Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx

• K Number: K221871
• Device Name: Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
• Manufacturer: Healstone Biotech Inc
• Date Cleared: 2022-08-30 ( 63 days)
• Product Code: NFT NFV NFW NFY NGG NGL NGM PTG PTH QAW QBF
• Regulation Number: 862.3100

Intended Use

The Healstone Accurate ™ Drug of Abuse Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication. This drug test cup may contain any combination of the drug tests listed in the table above. This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (CCMS) is the preferred method confirmation test. For in vitro diagnostic use only. The Healstone Accurate ™ Drug of Abuse Urine Test Cup Rx is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication. This drug test cup may contain any combination of the drug tests listed in the table above. This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test. It is intended for prescription use. For in vitro diagnostic use only.

Device Description

The Healstone Accurate™ Drug of Abuse Urine Test Cup and Healstone Accurate™ Drug of Abuse 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 Accurate™ Cup and two desiccants, and a package insert. The Healstone Accurate™ Drug of Abuse Urine Test Cup is intended for over-the-counter use and the Healstone Accurate™ Drug of Abuse Urine Test Cup Rx is intended for prescription use.

Predicate Devices

K191841

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a rapid qualitative immunoassay test cup, which is a chemical-based test. There is no mention of AI, ML, image processing, or any computational analysis of the results. The performance studies focus on analytical and comparison studies typical of immunoassay devices.

Therapeutic

No.
This device is an in vitro diagnostic device used to detect the presence of drugs of abuse in urine samples, not to treat or cure a condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "For in vitro diagnostic use only." Additionally, the "Device Description" calls it a "rapid, single-use in vitro diagnostic devices."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "rapid, single-use in vitro diagnostic device" and "Each test kit contains a test device in one pouch. One pouch contains a test Accurate™ Cup and two desiccants, and a package insert." This indicates a physical hardware component (the test cup) is the primary device, not software.

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 clearly states: "For in vitro diagnostic use only." This is repeated for both the standard and Rx versions of the device.
• Device Description: The "Device Description" section also explicitly states: "The Healstone Accurate™ Drug of Abuse Urine Test Cup and Healstone Accurate™ Drug of Abuse Urine Test Cup Rx are rapid, single-use in vitro diagnostic devices."
• Nature of the Test: The device performs a "rapid qualitative immunoassay" on a biological sample (urine) to detect the presence of substances (drugs). This is a classic example of an in vitro diagnostic test.
• Purpose: The purpose is to provide preliminary results for the detection of potential abuse of drugs, which is a diagnostic purpose.

The information provided strongly indicates that this device is intended to be used outside of the body to examine a biological sample for diagnostic purposes, which is the definition of an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Healstone Accurate TM Drug of Abuse Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication.

CODE	SUBSTANCE	CUT-OFF (ng/mL)
AMP	Amphetamine	1000 or 500
BUP	Buprenorphine	10
BAR	Secobarbital	300
BZO	Oxazepam	300
COC	Cocaine	300 or 150
EDDP	2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine	300
MET/mAMP	Methamphetamine	1000 or 500
MDMA	3,4-methylenedioxy-methamphetamine	500
OPI/MOP	Morphine	2000 or 300
MTD	Methadone	300
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	Propoxyphene	300
TCA	Nortriptyline	1000
THC	Marijuana	50

This drug test cup may contain any combination of the drug tests listed in the table above.

This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (CCMS) is the preferred method confirmation test. For in vitro diagnostic use only.

The Healstone Accurate ™ Drug of Abuse Urine Test Cup Rx is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication.

This drug test cup may contain any combination of the drug tests listed in the table above. This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test. It is intended for prescription use. For in vitro diagnostic use only.

Product codes

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

Device Description

The Healstone Accurate™ Drug of Abuse Urine Test Cup and Healstone Accurate™ Drug of Abuse 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 Accurate™ Cup and two desiccants, and a package insert. The Healstone Accurate™ Drug of Abuse Urine Test Cup is intended for over-the-counter use and the Healstone Accurate™ Drug of Abuse 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

Prescription Use (Part 21 CFR 801 Subpart D) and Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

The method comparison studies for Healstone Accurate™ Drug of Abuse 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 or GC/MS results.

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. 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. Eighty-one males and 59 females tested AccurateTM Drug of Abuse Urine Test Cup Configuration 1 (including AMP 1000, MET 1000, MOP 300, COC 300); 90 male and 50 females tested AccurateTM Drug of Abuse Urine Test Cup Configuration 2 (including AMP 500, MET 500, OPI 2000, COC 150). Each participant was provided one package insert, one blind labeled test solution, and one test device.

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

Analytical Performance - Precision Study:

• Study Type: Precision Study
• Sample Size: 25 days, 3 lots, 50 tests per lot. Total 3750 tests per drug type (5 concentration levels x 3 lots x 2 runs/day x 25 days).
• Key Results: The tables show the number of negative and positive results for each drug at various concentrations relative to the cutoff, across three different test lots. For concentrations at -100%, -75%, and -50% cutoff, all results were negative (50-/0+). For concentrations at +50%, +75%, and +100% cutoff, all results were positive (50+/0-). Around the cutoff and -25% cutoff, there were mixed negative and positive results, indicating the expected performance around the detection threshold.

Analytical Performance - Linearity:

• Not applicable.

Analytical Performance - Stability:

• Key Results: The devices are stable at 2-30℃ for 24 months based on real-time stability studies.

Analytical Performance - Interference:

• Study Type: Interference study
• Sample Size: Not explicitly stated but "samples with target drugs of -50% cutoff and +50% cutoff level" were used.
• Key Results: Compounds listed show no interference at a concentration of 100μg/mL.

Analytical Performance - Specificity:

• Study Type: Specificity testing for cross-reactivity
• Key Results: Percent cross-reactivity was provided for various drug metabolites and other compounds. Compounds that did not yield a positive result at the highest concentration tested are represented by a dash. For example, for BUP 10, Norbuprenorphine showed 100% cross-reactivity, while Morphine, Oxymorphone, and Hydromorphone showed no cross-reactivity at >100,000 ng/mL.

Analytical Performance - Effect of Urine Specific Gravity and Urine pH:

• Study Type: Effect of urine properties
• Key Results: Urine samples with specific gravity from 1.000 to 1.035 and pH values from 4 to 9 were tested. All results were positive for samples at +50% cutoff and negative for samples at -50% cutoff. No interference was observed.

Comparison Studies (Method Comparison):

• Study Type: In-house method comparison study
• Sample Size: 80 (40 negative and 40 positive) unaltered urine samples per drug type.
• Key Metrics: Shows the number of positive and negative results by the Healstone Accurate™ device compared to LC/MS or GC/MS results for drug-free, low negative, near cutoff negative, near cutoff positive, and high positive samples. Discordant results are also listed with specific sample numbers and LC/MS results.

Lay-User Study:

• Study Type: Lay-user study
• Sample Size: 280 participants recruited from three sites.
  • Configuration 1 (AMP 1000, MET 1000, MOP 300, COC 300): 81 males and 59 females (Total 140 participants).
  • Configuration 2 (AMP 500, MET 500, OPI 2000, COC 150): 90 males and 50 females (Total 140 participants).
  • Each participant tested one blind-labeled test solution and one test device.
• Key Metrics: Agreement (%) between lay-user results and expected results based on spiked concentrations for various drugs at different cutoff levels. For example, for BZO 300 in Configuration 1, agreement was 100% for -100%, -75%, -50%, +50%, +75% cutoff concentrations. For -25% cutoff, agreement was 85%, and for +25% cutoff, agreement was 90%. Similar agreement percentages are provided for all drugs and configurations tested.
• Key Results: All participants indicated that the device instruction is easy to understand and follow. The Flesch-Kincaid reading analysis showed a Grade Level of 7 for the package inserts.

