ng/mL) | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 646.2 | 545.3 | 455.1 | 371.0 | 290.7 | 229.5 | 148.8 | 77.0 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 28-/22+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

Wisdiag 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 |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 620.5 | 547.0 | 469.9 | 380.9 | 328.6 | 240.2 | 143.9 | 71.4 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

13

Wisdiag Multi-Drug Urine Test Cup MOP 300

| Concentration by
LC/MS
(ng/mL)

Lot Number	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
	622.4	530.2	468.8	381.8	322.8	220.8	159.0	75.4	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	22-/28+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup PPX 300

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)
Lot Number	622.3	562.7	451.3	383.3	297.7	218.3	152.5	75.8	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	28-/22+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup COC 150

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	298.2	246.1	237.0	193.6	157.7	106.5	76.2	36.0	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	28-/22+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup MDMA 500

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)
Lot Number	1048.5	861.5	740.8	614.9	522.8	342.0	250.6	128.4	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	22-/28+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+

14

Wisdiag Multi-Drug Urine Test Cup TCA 1000

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)	2175.2	1841.2	1597.5	1261.6	1081.5	708.2	493.1	251.5	0
Lot Number
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	27-/23+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	22-/28+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup AMP 500

| | Concentration
by LC/MS
(ng/mL) | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|------------|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| Lot Number | | 1011.8 | 846.4 | 772.7 | 646.8 | 544.3 | 357.6 | 225.0 | 120.9 | 0 |
| Lot I | | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

Wisdiag Multi-Drug Urine Test Cup MET 500

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)	1072.7	873.9	731.7	633.1	477.8	386.1	249.2	122.5	0
Lot Number
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag 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	4208.2	3672.9	3119.0	2590.5	2050.0	1460.4	1007.5	493.0	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	27-/23+	50-/0+	50-/0+	50-/0+	50-/0+

15

Wisdiag Multi-Drug Urine Test Cup COC 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 |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 610.6 | 558.5 | 461.6 | 373.4 | 329.9 | 235.6 | 156.7 | 74.5 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

Wisdiag Multi-Drug Urine Test Cup AMP 1000

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS
(ng/mL)	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
Lot Number	1933.3	1805.2	1562.7	1262.0	1051.1	812.0	540.9	271.9	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	27-/23+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup MET 1000

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
1954.6	1824.2	1593.1	1304.9	1003.4	736.7	464.8	251.1	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	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

16

Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Cannabinoids (THC 50)	50 ng/mL

b. Linearity

Not applicable

c. Stability

The devices are stable at 2-30℃ for 24 months based on accelerated stability studies at 55℃.

d. Interference

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

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

Acetaminophen	Acetophenetidin	Acetylsalicylic Acid
Acyclovir	Amiodarone Hydrochloride	Apomorphine
Afrin	Albumin (100mg/dL)	Amlodipine Mesylate
Aminophylline	Amoxicillin	Aripiprazole
Aminopyrine	Ampicillin	Aspartame
Benzilic Acid	Atropine	Atomoxetine
Benzoic Acid	Carbamazepine	Atorvastatin Calcium
Bilirubin	Cefradine	Chloramphenicol
Bupropion	Cephalexin	Chlorothiazide
Captopril	Chloral Hydrate	Chloroquine
Ciprofloxacin Hydrochloride	Clonidine	Cholesterol
Citalopram	Clopidogrel Hydrogen Sulphate	(-) Cotinine
Clarithromycin	Clozapine	chlorpheniramine
Deoxy- corticosterone	D,L-Tyrosine	D,L-Octopamine
Dextromethorphan	Digoxin	D,L-Propranolol
Diclofenac	Diphenhydramine	D-Norpropoxy- phene
Diflunisal	Dirithromycin	Domperidone

