AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)

K153465 · Assure Tech. (Hangzhou) Co, Ltd. · DKZ · Mar 31, 2016 · Clinical Toxicology

Device Facts

• Record ID: K153465
• Device Name: AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)
• Applicant: Assure Tech. (Hangzhou) Co, Ltd.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Mar 31, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

AssureTech Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. AssureTech Cocaine Tests are immunochromatographic assays for the qualitative determination of Benzoylecgonine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. AssureTech Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 2000 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

Device Story

Lateral flow immunochromatographic assays for qualitative detection of d-Amphetamine, Benzoylecgonine, and Morphine in human urine; competitive binding principle using monoclonal mouse antibodies. Urine sample migrates via capillary action; target drugs below cut-off allow antibody-coated particles to bind immobilized drug-conjugate, forming visible test line. Drug presence above cut-off saturates binding sites, preventing test line formation. Control line indicates proper test performance. Available in strip, dip card, and split cup formats. Used by lay users (OTC) or clinicians (prescription) for preliminary drug screening. Positive results require confirmatory testing via GC/MS. Benefits include rapid, preliminary screening for drug abuse.

Clinical Evidence

Bench testing only. Precision/reproducibility studies conducted with 3 operators, 3 lots, over 25 days (n=50 per concentration). Analytical specificity tested against numerous endogenous/exogenous compounds. Method comparison performed against GC/MS using 80 clinical samples per device. Lay-user study conducted with 1638 participants across 3 sites, demonstrating high concordance with GC/MS results across various concentrations relative to cutoff. No clinical studies performed.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Materials: monoclonal mouse antibodies, immobilized drug-conjugate. Formats: strip, dip card, cup, turn-key split cup. Connectivity: none (standalone). Sterilization: not specified. Software: none.

Indications for Use

Indicated for qualitative detection of d-Amphetamine (1000 ng/mL), Benzoylecgonine (300 ng/mL), or Morphine (2000 ng/mL) in human urine. Intended for OTC and prescription use. Provides preliminary results; requires confirmation by GC/MS.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• The Chemtrue® Multi-Panel Drug Screen Dip Card Tests (K142396)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of three faces in profile, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 31, 2016

ASSURE TECH., INC. C/O JOE SHIA REGULATORY CONSULTANT 504 EAST DIAMOND AVE. SUITE I GAITHERSBURG MD 20877

Re: K153465 Trade/Device Name: AssureTech Amphetamine Tests, AssureTech Cocaine Tests, AssureTech Morphine Tests Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Dated: February 2, 2016 Received: February 17, 2016

Dear Mr. 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) k153465

Device Name AssureTech Amphetamine Tests AssureTech Cocaine Tests AssureTech Morphine Tests

#### Indications for Use (Describe)

AssureTech Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

AssureTech Cocaine Tests are immunochromatographic assays for the qualitative determination of Benzoylecgonine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

AssureTech Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 2000 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

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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#### 510(k) SUMMARY

| 1. Date: | March 26, 2016 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Submitter: | Assure Tech. Co., Ltd.<br>Building 1, No.10, Xiyuansan Road, Westlake<br>Economic Zone<br>Hangzhou, China, 310030 |
| 3. Contact person: | Eric Lin<br>Assure Tech. Co., Ltd.<br>Building 1, No.10, Xiyuansan Road, Westlake<br>Economic Zone<br>Hangzhou, China, 310030<br>Telephone: [phone]<br>Email: [e-mail]. |
| 4. Device Name: | AssureTech Amphetamine Tests<br>AssureTech Cocaine Tests<br>AssureTech Morphine Tests |

#### Classification:

| Product Code | CFR | Panel |
|--------------|------------------------------------------|------------|
| DKZ | 21 CFR, 862.3100 Amphetamine Test System | Toxicology |
| DIO | 21 CFR, 862.3250 Cocaine Test System | Toxicology |
| DJG | 21 CFR, 862.3650 Opiate Test System | Toxicology |

#### 5. Predicate Devices: K142396

The Chemtrue® Multi-Panel Drug Screen Dip Card Tests

- 6. Intended Use
AssureTech Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

AssureTech Cocaine Tests are immunochromatographic assays for the qualitative determination of Benzoylecgonine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must