Conclusion: Based on the test principle and performance characteristics of the device, it is concluded that Healstone Accurate™ Drug of Abuse Urine Test Cup and Healstone Accurate™ Drug of Abuse Urine Test Cup Rx are substantially equivalent to the predicate devices.

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

Key metrics are presented in tables detailing the number of positive and negative results for different concentration ranges (drug-free, low negative, near cutoff negative, near cutoff positive, high positive) as observed by three operators. For example, for AMP 500, Operator A had 0 false positives in drug-free and low negative samples. For samples near cutoff negative, Operator A had 2 positive results ("false positives" at that specific range), and for near cutoff positive, 2 negative results ("false negatives" at that range). The actual sensitivity, specificity, PPV, and NPV values are not explicitly calculated, but can be derived from the provided tables.

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.

K191841

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

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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 30, 2022

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

Re: K221871

Trade/Device Name: Healstone Accurate™ Drug of Abuse Urine Test Cup, Healstone Accurate™ Drug of Abuse 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, QBF, NGG, QAW, NFW, NGM Dated: June 26, 2022 Received: June 28, 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Paula Caposino, Ph.D. Acting Deputy 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

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Indications for Use

510(k) Number (if known)

K221871

Device Name

Healstone Accurate™ Drug of Abuse Urine Test Cup

Indications for Use (Describe)

The Healstone Accurate ™ Drug of Abuse Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication.

| CODE | SUBSTANCE | CUT-OFF
(ng/mL) |
|----------|---------------------------------------------------------|--------------------|
| AMP | Amphetamine | 1000 or 500 |
| BUP | Buprenorphine | 10 |
| BAR | Secobarbital | 300 |
| BZO | Oxazepam | 300 |
| COC | Cocaine | 300 or 150 |
| EDDP | 2-ethylidene-1, 5-dimethyl-3, 3-
diphenylpyrrolidine | 300 |
| MET/mAMP | Methamphetamine | 1000 or 500 |
| MDMA | 3,4-methylenedioxy-methamphetamine | 500 |
| OPI/MOP | Morphine | 2000 or 300 |
| MTD | Methadone | 300 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | Marijuana | 50 |

This drug test cup may contain any combination of the drug tests listed in the table above.

This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (CCMS) is the preferred method confirmation test. For in vitro diagnostic use only.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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."

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Indications for Use

510(k) Number (if known)

K221871

Device Name

Healstone Accurate™Drug of Abuse Urine Test Cup Rx

Indications for Use (Describe)

The Healstone Accurate ™ Drug of Abuse Urine Test Cup Rx is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication.

| CODE | SUBSTANCE | CUT-OFF
(ng/mL) |
|----------|---------------------------------------------------------|--------------------|
| AMP | Amphetamine | 1000 or 500 |
| BUP | Buprenorphine | 10 |
| BAR | Secobarbital | 300 |
| BZO | Oxazepam | 300 |
| COC | Cocaine | 300 or 150 |
| EDDP | 2-ethylidene-1, 5-dimethyl-3, 3-
diphenylpyrrolidine | 300 |
| MET/mAMP | Methamphetamine | 1000 or 500 |
| MDMA | 3,4-methylenedioxy-methamphetamine | 500 |
| OPI/MOP | Morphine | 2000 or 300 |
| MTD | Methadone | 300 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | Marijuana | 50 |

This drug test cup may contain any combination of the drug tests listed in the table above.

This drug tests cup provides only a preliminary result. An alternative laboratory test must be results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test. It is intended for prescription use. For in vitro diagnostic use only.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

5

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

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

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

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

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

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• Date August 30, 2022 1 Healstone Biotech Inc. 2 Submitter 655 W Kent Ave N #650 Vancouver, BC V6P 6T7, Canada
• Contact Person Joe Shia 3 LSI International Inc. 504 East Diamond Ave., Suite I Gaithersburg, MD 20877 Telephone: [phone] Fax: [phone] Email: [e-mail]
• Healstone Accurate™ Drug of Abuse Urine Test Cup 4 Device Name Healstone Accurate™ Drug of Abuse Urine Test Cup Rx
• 5 Classification Class II

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

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

Predicate Device K191841 6.

Healstone Accurate™ Multi Panel Drug Urine Test Cup

7. Intended Use

The Healstone Accurate TM Drug of Abuse Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication.

CODE	SUBSTANCE	CUT-OFF (ng/mL)
AMP	Amphetamine	1000 or 500
BUP	Buprenorphine	10
BAR	Secobarbital	300
BZO	Oxazepam	300
COC	Cocaine	300 or 150
EDDP	2-ethylidene-1, 5-dimethyl-3, 3-
diphenylpyrrolidine	300
MET/mAMP	Methamphetamine	1000 or 500
MDMA	3,4-methylenedioxy-methamphetamine	500
OPI / MOP	Morphine	2000 or 300
MTD	Methadone	300
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	Propoxyphene	300
TCA	Nortriptyline	1000
THC	Marijuana	50

This drug test cup may contain any combination of the drug tests listed in the table above.

This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test.

For in vitro diagnostic use only.

The Healstone Accurate ™ Drug of Abuse Urine Test Cup Rx is a rapid qualitative immunoassay.

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The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication.

CODE	SUBSTANCE	CUT-OFF (ng/mL)
AMP	Amphetamine	1000 or 500
BUP	Buprenorphine	10
BAR	Secobarbital	300
BZO	Oxazepam	300
COC	Cocaine	300 or 150
EDDP	2-ethylidene-1, 5-dimethyl-3, 3-
diphenylpyrrolidine	300
MET/mAMP	Methamphetamine	1000 or 500
MDMA	3,4-methylenedioxy-methamphetamine	500
OPI/MOP	Morphine	2000 or 300
MTD	Methadone	300
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	Propoxyphene	300
TCA	Nortriptyline	1000
THC	Marijuana	50

This drug test cup may contain any combination of the drug tests listed in the table above. This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test. It is intended for prescription use. For in vitro diagnostic use only.

Device Description 8.

The Healstone Accurate™ Drug of Abuse Urine Test Cup and Healstone Accurate™ Drug of Abuse 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 Accurate™ Cup and two desiccants, and a package insert. The Healstone Accurate™ Drug of Abuse Urine Test Cup is intended for over-the-counter use and the Healstone Accurate™ Drug of Abuse Urine Test Cup Rx is intended for prescription use.

9. Substantial Equivalence Information

| Item | Proposed Device | Predicate
(K191841) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| 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 |

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Type of Test	Qualitative	Same
Specimen Type	Human urine	Same
Target Drug and
Cut Off Values	Target Drug	Cutoff (ng/mL)	Same except that
	Amphetamine (AMP)	1000 or 500	AMP and MET have
	Buprenorphine (BUP)	10	no 500 cutoff, and
	Secobarbital (BAR)	300	COC has no 150
	Oxazepam (BZO)	300	cutoff.
	Cocaine (COC)	300 or 150
	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

Healstone Accurate™ Drug of Abuse Urine Test Cup and Healstone Accurate™ Drug of Abuse Urine Test Cup Rx are rapid tests for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-dipheny|pyrrolidine,Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in urine samples. They are lateral flow chromatographic immunoassay. When urine sample is added to the cup device, urine is absorbed into the test strip and migrates upwards by capillary action. If the concentration of target drug presented in the urine sample is below the cutoff level, the target drug will not saturate the binding sites of its specific monoclonal antibody-coated particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored band will be formed on the test line region. If the concentration of target is beyond the cutoff level, the target drug will saturate the binding sites of its specific monoclonal antibody-particles, thus the antibody-coated particles will not be captured by immobilized drug-conjugate hence no colored band will be formed on the test line region.

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

10

11. Performance Characteristics

1. Analytical Performance

Precision a.

