CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests

K161251 · Hangzhou Clongene Biotech Co., Ltd. · DKZ · Aug 30, 2016 · Clinical Toxicology

Device Facts

• Record ID: K161251
• Device Name: CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
• Applicant: Hangzhou Clongene Biotech Co., Ltd.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Aug 30, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

CLUNGENE 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 Cassette format, a Cup format, a Dip Card format, and a Split Key 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. CLUNGENE Cocaine Tests are immunochromatographic assays for the qualitative determination of Cocaine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key 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. CLUNGENE Oxazepam Tests are immunochromatographic assays for the qualitative determination of Oxazepam in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Dip Card format, and a Split Key Cup format. The test may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxazepam in urine. 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, Cocaine, and Oxazepam in human urine; competitive binding principle; antibody-coated particles bind to drug-specific conjugate; colored line indicates negative result (drug below cutoff); absence of line indicates positive result (drug above cutoff); procedural control line confirms proper migration; available in Cassette, Cup, Dip Card, and Split Key Cup formats; intended for OTC and prescription use; results are preliminary and require GC/MS confirmation; clinical judgment required for positive results.

Clinical Evidence

No clinical diagnostic studies performed. Analytical performance validated via precision/reproducibility studies (1350 results per analyte/format) and method comparison against GC/MS. Consumer study conducted with 1680 subjects (140 per format/analyte) demonstrated lay-user ability to correctly interpret results across various drug concentrations relative to cutoff.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle; qualitative; visually read; no instrumentation required; stable at 4-30°C for 24 months; internal procedural control line included.

Indications for Use

Indicated for qualitative detection of d-Amphetamine (1000 ng/mL), Cocaine (300 ng/mL), and Oxazepam (300 ng/mL) in human urine. Intended for OTC and prescription use to provide preliminary screening results. Not intended to distinguish between prescription use and abuse for Oxazepam.

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 FIRST CHECK MULTI DRUG CUP Urine Test (k052115)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

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

2016 August 30,

HANGZHOU CLONGENE BIOTECH CO., LTD C/O JESSE XIA MANAGER 504 E DIAMOND AVE., SUITE I GAITHERSBURG MD 20877

Re: k161251

Trade/Device Name: Clungene Amphetamine Tests, Clungene Cocaine Tests, Clungene Oxazepam Tests Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DIO, JXM Dated: July 22, 2016 Received: July 27, 2016

Dear Mr. Xia:

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

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If you desire specific advice for your device on our labeling regulations (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/ResourcesforYou/Industry/default.htm. 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

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

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) k161251

Device Name Clungene Amphetamine Tests Clungene Cocaine Tests Clungene Oxazepam Tests

#### Indications for Use (Describe)

CLUNGENE 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 Cassette format, a Cup format, a Dip Card format, and a Split Key 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.

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

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

The test may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxazepam in urine. 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)

X 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

Email: [e-mail].

- 1. Date: August 29, 2016 Hangzhou Clongene Biotech Co., Ltd. 2. Submitter: 20 Longquan Road Hangzhou 311121, China 3. Contact person: Zheng Shujian Hangzhou Clongene Biotech Co., Ltd. 20 Longquan Road Hangzhou 311121, China Telephone: [phone]
- 4. Device Name: CLUNGENE Amphetamine Tests CLUNGENE Cocaine Tests CLUNGENE Oxazepam Tests

Classification:

| Product Code | CFR # | Panel |
|--------------|---------------------------------------------|------------|
| DKZ | 21 CFR, 862.3100 Amphetamine Test System | Toxicology |
| JXM | 21 CFR, 862.3170 Benzodiazepine Test System | Toxicology |
| DIO | 21 CFR, 862.3250 Cocaine Test System | Toxicology |

### 5. Predicate Devices: K052115

The FIRST CHECK MULTI DRUG CUP Urine Test

### 6. Intended Use

CLUNGENE 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 Cassette format, a Cup format, a Dip Card format, and a Split Key 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.

