Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a traditional lateral flow immunochromatographic assay, with no mention of AI/ML components for analysis or interpretation.

Therapeutic

No.
The device is an in vitro diagnostic test for detecting drugs in urine, not for treating conditions.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "It is for in vitro diagnostic use only." Furthermore, its purpose is to detect various drugs in human urine, which falls under the definition of diagnosing the presence of substances in a biological sample.

SaMD (Software as a Medical Device)

No

The device is a physical test cup that performs immunochromatographic assays on urine samples. It is an in vitro diagnostic device with hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, 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."
Nature of the Test: The device performs a qualitative and simultaneous detection of various substances (drugs) in a biological sample (human urine). 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 diagnosis, monitoring, or screening.
Device Description: The description confirms it's an immunochromatographic assay using a lateral flow system, which is a common technology for IVD tests.
Performance Studies: The document details various performance studies (comparison studies, precision studies, interference studies, lay-user study) which are typical evaluations required for IVD devices to demonstrate their accuracy and reliability.
Predicate Device: The mention of a predicate device (K182701; Wondfo T-Cup® Multi-Drug Urine Test Cup) further indicates that this device is being compared to another device already classified as an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Accurate Multi Panel 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-diphenylpyrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off
Amphetamine (AMP)	1000 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	300 ng/mL or 2000 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)	50 ng/mL

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

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

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

Product codes (comma separated list FDA assigned to the subject device)

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

Device Description

Accurate® Multi Panel 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 Marijuana in human urine. Each Accurate® Multi Panel Drug Urine Test Cup device consists of a test cup and a package insert. Each test cup is sealed with desiccant in an aluminum pouch.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Analytical Performance

Precision: Studies were carried out for samples with concentrations of -100%cutoff, -75%cutoff, -50%cutoff, -25%cutoff, +25%cutoff, +50%cutoff, +75%cutoff and +100%cutoff. For each concentration, tests were performed two runs per day for 25 days. The results summarized in tables for BUP, PCP, THC, OXY, BAR, BZO, EDDP, MTD, MOP, PPX, MDMA, TCA, OPI, COC, AMP, MET.
Linearity: Not applicable
Stability: The devices are stable at 4-30℃ for 24 months based on real-time stability studies.
Interference: Potential interfering substances were added to drug-free urine samples with target drugs of -50% cutoff and +50% cutoff level. Compounds that show no interference at a concentration of 100μg/mL are summarized in a table.
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 with their minimum concentration and % Cross-Reactivity for BUP, PCP, THC, OXY, BAR, BZO, EDDP, MTD, MOP 300, PPX, MDMA, TCA 1000, COC, AMP, MET, OPI 2000.
Effect of Urine Specific Gravity and Urine pH: Urine samples with specific gravity from 1.000 to 1.035 were spiked with target drugs at +50% cutoff and -50% cutoff levels. Three operators tested samples using test devices from three different lots. Results were all positive for +50% cutoff and all negative for -50% cutoff, indicating no effect. Urine samples with pH value from 4 to 9 were spiked with target drugs at +50% cutoff and -50% cutoff levels. Three operators tested samples using test devices from three different lots. Results were all positive for +50% cutoff and all negative for -50% cutoff, indicating no effect.

Comparison Studies
Method comparison studies were performed in-house with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine samples, blindly labeled, and compared to LC/MS or GC/MS results. Results are presented in tables for BUP, BAR, BZO, EDDP, MDMA, MOP 300, MTD, OXY, PCP, PPX, TCA, THC, AMP, COC, MET, OPI 2000, including discordant results for each.

Lay-user study
184 males and 126 females tested Accurate® Multi Panel Drug Urine Test Cup Configuration 1 (including MOP 300); 178 male and 132 females tested Accurate® Multi Panel Drug Urine Test Cup Configuration 2 (including MOP 2000 (OPI). Participants had diverse educational and professional backgrounds and were fluent in English, with an age range from 20 to over 50. Urine samples were prepared at -100%, +/-75%, +/-25% of the cutoff by spiking drug(s) into drug-free pooled urine specimens. Concentrations were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Participants received the package insert, 1 blind labeled sample, and a device. The results are summarized in tables for Configuration 1 and Configuration 2 for various drugs, showing the number of positive/negative results and percentage agreement for each % of cutoff tested. All participants indicated the device instruction is easy to understand and follow, with a Flesch-Kincaid reading Grade Level of 7.

Clinical Studies
Not applicable.

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

Key metrics are presented in tables for the Precision, Specificity, and Comparison Studies in the "Summary of Performance Studies" section, detailing positive/negative counts at various concentrations relative to cutoff levels.

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

K182701

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

Not Found

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

Not Found

Regulation Number and Section

§ 862.3100 Amphetamine test system.

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

Summary

0

Image /page/0/Picture/0 description: The image 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 7, 2019

Healstone Biotech Inc % Joe Shia, Director LSI International Inc. 504 East Diamond Ave. Suite I Gaithersburg, MD 20877

Re: K191841

Trade/Device Name: Accurate Multi Panel 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, QBF, NGG, QAW, NGM, NFW Dated: July 5, 2019 Received: July 9, 2019

Dear Joe Shia:

We have reviewed vour 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

1

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

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

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

Sincerely,

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Accurate Multi Panel Drug Urine Test Cup

Indications for Use (Describe)

Accurate Multi Panel 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-diphenylpyrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

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

l flow immunochromatographic
barbital, Oxazepam, Cocaine, 2-
nedioxymethamphetamine, Morp
ijuana in human urine at the cuto

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

level /mL /mL /mL /mL z/mL g/mL g/mL /mL g/mL or 2000 ng/mL g/mL g/mL g/mL g/mL g/mL 50 ng/mL

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

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

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

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:

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4

510(k) SUMMARY K191841

1 Date August 7, 2019 Submitter Healstone Biotech Inc. 2 650-655 W Kent N. Vancouver, BC V6P6T7 Canada 3 Contact Joe Shia Person LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: Fax: 301-916-6213 Email: shiajl@yahoo.com
4 Device Name Accurate® Multi Panel Drug Urine Test Cup
Classification Class II 5

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

5

Morphine (MOP/OPI)
PTG
Methadone (MTD)	862.3620, Methadone Test System	Toxicology
NGL
Oxycodone (OXY)	862.3650, Opiate Test System	Toxicology
NGM
Phencyclidine (PCP)	Unclassified, Enzyme
Immunoassay Phencyclidine	Toxicology
QBF
Propoxyphene (PPX)	862.3700 Propoxyphene test
system.	Toxicology
QAW
Nortriptyline (TCA)	862.3910 Tricyclic antidepressant
drugs test system	Toxicology
NFW
Marijuana (THC 50)	862.3870, Cannabinoids Test
System	Toxicology
K182701

б Predicate Device

Wondfo T-Cup® Multi-Drug Urine Test Cup

7. Intended Use

Accurate Multi Panel 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
Buprenorphine (BUP)	10ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	300 ng/mL or 2000 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1,000 ng/mL
Marijuana (THC 50)	50 ng/mL

6

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

The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Device Description 8.