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

| Concentration
(ng/mL)
Lot Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| 0 | 2.4 | 5.1 | 7.5 | 10.2 | 12.3 | 14.8 | 17.6 | 19.6 | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 25-/25+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 27-/23+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |

Accurate™ Drug of Abuse Urine Test Cup BUP 10

Accurate™ Drug of Abuse Urine Test Cup PCP 25

| Concentration
(ng/mL)
Lot Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | 0 | 5.8 | 11.9 | 18.7 | 25.2 | 32.0 | 38.7 | 43.1 | 50.8 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 22-/28+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 22-/28+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 23-/27+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |

Accurate™ Drug of Abuse Urine Test Cup THC 50

| Concentration | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| (ng/mL) | 0 | 12.4 | 26.9 | 39.3 | 53.5 | 64.5 | 77.7 | 89.6 | 102.4 |
| Lot Number | | | | | | | | | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 23-/27+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 22-/28+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 23-/27+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |

Accurate™ Drug of Abuse Urine Test Cup OXY 100

Concentration	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%
---------------	-------	------	------	------	---------	------	------	------	-------

11

(ng/mL)	cut off	cut off	cut off	cutoff	cut off	cut off	cut off	cut off	cut off
Lot Number	0	26.8	49.2	81.1	101.5	131.6	153.4	174.1	192.0
Lot 1	50-/0+	50-/0+	50-/0+	49-/1+	25-/25+	48+/2-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	49-/1+	24-/26+	49+/1-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	48-/2+	27-/23+	48+/2-	50+/0-	50+/0-	50+/0-

Accurate™ Drug of Abuse Urine Test Cup BAR 300

| Concentration
(ng/mL)
Lot Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | 0 | 78.2 | 145.0 | 230.9 | 316.6 | 382.5 | 455.2 | 533.0 | 587.7 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 24-/26+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 25-/25+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 21-/29+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |

Accurate™ Drug of Abuse Urine Test Cup BZO 300

| Concentration
(ng/mL) | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|--------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot Number | 0 | 76.6 | 148.6 | 222.9 | 300.0 | 374.3 | 455.7 | 516.0 | 598.6 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 23-/27+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 22-/28+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |

Accurate™ Drug of Abuse Urine Test Cup EDDP 300

| Concentration
(ng/mL) | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|--------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot Number | 0 | 72.4 | 149.2 | 233.2 | 312.4 | 385.2 | 451.2 | 522.0 | 599.0 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 23-/27+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 22-/28+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |

Accurate™ Drug of Abuse Urine Test Cup MTD 300

| Concentration
(ng/mL)
Lot Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | 0 | 73.7 | 156.5 | 229.9 | 314.4 | 365.1 | 456.9 | 521.2 | 590.2 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 23-/27+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |

12

Lot 2	50-/0+	50-/0+	50-/0+	48-/2+	23-/27+	48+/2-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	48-/2+	24-/26+	48+/2-	50+/0-	50+/0-	50+/0-

Accurate™ Drug of Abuse Urine Test Cup MOP 300

| Concentration
(ng/mL)
Lot Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | 0 | 69.1 | 148.2 | 228.7 | 302.0 | 382.1 | 445.0 | 509.1 | 583.2 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 23-/27+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 23-/27+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |

Accurate™ Drug of Abuse Urine Test Cup PPX 300

| Concentration
(ng/mL)
Lot Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | 0 | 73.0 | 160.0 | 236.0 | 320.7 | 384.7 | 458.7 | 538.6 | 579.9 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 25-/25+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |

Accurate™ Drug of Abuse Urine Test Cup COC 150

| Concentration
(ng/mL)
Lot Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 22-/28+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 21-/29+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 23-/27+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |

Accurate™ Drug of Abuse Urine Test Cup MDMA 500

| Concentration
(ng/mL)
Lot Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off | |
|----------------------------------------|------------------|-----------------|-----------------|----------------|-----------------|-----------------|-----------------|------------------|--------|
| 0 | 122.9 | 272.8 | 370.6 | 499.5 | 628.4 | 752.1 | 870.4 | 935.7 | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 22-/28+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 21-/29+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 23-/27+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |

13

Accurate™ Drug of Abuse Urine Test Cup TCA 1000

| Concentration
(ng/mL) | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|--------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot Number | 0 | 248.7 | 489.5 | 758.2 | 988.3 | 1288.6 | 1536.5 | 1701.3 | 1958.2 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Accurate™ Drug of Abuse Urine Test Cup AMP 500

| Concentration
(ng/mL) | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|--------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | Lot Number | 0 | 123.4 | 267.8 | 354.5 | 498.5 | 630.4 | 716.0 | 850.7 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 25-/25+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |

Accurate™ Drug of Abuse Urine Test Cup MET 500

| Concentration
(ng/mL)
Lot Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | 0 | 128.8 | 262.7 | 365.1 | 512.9 | 680.8 | 790.4 | 909.2 | 1021.3 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 25-/25+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |

Accurate™ Drug of Abuse Urine Test Cup OPI 2000

| Concentration
(ng/mL)
Lot Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| 0 | 535.8 | 1070.4 | 1636.6 | 2122.3 | 2632.6 | 3014.8 | 3337.5 | 3762.8 | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Accurate™ Drug of Abuse Urine Test Cup COC 300

| Concentration
(ng/mL)
Lot Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | 0 | 79.9 | 159.9 | 229.9 | 301.1 | 380.2 | 463.4 | 529.1 | 593.2 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 22-/28+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |

14

Lot 2	50-/0+	50-/0+	50-/0+	48-/2+	22-/28+	49+/1-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	49-/1+	24-/26+	49+/1-	50+/0-	50+/0-	50+/0-

Accurate™ Drug of Abuse Urine Test Cup AMP 1000

| Concentration
(ng/mL)
Lot Number | -100%
cut off
0 | -75%
cut off
235.8 | -50%
cut off
525.0 | -25%
cutoff
785.9 | cut off
1086.6 | +25%
cut off
1315.3 | +50%
cut off
1599.2 | +75%
cut off
1816.7 | +100%
cut off
2040.5 |
|----------------------------------------|-----------------------|--------------------------|--------------------------|-------------------------|-------------------|---------------------------|---------------------------|---------------------------|----------------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Accurate™ Drug of Abuse Urine Test Cup MET 1000

| Concentration
(ng/mL)
Lot Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | 0 | 252.5 | 512.2 | 767.2 | 1021.9 | 1251.6 | 1496.4 | 1781.4 | 2005.1 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

The following cutoff values are verified:

Target Drug	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (OPI 2000/MOP 300)	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

15

b. Linearity

Not applicable

• c. Stability
  The devices are stable at 2-30℃ 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.

(-) Cotinine	Diphenhydramine HCl	Noscapine
(±)-4-Methylephedrine-D3	D,L-Propranolol	O-Hydroxyhippuric acid
3-Hydroxytyramine	D,L-Tyrosine	Olanzapine
Acetaminophen	Doxylamine	Oxalic acid
Acetophenetidin	D-Pseudoephedrine	Oxolinic acid
Acetylsalicylic acid	Ecgonine methyl ester	Oxymetazoline
Albumin(100mg/dL)	EMDP	Papaverine
Alpha Methadol	Erythromycin	Penicillin-G
Aminopyrine	Ethanol (1%)	Perphenazine
Amoxicillin	Fenoprofen	Phenacetin
Ampicillin	Furosemide	Phenelzine
Apomorphine	Gabapentin	Phenethylamine
Ascorbic acid	Gatifloxacin	Phenylpropanolamine
Aspartame	Gentisic acid	Prednisone
Aspirin	Glucose	Procaine
Atropine	Hemoglobin	Promethazine
Azithromycin	Hydralazine	Quetiapine
Benzilic acid	Hydrochlorothiazide	Quinine
Benzoic acid	Hydrocortisone	Ranitidine
Benzphetamine	Ibuprofen	Salicylic acid
Bilirubin	Isoxsuprine	Serotonin