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be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

AssureTech Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 2000 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

- 7. Device Description
The AssureTech Amphetamine Tests, AssureTech Cocaine Tests, and AssureTech Morphine Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Benzoylecgonine and Morphine (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

### 8. Substantial Equivalence Information

A summary comparison of features of the AssureTech Amphetamine Tests, AssureTech Cocaine Tests and AssureTech Morphine Tests and the predicate devices is provided in following tables.

| Item | Device | Predicate - K142396 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of drugs of<br>abuse in human urine. | Same (but the number of<br>drugs detected is different) |
| Calibrator | d-Amphetamine | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 1000 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Strip, Dip Card, Cup, Turn Key Cup | Dip Card |

| | | | Table 1: Features Comparison of AssureTech Amphetamine Tests and the | | |
|--|-------------------|--|----------------------------------------------------------------------|--|--|
| | Predicate Devices | | | | |

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| Table 2: Features Comparison of AssureTech Cocaine Tests and the Predicate Devices | | |
|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Item | Device | Predicate - K142396 |
| Indication(s)<br>for Use | For the qualitative determination of<br>drugs of abuse in human urine. | Same (but the number of<br>drugs detected is different) |
| Calibrator | Benzoylecgonine | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 300 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Strip, Dip Card, Cup, Turn Key Cup | Dip Card |

Table 2: Features Comparison of AssureTech Cocaine Tests and the Predicate Devices

#### Table 3: Features Comparison of AssureTech Morphine Tests and the Predicate Devices

| Item | Device | Predicate - K142396 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of<br>drugs of abuse in human urine. | Same (but the number of<br>drugs detected is different) |
| Calibrator | Morphine | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 2000 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Strip, Dip Card, Cup, Turn Key Cup | DipCard |

#### 9. Test Principle

The AssureTech Amphetamine Tests, AssureTech Cocaine Tests, and AssureTech Morphine Tests are rapid tests for the qualitative detection of d-Amphetamine, Benzoylecgonine and Morphine in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific

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monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.

#### 10. Performance Characteristics

### 1. Analytical Performance

- a. Precision
Precision studies were carried out for samples with concentrations of -100% cut off. -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables.

| Strip | | | | | | | | | |
|--------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Dip Card | | | | | | | | | |
| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 13-/37+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Turn-Key Split Cup | | | | | | | | | |
| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Quick Cup | | | | | | | | | |
| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 13-/37+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

### AssureTech Amphetamine Tests

## AssureTech Cocaine Tests Strip

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| Lot | -100% | -75% | -50% | -25% | | +25% | +50% | +75% | +100% | |
|--------------------|---------|---------|---------|--------|---------|---------|---------|---------|---------|--|
| Number | cut off | cut off | cut off | cutoff | cut off | cut off | cut off | cut off | cut off | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Dip Card | | | | | | | | | | |
| Lot | -100% | -75% | -50% | -25% | | +25% | +50% | +75% | +100% | |
| Number | cut off | cut off | cut off | cutoff | cut off | cut off | cut off | cut off | cut off | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 8-/42+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Turn-Key Split Cup | | | | | | | | | | |
| Lot | -100% | -75% | -50% | -25% | | +25% | +50% | +75% | +100% | |
| Number | cut off | cut off | cut off | cutoff | cut off | cut off | cut off | cut off | cut off | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Quick Cup | | | | | | | | | | |
| Lot | -100% | -75% | -50% | -25% | | +25% | +50% | +75% | +100% | |
| Number | cut off | cut off | cut off | cutoff | cut off | cut off | cut off | cut off | cut off | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 13-/37+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |

## AssureTech Morphine Tests

Strip

| Strip | | | | | | | | | |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Dip Card

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

### Turn-Key Split Cup

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Quick Cup

{9}------------------------------------------------

| 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+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

b. Linearity

Not applicable.

#### c. Stability

The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C and real time stability determination at both 4 °C and 30 °C.

#### d. Cut-off

A total of 150 samples equally distributed at concentrations of -50% Cut-Off; -25% Cut-Off; Cut-Off; +25% Cut-Off; +50% Cut-Off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off for Amphetamine, Cocaine and Morphine.