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

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

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

The test may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses: it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxazepam in urine. The tests provide only preliminary test results. A more specific alternative chemical method must 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 CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, and CLUNGENE Oxazepam Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Cocaine and Oxazepam (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 CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests and CLUNGENE Oxazepam Tests and the predicate devices is provided in following tables.

| Item | Device | Predicate - K052115 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Indication(s) for Use | For the qualitative determination of drugs of abuse in human urine. | Same (but the number of 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 | Cassette, Dip Card and Cups | Cup |

Table 1: Features Comparison of CLUNGENE Amphetamine Tests and the Predicate Devices

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

| Item | Device | Predicate - K052115 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| 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 | Cocaine | 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 | Cassette, Dip Card and Cups | Cup |

### Table 3: Features Comparison of CLUNGENE Oxazepam Tests and the Predicate Devices

| Item | Device | Predicate - K052115 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| 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 | Oxazepam | 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 | Cassette, Dip Card and Cups | Cup |

# 9. Test Principle

The CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, and CLUNGENE Oxazepam Tests are rapid tests for the qualitative detection of d-Amphetamine, Cocaine and Oxazepam 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 monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by

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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 cutoffconcentration 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.

| Cassette | | | | | | | | | |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| 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+ | 28-/22+ | 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+ | 20-/30+ | 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+ | 19-/31+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 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- |
| Split-Key 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+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 31-/19+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Easy 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+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 19-/31+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

## CLUNGENE Amphetamine Tests

Cassette

### CLUNGENE Cocaine Tests

Cassette

| 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 |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|

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| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 30-/20+ | 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+ | 25-/25+ | 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+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Split-Key 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+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 32-/18+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Easy 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+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 31-/19+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

# CLUNGENE Oxazepam Tests

Cassette

| | -100% | -75% | -50% | -25% | cut off | +25% | +50% | +75% | +100% |
|----------------------|---------------|--------------|--------------|-------------|---------|--------------|--------------|--------------|---------------|
| Cassette 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+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 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- |
| Dip Card 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+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Split-Key Cup 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+ | 30-/20+ | 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+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Easy Cup 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+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

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

| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 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 Oxazepam. didata davia for the a

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

| Calibrator | Cut-off (ng/mL) |
|---------------|-----------------|
| d-Amphetamine | 1000 |
| Cocaine | 300 |
| Oxazepam | 300 |

### 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 | Diazepam | O-Hydroxyhippuric acid |
|-----------------------|------------------------|------------------------|
| (-)-Cotinine | Diclofenac | Oxalic acid |
| (-)-Isoproterenol | Diflunisal | Oxazepam |
| (-)-Y-Ephedrine | Digoxin | Oxolinic acid |
| (±)-Chlorpheniramine | Diphenhydramine | Oxycodone |
| (IR,2S)-(-)-Ephedrine | Doxylamine | Oxymetazoline |
| 3-Hydroxytyramine | Ecgonine hydrochloride | Papaverine |
| Acetophenetidin | Ecgonine methylester | Penicillin-G |
| Acetylsalicylic acid | Erythromycin | Pentazocaine |
| Aminopyrine | Estrone-3-sulfate | Pentobarbital |
| Amitriptyline | Ethyl-p-aminobenzoate | Perphenazine |
| Amobarbital | Fenfluramine | Phencyclidine |
| Amoxicillin | Fenoprofen | Phenelzine |
| Ampicillin | Furosemide | Phenobarbital |

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

| Ascorbic acid | Gentisic acid | Phenylpropanolamine |
|-----------------------|--------------------------|---------------------|
| Aspartame | Hemoglobin | Prednisolone |
| Atropine | Hydralazine | Prednisone |
| Benzilic acid | Hydrochlorothiazide | Procaine |
| Benzoic acid | Hydrocodone | Promazine |
| Benzoylecgonine | Hydrocortisone | Promethazine |
| Bilirubin | Ibuprofen | Quinidine |
| Brompheniramine | Imipramine | Quinine |
| Caffeine | Isoxsuprine | Ranitidine |
| Cannabidiol | Ketamine | Salicylic acid |
| Cannabinol | Ketoprofen | Secobarbital |
| Chloralhydrate | L-Ephedrine | Sulfamethazine |
| Chloramphenicol | L-Phenylephrine | Sulindac |
| Chlordiazepoxide | Labetalol | Temazepam |
| Chloroquine | Levorphanol | Tetracycline |
| Chlorothiazide | Loperamide | Tetrahydrocortisone |
| Chlorpromazine | Maprotiline | Tetrahydrozoline |
| Cholesterol | Meperidine | Thebaine |
| Clomipramine | Meprobamate | Thiamine |
| Clonidine | Methadone | Thioridazine |
| Cocaine hydrochloride | Methylphenidate | Tolbutamine |
| Codeine | Morphine-3-D-glucuronide | Triamterene |
| Cortisone | N-Acetylprocainamide | Trifluoperazine |
| Creatinine | Nalidixic acid | Trimethoprim |
| D-Norpropox yphene | Naloxone | Trimipramine |
| D-Propoxyphene | Naltrexone | Tryptamine |
| D/L-Octopamine | Naproxen | Uric acid |
| D/L-Propanolol | Niacinamide | Verapamil |
| D/L-Thyroxine | Nifedipine | Zomepirac |
| D/L-Tyrosine | Norcodeine | ß-Estradiol |
| Deoxycorticosterone | Norethindrone | 49-THC-COOH |
| Dextromethorphan | Noscapine | |