16

Cannabidiol	Ketamine	Serotonin (5- Hydroxytyramine)
Carfentanil	Ketoprofen	Sertraline
Chloralhydrate	LAAM HCl	Sulfamethazine
Chloramphenicol	Labetalol	Sulindac
Chloroquine	L-Ephedrine	Telmisartan
Chlorothiazide	L-Epinephrine	Tetrahydrocortisone 3-(β-Dglucuronide)
Chlorpromazine	Loperamide	Tetrahydrocortisone, 3-acetate
Cholesterol	Loratadine	Tetrahydrozoline
Clonidine	L-phenylephrine	Thiamine
Cortisone	Magnesium	Thioridazine
Creatinine	Maprotiline	Triamterene
D,L-Tryptophan	Meperidine	Trifluoperazine
D,L-Isoproterenol	Meprobamate	Trimethobenzamide
D,L-Octopamine	Methoxyphenamine	Trimethoprim
D,L-Epinephrine	N-Acetylprocainamide	Uric acid
Delorazepam	Nalidixic acid	Verapamil
Deoxycorticosterone	Naproxen	Vitamin B2
Desloratadine	Niacinamide	Vitamin C
Dextromethorphan	Nicotine	Zaleplon
Diclofenac	Nifedipine	Zomepirac
Diclofenac sodium	Nordoxepin	β-Estradiol
Diflunisal	Norethindrone
Digoxin	Norfentanyl

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

Percent cross-reactivity, provided in the below table, was calculated by dividing the cutoff concentration by the minimum concentration required to obtain 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:

17

| BUP 10 (Buprenorphine,
Cutoff=10 ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|--------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Buprenorphine -3-D-Glucuronide | 160 | 6.25% |
| Norbuprenorphine | 10 | 100% |
| Norbuprenorphine-3-D-Glucuronide | 200 | 5% |
| Morphine | >100,000 | - |
| Oxymorphone | >100,000 | -- |
| Hydromorphone | >100,000 | -- |

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

| THC 50
(11-nor-Δ9-THC-9-COOH,
Cutoff=50 ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 11-nor-Δ8-THC 50-9-COOH | 30 | 167% |
| (-)-11-nor-9-carboxy-Δ 9-THC 50 | 50 | 100% |
| 11-nor-Δ9-THC 50-carboxy glucuronide | 100 | 50% |
| 11-hydroxy-Δ9-Tetrahydrocannabinol | 5000 | 1% |
| Δ8- Tetrahydrocannabinol | 1300 | 3.8% |
| Δ9- Tetrahydrocannabinol | 5000 | 1% |
| Cannabinol | 20000 | 0.25% |
| Cannabidiol | >100000 | -- |

| OXY 100
(Oxycodone, Cutoff=100 ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Ethyl Oxycodone | 75,000 | 0.13% |
| Hydrocodone | 5,000 | 2% |
| Hydromorphone | 25,000 | 0.4% |
| Levorphanol tartrate | 25,000 | 0.4% |
| Naloxone hydrochloride | 10,000 | 1% |
| Naltrexone hydrochloride | 50,000 | 0.2% |
| Oxymorphone | 200 | 50% |
| Oxymorphone-D3 | 200 | 50% |
| Dihydrocodeine | >100,000 | -- |
| Codeine | >100,000 | -- |
| Morphine | >100,000 | -- |
| Acetylmorphine | >100,000 | -- |

18

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 |
|------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Cocaethylene | 150 | 100% |
| Cocaine HCl | 150 | 100% |
| Ecgonine | 25,000 | 0.6% |
| Norcocaine | 50,000 | 0.3% |
| Ecgonine methyl Ester | >100000 | -- |

| BAR 300
(Secobarbital, Cutoff=300ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|--------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Alphenal | 150 | 200% |
| Amobarbital | 300 | 100% |
| Aprobarbital | 250 | 120% |
| Butabarbital | 2,500 | 12% |
| Butethal | 100 | 300% |
| Cyclopentobarbital | 600 | 50% |
| Pentobarbital | 250 | 120% |
| Phenobarbital | 250 | 120% |
| Butalbital | 2,500 | 12% |

| BZO 300
(Oxazepam, Cutoff=300ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|----------------------------------------|--------------------------------------------------------------------------|------------------------|
| a-Hydroxyalprazolam | 1,260 | 23.8% |
| Alprazolam | 200 | 150% |
| Bromazepam | 1,560 | 19.2% |
| Chlordiazepoxide | 1,560 | 19.2% |
| Clobazam | 100 | 300% |
| Clonazepam | 2,500 | 12% |
| Clorazepate Dipotassium | 200 | 150% |
| Desalkylflurazepam | 400 | 75% |
| Diazepam | 200 | 150% |
| Estazolam | 2,500 | 12% |
| Flunitrazepam | 400 | 75% |
| D,L-Lorazepam | 1,560 | 19.2% |
| Midazolam | 12,500 | 2.4% |

19

Nitrazepam	100	300%
Norchlordiazepoxide	200	150%
Nordiazepam	400	75%
R,S-Lorazepam glucuronide	160	187.5%
Temazepam	100	300%
Triazolam	2,500	12%
Demoxepam	2,000	15%
Flurazepam	500	60%
Delorazepam	>100,000	--

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

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

| MOP 300
(Morphine, Cutoff=300ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|----------------------------------------|--------------------------------------------------------------------------|------------------------|
| 6-acetylmorphine | 400 | 75% |
| Codeine | 300 | 100% |
| Dihydrocodeine | 1,000 | 30% |
| EthylMorphine | 100 | 300% |
| Heroin | 600 | 50% |
| 6-Monoacetylmorphine | 150 | 200% |
| Hydrocodone | 10,000 | 3% |
| Hydromorphone | 500 | 60% |
| Levorphanol tartrate | 10,000 | 3% |
| Nalorphine HCl | 50,000 | 0.6% |

20

Thebaine	6,240	4.8%
s-Monoacetylmorphine	300	100%
Morphine-3-β-d-glucuronide	1,000	30%
Normorphine	>100,000	--
Oxycodone	>100000	--
Oxymorphone	>100000	--
Norcodeine	>100000	--
Procaine	>100000	--

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

| MDMA 500
(3,4-Methylenedioxymethamphetamine HCl,
Cutoff=500ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine
(MDEA) | 300 | 166.7% |
| (+/-)-Methylenedioxyamphetamine(MDA) | 3,000 | 16.7% |
| L-Methamphetamine | 50,000 | 1% |
| D-Methamphetamine | >100,000 | -- |
| D-Amphetamine | >100,000 | -- |
| L-Amphetamine | >100,000 | -- |

| AMP 500
(Amphetamine, Cutoff=500ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Hydroxyamphetamine | 4,000 | 12.5% |
| (+/-)-Methylenedioxyamphetamine(MDA) | 200 | 250% |
| D,L-Amphetamine | 500 | 100% |
| Diethylstilbestrol | 2,500 | 20% |
| L-Amphetamine | 25,000 | 2% |
| p-Hydroxyamphetamine | 50,000 | 1% |
| Phentermine | 4,000 | 12.5% |
| β-Phenylethylamine | 50,000 | 1% |
| Tyramine | 50,000 | 1% |
| p-Hydroxynorephedrine | 50,000 | 1% |
| D,L-Norephedrine | 50,000 | 1% |
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine
(MDEA) | 100,000 | 0.5% |