The following cut-off values for the candidate devices have been verified.

| Calibrator | Cut-off (ng/mL) |
|-----------------|-----------------|
| d-Amphetamine | 1000 |
| Benzoylecgonine | 300 |
| Morphine | 2000 |

#### e. Interference

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100µg/mL are summarized in the following tables. There were no differences observed for different devices.

#### Amphetamine:

| 4-Acetamidophenol | L-Ephedrine | Oxycodone |
|----------------------|-----------------------|---------------------|
| Acetophenetidin | (-) Y Ephedrine | Oxymetazoline |
| N-Acetylprocainamide | Erythromycin | Papaverine |
| Acetylsalicylic acid | $\beta$ -Estradiol | Penicillin-G |
| Aminopyrine | Estrone-3-sulfate | Pentazocaine |
| Amitriptyline | Ethyl-p-aminobenzoate | Pentobarbital |
| Amobarbital | Fenfluramine | Perphenazine |
| Amoxicillin | Fenoprofen | Phencyclidine |
| Ampicillin | Furosemide | Phenelzine |
| Ascorbic acid | Gentisic acid | Phenobarbital |
| Aspartame | Hemoglobin | Phenytoin |
| Atropine | Hydralazine | L-Phenylephrine |
| Benzilic acid | Hydrochlorothiazide | Phenylpropanolamine |

{10}------------------------------------------------

| Benzoic acid | Hydrocodone | Prednisolone |
|------------------------|-------------------------|---------------------|
| Benzoylecgonine | Hydrocortisone | Prednisone |
| Bilirubin | O-Hydroxyhippuric acid | Procaine |
| Brompheniramine | 3-Hydroxytyramine | Promazine |
| Caffeine | Ibuprofen | Promethazine |
| Cannabidiol | Imipramine | D,L-Propanolol |
| Cannabinol | (-) Isoproterenol | D-Propoxyphene |
| Chloralhydrate | Isoxsuprine | Quinidine |
| Chloramphenicol | Ketamine | Quinine |
| Chlordiazepoxide | Ketoprofen | Ranitidine |
| Chlorothiazide | Labetalol | Salicylic acid |
| (±) Chlorpheniramine | Levorphanol | Secobarbital |
| Chlorpromazine | Loperamide | Sulfamethazine |
| Chloroquine | Maprotiline | Sulindac |
| Cholesterol | Meperidine | Temazepam |
| Clomipramine | Meprobamate | Tetracycline |
| Clonidine | Methadone | Tetrahydrocortisone |
| Cocaine hydrochloride | Methylphenidate | Tetrahydrozoline |
| Codeine | Morphine-3-Dglucuronide | Δ9-THC-COOH |
| Cortisone | Nalidixic acid | Thebaine |
| (-) Cotinine | Naloxone | Thiamine |
| Creatinine | Naltrexone | Thioridazine |
| Deoxycorticosterone | Naproxen | D,L-Thyroxine |
| Dextromethorphan | Niacinamide | Tolbutamide |
| Diazepam | Nifedipine | Triamterene |
| Diclofenac | Norcodein | Trifluoperazine |
| Diflunisal | Norethindrone | Trimethoprim |
| Digoxin | D-Norpropoxyphene | Trimipramine |
| Diphenhydramine | Noscapine | Tryptamine |
| Doxylamine | D,L-Octopamine | D, L-Tyrosine |
| Ecgonine hydrochloride | Oxalic acid | Uric acid |
| Ecgonine methylester | Oxazepam | Verapamil |
| (IR,2S)-(-)-Ephedrine | Oxolinic acid | Zomepirac |

### Cocaine

| Cocaine | | |
|----------------------|-----------------------|---------------|
| Acetaminophen | Estrone-3-sulfate | Oxymetazoline |
| Acetophenetidin | Ethyl-p-aminobenzoate | Papaverine |
| N-Acetylprocainamide | Fenoprofen | Penicillin-G |
| Acetylsalicylic acid | Furosemide | Pentobarbital |
| Aminopyrine | Gentisic acid | Perphenazine |
| Amitryptyline | Hemoglobin | Phencyclidine |
| Amobarbital | Hydralazine | Phenelzine |
| Amoxicillin | Hydrochlorothiazide | Phenobarbital |