Accurate® Multi Panel 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 Marijuana in human urine. Each Accurate® Multi Panel Drug Urine Test Cup device consists of a test cup and a package insert. Each test cup is sealed with desiccant in an aluminum pouch.

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 Marijuana 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
	Buprenorphine (BUP)	10
	Secobarbital (BAR)	300
	Oxazepam (BZO)	300
	Cocaine (COC)	300
	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300
	Methamphetamine (MET)	1000

Substantial Equivalence Information 9.

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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
Marijuana (THC 50)	50
Configurations	Same
Intended Use	Same

10. Test Principle

Accurate® Multi Panel 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, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana 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

Analytical Performance 1.
- 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.

Accurate® Multi Panel Drug Urine Test Cup BUP

| Concentration by
LC/MS
(ng/mL) | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|--------|----------------|----------------|----------------|------------------|
| | 19.1 | 16.1 | 15.2 | 12.9 | 9.4 | 7.1 | 5.4 | 2.4 | 0 |

8

Lot Number
Lot I	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	48-/2+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	1-/49+	22-/28+	49-/1+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	2-/48+	20-/30+	49-/1+	50-/0+	50-/0+	50-/0+

Accurate® Multi Panel Drug Urine Test Cup PCP

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	50.3	43.1	36.2	30.4	25.0	17.9	12.2	6.4	0
Lot I	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	1-/49+	26-/24+	48-/2+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	1-/49+	21-/29+	49-/1+	50-/0+	50-/0+	50-/0+

Accurate® Multi Panel Drug Urine Test Cup THC

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	100.8	88.6	72.9	65.8	50.2	39.5	25.2	12.6	0
Lot I	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	47-/3+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	2-/48+	28-/22+	48-/2+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	3-/47+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+

Accurate® Multi Panel Drug Urine Test Cup OXY

| 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 | 200.3 | 170.6 | 150.1 | 118.5 | 98.4 | 77.9 | 52.5 | 28.3 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 22-/28+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 21-/29+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |

Accurate® Multi Panel Drug Urine Test Cup BAR

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)	645.0	510.9	437.8	394.7	270.1	235.5	161.8	77.9	0

9

Lot Number
Lot I	0-/50+	0-/50+	0-/50+	1-/49+	24-/26+	49-/1+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	2-/48+	19-/31+	47-/3+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	48-/2+	50-/0+	50-/0+	50-/0+

Accurate® Multi Panel Drug Urine Test Cup BZO

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	580.3	530.3	488.3	386.6	307.9	247.0	142.3	71.8	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	48-/2+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	2-/48+	21-/29+	49-/1+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	2-/48+	22-/28+	49-/1+	50-/0+	50-/0+	50-/0+

Accurate® Multi Panel Drug Urine Test Cup EDDP

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS
(ng/mL)
Lot Number	cutoff
571.3	cutoff
498.7	cutoff
430.7	cutoff
358.5	300.7	cutoff
222.8	cutoff
142.4	cutoff
79.5	cut-off
0
Lot I	0-/50+	0-/50+	0-/50+	1-/49+	20-/30+	49-/1+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	1-/49+	22-/28+	49-/1+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	1-/49+	20-/30+	50-/0+	50-/0+	50-/0+	50-/0+

Accurate® Multi Panel Drug Urine Test Cup MTD

| Concentration by
LC/MS
(ng/mL) | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 588.6 | 514.8 | 471.0 | 393.1 | 314.6 | 223.5 | 140.9 | 74.6 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 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+ |

Accurate® Multi Panel Drug Urine Test Cup MOP

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)	591.7	504.6	470.3	384.0	289.0	244.9	163.6	74.0	0

10

Lot Number
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+	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+

Accurate® Multi Panel Drug Urine Test Cup PPX

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)	626.7	534.8	433.6	364.2	308.6	225.3	159.1	79.4	0
Lot Number
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	48-/2+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	22-/28+	48-/2+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	1-/49+	22-/28+	49-/1+	50-/0+	50-/0+	50-/0+

Accurate® Multi Panel Drug Urine Test Cup MDMA

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	1208.1	863.1	711.1	592.8	516.6	375.2	259.9	124.1	0
Lot I	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	49-/1+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	2-/48+	19-/31+	49-/1+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	49-/1+	50-/0+	50-/0+	50-/0+

Accurate® Multi Panel Drug Urine Test Cup TCA

| Concentration by
LC/MS
(ng/mL) | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 2024.2 | 1727.6 | 1459.5 | 1276.1 | 1091.2 | 718.8 | 505.0 | 257.5 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 21-/29+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |

Accurate® Multi Panel Drug Urine Test Cup OPI

| Concentration by
LC/MS | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|---------------------------|-----------------|----------------|----------------|----------------|--------|----------------|----------------|----------------|------------------|
| | | | | | cutoff | | | | |

11

(ng/mL)	4166.3	3535.6	3077.2	2407.8	2008.3	1611.8	1041.0	509.5	0
Lot Number
Lot I	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	48-/2+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	1-/49+	23-/27+	48-/2+	50-/0+	50-/0+	50-/0+

Accurate® Multi Panel Drug Urine Test Cup COC

| Concentration by
LC/MS
(ng/mL) | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 619.3 | 533.4 | 432.2 | 360.6 | 303.1 | 226.4 | 157.7 | 73 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 20-/30+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |

Accurate® Multi Panel Drug Urine Test Cup AMP

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS
(ng/mL)
Lot Number	cutoff
2015.9	cutoff
1749.1	cutoff
1496.0	cutoff
1202.3	1091.8	cutoff
789.2	cutoff
532.7	cutoff
270.3	cut-off
0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	49-/1+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	2-/48+	24-/26+	48-/2+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	1-/49+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+

Accurate® Multi Panel Drug Urine Test Cup MET

| 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 | 1906.8 | 1629.3 | 1459.1 | 1229.8 | 949.7 | 733.1 | 491.1 | 236.2 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 20-/30+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 19-/31+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 19-/31+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |

The following cutoff values are verified:

12

Amphetamine (AMP)	1000 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 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)	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 samples with target drugs of -50% cutoff and +50% cutoff level.