17

D-Pseudo- ephedrine	Ecgonine Methyl Ester	Doxylamine
Duloxetine	Effexor	Epinephrine Hydrochloride
Dicyclomine	Enalapril Maleate	Erythromycin
β-Estradiol	Fentanyl Citrate	Esomeprazole Magnesium
Ethanol (1%)	Fluoxetine Hydrochloride	Furosemide
Fenofibrate	Fluvoxamine	Gabapentin
Fenoprofen	Glucose	Gentisic Acid
Glibenclamide	Haloperidol	3-Hydroxy- tyramine
Gliclazide	Hemoglobin	Isosorbide Dinitrate
Glipizide	Ketamine	Isoxsuprine
Ibuprofen	Kratom powder	Lamotrigine
Ketoconazole	Labetalol	Levofloxacin Hydrochloride
Ketoprofen	Liverite	Levonorgestrel
Lidocaine Hydrochloride	Loperamide	Levothyroxine Sodium
Lisinopril	Loratadine	Minocycline
Lithium Carbonate	Naproxen	Nalidixic Acid
Metoprolol Tartrate	Mifepristone	Niacinamide
Magnesium	Mirtazapine	Nifedipine
Meperidine	Montelukast Sodium	Nikethamide
Meprobamate	Phenelzine	Sulfamethazine
Mosapride Citrate	Pioglitazone Hydrochloride	Sulindac
Maprotiline	Piracetam	Tetrahydrocortisone 3 -acetate
Nimodipine	Pravastatin Sodium	Tetrahydrocortisone 3-(β-D-glucuronide)
Norethindrone	Prednisone	Tetrahydrozoline
N-Acetylprocain-amide	Propylthiouracil	Tetracycline
O-Hydroxyhippu-ric Acid	Promethazine	Thiamine
Olanzapine	Quetiapine Fumarate	Thioridazine
Omeprazole	Quinine	Topiramate
Oxalic Acid	Ranitidine	Tramadol Hydrochloride
Oxolinic Acid	Rifampicin	Trazodone Hydrochloride
Oxymetazoline	Risperidone	Triamterene
Ondansetran	Salicylic Acid	Trifluoperazine
Paliperidone	Serotonin	Trimethoprim
Pantoprazole	Sertraline Hydrochloride	Uric Acid
Papaverine	Sildenafil Citrate	Valproate
Paroxetine Hydrochloride	Simvastatin	Verapamil
Penfluridol	Sodium Valproate	Vitamin B2
PenicillinV Potassium	Spironolactone	Vitamin C

18

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

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

| BUP 10 (Buprenorphine,
Cutoff=10 ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|--------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Buprenorphine -3-D-Glucuronide | 15 | 66.67% |
| Norbuprenorphine | 20 | 50% |
| Norbuprenorphine-3-D-Glucuronide | 200 | 5% |
| Morphine | >100000 | - |
| Oxymorphone | >100000 | - |
| Hydromorphone | >100000 | - |

| 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-9-carboxy-Δ9-THC | 50 | 100% |
| 11-nor-Δ8-THC-9-COOH | 50 | 100% |
| 11-nor-Δ9-THC-carboxy glucuronide | 100 | 50% |
| Cannabidiol | 100,000 | -- |
| Cannabinol | 100,000 | -- |
| Δ8- Tetrahydrocannabinol | 15,000 | 0.5% |
| Δ9- Tetrahydrocannabinol | 15,000 | 0.5% |
| 11-hydroxy-Δ9-Tetrahydrocannabinol | 5,000 | 1% |

| OXY 100
(Oxycodone, Cutoff=100 ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Dihydrocodeine | 20,000 | 0.5% |
| Hydrocodone | 80 | 125% |
| Oxymorphone | 1,000 | 10% |

19

Codeine	100,000	--
Hydromorphone	36,000	0.278%
Morphine	100,000	--
Acetylmorphine	100,000	--
Buprenorphine	100,000	--
Ethylmorphine	100,000	--
Thebaine	100,000	--

| COC 150
(Benzoylecgonine, Cutoff=150 ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Cocaine | 375 | 40% |
| Cocaethylene | 6,250 | 2.4% |
| Ecgonine | 16,000 | 100000 | - |
| EMDP | >100000 | - |
| Doxylamine | >100000 | - |
| Disopyramide | >100000 | - |
| LAAM (Levo-alpha-acetylmethadol) HCl | >100000 | - |
| Alpha Methadol | >100000 | - |

| MTD 300
(Methadone, Cutoff=300ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Doxylamine | >100000 | - |
| EDDP | >100000 | - |
| EMDP | >100000 | - |
| LAAM | >100000 | - |
| Alpha Methadol | >100000 | - |

| MOP 300
(Morphine, Cutoff=300ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Normorphine | 300 | 100% |
| Codeine | 300 | 100% |
| s-Monoacetylmorphine | 300 | 100% |
| Ethyl Morphine | 200 | 150% |
| Heroin | 300 | 100% |
| Hydrocodone | 700 | 42.8% |
| Hydromorphone | 200 | 150% |