{11}------------------------------------------------

| Ampicillin | Hydrocodone | Phentermine |
|------------------------|---------------------------------|---------------------------|
| L-Ascorbic acid | Hydrocortisone | L-Phenylephrine |
| DL-Amphetamine | O-Hydroxyhippuric acid | β-Phenylethylamine |
| Apomorphine | p-Hydroxymethamphetamine | Phenylpropanolamine |
| Aspartame | 3-Hydroxytyramine | Prednisolone |
| Atropine | Ibuprofen | Prednisone |
| Benzilic acid | Imipramine | Procaine |
| Benzoic acid | Iproniazid | Promazine |
| Benzphetamine | (±) - Isoproterenol | Promethazine |
| (±) -Brompheniramine | Isoxsuprine | DL-Propranolol |
| Caffeine | Ketamine | D-Propoxyphene |
| Cannabidiol | Ketoprofen | D-Pseudoephedrine |
| Cannabinol | Labetalol | Quinidine |
| Chloralhydrate | Levorphanol | Quinine |
| Chloramphenicol | Loperamide | Ranitidine |
| Chlordiazepoxide | Maprotiline | Salicylic acid |
| Chlorothiazide | Meperidine | Secobarbital |
| (±) -Chlorpheniramine | Meprobamate | Serotonin |
| Chlorpromazine | Methadone | Sulfamethazine |
| Chloroquine | Methoxyphenamine | Sulindac |
| Cholesterol | 3,4-Methylene dioxyamphetamine | Temazepam |
| Clomipramine | 3,4-Methylene- | Tetrahydrocortisone 3-(β- |
| | dioxymethamphetamine | D glucuronide) |
| Clonidine | Morphine-3-β-D glucuronide | Tetracycline |
| Codeine | Morphine Sulfate | Tetrahydrozoline |
| Cortisone | Nalidixic acid | Thebaine |
| (-) Cotinine | Naloxone | Thiamine |
| Creatinine | Naltrexone | Thioridazine |
| Deoxycorticosterone | Naproxen | DL-Tyrosine |
| Dextromethorphan | Niacinamide | Tolbutamide |
| Diazepam | Nifedipine | Triamterene |
| Diclofenac | Norcodein | Trifluoperazine |
| Diflunisal | Norethindrone | Trimethoprim |
| Digoxin | D-Norpropoxyphene | Trimipramine |
| Diphenhydramine | Noscapine | Tryptamine |
| Doxylamine | DL-Octopamine | DL-Tryptophan |
| Ecgonine methylester | Oxalic acid | Tyramine |
| (-) - Ψ-Ephedrine | Oxazepam | Uric acid |
| Erythromycin | Oxolinic acid | Verapamil |
| | | |
| β-Estradiol | Oxycodone | Zomepirac |
| Morphine | | |
| Acebutolol | L -Ψ-Ephedrine | Papaverine |
| Acetopromazined-6 | Erythromycin | Penicillin G |
| Acetamidophenol | β-Estradiol | Pentazocine |
| Acetophenetidin | Estrone-3-sulfate | Pentobarbital |
| Acetylprocainamide | Ethylpaminobenzoate | Perphenazine |
| Acetylsalicylic acid | Fenoprofen | Phencyclidine |
| Aminopyrine | Furosemide | Phenelzine |
| Amitryptyline | Gentisic acid | Phenobarbital |
| Amobarbital | Hemoglobin | Phentermine |
| Amoxicillin | Hydralazine | L-Phenylephrine |
| Ampicillin | Hydrochlorothiazide | β-Phenethylamine |
| Ascorbic acid | Hydrocortisone | Phenylpropanolamine |
| D/L-Amphetamine | α-Hydroxyhippuric acid | Prednisolone |
| L-Amphetamine | 3-Hydroxytyramine | Prednisone |
| Apomorphine | Ibuprofen | Promazine |
| Aspartame | Imipramine | Promethazine |
| Atropine | Iproniazid | D/L-Propranolol |
| Benzilic acid | (+/-)-Isoproterenol | D-Propoxyphene |
| Benzoic acid | Isoxsuprine | D-Pseudoephedrine |
| Benzoylecgonine | Ketamine | Quinidine |
| Benzphetamine | Ketoprofen | Quinine |
| Bilirubin | Labetalol | Ranitidine |
| Brompheniramine | Loperamide | Salicylic acid |
| Caffeine | Maprotiline | Secobarbital |
| Chloralhydrate | Meprobamate | Serotonin (5- |
| Chloramphenicol | Methadone | Sulfamethazine |
| Chlordiazepoxide | Methoxyphenamine | Sulindac |
| Chlorothiazide | 3,4Methylenedioxyamphetamine | Temazepam |
| Chlorpheniramine | 3,4Methylenedioxymethamphetamin | Tetracycline |
| Chlorpromazine | Methylphenidate | Tetrahydrocortisone |
| Chloroquine | Methyprylon | Tetrahydrocortisone3 (β- |
| Cholesterol | Nalorphine | Tetrahydrozoline |
| Clomipramine | Naloxone | Thiamine |
| Clonidine | Nalidixic acid | Thioridazine |
| Cocaine hydrochloride | Naltrexone | D/L-Thyroxine |
| Cortisone | Naproxen | Tolbutamide |
| (-)- Cotinine | Niacinamide | Triamterene |
| Creatinine | Nifedipine | Trifluoperazine |
| Deoxycorticosterone | Norcodein | Trimethoprim |
| Dextromethorphan | Norethindrone | Trimipramine |
| Diazepam | D-Norpropoxyphene | Tryptamine |
| Diclofenac | Noscapine | D/L-Tryptophan |
| Diflunisal | D/L-Octopamine | Tyramine |
| Digoxin | Oxalic acid | D/L-Tyrosine |
| Diphenhydramine | Oxazepam | Uric acid |
| Doxylamine | Oxolinic acid | Verapamil |
| Ecgonine hydrochloride | Oxymetazoline | Zomepirac |
| Ecgoninemethylester | p-Hydroxymethamphetamine | |