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

(±)-4-Methylephedrine	Ecgonine methylester	Oxalic acid
Acetaminophen	ß-Estradiol	Oxolinic acid
Acetophenetidin	Erythromycin	Oxymetazoline
N-Acetylprocainamide	Fenoprofen	Papaverine
Acetylsalicylic acid	Furosemide	Penicillin G
Albumin (100 mg/dL)	Gentisic acid	Perphenazine
Aminopyrine	Hemoglobin	Phenelzine
Amoxicillin	Hydralazine	Prednisone
Ampicillin	Hydrochlorothiazide	(±)-Propranolol
Apomorphine	Hydrocortisone	Pseudoephedrine

13

Ascorbic acid	O-Hydroxyhippuric acid	Quinine
Aspartame	3-Hydroxytyramine	Ranitidine
Atropine	Ibuprofen	Salicylic acid
Benzilic acid	Isoproterenol	Serotonin (5-
Hydroxytyramine)
Benzoic acid	Isoxsuprine	Sulfamethazine
Bilirubin	Ketamine	Sulindac
Chloral hydrate	Ketoprofen	Tetrahydrocortisone 3-
(β-Dglucuronide)
Chloramphenicol	Labetalol	Tetrahydrocortisone 3-
acetate
Chlorothiazide	Loperamide	Tetrahydrozoline
Chlorpromazine	Meperidine	Thiamine
Cholesterol	Meprobamate	Thioridazine
Clonidine	Methoxyphenamine	Triamterene
Cortisone	Nalidixic acid	Trifluoperazine
(-)-Cotinine	Naproxen	Trimethoprim
Creatinine	Niacinamide	DL-Tryptophan
Deoxycorticosterone	Nifedipine	DL-Tyrosine
Dextromethorphan	Norethindrone	Uric acid
Diclofenac	Noscapine	Verapamil
Diflunisal	(±)-Octopamine	Zomepirac
Digoxin

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

Compounds that produced positive results are listed below.

| BUP (Buprenorphine,
Cutoff=10 ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Buprenorphine | 10 | 100% |
| Buprenorphine -3-D-Glucuronide | 160 | 6% |
| Norbuprenorphine | 10 | 100% |
| Norbuprenorphine-3-D-Glucuronide | 200 | 5% |
| Morphine | 100000 (negative) | Not detected |
| Oxymorphone | 100000 (negative) | Not detected |
| Hydromorphone | 100000 (negative) | Not detected |

14

| PCP (Phencyclidine)
(Phencyclidine,
Cutoff=25 ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Phencyclidine | 25 | 100% |
| 4-Hydroxy Phencyclidine | 12500 | 0.2% |

| THC
(11-nor-Δ9-THC-9-COOH,
Cutoff=50 ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|---------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 11-nor-Δ8-THC -9-COOH | 30 | 167% |
| (-)-11-nor-9-carboxy-Δ 9-THC | 50 | 100% |
| (±)-11-nor-9-Carboxy-Δ9-THC | 50 | 100% |
| 11-nor-Δ9-THC -carboxy glucuronide | 100 | 50% |
| 11-hydroxy-Δ9-Tetrahydrocannabinol | 5,000 | 1% |
| Δ8- Tetrahydrocannabinol | 1,300 | 4% |
| Δ9- Tetrahydrocannabinol | 5,000 | 1% |
| Cannabinol | 20,000 | 0.25% |
| Cannabidiol | 100000(negative) | Not Detected |

| OXY
(Oxycodone, Cutoff=100 ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|--------------------------------------|--------------------------------------------------------------------------|------------------------|
| Ethyl Oxycodone | 75,000 | 0.1% |
| Hydrocodone | 5,000 | 2% |
| Hydromorphone | 25,000 | 0.4% |
| Levorphanol | 10,000 | 1 % |
| Oxycodone | 100 | 100% |
| Oxymorphone | 200 | 50% |
| Dihydrocodeine | 100000(negative) | Not Detected |
| Codeine | 100000(negative) | Not Detected |
| Morphine | 100000(negative) | Not Detected |
| Acetylmorphine | 100000(negative) | Not Detected |
| Buprenorphine | 100000(negative) | Not Detected |
| Ethylmorphine | 100000(negative) | Not Detected |
| Thebaine | 100000(negative) | Not Detected |

| BAR
(Secobarbital, Cutoff=300ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Alphenal | 150 | 200% |
| Amobarbital | 300 | 100% |

15

Aprobarbital	250	120%
Butabarbital	2,500	12%
Butethal	100	300%
Butalbital	2,500	12%
Cyclopentobarbital	600	50%
Pentobarbital	250	120%
Phenobarbital	250	120%
Secobarbital	300	100%

| BZO
(Oxazepam, Cutoff=300ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------|--------------------------------------------------------------------------|------------------------|
| Alprazolam | 200 | 150% |
| a-Hydroxyalprazolam | 1,260 | 24% |
| Bromazepam | 1,560 | 19% |
| Chlordiazepoxide | 1,560 | 19% |
| Clobazam | 100 | 300% |
| Clonazepam | 2,500 | 12% |
| Clorazepate dipotassium | 200 | 150% |
| Desalkylflurazepam | 400 | 75% |
| Diazepam | 200 | 150% |
| Estazolam | 2,500 | 12% |
| Flunitrazepam | 400 | 75% |
| Midazolam | 12,500 | 2.4% |
| Nitrazepam | 100 | 300% |
| Norchlordiazepoxide | 200 | 150% |
| Nordiazepam | 400 | 75% |
| Temazepam | 100 | 300% |
| Triazolam | 2,500 | 12% |
| Demoxepam | 2,000 | 15% |
| Flurazepam | 500 | 60% |
| D,L-Lorazepam | 1,560 | 20% |
| Oxazepam | 300 | 100% |
| RS-Lorazepam glucuronide | 160 | 188% |
| Delorazepam | 100000 (negative) | Not detected |

| EDDP
(2-ethylidene-1,5-dimethyl-3,3-
diphenylpyrrolidine, Cutoff = 300 ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine | 300 | 100% |
| Methadone | >100000 | Not detected |
| EMDP | >100000 | Not detected |

16

Doxylamine	>100000	Not detected
Disopyramide	>100000	Not detected
LAAM (Levo-alpha-acetylmethadol)	>100000	Not detected
Alpha Methadol	>100000	Not detected

| MTD
(Methadone, Cutoff=300ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-------------------------------------|--------------------------------------------------------------------------|------------------------|
| Methadone | 300 | 100% |
| Doxylamine | >100000 | Not detected |
| EDDP | >100000 | Not detected |
| EMDP | >100000 | Not detected |
| LAAM | >100000 | Not detected |
| Alpha Methadol | >100000 | Not detected |

| MOP 300
(Morphine, Cutoff=300ng/mL) | Minimum required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|----------------------------------------|---- | Morphine | 300 | Normorphine | 300 | s-Monoacetylmorphine | 300 | Codeine | 300 | Ethyl Morphine | 100 | Heroin | 600 | Hydrocodone | 10000 | Hydromorphone | 500 | Morphinie-3-β-d-glucuronide | 1000 | Thebaine | 6,240 | Levorphanol | 10000 | 6-Monoacetylmorphine (6-MAM) | 150 | 6-acetylmorphine | 400 | Dihydrocodeine | 1000 | Normorphine | >100000 | Oxycodone | >100000 | Oxymorphone | >100000 | Norcodeine | >100000 | Procaine | >100000 concentration
----------------------------------------------------------------------|------------------------|
| 100% |
| 100% |
| 100% |
| 100% |
| 300% |
| 50% |
| 3% |
| 60% |
| 30% |
| 4.8% |
| 3% |
| 200% |
| 75% |
| 30% |
| Not detected |
| Not detected |
| Not detected |
| Not detected |
| Not detected |