21

Morphinie-3-β-d-glucuronide	1,000	30%
Oxycodone	100,000	--
Oxymorphone	100,000	--
Thebaine	20,000	1.5%
Levorphanol	10,000	3%
6-Monoacetylmorphine (6-MAM)	300	100%
Norcodeine	6,250	4.8%
Procaine	100,000	--

| PPX 300
(d-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) | 4,000 | 12.5% |
| 3,4-Methylenedioxyethylamphetamine (MDE) | 400 | 125% |
| d-methamphetamine | >100000 | - |
| d-amphetamine | >100000 | - |
| l-methamphetamine | >100000 | - |
| l-amphetamine | >100000 | - |

| AMP (Amphetamine) (Amphetamine,
Cutoff=500ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-----------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| l-Amphetamine | >100000 | - |
| dl- Amphetamine | 1,500 | 33.3% |
| (+/-) 3,4-Methylenedioxyamphetamine (MDA) | 500 | 100% |
| Phentermine | 6,000 | 8.3% |
| Hydroxyamphetamine | >100000 | - |
| d-Methamphetamine | >100000 | - |
| l-Methamphetamine | >100000 | - |
| (+/-) 3,4-Methylenedioxyethylamphetamine (MDE) | >100000 | - |
| (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | >100000 | - |
| β-Phenylethylamine | >100000 | - |
| Tyramine | >100000 | - |
| p-Hydroxynorephedrine | >100000 | - |
| Phenylpropanolamine | >100000 | - |

22

(±)Phenylpropanolamine	>100000	-
p-Hydroxyamphetamine	>100000	-
d/l-Norephedrine	>100000	-
Benzphetamine	>100000	-
l-Ephedrine	>100000	-
l-Epinephrine	>100000	-
d/l-Epinephrine	>100000	-
Ephedrine	>100000	-

| MET 500
(D(+)-Methamphetamine, required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-------------------- | (+/-)3,4-Methylenedioxy-n-
ethylamphetamine(MDE) | 12,500 | D/L-Methamphetamine | p-Hydroxymethamphetamine | D-Amphetamine | L-Amphetamine | Chloroquine | (+/-)-Ephedrine | (-)-Methamphetamine | (+/-)3,4-Methylened | (+/-)3,4-Methylened (MDMA) | 4,000 | β-Phenylethylamine | Trimethobenzamide | d,l-Amphetamine | Mephentermine | (1R,2S)-(-)-Ephedrine | 1-phenylephrine | L-Methamphetamine Cutoff=500ng/mL) | Minimum concentration
---------------------------------|--------------------------------------------------------------------------|------------------------|
| 4% |
| 500 | 100% |
| 15,000 | 3.3% |
| >100000 | - |
| >100000 | - |
| 50,000 | 1% |
| 100,000 | - |
| 65,000 | 0.8% |
ioxyamphetamine (MDA) | >100000 | - |
ioxymethamphetamine
| 12.5% |
| 25,000 | 2% |
| 10,000 | 5% |
| >100000 | - |
| 25,000 | 2% |
| >100000 | - |
| >100000 | - |
| 65,000 | 0.8% |

| TCA 1000
(Nortriptyline, Cutoff=1000ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-----------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Nordoxepine | 1,000 | 100% |
| Trimipramine | 3,000 | 33.3% |
| Amitriptyline | 450 | 222.2% |
| Promazine | 1,500 | 66.7% |
| Desipramine | 200 | 500% |
| Imipramine | 80 | 1250% |