21

D-Methamphetamine	>100,000	--
L-Methamphetamine	>100,000	--
(+/-)3,4-Methylenedioxymethamphetamine
(MDMA)	>100,000	--
Ephedrine HCl	>100,000	--
Phenylpropanolamine	>100,000	--
Benzphetamine	>100,000	--
L-Ephedrine	>100,000	--
L-Epinephrine	>100,000	--
D,L-Epinephrine	>100,000	--

| MET 500
(D(+)-Methamphetamine, Cutoff=500ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine
(MDEA) | 10,000 | 5% |
| (±)-MDMA | 1,250 | 40% |
| L-Methamphetamine | 12,500 | 4% |
| Fenfluramine | 25,000 | 2% |
| p-Hydroxymethamphetamine | 5,000 | 10% |
| D,L-Methamphetamine | 500 | 100% |
| β-Phenylethylamine | 25,000 | 2% |
| Mephetermine | 25,000 | 2% |
| L-Amphetamine | 40,000 | 1.25% |
| Ephedrine HCl | 100,000 | 0.5% |
| (1R,2S)-(-)-Ephedrine | 100,000 | 0.5% |
| D-Amphetamine | >100,000 | -- |
| Chloroquine | >100,000 | -- |
| (+/-)3,4- Methylenedioxyamphetamine(MDA) | >100,000 | -- |
| L-Phenylephrine | >100,000 | -- |

| TCA 1000
(Nortriptyline, Cutoff=1000ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-----------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Amitriptyline | 1,500 | 66.7% |
| Chlorpheniramine | 50,000 | 2% |
| Clomipramine | 10,000 | 10% |
| Cyclobenzaprine Hydrochloride | 5,000 | 20% |
| Desipramine | 1,000 | 100% |
| Doxepine | 2,000 | 50% |
| Duloxetine | 10,000 | 10% |

22

Imipramine	1,000	100%
Norclomipramine	12,500	8%
Nordoxepine	1,000	100%
Promazine	50,000	2%
Trimipramine	10,000	10%
Maprotiline	>100,000	--
Promethazine hydrochloride	>100,000	--

| COC 300
(Benzoylecgonine, Cutoff=300ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|-----------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Cocaethylene | 300 | 100% |
| Cocaine HCl | 300 | 100% |
| Ecgonine | 50,000 | 0.6% |
| Norcocaine | 100,000 | 0.3% |
| Ecgonine methyl ester | >100,000 | -- |

| AMP 1000
(d-Amphetamine, Cutoff=1000ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|---------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Hydroxyamphetamine | 8000 | 12.5% |
| (+/-)-Methylenedioxyamphetamine(MDA) | 400 | 250% |
| D,L-Amphetamine | 1,000 | 100% |
| Diethylstilbestrol | 5,000 | 20% |
| L-Amphetamine | 50,000 | 2% |
| p-Hydroxyamphetamine | 100,000 | 1% |
| Phentermine | 8,000 | 12.5% |
| β-Phenylethylamine | 100,000 | 1% |
| Tyramine | 100,000 | 1% |
| p-Hydroxynorephedrine | 100,000 | 1% |
| D,L-Norephedrine | 100,000 | 1% |
| D-Methamphetamine | >100000 | -- |
| L-Methamphetamine | >100000 | -- |
| Ephedrine HCl | >100000 | -- |
| (+/-)3,4- Methylenedioxymethamphetamine
(MDMA) | >100000 | -- |
| Phenylpropanolamine | >100000 | -- |
| Benzphetamine | >100000 | -- |
| L-Ephedrine | >100,000 | -- |
| L-Epinephrine | >100,000 | -- |
| D,L-Epinephrine | >100,000 | -- |

23

| MET 1000
(D(+)-Methamphetamine, Cutoff=1000ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine
(MDEA) | 20,000 | 5% |
| (+/-)3,4-Methylenedioxymethamphetamine
(MDMA) | 2,500 | 40% |
| L-Methamphetamine | 25,000 | 4% |
| Fenfluramine | 50,000 | 2% |
| p-Hydroxymethamphetamine | 10,000 | 10% |
| D,L-Methamphetamine | 1,000 | 100% |
| β-Phenylethylamine | 50,000 | 2% |
| Mephetermine | 50,000 | 2% |
| L-Amphetamine | 75,000 | 1.33% |
| D-Amphetamine | >100000 | -- |
| D,L-Amphetamine | >100000 | -- |
| Chloroquine | >100000 | -- |
| Ephedrine HCl | >100000 | -- |
| (+/-)3,4-Methylenedioxyamphetamine (MDA) | >100000 | -- |
| Trimethobenzamide | >100000 | -- |
| L-Phenylephrine | >100000 | -- |
| (1R,2S)-(-)-Ephedrine | >100000 | -- |

| OPI 2000
(Morphine, Cutoff=2000ng/mL) | Minimum concentration
required to obtain a
positive result (ng/mL) | % Cross-
Reactivity |
|------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 6-acetylmorphine | 2,500 | 80% |
| Codeine | 1,000 | 200% |
| Dihydrocodeine | 1,500 | 133.3% |
| EthylMorphine | 2,500 | 80% |
| 6-Monoacetylmorphine | 1500 | 133% |
| Heroin | 5,000 | 40% |
| Hydrocodone | 5,000 | 40% |
| Hydromorphone | 25,000 | 8% |
| Levorphanol tartrate | 10,000 | 20% |
| Nalorphine HCl | 5,000 | 40% |
| Norcodeine | 4,000 | 50% |
| Normorphine | 5,000 | 40% |
| Oxymorphone | 75,000 | 2.7% |
| s-Monoacetylmorphine | 2,000 | 100% |

24

Thebaine	13,000	15.4%
Morphine 3-β-D-glucuronide	2,000	100%
Oxycodone	>100,000	--
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 +50% cutoff and -50% cutoff levels. Three operators tested each sample 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. No interference was observed at any specific gravity condition tested.

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 each sample 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 interference with the test device.

• 2. Comparison Studies
     The method comparison studies for Healstone Accurate™ Drug of Abuse 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 or GC/MS results. The results are presented in the table below:

For Accurate™ Drug of Abuse Urine Test Cup:

| Healstone
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%) |
|------------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator A | Positive | 0 | 0 | 2 | 20 | 18 |
| | Negative | 10 | 19 | 9 | 2 | 0 |
| Operator B | Positive | 0 | 0 | 1 | 19 | 18 |
| | Negative | 10 | 19 | 10 | 3 | 0 |
| Operator C | Positive | 0 | 0 | 1 | 20 | 18 |
| | Negative | 10 | 19 | 10 | 2 | 0 |

AMP 500

Discordant Results for AMP 500:

Operator	Sample Number	LC/MS Result (ng/mL)	Healstone AccurateTM Result
----------	---------------	----------------------	-----------------------------

25

Operator A	TN-SAMP06072	450.4	+
Operator A	TN-SAMP06044	467.2	+
Operator B	TN-SAMP06072	450.4	+
Operator C	TN-SAMP06044	467.2	+
Operator A	TN-SAMP06006	518.5	-
Operator A	TN-SAMP06022	526.4	-
Operator B	TN-SAMP06041	532.0	-
Operator B	TN-SAMP06057	532.5	-
Operator B	TN-SAMP06073	539.1	-
Operator C	TN-SAMP06006	518.5	-
Operator C	TN-SAMP06057	532.5	-

BUP 10

| Healstone
AccurateTM | | 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 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Operator B | Positive | 0 | 0 | 1 | 13 | 24 |
| | Negative | 10 | 15 | 14 | 3 | 0 |
| Operator C | Positive | 0 | 0 | 3 | 16 | 24 |
| | Negative | 10 | 15 | 12 | 0 | 0 |

Discordant Results for BUP 10:

| Operator | Sample Number | LC/MS Result (ng/mL) | Healstone AccurateTM
Result |
|------------|---------------|----------------------|--------------------------------|
| Operator B | TN-BUP06042 | 9.6 | + |
| Operator C | TN-BUP06040 | 9.5 | + |
| Operator C | TN-BUP06042 | 9.6 | + |
| Operator C | TN-BUP06013 | 9.8 | + |
| Operator A | TN-BUP06048 | 10.0 | - |
| Operator A | TN-BUP06058 | 10.1 | - |
| Operator A | TN-BUP06002 | 10.8 | - |
| Operator B | TN-BUP06037 | 10.2 | - |
| Operator B | TN-BUP06002 | 10.8 | - |
| Operator B | TN-BUP06023 | 11.0 | - |