{12}------------------------------------------------

{13}------------------------------------------------

#### f. Specificity

To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below. There were no differences observed for different devices.

| Amphetamine<br>(Cut-off=1000 ng/mL) | Result<br>Positive at (ng/mL) | % Cross-Reactivity |
|----------------------------------------------|-------------------------------|--------------------|
| D - Amphetamine | 1000 | 100% |
| L - Amphetamine | 20000 | 5% |
| D,L - Amphetamine | 3000 | 33% |
| Phentermine | 30000 | 3.3% |
| Hydroxyamphetamine | 8000 | 12.5% |
| Methylenedioxyamphetamine (MDA) | 20000 | 5% |
| d-Methamphetamine | Negative at 100000 | Not Detected |
| 1-Methamphetamine | Negative at 100000 | Not Detected |
| ephedrine | Negative at 100000 | Not Detected |
| Methylenedioxyethylamphetamine (MDE) | Negative at 100000 | Not Detected |
| 3,4-methylenedioxy-methamphetamine<br>(MDMA) | Negative at 100000 | Not Detected |

| Cocaine<br>(Cut-off=300 ng/mL) | Result<br>Positive at (ng/mL) | % Cross-Reactivity |
|--------------------------------|-------------------------------|--------------------|
| Benzoylecgonine | 300 | 100% |
| Cocaine HCl | 750 | 40% |
| Cocaethylene | 12500 | 2.4% |
| Ecgonine | 32000 | 0.9% |
| Norcocaine | 100000 | 0.3% |

| Morphine<br>(Cut-off=2000 ng/mL) | Result<br>Positive at(ng/mL) | % Cross-Reactivity |
|----------------------------------|------------------------------|--------------------|
| Morphine | 2000 | 100% |
| Acetylmorphine | 2500 | 80% |

{14}------------------------------------------------

| Codeine | 1000 | 200% |
|---------------------------|--------------------|-------|
| Ethyl Morphine | 250 | 800% |
| Heroin | 5000 | 40% |
| Hydromorphone | 2500 | 80% |
| Hydrocodone | 5000 | 40% |
| Thebaine | 13000 | 15.4% |
| Morphine-3- β-glucuronide | Negative at 200000 | <1% |
| Oxycodone | Negative at 400000 | <0.5% |
| Oxymorphine | Negative at 400000 | <0.5% |
| Procaine | Negative at 400000 | <0.5% |
| Levorphanol | Negative at 400000 | <0.5% |