23

Clomipramine	1,200	83.3%
Doxepin	2,000	50%
Maprotiline	2,000	50%
Promethazine	>100,000	--
Cyclobenzaprine	800	125%
Norclomipramine	12,500	8%

| COC 300
(Benzoylecgonine, Cutoff=300ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-----------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Cocaine | 780 | 38.5% |
| Cocaethylene | 12,500 | 2.4% |
| Ecgonine | 32,000 | 0.9% |
| Ecgonine methyl ester | 100,000 | 0.3% |
| Norcocaine | 100,000 | 0.3% |

| AMP 1000
(d-Amphetamine, Cutoff=1000ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|--------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| l-Amphetamine | >100000 | - |
| dl- Amphetamine | 3,000 | 33.3% |
| (+/-)3,4-Methylenedioxyamphetamine (MDA) | 1,000 | 100%, |
| Phentermine | 6,000 | 16.7% |
| Hydroxyamphetamine | >100000 | - |
| d-Methamphetamine | >100000 | - |
| l-Methamphetamine | >100000 | - |
| (+/-)3,4-Methylenedioxyethylamphetamine(MDE) | >100000 | - |
| (+/-)3,4-
Methylenedioxymethamphetamine(MDMA) | >100000 | - |
| β-Phenylethylamine | >100000 | - |
| Tyramine | >100000 | - |
| p-Hydroxynorephedrine | >100000 | - |
| Phenylpropanolamine | >100000 | - |
| (±)Phenylpropanolamine | >100000 | - |
| p-Hydroxyamphetamine | >100000 | - |
| d/l-Norephedrine | >100000 | - |
| Benzphetamine | >100000 | - |
| l-Ephedrine | >100000 | - |
| l-Epinephrine | >100000 | - |
| d/l-Epinephrine | >100000 | - |
| Ephedrine | >100000 | - |

24

| MET 1000
(D(+)-Methamphetamine, Cutoff=1000ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine
(MDE) | 25,000 | 4% |
| D/L-Methamphetamine | 1,000 | 100% |
| p-Hydroxymethamphetamine | 30,000 | 0.3% |
| D-Amphetamine | >100000 | - |
| L-Amphetamine | >100000 | - |
| Chloroquine | 50,000 | 2% |
| (+/-)-Ephedrine | >100000 | - |
| (-)-Methamphetamine | >100000 | - |
| (+/-)3,4-Methylenedioxyamphetamine (MDA) | >100000 | - |
| (+/-)3,4-Methylenedioxymethamphetamine
(MDMA) | 8,000 | 12.5% |
| β-Phenylethylamine | 50,000 | 2% |
| Trimethobenzamide | 20,000 | 5% |
| d,l-Amphetamine | >100000 | - |
| Mephetermine | 50,000 | 2% |
| (1R,2S)-(-)-Ephedrine | >100000 | - |
| 1-phenylephrine | >100000 | - |
| L-Methamphetamine | >100000 | - |

| OPI 2000
(Morphine, Cutoff=2000ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Normorphine | 50,000 | 4% |
| Codeine | 2,000 | 100% |
| s-Monoacetylmorphine | 2,000 | 100% |
| Ethyl Morphine | 1,500 | 133.3% |
| Heroin | 2,000 | 100% |
| Hydrocodone | 12,500 | 16% |
| Hydromorphone | 3,500 | 57.1% |
| Morphinie-3-β-d-glucuronide | 2,000 | 100% |
| Oxycodone | 25,000 | 8% |
| Oxymorphone | 25,000 | 8% |
| Thebaine | 50,000 | 4% |
| Levorphanol | 75,000 | 2.7% |
| 6-Monoacetylmorphine (6-MAM) | 2,000 | 100% |
| Norcodeine | 12,500 | 16% |

25

Procaine	>100,000	--
----------	----------	----

f. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity, urine samples with specific gravity from 1.000 to 1.035 were spiked with target drugs at +25% cutoff and -25% cutoff levels. Three Operators 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 Operators 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 Wisdiag Multi-Drug Urine Test Cup were performed in-house with three operators.