26

| Healstone
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%) |
|------------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator A | Positive | 0 | 0 | 2 | 17 | 22 |
| | Negative | 10 | 15 | 13 | 1 | 0 |
| Operator B | Positive | 0 | 0 | 2 | 14 | 22 |
| | Negative | 10 | 15 | 13 | 4 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 15 | 22 |
| | Negative | 10 | 15 | 15 | 3 | 0 |

Discordant Results for BAR 300:

| Operator | Sample Number | LC/MS Result (ng/mL) | Healstone Accurate™
Result |
|------------|---------------|----------------------|-------------------------------|
| Operator A | TN-BAR06061 | 266.1 | + |
| Operator A | TN-BAR06013 | 288.3 | + |
| Operator B | TN-BAR06046 | 286.3 | + |
| Operator B | TN-BAR06076 | 299.7 | + |
| Operator A | TN-BAR06054 | 317.2 | - |
| Operator B | TN-BAR06011 | 314.7 | - |
| Operator B | TN-BAR06074 | 315.8 | - |
| Operator B | TN-BAR06039 | 320.1 | - |
| Operator B | TN-BAR06004 | 324.9 | - |
| Operator C | TN-BAR06074 | 315.8 | - |
| Operator C | TN-BAR06054 | 317.2 | - |
| Operator C | TN-BAR06039 | 320.1 | - |

BZO 300

| Healstone
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%) |
|------------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator A | Positive | 0 | 0 | 2 | 16 | 24 |
| | Negative | 10 | 16 | 12 | 0 | 0 |
| Operator B | Positive | 0 | 0 | 2 | 16 | 24 |
| | Negative | 10 | 16 | 12 | 0 | 0 |
| Operator C | Positive | 0 | 0 | 2 | 16 | 24 |

27

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

Discordant Results for BZO 300:

Operator	Sample Number	LC/MS Result (ng/mL)	Healstone AccurateTM Result
Operator A	TN-BZO06041	294.7	+
Operator A	TN-BZO06006	296.2	+
Operator B	TN-BZO06022	239.6	+
Operator B	TN-BZO06041	294.7	+
Operator C	TN-BZO06076	233.4	+
Operator C	TN-BZO06006	296.2	+

COC 150

| Healstone
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%) |
|------------------------|----------|-----------|-----------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------|
| Operator A | Positive | 0 | 0 | 3 | 14 | 25 |
| | Negative | 10 | 13 | 14 | 1 | 0 |
| Operator B | Positive | 0 | 0 | 2 | 14 | 25 |
| | Negative | 10 | 13 | 15 | 1 | 0 |
| Operator C | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 13 | 16 | 0 | 0 |

Discordant Results for COC 150:

| Operator | Sample Number | LC/MS Result (ng/mL) | Healstone
AccurateTM Result |
|------------|---------------|----------------------|--------------------------------|
| Operator A | TN-SCOC06066 | 126.0 | + |
| Operator A | TN-SCOC06067 | 134.4 | + |
| Operator A | TN-SCOC06005 | 141.4 | + |
| Operator B | TN-SCOC06005 | 141.4 | + |
| Operator B | TN-SCOC06040 | 146.6 | + |
| Operator C | TN-SCOC06066 | 126.0 | + |
| Operator A | TN-SCOC06025 | 178.4 | - |
| Operator B | TN-SCOC06049 | 153.2 | - |

28

| Healstone
AccurateTM | | 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 | 3 |
| | Negative | 10 | 15 | 12 | 2 | 0 |
| Operator B | Positive | 0 | 0 | 1 | 16 | 23 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
| Operator C | Positive | 0 | 0 | 1 | 16 | 23 |
| | Negative | 10 | 15 | 14 | 1 | 0 |

Discordant Results for EDDP 300:

| Operator | Sample Number | LC/MS Result (ng/mL) | Healstone
Accurate™ Result |
|------------|---------------|----------------------|-------------------------------|
| Operator A | TN-EDDP06031 | 236.0 | + |
| Operator A | TN-EDDP06054 | 292.9 | + |
| Operator A | TN-EDDP06078 | 294.9 | + |
| Operator B | TN-EDDP06065 | 251.0 | + |
| Operator C | TN-EDDP06074 | 274.7 | + |
| Operator A | TN-EDDP06038 | 341.8 | - |
| Operator A | TN-EDDP06003 | 342.4 | - |
| Operator B | TN-EDDP06047 | 331.2 | - |
| Operator C | TN-EDDP06047 | 331.2 | - |

MET 500

| Healstone
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%) |
|------------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator A | Positive | 0 | 0 | 2 | 18 | 20 |
| | Negative | 10 | 20 | 8 | 2 | 0 |
| Operator B | Positive | 0 | 0 | 1 | 17 | 20 |
| | Negative | 10 | 20 | 9 | 3 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 16 | 20 |
| | Negative | 10 | 20 | 10 | 4 | 0 |

Discordant Results for MET 500:

29

| Operator | Sample Number | LC/MS Result (ng/mL) | Healstone
AccurateTM Result |
|------------|---------------|----------------------|--------------------------------|
| Operator A | TN-SMET06057 | 433.5 | + |
| Operator A | TN-SMET06033 | 489.7 | + |
| Operator B | TN-SMET06068 | 497.6 | + |
| Operator A | TN-SMET06014 | 569.7 | - |
| Operator A | TN-SMET06078 | 594.0 | - |
| Operator B | TN-SMET06012 | 540.8 | - |
| Operator B | TN-SMET06014 | 569.7 | - |
| Operator B | TN-SMET06077 | 571.4 | - |
| Operator C | TN-SMET06012 | 540.8 | - |
| Operator C | TN-SMET06014 | 569.7 | - |
| Operator C | TN-SMET06007 | 587.6 | - |
| Operator C | TN-SMET06042 | 610.4 | - |

MDMA 500

| Healstone
AccurateTM | | 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 | 3 | 19 | 20 |
| | Negative | 10 | 13 | 14 | 1 | 0 |
| Operator B | Positive | 0 | 0 | 3 | 17 | 20 |
| | Negative | 10 | 13 | 14 | 3 | 0 |
| Operator C | Positive | 0 | 0 | 1 | 17 | 20 |
| | Negative | 10 | 13 | 16 | 3 | 0 |

Discordant Results for MDMA 500:

| Operator | Sample Number | LC/MS Result (ng/mL) | Healstone
AccurateTM Result |
|------------|---------------|----------------------|--------------------------------|
| Operator A | TN-MDMA06032 | 478.7 | + |
| Operator A | TN-MDMA06004 | 479.3 | + |
| Operator A | TN-MDMA06005 | 496.8 | + |
| Operator B | TN-MDMA06038 | 459.1 | + |
| Operator B | TN-MDMA06076 | 473.3 | + |
| Operator B | TN-MDMA06005 | 496.8 | + |
| Operator C | TN-MDMA06005 | 496.8 | + |
| Operator A | TN-MDMA06075 | 518.6 | - |
| Operator B | TN-MDMA06065 | 501.8 | - |

30

Operator B	TN-MDMA06057	529.3	-
Operator B	TN-MDMA06022	587	-
Operator C	TN-MDMA06057	529.3	-
Operator C	TN-MDMA06067	529.3	-
Operator C	TN-MDMA06047	595.7	-

MOP 300

| Healstone
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%) |
|------------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator A | Positive | 0 | 0 | 1 | 10 | 28 |
| | Negative | 10 | 17 | 12 | 2 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 11 | 28 |
| | Negative | 10 | 17 | 13 | 1 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 11 | 28 |
| | Negative | 10 | 17 | 13 | 1 | 0 |

Discordant Results for MOP 300:

| Operator | Sample Number | LC/MS Result (ng/mL) | Healstone
Accurate™ Result |
|------------|---------------|----------------------|-------------------------------|
| Operator A | TN-MOP06014 | 295.8 | + |
| Operator A | TN-MOP06061 | 308.6 | - |
| Operator A | TN-MOP06074 | 314.9 | - |
| Operator B | TN-MOP06061 | 308.6 | - |
| Operator C | TN-MOP06074 | 314.9 | - |