### g. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different devices.

#### 2. Comparison Studies

Method comparison studies for the AssureTech Amphetamine Tests, the AssureTech Cocaine Tests and the AssureTech Morphine Tests were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to GC/MS results are presented in the tables below:

| Amphetamine | | | | | | |
|-------------|----------|----------|----------------------------------------|---------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------|
| Strip | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| Viewer | Positive | 0 | 0 | 1 | 14 | 25 |
| A | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 14 | 25 |
| B | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 13 | 25 |
| C | Negative | 10 | 20 | 9 | 2 | 0 |

| 10 | 20 | 5 |
|-----------------------------------------|----|---|
| Discordant Results of Amphetamine Strip | | |

| Viewer | Sample Number | GC/MS Result | Strip<br>Viewer Results |
|----------|---------------|--------------|-------------------------|
| Viewer A | 78081 | 984 | Positive |
| Viewer B | 78081 | 984 | Positive |
| Viewer C | 78081 | 984 | Positive |
| Viewer A | 72430 | 1083 | Negative |

{15}------------------------------------------------

| Viewer B | 79915 | 1024 | Negative |
|----------|-------|------|----------|
| Viewer C | 79915 | 1024 | Negative |
| Viewer C | 72430 | 1083 | Negative |

| Dip<br>Card | | Negative | Low Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff Positive by<br>GC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by GC/MS<br>(greater than<br>+50%) |
|-------------|----------|----------|-------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |

## Discordant Results of Amphetamine Dip Card

| Viewer | Sample Number | GC/MS Result | Dip Card Viewer Results |
|----------|---------------|--------------|-------------------------|
| Viewer B | 78081 | 984 | Positive |
| Viewer A | 79915 | 1024 | Negative |
| Viewer C | 79915 | 1024 | Negative |

| Turn-<br>Key<br>Split<br>Cup | | Negative | Low Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by GC/MS<br>(greater than<br>+50%) |
|------------------------------|----------|----------|-------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 1 | 20 | 9 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 13 | 25 |
| | Negative | 1 | 20 | 9 | 2 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 1 | 20 | 10 | 1 | 0 |

Discordant Results of Amphetamine Turn-Key Split Cup

| Viewer | Sample Number | GC/MS Result | Turn-Key Split<br>Cup |
|----------|---------------|--------------|-----------------------|
| Viewer A | 78081 | 984 | Positive |
| Viewer B | 78081 | 984 | Positive |
| Viewer A | 79915 | 1024 | Negative |
| Viewer B | 79915 | 1024 | Negative |
| Viewer B | 79915 | 1024 | Negative |
| Viewer C | 87184 | 1257 | Negative |

{16}------------------------------------------------

| Quick | | | Low | Near Cutoff | Near Cutoff | |
|--------|----------|----------|-------------|-------------|--------------|---------------|
| Cup | | Negative | Negative by | Negative by | Positive by | High Positive |
| | | | GC/MS | GC/MS | GC/MS | by GC/MS |
| | | | (less than | (Between | (Between the | (greater than |
| | | | -50%) | -50% and | cutoff and | +50%) |
| | | | | cutoff) | +50%) | |
| Viewer | Positive | 0 | 0 | 0 | 14 | 25 |
| A | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 14 | 25 |
| B | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 0 | 15 | 25 |
| C | Negative | 10 | 20 | 10 | 0 | 0 |

## Discordant Results of Amphetamine Quick Cup

| Viewer | Sample Number | GC/MS Result | Quick Cup<br>Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer B | 78081 | 984 | Positive |
| Viewer A | 79915 | 1024 | Negative |
| Viewer B | 79915 | 1024 | Negative |

## Cocaine

| Strip | | Negative | Low<br>Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by GC/MS<br>(greater than<br>+50%) |
|--------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer | Positive | 0 | 0 | 1 | 15 | 25 |
| A | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer | Positive | 0 | 0 | 0 | 14 | 25 |
| B | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 2 | 15 | 25 |
| C | Negative | 10 | 20 | 8 | 0 | 0 |