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

For Wisdiag Multi-Drug Urine Test Cup:

| Wisdiag
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%) |
|----------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator
A | Positive | 0 | 0 | 1 | 20 | 20 |
| | Negative | 10 | 12 | 17 | 0 | 0 |
| Operator
B | Positive | 0 | 0 | 1 | 20 | 20 |
| | Negative | 10 | 12 | 17 | 0 | 0 |
| Operator
C | Positive | 0 | 0 | 1 | 20 | 20 |
| | Negative | 10 | 12 | 17 | 0 | 0 |

AMP 500

Discordant Results for AMP 500:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	AMP136	499.0	+
Operator B	AMP028	477.4	+
Operator C	AMP136	499.0	+

26

| Wisdiag
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%) |
|----------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator | Positive | 0 | 0 | 1 | 18 | 20 |
| A | Negative | 10 | 15 | 14 | 2 | 0 |
| Operator | Positive | 0 | 0 | 2 | 20 | 20 |
| B | Negative | 10 | 15 | 13 | 0 | 0 |
| Operator | Positive | 0 | 0 | 0 | 18 | 20 |
| C | Negative | 10 | 15 | 15 | 2 | 0 |

Discordant Results for BUP 10:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	BUP029	10.2	-
Operator C	BUP029	10.2	-
Operator A	BUP055	10.8	-
Operator C	BUP055	10.8	-
Operator A	BUP058	9.8	+
Operator B	BUP058	9.8	+
Operator B	BUP070	9.9	+

BAR 300

| Wisdiag
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%) |
|----------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator | Positive | 0 | 0 | 0 | 17 | 20 |
| A | Negative | 10 | 16 | 14 | 3 | 0 |
| Operator | Positive | 0 | 0 | 0 | 18 | 20 |
| B | Negative | 10 | 16 | 14 | 2 | 0 |
| Operator | Positive | 0 | 0 | 0 | 19 | 20 |
| C | Negative | 10 | 16 | 14 | 1 | 0 |

Discordant Results for BAR 300:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	BAR011	303.8	-
Operator B	BAR011	303.8	-
Operator C	BAR011	303.8	-
Operator A	BAR017	300.9	-

27

Operator B	BAR017	300.9	-
Operator A	BAR033	312.2	-

BZO 300

| Wisdiag
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%) |
|----------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator | Positive | 0 | 0 | 0 | 16 | 23 |
| A | Negative | 10 | 15 | 15 | 1 | 0 |
| Operator | Positive | 0 | 0 | 0 | 15 | 23 |
| B | Negative | 10 | 15 | 15 | 2 | 0 |
| Operator | Positive | 0 | 0 | 0 | 17 | 23 |
| C | Negative | 10 | 15 | 15 | 0 | 0 |

Discordant Results for BZO 300:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	BZO018	303.6	-
Operator B	BZO018	303.6	-
Operator B	BZO058	307.2	-

COC 150

| Wisdiag
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%) |
|----------------|----------|-----------|-----------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------|
| Operator A | Positive | 0 | 0 | 1 | 18 | 22 |
| | Negative | 10 | 16 | 13 | 0 | 0 |
| Operator B | Positive | 0 | 0 | 1 | 18 | 22 |
| | Negative | 10 | 16 | 13 | 0 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 17 | 22 |
| | Negative | 10 | 16 | 14 | 1 | 0 |

Discordant Results for COC 150:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	COC046	144.8	+
Operator B	COC146	148.9	+
Operator C	COC128	162.8	-

28

EDDP 300

| Wisdiag
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%) |
|----------------|----------|-----------|-------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| | | | | | | |
| Operator A | Positive | 0 | 0 | 0 | 17 | 21 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Operator B | Positive | 0 | 0 | 1 | 19 | 21 |
| | Negative | 10 | 15 | 14 | 0 | 0 |
| Operator C | Positive | 0 | 0 | 1 | 19 | 21 |
| | Negative | 10 | 15 | 14 | 0 | 0 |

Discordant Results for EDDP 300:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator B	EDDP075	290.6	+
Operator C	EDDP075	290.6	+
Operator A	EDDP010	318.6	-
Operator A	EDDP061	318.5	-