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

17

d-Norpropoxyphene	300	100%
-------------------	-----	------

| MDMA
(3,4-Methylenedioxymethamphetamine HCl,
Cutoff=500ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|---------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 3,4-Methylenedioxymethamphetamine (MDMA) | 500 | 100% |
| 3,4-Methylenedioxyamphetamine HCl (MDA) | 3000 | 17% |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | 300 | 167% |
| l-Methamphetamine | 50000 | 1% |
| d-methamphetamine | 100000(Negative) | Not detected |
| d-amphetamine | 100000(Negative) | Not detected |
| l-amphetamine | 100000(Negative) | Not detected |

TCA 1000 (Nortriptyline, Cutoff=1000ng/mL)	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
Chlorpheniramine maleate	50000	2%
Nortriptyline	1000	100%
Nordoxepine	1000	100%
Trimipramine	10000	10%
Amitriptyline	1500	66.7%
Promazine	50000	2%
Desipramine	1000	100%
Imipramine	1000	100%
Clomipramine	10000	10%
Doxepin	2000	50%
Maprotiline	100000(Negative)	Not detected
Promethazine	100000(Negative)	Not detected
Cyclobenzaprine	5000	20%
Norclomipramine	12500	8%
Duloxetine	10000	10%

| COC
(Benzoylecgonine, Cutoff=300ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Benzoylecgonine | 300 | 100% |
| Cocaine | 300 | 100% |
| Cocaethylene | 300 | 100% |
| Ecgonine | 300 | 100% |
| Ecgonine methyl ester | 100000 (negative) | Not detected |
| Norcocaine | 100000 (negative) | Not detected |

18

| AMP
(d-Amphetamine, Cutoff=1000ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------|--------------------------------------------------------------------------|------------------------|
| (+/-)-4-Hydroxyamphetamine | 8000 | 12.5% |
| Methylenedioxyamphetamine(MDA) | 400 | 250% |
| D,L-Amphetamine | 1,000 | 100% |
| D-Amphetamine | 1,000 | 100% |
| Diethylstilbestrol | 5,000 | 20% |
| L-Amphetamine | 50,000 | 2% |
| Phentermine | 8,000 | 12.5% |
| ß-Phenylethylamine | 100000 | 1% |
| p-Hydroxynorephedrine | 100000 | 1% |
| p-Hydroxyamphetamine | 100,000 | 1% |
| d/l-Norephedrine | 100,000 | 1% |
| d-Methamphetamine | 50,000 | 2% |
| l-Methamphetamine | 1,000 | 100% |
| Ephedrine | 100000 (negative) | Not detected |
| Methylenedioxymethamphetamine
(MDMA) | 100000 (negative) | Not detected |
| Phenylpropanolamine | 100000 (negative) | Not detected |
| Benzphetamine | 100000 (negative) | Not detected |
| l-Ephedrine | 100000 (negative) | Not detected |
| l-Epinephrine | 100000 (negative) | Not detected |
| d/l-Epinephrine | 100000 (negative) | Not detected |

| MET
(D(+)-Methamphetamine, Cutoff=1000ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine
(MDEA) | 20,000 | 5% |
| (±)-MDMA | 2,500 | 40% |
| d-Methamphetamine | 1,000 | 100% |
| l-Methamphetamine | 25,000 | 4% |
| d/l-Methamphetamine | 1,000 | 100% |
| p-Hydroxymethamphetamine | 10,000 | 10% |
| L-Amphetamine | 75000 | 1.3% |
| β-Phenylethylamine | 50000 | 2% |
| Mephetermine | 50000 | 2% |
| Fenfluramine | 50000 | 2% |
| D-Amphetamine | 100000(negative) | Not Detected |
| Chloroquine | 100000(negative) | Not Detected |

19

(+/-)3,4-Methylenedioxyamphetamine (MDA)	100000(negative)	Not Detected
Trimethobenzamide	100000(negative)	Not Detected
d,l-Amphetamine	100000(negative)	Not Detected
(1R,2S)-(-)-Ephedrine	100000(negative)	Not Detected
l-phenylephrine	100000(negative)	Not Detected

| OPI
(Morphine, Cutoff=2000ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-------------------------------------|--------------------------------------------------------------------------|------------------------|
| Morphine | 2000 | 100% |
| Codeine | 1000 | 200% |
| Ethyl Morphine | 2500 | 80% |
| Hydrocodone | 5000 | 40% |
| Hydromorphone | 25000 | 8% |
| Levorphanol | 10000 | 20% |
| 6-Monoacetylmorphine (6-MAM) | 1500 | 133% |
| Morphine 3-β-D-glucuronide | 2000 | 100% |
| Norcodeine | 4000 | 50% |
| Normorphine | 5000 | 40% |
| Oxymorphone | 75000 | 3% |
| Thebaine | 13000 | 15% |
| Heroin | 5000 | 40% |
| s-Monoacetylmorphine | 2000 | 100% |
| Dihydrocodeine | 1500 | 133% |
| Nalorphine | 5000 | 40% |
| 6-acetylmorphine | 2,500 | 80% |
| Procaine | 100000(negative) | Not Detected |
| Oxycodone | 100000(negative) | Not Detected |

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 +50% cutoff and -50% cutoff levels. Three operators tested samples using test devices from three different lots. The results were all positive for samples at +50% cutoff and all negative for samples at -50% 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 +50% cutoff and -50% cutoff levels. Three operators tested samples using test devices from three different lots. The results were all positive for samples at +50% cutoff and all negative for samples at -50% cutoff, indicating that urine pH value between 4.0 and 9.0 has no effect on the accuracy and precision of the test device.

20

1. Comparison Studies
  The method comparison studies for Accurate® Multi Panel Drug Urine Test cup were performed inhouse with three operators.

