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.

AI/ML Overview

The provided text describes the performance characteristics of the "Healstone Accurate™ Drug of Abuse Urine Test Cup" and "Healstone Accurate™ Drug of Abuse Urine Test Cup Rx", but does not specify explicit acceptance criteria in the form of numerical thresholds for sensitivity, specificity, accuracy, or other performance metrics. The tables presented show the reported device performance across various drug tests at different concentrations relative to the cutoff level.

Here's an attempt to extract the information requested, based on what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, no explicit acceptance criteria are stated in the document. However, the reported performance in both the precision studies and lay-user studies consistently shows a high level of agreement with expected outcomes at concentrations well below and well above the cutoff. At the cutoff concentration, the device exhibits approximately 50% positive and 50% negative results, which is a typical characteristic for qualitative immunoassays designed to detect substances at a specific threshold.

For the precision studies, for concentrations at -100%, -75%, -50% cut off and +50%, +75%, +100% cut off, the results were almost always 100% negative and 100% positive, respectively. For concentrations at -25% cut off, a small number of false positives (1-3 out of 50) were observed across different lots and drugs. For concentrations at +25% cut off, a small number of false negatives (1-3 out of 50) were observed. This indicates that the device has a narrow window around the cutoff where results can be variable, which is expected for such tests.

For the lay-user studies, the agreement percentages for concentrations clearly below (-100%, -75%, -50% cutoff) and clearly above (+50%, +75% cutoff) the cutoff are all 100%. At -25% cutoff, agreement is generally high (85-95% negative). At +25% cutoff, agreement is also high (85-95% positive).

Without explicit acceptance criteria, it's impossible to state whether these results "meet" them. However, they demonstrate consistent performance around the designed cutoff levels.

2. Sample Size and Data Provenance

Precision Test Set Sample Size: For each drug and each concentration level, 50 tests were performed (2 runs per day for 25 days). This was done for three different lots of test cups. So, for each drug and each concentration, the total number of tests across three lots is 50 * 3 = 150.
Comparison Studies (Professional Operator) Test Set Sample Size: For each drug, 80 unaltered urine samples were used (40 negative and 40 positive). This was tested by three operators.
Lay-user Study Test Set Sample Size:
- Configuration 1 (AMP 1000, MET 1000, MOP 300, COC 300): 140 participants (81 males, 59 females). Each participant tested one blind-labeled test solution. Given that there were 7 concentration levels tested per drug in the table, and 14 drugs are listed for configuration 1, this would imply (20 samples per concentration level, 7 concentration levels, for 14 drugs means) a total of 14 * 7 * 20 = 1960 samples for Configuration 1.
- Configuration 2 (AMP 500, MET 500, OPI 2000, COC 150): 140 participants (90 males, 50 females). Similar breakdown of sample numbers as Configuration 1.
- Total participants across both configurations = 280. Total samples tested would be approximately 1960 samples per configuration, totaling around 3920 samples.
Data Provenance: The document does not specify the country of origin for the data. The studies appear to be prospective as samples were prepared at specific concentrations and then blinded for testing.

3. Number of Experts and Qualifications for Ground Truth

Comparison Studies (Professional Operator): The ground truth for the comparison studies was established using LC/MS or GC/MS results. These are laboratory-based, highly accurate analytical methods, widely considered the "gold standard" for drug concentration determination. The document does not specify the number of experts (e.g., lab technicians, chemists) that performed or interpreted the LC/MS/GC/MS results, nor their specific qualifications.
Lay-user Study: The ground truth for the lay-user study was also based on the known concentrations established by LC/MS.

4. Adjudication Method for the Test Set

Precision Studies: Not applicable. The results are reported directly (number of negative/positive results for the given concentration).
Comparison Studies (Professional Operator): The results from the test device (Healstone Accurate™) were compared directly against the LC/MS or GC/MS results. Discordant results are noted for each drug and operator. This is a direct comparison rather than an adjudication among human readers.
Lay-user Study: The lay users read the device results, and these were compared to the known concentrations (ground truth from LC/MS). The document does not describe any adjudication process for lay-user interpretations if they differed from a pre-determined "correct" visual interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done regarding human readers improving with AI vs without AI assistance. This device is a rapid qualitative immunoassay (a test strip/cup that shows lines), not an AI-powered diagnostic tool requiring human interpretation of AI-generated insights. The "lay-user study" involved human readers (lay individuals) interpreting the device directly, without AI assistance.