MET 500

| Wisdiag
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%) |
|----------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator | Positive | 0 | 0 | 0 | 18 | 20 |
| A | Negative | 10 | 15 | 15 | 2 | 0 |
| Operator | Positive | 0 | 0 | 0 | 19 | 20 |
| B | Negative | 10 | 15 | 15 | 1 | 0 |
| Operator | Positive | 0 | 0 | 0 | 20 | 20 |
| C | Negative | 10 | 15 | 15 | 0 | 0 |

Discordant Results for MET 500:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	MET062	519.5	-
Operator A	MET102	521.1	-
Operator B	MET102	521.1	-

MDMA 500

29

| Wisdiag
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%) | |
|----------------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|----|
| Operator
A | Positive | 0 | 0 | 2 | 20 | 20 |
| A | Negative | 10 | 17 | 11 | 0 | 0 |
| Operator
B | Positive | 0 | 0 | 0 | 20 | 20 |
| B | Negative | 10 | 17 | 13 | 0 | 0 |
| Operator
C | Positive | 0 | 0 | 1 | 20 | 20 |
| C | Negative | 10 | 17 | 12 | 0 | 0 |

Discordant Results for MDMA 500:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	MDMA026	488.3	+
Operator C	MDMA026	488.3	+
Operator A	MDMA060	492.0	+

MOP 300

| Wisdiag
Cup | | | 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%) |
|----------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| | | Drug-Free | | | | |
| Operator | Positive | 0 | 0 | 0 | 18 | 22 |
| A | Negative | 10 | 14 | 16 | 0 | 0 |
| Operator | Positive | 0 | 0 | 2 | 18 | 22 |
| B | Negative | 10 | 14 | 14 | 0 | 0 |
| Operator | Positive | 0 | 0 | 0 | 18 | 22 |
| C | Negative | 10 | 14 | 16 | 0 | 0 |

Discordant Results for MOP 300:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator B	MOP057	293.2	+
Operator B	MOP150	282.8	+

MTD 300

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

30

| | | | | | (Between the
cutoff and
+50%) | |
|----------|----------|----|----|----|-------------------------------------|----|
| Operator | Positive | 0 | 0 | 0 | 18 | 20 |
| A | Negative | 10 | 16 | 14 | 2 | 0 |
| Operator | Positive | 0 | 0 | 2 | 20 | 20 |
| B | Negative | 10 | 16 | 12 | 0 | 0 |
| Operator | Positive | 0 | 0 | 1 | 20 | 20 |
| C | Negative | 10 | 16 | 13 | 0 | 0 |

Discordant Results for MTD 300:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator B	MTD022	298.2	+
Operator B	MTD049	289.2	+
Operator C	MTD049	289.2	+
Operator A	MTD003	309.1	-
Operator A	MTD045	301.7	-

OXY 100

| Wisdiag
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%) |
|----------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator
A | Positive | 0 | 0 | 2 | 19 | 21 |
| | Negative | 10 | 14 | 14 | 0 | 0 |
| Operator
B | Positive | 0 | 0 | 0 | 18 | 21 |
| | Negative | 10 | 14 | 16 | 1 | 0 |
| Operator
C | Positive | 0 | 0 | 0 | 17 | 21 |
| | Negative | 10 | 14 | 16 | 2 | 0 |

Discordant Results for OXY 100:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	OXY012	96.3	+
Operator A	OXY071	95.2	+
Operator B	OXY002	101.4	-
Operator C	OXY002	101.4	-
Operator C	OXY006	111.0	-

PCP 25

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

31

| | | | LC/MS (less
than -50%) | (Between -50%
and the Cutoff) | (Between the
cutoff and
+50%) | (greater than
+50%) |
|----------|----------|----|---------------------------|----------------------------------|-------------------------------------|------------------------|
| Operator | Positive | 0 | 0 | 1 | 21 | 18 |
| A | Negative | 10 | 18 | 11 | 1 | 0 |
| Operator | Positive | 0 | 0 | 1 | 21 | 18 |
| B | Negative | 10 | 18 | 11 | 1 | 0 |
| Operator | Positive | 0 | 0 | 1 | 22 | 18 |
| C | Negative | 10 | 18 | 11 | 0 | 0 |