## Discordant Results of Cocaine Strip

| Viewer | Sample Number | GC/MS Result | Strip<br>Viewer Results |
|----------|---------------|--------------|-------------------------|
| Viewer A | 38238 | 285 | Positive |
| Viewer C | 58356 | 280 | Positive |
| Viewer C | 38238 | 285 | Positive |
| Viewer B | 71282 | 312 | Negative |

{17}------------------------------------------------

| Dip<br>Card | | Negative | Low<br>Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by GC/MS<br>(greater than<br>+50%) |
|-------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 2 | 15 | 25 |
| Viewer<br>A | Negative | 10 | 20 | 8 | 0 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 15 | 25 |
| Viewer<br>B | Negative | 10 | 20 | 10 | 0 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 13 | 25 |
| Viewer<br>C | Negative | 10 | 20 | 9 | 2 | 0 |

## Discordant Results of Cocaine Dip Card

| Viewer | Sample Number | GC/MS Result | Dip Card<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | 38238 | 285 | Positive |
| Viewer A | 58356 | 280 | Positive |
| Viewer C | 38238 | 285 | Positive |
| Viewer C | 71282 | 312 | Negative |
| Viewer C | 35525 | 317 | Negative |

| Turn-Key<br>Split<br>Cup | | Negative | Low Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by GC/MS<br>(greater than<br>+50%) |
|--------------------------|----------|----------|-------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 2 | 15 | 25 |
| Viewer<br>A | Negative | 1 | 20 | 8 | 0 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 14 | 25 |
| Viewer<br>B | Negative | 1 | 20 | 10 | 1 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 14 | 25 |
| Viewer<br>C | Negative | 1 | 20 | 10 | 1 | 0 |

## Discordant Results of Cocaine Turn-Key Split Cup

| Viewer | Sample Number | GC/MS Result | Split Cup<br>Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer A | 38238 | 285 | Positive |
| Viewer A | 58356 | 280 | Positive |
| Viewer B | 71282 | 312 | Negative |
| Viewer C | 35525 | 317 | Negative |

{18}------------------------------------------------

| Quick<br>Cup | | Negative | Low Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff Positive by<br>GC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by GC/MS<br>(greater than<br>+50%) |
|--------------|----------|----------|-------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |

## Discordant Results of Cocaine Quick Cup

| Viewer | Sample Number | GC/MS Result | Quick Cup<br>Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer A | 38238 | 285 | Positive |
| Viewer B | 38238 | 285 | Positive |
| Viewer C | 63906 | 225 | Positive |
| Viewer B | 71282 | 312 | Negative |
| Viewer C | 71282 | 312 | Negative |

## Morphine

| Strip | Morphine | | | | | |
|----------|----------|-------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------|----|
| | Negative | Low Negative by GC/MS<br>(less than -50%) | Near Cutoff Negative by GC/MS<br>(Between -50% and cutoff) | Near Cutoff Positive by GC/MS<br>(Between the cutoff and +50%) | High Positive by GC/MS<br>(greater than +50%) | |
| Viewer A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |

## Discordant Results of Morphine Strip

| Viewer | Sample Number | GC/MS Result | Strip<br>Viewer Results |
|----------|---------------|--------------|-------------------------|
| Viewer A | 91558 | 1890 | Positive |
| Viewer B | 99379 | 1917 | Positive |
| Viewer A | 65159 | 2231 | Negative |

{19}------------------------------------------------

| Dip<br>Card | | Negative | Low<br>Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by GC/MS<br>(greater than<br>+50%) |
|-------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 2 | 15 | 25 |
| | Negative | 10 | 20 | 8 | 0 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |

## Discordant Results of Morphine Dip Card

| Viewer | Sample Number | GC/MS Result | Dip Card<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | 99379 | 1917 | Positive |
| Viewer A | 91558 | 1890 | Positive |
| Viewer B | 91558 | 1890 | Positive |
| Viewer B | 62657 | 2115 | Negative |
| Viewer C | 59704 | 2022 | Negative |

| Turn-<br>Key<br>Split<br>Cup | | Negative | Low Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by GC/MS<br>(greater than<br>+50%) |
|------------------------------|----------|----------|-------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 1 | 20 | 9 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1…