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

BUP

| Accurate
® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|---------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 14 | 23 |
| | Negative | 10 | 16 | 13 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 3 | 14 | 23 |
| | Negative | 10 | 16 | 11 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 14 | 23 |
| | Negative | 10 | 16 | 13 | 3 | 0 |

Discordant Results for BUP:

Viewer	Sample Number	LC/MS Result (ng/mL)	Accurate Result
Viewer A	MCP-BUP-A75	10.2	-
Viewer A	MCP-BUP-A42	10.9	-
Viewer A	MCP-BUP-A61	11.2	-
Viewer B	MCP-BUP-A58	10.3	-
Viewer B	MCP-BUP-A42	10.9	-
Viewer B	MCP-BUP-A06	12.3	-
Viewer C	MCP-BUP-A58	10.3	-
Viewer C	MCP-BUP-A70	11.3	-
Viewer C	MCP-BUP-A11	12.9	-
Viewer A	MCP-BUP-A79	9.0	+
Viewer B	MCP-BUP-A01	8.4	+
Viewer B	MCP-BUP-A79	9.0	+
Viewer B	MCP-BUP-A54	9.5	+
Viewer C	MCP-BUP-A54	9.5	+

BAR

Accurate ®	Drug-Free	Low Negative by LC/MS (less than -50%)	Near Cutoff Negative by LC/MS	Near Cutoff Positive by LC/MS	High Positive by LC/MS (greater than +50%)
------------------------	-----------	----------------------------------------	-------------------------------	-------------------------------	--------------------------------------------

21

| | | | | (Between -50%
and the Cutoff) | (Between the
cutoff and
+50%) | |
|----------|----------|----|----|----------------------------------|-------------------------------------|----|
| Viewer A | Positive | 0 | 0 | 3 | 14 | 23 |
| | Negative | 10 | 16 | 11 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 14 | 23 |
| | Negative | 10 | 16 | 12 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 14 | 23 |
| | Negative | 10 | 16 | 12 | 3 | 0 |

Discordant Results for BAR:

Viewer	Sample Number	LC/MS Result (ng/mL)	Accurate Result
Viewer A	MCP-BAR-A64	271.6	+
Viewer A	MCP-BAR-A02	285.9	+
Viewer A	MCP-BAR-A41	295.6	+
Viewer B	MCP-BAR-A23	246.0	+
Viewer B	MCP-BAR-A02	285.9	+
Viewer C	MCP-BAR-A02	285.9	+
Viewer C	MCP-BAR-A41	295.6	+
Viewer A	MCP-BAR-A14	301.7	-
Viewer A	MCP-BAR-A03	317.8	-
Viewer A	MCP-BAR-A52	332.9	-
Viewer B	MCP-BAR-A47	311.9	-
Viewer B	MCP-BAR-A78	327.1	-
Viewer B	MCP-BAR-A27	347.5	-
Viewer C	MCP-BAR-A14	301.7	-
Viewer C	MCP-BAR-A47	311.9	-
Viewer C	MCP-BAR-A20	347.5	-

BZO

| Accurate
@ | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|---------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 14 | 23 |
| | Negative | 10 | 16 | 13 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 3 | 13 | 23 |
| | Negative | 10 | 16 | 11 | 4 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 14 | 23 |

22

	Negative	10	16	12	3	0
--	----------	----	----	----	---	---

Discordant Results for BZO:

Viewer	Sample Number	LC/MS Result (ng/mL)	Accurate Result
Viewer A	MCP-BZO-A37	274.5	+
Viewer B	MCP-BZO-A51	227.5	+
Viewer B	MCP-BZO-A42	264.1	+
Viewer B	MCP-BZO-A18	288.6	+
Viewer C	MCP-BZO-A75	235.0	+
Viewer C	MCP-BZO-A37	274.5	+
Viewer A	MCP-BZO-A76	304.6	-
Viewer A	MCP-BZO-A56	350.5	-
Viewer A	MCP-BZO-A73	358.2	-
Viewer B	MCP-BZO-A76	304.6	-
Viewer B	MCP-BZO-A03	311.2	-
Viewer B	MCP-BZO-A63	335.5	-
Viewer B	MCP-BZO-A73	358.2	-
Viewer C	MCP-BZO-A27	309.5	-
Viewer C	MCP-BZO-A08	332.0	-
Viewer C	MCP-BZO-A56	350.5	-

EDDP

| Accurate® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -
50% and the
Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|-----------|----------|-----------|-------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 14 | 23 |
| | Negative | 10 | 16 | 13 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 23 |
| | Negative | 10 | 16 | 13 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 15 | 23 |
| | Negative | 10 | 16 | 13 | 2 | 0 |

Discordant Results for EDDP:

Viewer	Sample Number	LC/MS Result (ng/mL)	Accurate Result
Viewer A	MCP-EDDP-A07	254.8	+
Viewer B	MCP-EDDP-A07	254.8	+
Viewer C	MCP-EDDP-A21	245.1	+
Viewer A	MCP-EDDP-A12	303.7	-
Viewer A	MCP-EDDP-A34	306.8	-
Viewer A	MCP-EDDP-A20	316.7	-

23

Viewer B	MCP-EDDP-A38	302.4	-
Viewer B	MCP-EDDP-A46	310.5	-
Viewer B	MCP-EDDP-A14	319.9	-
Viewer C	MCP-EDDP-A12	303.7	-
Viewer C	MCP-EDDP-A20	316.7	-

MDMA

Accurate ®		Drug-Free	Low Negative by LC/MS (less than -50%)	Near Cutoff Negative by LC/MS (Between -50% and the Cutoff)	Near Cutoff Positive by LC/MS (Between the cutoff and +50%)	High Positive by LC/MS (greater than +50%)
Viewer A	Positive	0	0	1	13	23
	Negative	10	16	13	4	0
Viewer B	Positive	0	0	2	14	23
	Negative	10	16	12	3	0
Viewer C	Positive	0	0	1	14	23
	Negative	10	16	13	3	0

Discordant Results for MDMA:

Viewer	Sample Number	LC/MS Result (ng/mL)	Accurate Result
Viewer A	MCP-MDMA-A10	451.4	+
Viewer B	MCP-MDMA-A48	379.2	+
Viewer B	MCP-MDMA-A26	476.0	+
Viewer C	MCP-MDMA-A10	451.4	+
Viewer A	MCP-MDMA-A21	525.2	-
Viewer A	MCP-MDMA-A04	538.5	-
Viewer A	MCP-MDMA-A07	562.6	-
Viewer A	MCP-MDMA-A38	542.7	-
Viewer B	MCP-MDMA-A78	532.6	-
Viewer B	MCP-MDMA-A38	542.7	-
Viewer B	MCP-MDMA-A24	591.1	-
Viewer C	MCP-MDMA-A39	528.9	-
Viewer C	MCP-MDMA-A56	551.9	-
Viewer C	MCP-MDMA-A24	591.1	-

24

| Accurate
® | | Drug-Free | Low
Negative by
GC/MS (less
than -50%) | Near Cutoff
Negative by
GC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
GC/MS
(Between the
cutoff and
+50%) | High Positive
by GC/MS
(greater than
+50%) |
|---------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 2 | 15 | 23 |
| | Negative | 10 | 16 | 12 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 3 | 15 | 23 |
| | Negative | 10 | 16 | 11 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 15 | 23 |
| | Negative | 10 | 16 | 12 | 2 | 0 |

Discordant Results for MOP 300:

Viewer	Sample Number	GC/MS Result (ng/mL)	Accurate Result
Viewer A	MCP-MOP-A152	277.0	+
Viewer A	MCP-MOP-A141	283.1	+
Viewer B	MCP-MOP-A135	240.9	+
Viewer B	MCP-MOP-A098	272.3	+
Viewer B	MCP-MOP-A147	290.0	+
Viewer C	MCP-MOP-A098	272.3	+
Viewer C	MCP-MOP-A141	283.1	+
Viewer A	MCP-MOP-A151	305.6	-
Viewer A	MCP-MOP-A114	372.5	-
Viewer B	MCP-MOP-A081	300.4	-
Viewer B	MCP-MOP-A151	305.6	-
Viewer C	MCP-MOP-A081	300.4	-
Viewer C	MCP-MOP-A157	331.8	-

MTD

| Accurate
® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|---------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 13 | 23 |
| | Negative | 10 | 16 | 13 | 4 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 14 | 23 |
| | Negative | 10 | 16 | 12 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 13 | 23 |
| | Negative | 10 | 16 | 13 | 4 | 0 |

25

Discordant Results for MTD:

Viewer	Sample Number	LC/MS Result (ng/mL)	Accurate Result
Viewer A	MCP-MTD-A71	290.9	+
Viewer B	MCP-MTD-A25	262.4	+
Viewer B	MCP-MTD-A36	272.2	+
Viewer C	MCP-MTD-A71	290.9	+
Viewer A	MCP-MTD-A52	309.6	-
Viewer A	MCP-MTD-A80	316.6	-
Viewer A	MCP-MTD-A10	326.3	-
Viewer A	MCP-MTD-A43	363.5	-
Viewer B	MCP-MTD-A52	309.6	-
Viewer B	MCP-MTD-A10	326.3	-
Viewer B	MCP-MTD-A42	319.1	-
Viewer C	MCP-MTD-A45	300.5	-
Viewer C	MCP-MTD-A52	309.6	-
Viewer C	MCP-MTD-A42	319.1	-
Viewer C	MCP-MTD-A76	327.8	-

OXY

| Accurate
® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|---------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 12 | 23 |
| | Negative | 10 | 16 | 13 | 5 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 23 |
| | Negative | 10 | 16 | 13 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 13 | 23 |
| | Negative | 10 | 16 | 13 | 4 | 0 |

Discordant Results for OXY:

Viewer	Sample Number	LC/MS Result (ng/mL)	Accurate Result
Viewer A	MCP-OXY-A54	77.1	+
Viewer B	MCP-OXY-A33	92.3	+
Viewer C	MCP-OXY-A33	92.3	+
Viewer A	MCP-OXY-A76	102.8	-
Viewer A	MCP-OXY-A31	105.3	-
Viewer A	MCP-OXY-A14	105.5	-
Viewer A	MCP-OXY-A38	109.7	-

26

Viewer A	MCP-OXY-A52	115.5	-
Viewer B	MCP-OXY-A15	103.7	-
Viewer B	MCP-OXY-A34	109.4	-
Viewer B	MCP-OXY-A27	120.5	-
Viewer C	MCP-OXY-A60	100.5	-
Viewer C	MCP-OXY-A15	103.7	-
Viewer C	MCP-OXY-A65	105.8	-
Viewer C	MCP-OXY-A34	109.4	-

РСР

| Accurate
® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|---------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 12 | 23 |
| | Negative | 10 | 16 | 13 | 5 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 23 |
| | Negative | 10 | 16 | 14 | 4 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 11 | 23 |
| | Negative | 10 | 16 | 13 | 6 | 0 |

Discordant Results for PCP:

Viewer	Sample Number	LC/MS Result (ng/mL)	Accurate Result
Viewer A	MCP-PCP-A38	23.6	+
Viewer C	MCP-PCP-A65	23.1	+
Viewer A	MCP-PCP-A04	25.5	-
Viewer A	MCP-PCP-A73	25.5	-
Viewer A	MCP-PCP-A20	26.6	-
Viewer A	MCP-PCP-A22	27.3	-
Viewer A	MCP-PCP-A55	28.3	-
Viewer B	MCP-PCP-A04	25.5	-
Viewer B	MCP-PCP-A59	25.9	-
Viewer B	MCP-PCP-A22	27.3	-
Viewer B	MCP-PCP-A46	27.6	-
Viewer C	MCP-PCP-A53	25.1	-
Viewer C	MCP-PCP-A73	25.5	-
Viewer C	MCP-PCP-A59	25.9	-
Viewer C	MCP-PCP-A20	26.6	-
Viewer C	MCP-PCP-A29	26.8	-

27

| MCP-PCP-A08
र्
Viewer C | f Children Children Station of Children Children Station of Children Station of Children Station of Children Station of Station of Station of Station of Station of Station of
September 19, 2017 11:00 PM | |

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

| Accurate
® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|---------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 14 | 23 |
| | Negative | 10 | 16 | 13 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 15 | 23 |
| | Negative | 10 | 16 | 13 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 15 | 23 |
| | Negative | 10 | 16 | 13 | 2 | 0 |

PPX

Discordant Results for PPX 300:

Viewer	Sample Number	LC/MS Result (ng/mL)	Accurate Result
Viewer A	MCP-PPX-A78	255.3	+
Viewer B	MCP-PPX-A20	295.8	+
Viewer C	MCP-PPX-A20	295.8	+
Viewer A	MCP-PPX-A38	314.2	-
Viewer A	MCP-PPX-A46	327.2	-
Viewer A	MCP-PPX-A22	349.3	-
Viewer B	MCP-PPX-A38	314.2	-
Viewer B	MCP-PPX-A42	339.5	-
Viewer C	MCP-PPX-A12	307.1	-
Viewer C	MCP-PPX-A38	314.2	-

TCA

| Accurate
® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|---------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 2 | 14 | 23 |
| | Negative | 10 | 16 | 12 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 14 | 23 |
| | Negative | 10 | 16 | 12 | 3 | 0 |

28

Viewer C	Positive	0	0	3	15	23
	Negative	10	16	11	2	0

Discordant Results for TCA:

Viewer	Sample Number	LC/MS Result (ng/mL)	Accurate Result
Viewer A	MCP-TCA-A45	806.6	+
Viewer A	MCP-TCA-A66	983.7	+
Viewer B	MCP-TCA-A09	925.4	+
Viewer B	MCP-TCA-A21	955.8	+
Viewer C	MCP-TCA-A57	780.7	+
Viewer C	MCP-TCA-A09	925.4	+
Viewer C	MCP-TCA-A66	983.7	+
Viewer A	MCP-TCA-A06	1070.1	-
Viewer A	MCP-TCA-A05	1111.1	-
Viewer A	MCP-TCA-A77	1239.5	-
Viewer B	MCP-TCA-A33	1045.4	-
Viewer B	MCP-TCA-A06	1070.1	-
Viewer B	MCP-TCA-A05	1111.1	-
Viewer C	MCP-TCA-A06	1070.1	-
Viewer C	MCP-TCA-A05	1111.1	-

THC

| Accurate
® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|---------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 15 | 23 |
| | Negative | 10 | 16 | 13 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 23 |
| | Negative | 10 | 16 | 13 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 15 | 23 |
| | Negative | 10 | 16 | 12 | 2 | 0 |