Discordant Results for PCP 25:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	PCP003	22.4	+
Operator B	PCP060	22.7	+
Operator C	PCP060	22.7	+
Operator A	PCP023	25.5	-
Operator B	PCP023	25.5	-

PPX 300

| Wisdiag
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%) |
|----------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator | Positive | 0 | 0 | 2 | 19 | 21 |
| A | Negative | 10 | 16 | 12 | 0 | 0 |
| Operator | Positive | 0 | 0 | 0 | 16 | 21 |
| B | Negative | 10 | 16 | 14 | 3 | 0 |
| Operator | Positive | 0 | 0 | 1 | 18 | 21 |
| C | Negative | 10 | 16 | 13 | 1 | 0 |

Discordant Results for PPX 300:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	PPX024	292.5	+
Operator A	PPX029	291.4	+
Operator C	PPX024	292.5	+
Operator B	PPX043	300.7	-
Operator B	PPX053	300.8	-
Operator B	PPX073	303.4	-
Operator C	PPX043	300.7	-

TCA 1000

32

| Wisdiag
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%) |
|----------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator | Positive | 0 | 0 | 0 | 16 | 22 |
| A | Negative | 10 | 15 | 15 | 2 | 0 |
| Operator | Positive | 0 | 0 | 1 | 18 | 22 |
| B | Negative | 10 | 15 | 14 | 0 | 0 |
| Operator | Positive | 0 | 0 | 2 | 18 | 22 |
| C | Negative | 10 | 15 | 13 | 0 | 0 |

Discordant Results for TCA 1000:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator B	TCA005	991.3	+
Operator C	TCA005	991.3	+
Operator C	TCA043	969.0	+
Operator A	TCA010	1015.1	-
Operator A	TCA052	1015.9	-

THC 50

| Wisdiag
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%) |
|----------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator
A | Positive | 0 | 0 | 1 | 16 | 22 |
| A | Negative | 10 | 16 | 13 | 2 | 0 |
| Operator
B | Positive | 0 | 0 | 1 | 17 | 22 |
| B | Negative | 10 | 16 | 13 | 1 | 0 |
| Operator
C | Positive | 0 | 0 | 0 | 15 | 22 |
| C | Negative | 10 | 16 | 14 | 3 | 0 |

Discordant Results for THC 50:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	THC014	47.8	+
Operator B	THC054	46.8	+
Operator A	THC062	50.9	-
Operator A	THC069	53.5	-
Operator B	THC076	53.9	-

33

Operator C	THC036	50.5	-
Operator C	THC062	50.9	-
Operator C	THC069	53.5	-

AMP 1000

| Wisdiag
Cup | | | 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%) |
|----------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| | | Drug-Free | | | | |
| Operator
A | Positive | 0 | 0 | 0 | 17 | 21 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Operator
B | Positive | 0 | 0 | 1 | 19 | 21 |
| | Negative | 10 | 15 | 14 | 0 | 0 |
| Operator
C | Positive | 0 | 0 | 0 | 18 | 21 |
| | Negative | 10 | 15 | 15 | 1 | 0 |

Discordant Results for AMP 1000:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator B	AMP116	998.8	+
Operator A	AMP095	1035.1	-
Operator A	AMP102	1048.4	-
Operator C	AMP102	1048.4	-

COC 300

| Wisdiag
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%) |
|----------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator
A | Positive | 0 | 0 | 2 | 17 | 23 |
| | Negative | 10 | 14 | 14 | 0 | 0 |
| Operator
B | Positive | 0 | 0 | 0 | 15 | 23 |
| | Negative | 10 | 14 | 16 | 2 | 0 |
| Operator
C | Positive | 0 | 0 | 1 | 17 | 23 |
| | Negative | 10 | 14 | 15 | 0 | 0 |

Discordant Results for COC 300:

Operator	Sample Number	LC/MS Result	Hightop Result
Operator A	COC028	296.4	+
Operator A	COC143	283.8	+