# Cocaine

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

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

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

# Oxazepam

| 4-Acetamidophenol | D-Propoxyphene | Naproxen |
|--------------------------------------------|------------------------|-------------------------------|
| (-)-cotinine | D-Pseudoephedrine | Niacinamide |
| (-)-Y-Ephedrine | D/L-Amphetamine | Nifedipine |
| (+)-3,4-Methylenedioxy-<br>amphetamine | D/L-Octopamine | Norethindrone |
| (+)-3,4-Methylenedioxy-<br>methamphetamine | D/L-Propranolol | Noscapine |
| (±)-Chlorpheniramine | D/L-Tryptophan | O-Hydroxyhippuric acid |
| (±)-Chlorpheniramine | D/L-Tyrosine | Oxalic acid |
| (±)-Isoproterenol | Dextromethorphan | Oxolinic acid |
| 3-Hydroxytyramine | Diclofenac | p-Hydroxy- methamphetamine |
| Acetophenetidin | Diflunisal | Pentobarbital |
| Acetylsalicylic acid | Digoxin | Perphenazine |
| Aminopyrine | Diphenhydramine | Phencyclidine |
| Amitriptyline | Doxylamine | Phenelzine |
| Amorbarbital | Ecgonine hydrochloride | Phenobarbital |
| Amoxicillin | Ecgonine methylester | Phentermine |
| Ampicillin | Fenoprofen | Phenylpropanolamine |
| Aporphine | Furosemide | Prednisone |
| Aspartame | Gentisic acid | Quinine |
| Atropine | Hemoglobin | Ranitidine |
| Benzilic acid | Hydrocortisone | Salicylic acid |
| Benzoic acid | Ibuprofen | Secobarbital |
| Benzoylecgonine | Imipramine | Serotonin (5-Hydroxytyramine) |

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

| Benzphetamine | Iproniazid | Sertraline |
|-----------------------|----------------------|------------------------------------------|
| Bilirubin | Isoxsuprine | Sulfamethazine |
| Brompheniramine | Ketamine | Sulindac |
| Caffeine | Ketoprofen | Tetrahydrocortisone 3 ( β-D-glucuronide) |
| Caffeine | L-Ascorbic Acid | Tetrahydrozoline |
| Cannabidiol | L-Phenylephrine | Thiamine |
| Chloralhydrate | Labetalol | Thioridazine |
| Chloramphenicol | Loperamide | Tolbutamide |
| Chloroquine | Maprotiline | Triamterene |
| Chlorothiazide | Meperidine | Trifluoperazine |
| Chlorpromazine | Meprobamate | Trimethoprim |
| Cholesterol | Methadone | Tryptamine |
| Clomipramine | Methoxyphenamine | Tyramine |
| Clonidine | N-Acetylprocainamide | Uric acid |
| Cocaine hydrochloride | Nalidixic acid | Verapamil |
| Cortisone | Nalorphine | Zomepirac |
| Creatinine | Naloxone | β-Phenylethylamine |
| D-Norpropoxyphene | Naltrexone | |