6. Standalone (Algorithm Only) Performance Study

This device is a physical immunoassay test cup, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable. The performance described is the standalone performance of the physical device.

7. Type of Ground Truth Used

Precision, Comparison, and Lay-user Studies: The ground truth was established by known concentrations of spiked drugs in urine samples, confirmed by LC/MS or GC/MS (laboratory-based analytical methods). LC/MS and GC/MS are considered definitive methods for identifying and quantifying substances.

8. Sample Size for the Training Set

This information is not provided in the document. The document describes performance evaluation studies but does not detail the development or training of the immunoassay. Immunoassays are not "trained" in the same way machine learning algorithms are; their performance is inherent to their chemical and biological design.

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

As mentioned above, information on a "training set" and its ground truth is not provided in this document as it pertains to the development of an immunoassay, not an AI/ML model.

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

{1}------------------------------------------------

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

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

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

Sincerely,

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)

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:

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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)

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.

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: 240-505-7880 Fax: 301-916-6213 Email: shiajl@yahoo.com
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
NFTAmphetamine (AMP)	862.3100, Amphetamine TestSystem	Toxicology
NGLBuprenorphine (BUP)	862.3650, Opiate Test System	Toxicology
PTHSecobarbital (BAR)	862.3150, Barbiturate TestSystem	Toxicology
NFVOxazepam (BZO)	862.3170,Benzodiazepine Test System	Toxicology
NFYCocaine (COC)	862.3250, Cocaine Test System	Toxicology
PTG2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine(EDDP)	862.3620, Methadone Test System	Toxicology
NGGMethamphetamine(MET)	862.3610,Methamphetamine Test System	Toxicology
NGGMethylenedioxymethamphetamine (MDMA)	862.3610,Methamphetamine Test System	Toxicology

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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.

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.

9. Substantial Equivalence Information

Item	Proposed Device	Predicate(K191841)
Indication(s) foruse	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 andCannabinoids in human urine.	Same
Methodology	Competitive binding, lateral flow immunochromatographic assaybased on antigen-antibody reaction	Same

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Type of Test	Qualitative	Same
Specimen Type	Human urine	Same
Target Drug andCut 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-counteruse

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.

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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%
---------------	-------	------	------	------	---------	------	------	------	-------

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(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 off0	-75%cut off235.8	-50%cut off525.0	-25%cutoff785.9	cut off1086.6	+25%cut off1315.3	+50%cut off1599.2	+75%cut off1816.7	+100%cut off2040.5
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 concentrationrequired to obtain apositive 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 concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
4-Hydroxyphencyclidine	12500	0.2%

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

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

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

1. 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:

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

HealstoneAccurateTM		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
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 AccurateTMResult
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}------------------------------------------------

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

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

HealstoneAccurate™		Drug-Free	LowNegative byLC/MS(less than -50%)	Near CutoffNegative byLC/MS(Between -50% and theCutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	HighPositive byLC/MS(greaterthan +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)	HealstoneAccurateTM 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}------------------------------------------------

HealstoneAccurateTM		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50% and theCutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
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)	HealstoneAccurate™ 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

HealstoneAccurate™		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
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)	HealstoneAccurateTM 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

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

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

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

HealstoneAccurate™		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
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)	HealstoneAccurateTM 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

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

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

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

HealstoneAccurate™		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
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)	HealstoneAccurateTM 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

HealstoneAccurate™		Drug-Free	Low Negative byLC/MS (lessthan -50%)	Near Cutoff Negative byLC/MS(Between -50%and the Cutoff)	Near Cutoff Positive byLC/MS(Between thecutoff and+50%)	High Positive byLC/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)	HealstoneAccurate™ 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

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

HealstoneAccurate™	Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
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	HealstoneAccurateTM 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

HealstoneAccurate™		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and +50%)	High Positiveby LC/MS(greater than+50%)
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	HealstoneAccurateTM 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:

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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%

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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.

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).