Discordant Results for THC:

Viewer	Sample Number	LC/MS Result (ng/mL)	Accurate Result
Viewer A	MCP-THC-A80	39.1	+
Viewer B	MCP-THC-A55	48.2	+
Viewer C	MCP-THC-A48	40.2	+
Viewer C	MCP-THC-A55	48.2	+

29

Viewer A	MCP-THC-A59	50.5	-
Viewer A	MCP-THC-A66	54.1	-
Viewer B	MCP-THC-A53	52.2	-
Viewer B	MCP-THC-A66	54.1	-
Viewer B	MCP-THC-A60	60.1	-
Viewer C	MCP-THC-A53	52.2	-
Viewer C	MCP-THC-A79	57.5	-

AMP

| Accurate
® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|---------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 3 | 15 | 23 |
| | Negative | 10 | 16 | 11 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 4 | 14 | 23 |
| | Negative | 10 | 16 | 10 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 14 | 23 |
| | Negative | 10 | 16 | 12 | 3 | 0 |

Discordant Results for AMP:

Viewer	Sample Number	LC/MS Result (ng/mL)	Accurate Result
Viewer A	MCP-AMP-A60	906.4	+
Viewer A	MCP-AMP-A14	971.9	+
Viewer A	MCP-AMP-A50	988.0	+
Viewer B	MCP-AMP-A47	789.6	+
Viewer B	MCP-AMP-A24	951.4	+
Viewer B	MCP-AMP-A31	966.9	+
Viewer B	MCP-AMP-A50	988.0	+
Viewer C	MCP-AMP-A10	923.2	+
Viewer C	MCP-AMP-A26	965.0	+
Viewer A	MCP-AMP-A56	1013.8	-
Viewer A	MCP-AMP-A78	1180.9	-
Viewer B	MCP-AMP-A49	1053.4	-
Viewer B	MCP-AMP-A48	1201.4	-
Viewer B	MCP-AMP-A13	1255.2	-
Viewer C	MCP-AMP-A49	1053.4	-
Viewer C	MCP-AMP-A05	1166.2	-
Viewer C	MCP-AMP-A80	1235.3	-

30

COC

| Accurate
® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|---------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 14 | 23 |
| | Negative | 10 | 16 | 13 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 13 | 23 |
| | Negative | 10 | 16 | 13 | 4 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 14 | 23 |
| | Negative | 10 | 16 | 13 | 3 | 0 |

Discordant Results for COC:

Viewer	Sample Number	LC/MS Result	Accurate Result
Viewer A	MCP-COC-A75	267.4	+
Viewer B	MCP-COC-A14	267.8	+
Viewer C	MCP-COC-A38	291.6	+
Viewer A	MCP-COC-A15	309.0	-
Viewer A	MCP-COC-A73	322.7	-
Viewer A	MCP-COC-A25	337.0	-
Viewer B	MCP-COC-A50	302.3	-
Viewer B	MCP-COC-A15	309.0	-
Viewer B	MCP-COC-A73	322.7	-
Viewer B	MCP-COC-A11	344.4	-
Viewer C	MCP-COC-A50	302.3	-
Viewer C	MCP-COC-A54	317.8	-
Viewer C	MCP-COC-A76	334.4	-

MET

| Accurate
® | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|---------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 13 | 23 |
| | Negative | 10 | 16 | 14 | 4 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 23 |
| | Negative | 10 | 16 | 13 | 3 | 0 |

31

| Viewer C | Positive | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | C
j |
|----------|----------|----|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | Negative | 10 | 10

| | |

Discordant Results for MET:

Viewer	Sample Number	LC/MS Result	Accurate Result
Viewer B	MCP-MET-A27	846.8	+
Viewer C	MCP-MET-A71	732.5	+
Viewer A	MCP-MET-A50	1034.1	-
Viewer A	MCP-MET-A39	1059.0	-
Viewer A	MCP-MET-A36	1225.0	-
Viewer A	MCP-MET-A09	1288.3	-
Viewer B	MCP-MET-A39	1059.0	-
Viewer B	MCP-MET-A14	1122.5	-
Viewer B	MCP-MET-A01	1246.5	-
Viewer C	MCP-MET-A50	1034.1	-
Viewer C	MCP-MET-A23	1081.3	-
Viewer C	MCP-MET-A36	1225.0	-
Viewer C	MCP-MET-A38	1267.0	-

OPI 2000

| Wondfo
Q-Cup | | Drug-Free | Low
Negative by
LC/MS (less
than -50%) | Near Cutoff
Negative by
LC/MS
(Between -50%
and the Cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and +50%) | High Positive
by LC/MS
(greater than
+50%) |
|-----------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 13 | 23 |
| | Negative | 10 | 16 | 13 | 4 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 23 |
| | Negative | 10 | 16 | 13 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 12 | 23 |
| | Negative | 10 | 16 | 13 | 5 | 0 |

Discordant Results for OPI 2000:

Viewer	Sample Number	LC/MS Result	Accurate Result
Viewer A	MCP-MOP-A24	1423.7	+
Viewer B	MCP-MOP-A10	1955.2	+
Viewer C	MCP-MOP-A10	1955.2	+
Viewer A	MCP-MOP-A09	2018.7	-
Viewer A	MCP-MOP-A07	2028.1	-
Viewer A	MCP-MOP-A36	2153.3	-
Viewer A	MCP-MOP-A40	2368.2	-

32

Viewer B	MCP-MOP-A50	2024.3	-
Viewer B	MCP-MOP-A07	2028.1	-
Viewer B	MCP-MOP-A36	2153.3	-
Viewer C	MCP-MOP-A09	2018.7	-
Viewer C	MCP-MOP-A50	2024.3	-
Viewer C	MCP-MOP-A14	2050.8	-
Viewer C	MCP-MOP-A46	2064.1	-
Viewer C	MCP-MOP-A43	2398.2	-

Lay-user study:

184 males and 126 females tested Accurate® Multi Panel Drug Urine Test Cup Configuration 1 (including MOP 300); 178 male and 132 females tested Accurate® Multi Panel Drug Urine Test Cup Configuration 2 (including MOP 2000 (OPI). They had diverse educational and professional backgrounds and fluent in English 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. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.