MTD 300

| Healstone
AccurateTM | | 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 | 17 | 22 |
| | Negative | 10 | 18 | 11 | 1 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 15 | 22 |
| | Negative | 10 | 18 | 12 | 3 | 0 |

31

Operator C
Operator C	Positive	0	0	1	17	22
	Negative	10	18	11	1	0

Operator	Sample Number	LC/MS Result (ng/mL)	Healstone AccurateTM Result
Operator A	TN-MTD06078	273.6	+
Operator C	TN-MTD06078	273.6	+
Operator A	TN-MTD06072	305.1	-
Operator B	TN-MTD06042	301.7	-
Operator B	TN-MTD06072	305.1	-
Operator B	TN-MTD06077	333.9	-
Operator C	TN-MTD06024	339.6	-

Discordant Results for MTD 300:

OXY 100

| Healstone
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%) |
|------------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator A | Positive | 0 | 0 | 0 | 16 | 21 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Operator B | Positive | 0 | 0 | 1 | 18 | 21 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
| Operator C | Positive | 0 | 0 | 1 | 16 | 21 |
| | Negative | 10 | 15 | 14 | 3 | 0 |

Discordant Results for OXY 100:

| Operator | Sample Number | LC/MS Result (ng/mL) | Healstone
AccurateTM Result |
|------------|---------------|----------------------|--------------------------------|
| Operator B | TN-OXY06021 | 93.3 | + |
| Operator C | TN-OXY06021 | 93.3 | + |
| Operator A | TN-OXY06040 | 107.1 | - |
| Operator A | TN-OXY06010 | 109.6 | - |
| Operator A | TN-OXY06002 | 128.7 | - |
| Operator B | TN-OXY06010 | 109.6 | - |
| Operator C | TN-OXY06005 | 106.8 | - |
| Operator C | TN-OXY06040 | 107.1 | - |
| Operator C | TN-OXY06010 | 109.6 | - |

32

PCP 25

| Healstone
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%) |
|------------------------|------------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| | Operator A | Positive | 0 | 0 | 1 | 12 |
| Negative | | 10 | 18 | 11 | 1 | 0 |
| Operator B | Positive | 0 | 0 | 2 | 12 | 27 |
| | Negative | 10 | 18 | 10 | 1 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 12 | 27 |
| | Negative | 10 | 18 | 12 | 1 | 0 |

Discordant Results for PCP 25:

Operator	Sample Number	LC/MS Result (ng/mL)	Healstone AccurateTM	Result
Operator A	TN-PCP06052	22.0	+
Operator B	TN-PCP06052	22.0	+
Operator B	TN-PCP06031	20.6	+
Operator A	TN-PCP06069	27.1	-
Operator B	TN-PCP06069	27.1	-
Operator C	TN-PCP06076	27.5	-

PPX 300

| Healstone
AccurateTM | | 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 | 15 | 24 |
| | Negative | 10 | 17 | 11 | 1 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 17 | 13 | 3 | 0 |
| Operator C | Positive | 0 | 0 | 2 | 15 | 24 |
| | Negative | 10 | 17 | 11 | 1 | 0 |

Discordant Results for PPX 300:

Operator	Sample Number	LC/MS Result (ng/mL)	Healstone AccurateTM Result

33

Operator A	TN-PPX06035	289.0	+
Operator A	TN-PPX06070	292.4	+
Operator C	TN-PPX06035	289.0	+
Operator C	TN-PPX06070	292.4	+
Operator A	TN-PPX06020	335.1	-
Operator B	TN-PPX06038	331.9	-
Operator B	TN-PPX06040	331.9	-
Operator B	TN-PPX06003	350.5	-
Operator C	TN-PPX06040	331.9	-

TCA 1000

| Healstone
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%) |
|------------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator A | Positive | 0 | 0 | 3 | 14 | 22 |
| | Negative | 10 | 14 | 13 | 4 | 0 |
| Operator B | Positive | 0 | 0 | 3 | 16 | 22 |
| | Negative | 10 | 14 | 13 | 2 | 0 |
| Operator C | Positive | 0 | 0 | 1 | 16 | 22 |
| | Negative | 10 | 14 | 15 | 2 | 0 |

Discordant Results for TCA 1000:

| Operator | Sample Number | LC/MS Result (ng/mL) | Healstone
Accurate™ Result |
|------------|---------------|----------------------|-------------------------------|
| Operator A | TN-TCA06066 | 888.4 | + |
| Operator A | TN-TCA06050 | 908.9 | + |
| Operator A | TN-TCA06015 | 919.8 | + |
| Operator B | TN-TCA06018 | 890.8 | + |
| Operator B | TN-TCA06031 | 917.1 | + |
| Operator B | TN-TCA06015 | 919.8 | + |
| Operator C | TN-TCA06050 | 908.9 | + |
| Operator A | TN-TCA06054 | 1071.4 | - |
| Operator A | TN-TCA06044 | 1085.0 | - |
| Operator A | TN-TCA06055 | 1097.2 | - |
| Operator A | TN-TCA06019 | 1108.7 | - |
| Operator B | TN-TCA06044 | 1085.0 | - |
| Operator B | TN-TCA06019 | 1108.7 | - |
| Operator C | TN-TCA06044 | 1085.0 | - |

34

Operator C	TN-TCA06073	1100.4	-
------------	-------------	--------	---

THC 50

| Healstone
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%) |
|------------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator A | Positive | 0 | 0 | 1 | 15 | 22 |
| | Negative | 10 | 16 | 13 | 3 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 14 | 22 |
| | Negative | 10 | 16 | 14 | 4 | 0 |
| Operator C | Positive | 0 | 0 | 1 | 15 | 22 |
| | Negative | 10 | 16 | 13 | 3 | 0 |

Discordant Results for THC 50:

| Operator | Sample Number | LC/MS Result (ng/mL) | Healstone
AccurateTM Result |
|------------|---------------|----------------------|--------------------------------|
| Operator A | TN-THC06041 | 47.3 | + |
| Operator C | TN-THC06072 | 46.6 | + |
| Operator A | TN-THC06070 | 51.8 | - |
| Operator A | TN-THC06060 | 56.8 | - |
| Operator A | TN-THC06001 | 57.4 | - |
| Operator B | TN-THC06070 | 51.8 | - |
| Operator B | TN-THC06021 | 52.4 | - |
| Operator B | TN-THC06036 | 53.0 | - |
| Operator B | TN-THC06001 | 57.4 | - |
| Operator C | TN-THC06036 | 53.0 | - |
| Operator C | TN-THC06069 | 57.7 | - |
| Operator C | TN-THC06040 | 57.9 | - |

AMP 1000

| Healstone
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%) |
|------------------------|----------|-----------|----------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------|
| Operator A | Positive | 0 | 0 | 1 | 16 | 20 |
| | Negative | 10 | 14 | 15 | 4 | 0 |

35

Operator B	Positive	0	0	4	17	20
	Negative	10	14	12	3	0
Operator C	Positive	0	0	2	18	20
	Negative	10	14	14	2	0

Discordant Results for AMP 1000:

| Operator | Sample Number | LC/MS Result (ng/mL) | Healstone
Accurate™ Result |
|------------|---------------|----------------------|-------------------------------|
| Operator A | TN-AMP06043 | 955.5 | + |
| Operator B | TN-AMP06043 | 955.5 | + |
| Operator B | TN-AMP06077 | 960.5 | + |
| Operator B | TN-AMP06007 | 986.2 | + |
| Operator B | TN-AMP06008 | 996.1 | + |
| Operator C | TN-AMP06059 | 948.8 | + |
| Operator C | TN-AMP06008 | 996.1 | + |
| Operator A | TN-AMP06048 | 1087.4 | - |
| Operator A | TN-AMP06038 | 1097.7 | - |
| Operator A | TN-AMP06003 | 1147.4 | - |
| Operator A | TN-AMP06078 | 1147.4 | - |
| Operator B | TN-AMP06048 | 1087.4 | - |
| Operator B | TN-AMP06038 | 1097.7 | - |
| Operator B | TN-AMP06078 | 1147.4 | - |
| Operator C | TN-AMP06003 | 1147.4 | - |
| Operator C | TN-AMP06058 | 1178.0 | - |