34

Operator C	COC143	283.8	+
Operator B	COC033	317.7	-
Operator B	COC138	318.7	-

MET 1000

| Wisdiag
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%) |
|----------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator | Positive | 0 | 0 | 0 | 21 | 19 |
| A | Negative | 10 | 13 | 17 | 0 | 0 |
| Operator | Positive | 0 | 0 | 0 | 19 | 19 |
| B | Negative | 10 | 13 | 17 | 2 | 0 |
| Operator | Positive | 0 | 0 | 0 | 20 | 19 |
| C | Negative | 10 | 13 | 17 | 1 | 0 |

Discordant Results for MET 1000:

Operator	Sample Number	LC/MS Result	Hightop Result
Operator B	MET123	1049.5	-
Operator B	MET138	1068.2	-
Operator C	MET138	1068.2	-

OPI 2000

| Wisdiag
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%) |
|----------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------|
| Operator | Positive | 0 | 0 | 0 | 16 | 22 |
| A | Negative | 10 | 16 | 14 | 2 | 0 |
| Operator | Positive | 0 | 0 | 1 | 18 | 22 |
| B | Negative | 10 | 16 | 13 | 0 | 0 |
| Operator | Positive | 0 | 0 | 0 | 18 | 22 |
| C | Negative | 10 | 16 | 14 | 0 | 0 |

Discordant Results for OPI 2000:

Operator	Sample Number	LC/MS Result	Hightop Result
Operator B	MOP076	1943.3	+
Operator A	MOP089	2070.0	-
Operator A	MOP139	2105.7	-

35

Lay-user study:

A lay user study was performed using urine samples prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS or LC/MS. Each sample was aliquoted into individual containers and blind-labeled. A total of 280 participants with diverse educational and professional backgrounds aged 20 years and older were recruited from three sites. Sixty-six males and 74 females tested Wisdiag Multi-Drug Urine Test Cup Configuration 1 (including AMP 500, MET 500, MOP 300, COC 150); 72 male and 68 females tested Wisdiag Multi-Drug Urine Test Cup Configuration 2 (including AMP 1000, MET 1000, MOP 2000 (OPI), COC 300). Each participant was provided one package insert, one blind labeled test solution, and one test device. The results are summarized below:

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

Assay	Results	Concentration
		-100% cutoff	-75% cutoff	-50% cutoff	-25% cutoff	+25% cutoff	+50% cutoff	+75% cutoff
AMP 500	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	95%	100%	100%	100%
BAR 300	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	100%	95%	100%	100%
BZO 300	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	100%	95%	100%	100%
BUP 10	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%
COC 150	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%
EDDP 300	Negative	20	20	20	20	0	0	0
	Positive	0	0	0	0	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	100%	100%	100%	100%
MDMA 500	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%
MET 500	Negative	20	20	20	19	1	0	0
	Positive	0	0	0	1	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	95%	95%	100%	100%
MOP 300	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	95%	100%	100%	100%
MTD 300	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	100%	95%	100%	100%
OXY 100	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%
PCP 25	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%	100%	95%	100%	100%
PPX 300	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
TCA 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%	તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો	100%	100%	100%
THC 50	Negative	20	20	20	18	1	0	0
	Positive	0	0	0	2	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	90%	તે તે જેન્જી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલત	100%	100%

36

37

Lay-User Study Results for Wisdiag 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
	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
AMP 1000	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	95%	100%	100%	100%
	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
BAR 300	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	95%	100%	100%	100%
BZO 300	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	95%	100%	100%	100%
	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
BUP 10	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	100%	95%	100%	100%
COC 300	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	100%	95%	100%	100%

EDDP 300	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	95%	100%	100%	100%
MDMA 500	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	95%	100%	100%	100%
MET 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%
OPI 2000	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%
MTD 300	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	100%	95%	100%	100%
OXY 100	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%
PCP 25	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	100%	95%	100%	100%
PPX 300	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	95%	100%	100%	100%
TCA 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%	તે તે જેન્જી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામના	100%	100%	100%
THC 50	Negative	20	20	20	18	1	0	0
	Positive	0	0	0	2	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of
correct results (%)	100%	100%	100%	90%	તે જેન્જી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો	100%	100%

38

39

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 Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Test Cup Rx are substantially equivalent to the predicate devices.