	Lay-User Study Results for Accurate® Multi Panel Drug Urine Test Cup Configuration 1 (MOP 300):

| Drugs | % of Cutoff | Number
of samples | Lay person results | | The percentage
agreement
(%) |
|------------------------------|-------------|----------------------|--------------------|--------------------|------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| Methamphetamine | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 20 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 20 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Cocaine | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 20 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 20 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| Marijuana | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 20 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 17 | 3 | 85% |
| | +50% Cutoff | 20 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 20 | 0 | 170 | 100% |
| Morphine | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 20 | 0 | 100% |
| | +50% Cutoff | 20 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 20 | 0 | 170 | 100% |
| Oxazepam | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 20 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 20 | 0 | 170 | 100% |
| Amphetamine | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 20 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 20 | 0 | 170 | 100% |
| Oxycodone | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 20 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 20 | 0 | 170 | 100% |
| Methadone | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 20 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| MDMA | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 20 | 0 | 170 | 100% |
| | | | | | |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 20 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 20 | 0 | 170 | 100% |
| Secobarbital | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 18 | 2 | 90% |
| | +50% Cutoff | 20 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 20 | 0 | 170 | 100% |
| Buprenorphine | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 20 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 20 | 0 | 170 | 100% |
| Phencyclidine | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 17 | 3 | 85% |
| | +50% Cutoff | 20 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 20 | 0 | 170 | 100% |
| Propoxyphene | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 20 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| Tricyclic
Antidepressants | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 20 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 2 | 18 | 90% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 20 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |
| | -100%Cutoff | 20 | 0 | 20 | 100% |
| EDDP | -75%Cutoff | 20 | 0 | 20 | 100% |
| | -50% Cutoff | 20 | 0 | 170 | 100% |
| | -25% Cutoff | 20 | 1 | 19 | 95% |
| | +25% Cutoff | 20 | 19 | 1 | 95% |
| | +50% Cutoff | 20 | 40 | 0 | 100% |
| | +75% Cutoff | 20 | 20 | 0 | 100% |

33

34

35

Lay-User Study Results for Accurate® Multi Panel Drug Urine Test Cup Configuration 2 (MOP 2000 (OPI)):

Drugs	% of Cutoff	Number of samples	Lay person results		The percentage agreement (%)
			No. of Positive	No. of Negative
Methamphetamine	-100%Cutoff	20	0	20	100%
	-75%Cutoff	20	0	20	100%
	-50% Cutoff	20	0	170	100%
	-25% Cutoff	20	1	19	95%
	+25% Cutoff	20	19	1	95%
	+50% Cutoff	20	40	0	100%
	+75% Cutoff	20	20	0	100%
Cocaine	-100%Cutoff	20	0	20	100%
	-75%Cutoff	20	0	20	100%
	-50% Cutoff	20	0	170	100%
	-25% Cutoff	20	1	19	95%
	+25% Cutoff	20	19	1	95%
	+50% Cutoff	20	40	0	100%
	+75% Cutoff	20	20	0	100%
Marijuana	-100%Cutoff	20	0	20	100%
	-75%Cutoff	20	0	20	100%
	-50% Cutoff	20	0	170	100%
	-25% Cutoff	20	2	18	90%
	+25% Cutoff	20	18	2	90%
	+50% Cutoff	20	40	0	100%
	+75% Cutoff	20	20	0	100%
Morphine	-100%Cutoff	20	0	20	100%
	-75%Cutoff	20	0	20	100%
	-50% Cutoff	20	0	170	100%
	-25% Cutoff	20	1	19	95%
	+25% Cutoff	20	19	1	95%
	+50% Cutoff	20	40	0	100%
	+75% Cutoff	20	20	0	100%
Oxazepam	-100%Cutoff	20	0	20	100%
	-75%Cutoff	20	0	20	100%
	-50% Cutoff	20	0	170	100%
	-25% Cutoff	20	1	19	95%

	+25% Cutoff	20	19	1	95%
	+50% Cutoff	20	40	0	100%
	+75% Cutoff	20	20	0	100%
	-100% Cutoff	20	0	20	100%
	-75% Cutoff	20	0	20	100%
	-50% Cutoff	20	0	170	100%
Amphetamine	-25% Cutoff	20	2	18	90%
	+25% Cutoff	20	19	1	95%
	+50% Cutoff	20	40	0	100%
	+75% Cutoff	20	20	0	100%
	-100% Cutoff	20	0	20	100%
	-75% Cutoff	20	0	20	100%
	-50% Cutoff	20	0	170	100%
Oxycodone	-25% Cutoff	20	2	18	90%
	+25% Cutoff	20	19	1	95%
	+50% Cutoff	20	40	0	100%
	+75% Cutoff	20	20	0	100%
	-100% Cutoff	20	0	20	100%
	-75% Cutoff	20	0	20	100%
	-50% Cutoff	20	0	170	100%
Methadone	-25% Cutoff	20	1	19	95%
	+25% Cutoff	20	19	1	95%
	+50% Cutoff	20	40	0	100%
	+75% Cutoff	20	20	0	100%
	-100% Cutoff	20	0	20	100%
	-75% Cutoff	20	0	20	100%
	-50% Cutoff	20	0	170	100%
MDMA	-25% Cutoff	20	2	18	90%
	+25% Cutoff	20	19	1	95%
	+50% Cutoff	20	40	0	100%
	+75% Cutoff	20	20	0	100%
	-100% Cutoff	20	0	20	100%
	-75% Cutoff	20	0	20	100%
Secobarbital	-50% Cutoff	20	0	170	100%
	-25% Cutoff	20	1	19	95%
	+25% Cutoff	20	18	2	90%
	+50% Cutoff	20	40	0	100%
	+75% Cutoff	20	20	0	100%
	-100% Cutoff	20	0	20	100%
	-75% Cutoff	20	0	20	100%
Buprenorphine	-50% Cutoff	20	0	170	100%
	-25% Cutoff	20	3	17	85%

Phencyclidine	+25% Cutoff	20	18	2	90%
	+50% Cutoff	20	40	0	100%
	+75% Cutoff	20	20	0	100%
	-100% Cutoff	20	0	20	100%
	-75% Cutoff	20	0	20	100%
	-50% Cutoff	20	0	170	100%
	-25% Cutoff	20	2	18	90%
	+25% Cutoff	20	17	3	85%
	+50% Cutoff	20	40	0	100%
	+75% Cutoff	20	20	0	100%
Propoxyphene	-100% Cutoff	20	0	20	100%
	-75% Cutoff	20	0	20	100%
	-50% Cutoff	20	0	170	100%
	-25% Cutoff	20	2	18	90%
	+25% Cutoff	20	19	1	95%
	+50% Cutoff	20	40	0	100%
	+75% Cutoff	20	20	0	100%
Tricyclic
Antidepressants	-100% Cutoff	20	0	20	100%
	-75% Cutoff	20	0	20	100%
	-50% Cutoff	20	0	170	100%
	-25% Cutoff	20	1	19	95%
	+25% Cutoff	20	19	1	95%
	+50% Cutoff	20	40	0	100%
	+75% Cutoff	20	20	0	100%
EDDP	-100% Cutoff	20	0	20	100%
	-75% Cutoff	20	0	20	100%
	-50% Cutoff	20	0	170	100%
	-25% Cutoff	20	2	18	90%
	+25% Cutoff	20	19	1	95%
	+50% Cutoff	20	40	0	100%
	+75% Cutoff	20	20	0	100%

36

37

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

38

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 Accurate® Multi Panel Drug Urine Test Cup are substantially equivalent to the predicate devices.