COC 300

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

Discordant Results for COC 300:

| Operator | Sample Number | LC/MS Result | Healstone
Accurate™ Result |

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

36

Operator A	TN-COC06012	278.7	+
Operator A	TN-COC06059	287.7	+
Operator B	TN-COC06035	269.9	+
Operator B	TN-COC06038	287.7	+
Operator B	TN-COC06061	296.1	+
Operator C	TN-COC06038	287.7	+
Operator C	TN-COC06059	287.7	+
Operator A	TN-COC06011	313.9	-
Operator B	TN-COC06052	304.4	-
Operator C	TN-COC06040	336.6	-
Operator C	TN-COC06026	337.1	-

MET 1000

| Healstone
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%) |
|------------------------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator A Positive | 0 | 0 | 3 | 13 | 26 |
| Operator A Negative | 10 | 14 | 13 | 1 | 0 |
| Operator B Positive | 0 | 0 | 2 | 12 | 26 |
| Operator B Negative | 10 | 14 | 14 | 2 | 0 |
| Operator C Positive | 0 | 0 | 2 | 12 | 26 |
| Operator C Negative | 10 | 14 | 14 | 2 | 0 |

Discordant Results for MET 1000:

| Operator | Sample Number | LC/MS Result | Healstone
AccurateTM Result |
|------------|---------------|--------------|--------------------------------|
| Operator A | TN-MET06004 | 932.7 | + |
| Operator A | TN-MET06038 | 935.0 | + |
| Operator A | TN-MET06061 | 950.8 | + |
| Operator B | TN-MET06060 | 924.1 | + |
| Operator B | TN-MET06061 | 950.8 | + |
| Operator C | TN-MET06038 | 935.0 | + |
| Operator C | TN-MET06061 | 950.8 | + |
| Operator A | TN-MET06054 | 1001.0 | - |
| Operator B | TN-MET06054 | 1001.0 | - |
| Operator B | TN-MET06026 | 1045.7 | - |
| Operator C | TN-MET06054 | 1001.0 | - |
| Operator C | TN-MET06026 | 1045.7 | - |

37

OPI 2000

| Healstone
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%) |
|------------------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------|
| Operator A | Positive | 0 | 0 | 0 | 19 | 17 |
| | Negative | 10 | 16 | 14 | 4 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 20 | 17 |
| | Negative | 10 | 16 | 14 | 3 | 0 |
| Operator C | Positive | 0 | 0 | 1 | 19 | 17 |
| | Negative | 10 | 16 | 13 | 4 | 0 |

Discordant Results for OPI 2000:

| Operator | Sample Number | LC/MS Result | Healstone
AccurateTM Result |
|------------|---------------|--------------|--------------------------------|
| Operator C | TN-SMOP06018 | 1727.0 | + |
| Operator A | TN-SMOP06013 | 2218.9 | - |
| Operator A | TN-SMOP06078 | 2244.7 | - |
| Operator A | TN-SMOP06054 | 2309.0 | - |
| Operator A | TN-SMOP06019 | 2340.1 | - |
| Operator B | TN-SMOP06043 | 2064.9 | - |
| Operator B | TN-SMOP06008 | 2094.7 | - |
| Operator B | TN-SMOP06040 | 2226.2 | - |
| Operator C | TN-SMOP06043 | 2064.9 | - |
| Operator C | TN-SMOP06008 | 2094.7 | - |
| Operator C | TN-SMOP06013 | 2218.9 | - |
| Operator C | TN-SMOP06071 | 2276.4 | - |

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. 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. Eighty-one males and 59 females tested AccurateTM Drug of Abuse Urine Test Cup Configuration 1 (including AMP 1000, MET 1000, MOP 300, COC 300); 90 male and 50 females tested AccurateTM Drug of Abuse Urine Test Cup Configuration 2 (including AMP 500, MET 500, OPI 2000, COC 150). Each participant was provided one package insert, one blind labeled test solution, and one test device. The results are summarized below:

38

Lay-User Study Results for Accurate™ Drug of Abuse Urine Test Cup Configuration 1 (including AMP 1000, MET 1000, MOP 300, COC 300):

| Drug | Cutoff
(ng/mL) | Results | Concentration | | | | | | |
|------|-------------------|---------------|-----------------|----------------|----------------|----------------|----------------|----------------|----------------|
| | | | -100%
cutoff | -75%
cutoff | -50%
cutoff | -25%
cutoff | +25%
cutoff | +50%
cutoff | +75%
cutoff |
| | | Negative | 20 | 20 | 20 | 17 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 3 | 18 | 20 | 20 |
| BZO | 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 85% | 90% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | 1000 | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| TCA | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | 300 | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| BAR | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| MET | 1000 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| COC | 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 17 | 2 | 0 | 0 |
| | 50 | Positive | 0 | 0 | 0 | 3 | 18 | 20 | 20 |
| THC | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 85% | 90% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | 1000 | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| AMP | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | 300 | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| PPX | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 17 | 2 | 0 | 0 |
| BUP | 10 | Positive | 0 | 0 | 0 | 3 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 85% | 90% | 100% | 100% |
| OXY | 100 | Negative | 20 | 20 | 20 | 17 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 3 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 85% | 90% | 100% | 100% |
| MOP | 300 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% |
| PCP | 25 | Negative | 20 | 20 | 20 | 18 | 3 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 17 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% |
| MTD | 300 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 85% | 100% | 100% |
| MDMA | 500 | Negative | 20 | 20 | 20 | 18 | 3 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 17 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| EDDP | 300 | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 85% | 100% | 100% |

39

Lay-User Study Results for Accurate™ Drug of Abuse Urine Test Cup Configuration 2 (AMP 500, MET 500, OPI 2000, COC 1500):

| Drug | Cutoff
(ng/mL) | Results | Concentration | | | | | | |
|------|-------------------|---------------|------------------|----------------|----------------|----------------|----------------|----------------|----------------|
| | | | - 100%
cutoff | -75%
cutoff | -50%
cutoff | -25%
cutoff | +25%
cutoff | +50%
cutoff | +75%
cutoff |
| BZO | 300 | Negative | 20 | 20 | 20 | 18 | 3 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 17 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 85% | 100% | 100% |
| TCA | 1000 | Negative | 20 | 20 | 20 | 17 | 3 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 3 | 17 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 85% | 85% | 100% | 100% |
| BAR | 300 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% |
| MET | 500 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| COC | 150 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| THC | 50 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| AMP | 500 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| PPX | 300 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| BUP | 10 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| OXY | 100 | Negative | 20 | 20 | 20 | 17 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 3 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 85% | 90% | 100% | 100% |
| OPI | 2000 | Negative | 20 | 20 | 20 | 17 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 3 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 85% | 90% | 100% | 100% |
| PCP | 25 | Negative | 20 | 20 | 20 | 17 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 3 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 85% | 90% | 100% | 100% |
| MTD | 300 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| MDMA | 500 | Negative | 20 | 20 | 20 | 17 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 3 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 85% | 90% | 100% | 100% |
| EDDP | 300 | Negative | 20 | 20 | 20 | 17 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 3 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 85% | 90% | 100% | 100% |

40

41

Participants were given surveys on the ease of understanding the instruction for use. All participants indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

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 Healstone Accurate™ Drug of Abuse Urine Test Cup and Healstone Accurate™ Drug of Abuse Urine Test Cup Rx are substantially equivalent to the predicate devices.