### 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.

### AMP

| Drugs | Concentration (ng/ml) | % Cross Reactivity |
|-------------------------------------------|-----------------------|--------------------|
| D - Amphetamine | 1000 | 100% |
| L - Amphetamine | 50000 | 2% |
| D/L - Amphetamine | 3000 | 33% |
| Phentermine | 3000 | 33% |
| Hydroxyamphetamine | 5000 | 20% |
| Methylenedioxyamphetamine (MDA) | 5000 | 20% |
| 3,4-methylenedioxy-methamphetamine (MDMA) | Negative at 100000 | < 1% |
| Methylenedioxyethylamphetamine (MDE) | Negative at 100000 | < 1% |
| D-methamphetamine | Negative at 100000 | < 1% |

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

| L-methamphetamine | Negative at 100000 | < 1% |
|-------------------|--------------------|------|
| Ephedrine | Negative at 100000 | < 1% |
| Pseudoephedrine | Negative at 100000 | < 1% |

# COC

| Cocaine (COC) | Concentration(ng/ml) | % Cross-Reactivity |
|-----------------|----------------------|--------------------|
| Benzoylecgonine | 300 | 100 |
| Cocaine HCl | 780 | 38.5 |
| Cocaethylene | 12,500 | 2.4 |
| Ecgonine HCl | 32,000 | 0.9 |
| Norcocaine | 100,000 | 0.3 |

# BZO

| Drugs | Concentration (ng/ml) | % Cross Reactivity |
|-------------------------|-----------------------|--------------------|
| Oxazepam | 300 | 100% |
| Alprazolam | 200 | 150% |
| a-Hydroxyalprazolam | 1250 | 24% |
| Bromazepam | 1500 | 20% |
| Chlordiazepoxide | 1500 | 20% |
| Clobazam | 100 | 300% |
| Clonazepam | 800 | 37% |
| Clorazepate dipotassium | 200 | 150% |
| Delorazepam | 1500 | 20% |
| Desalkylflurazepam | 400 | 75% |
| Diazepam | 200 | 150% |
| Estazolam | 2500 | 12% |
| Flunitrazepam | 400 | 75% |
| Midazolam | 12500 | 2% |
| Nitrazepam | 100 | 300% |
| Norchlordiazepoxide | 200 | 150% |

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

| Nordiazepam | 400 | 75% |
|---------------|------|------|
| Temazepam | 100 | 300% |
| Triazolam | 2500 | 12% |
| D/L-Lorazepam | 1500 | 20% |

# 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 CLUNGENE Amphetamine Tests, the CLUNGENE Cocaine Tests and the CLUNGENE Oxazepam 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. The results are presented in the tables below:

| Cassette | | 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 | 20 | 20 |
| Viewer A | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 19 | 20 |
| Viewer B | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 18 | 20 |
| Viewer C | Negative | 10 | 15 | 15 | 2 | 0 |

Amphetamine

| Discordant Results of Amphetamine Cassette | | |
|--------------------------------------------|--|--|
| | | |

| Viewer | Sample Number | GC/MS Result | Cassette<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | AMP30 | 963 | Positive |
| Viewer B | AMP59 | 1005 | Negative |
| Viewer C | AMP59 | 1005 | Negative |
| Viewer C | AMP78 | 1037 | Negative |

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

| Panel<br>Dip | | 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 | 19 | 20 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 18 | 20 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 20 | 20 |
| | Negative | 10 | 15 | 14 | 0 | 0 |

# Discordant Results of Amphetamine Panel Dip

| Viewer | Sample Number | GC/MS Result | Panel Dip<br>Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer C | AMP30 | 963 | Positive |
| Viewer A | AMP59 | 1005 | Negative |
| Viewer B | AMP59 | 1005 | Negative |
| Viewer B | AMP78 | 1037 | Negative |

| Split-<br>Key<br>Cup | | Negative | Low Negative<br>by 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 | 0 | 20 | 20 |
| | Negative | 10 | 15 | 15 | 0 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 19 | 20 |
| | Negative | 10 | 15 | 15 | 1 | 0 |

Discordant Results of Amphetamine Split-Key Cup

| Viewer | Sample Number | GC/MS Result | Split-Key Cup<br>Viewer Results |
|----------|---------------|--------------|---------------------------------|
| Viewer B | AMP30 | 963 | Positive |
| Viewer B | AMP59 | 1005 | Negative |
| Viewer C | AMP59 | 1005 | Negative |

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

| Easy<br>Cup | | 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 | 0 | 18 | 20 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 2 | 20 | 20 |
| | Negative | 10 | 15 | 13 | 0 | 0 |

# Discordant Results of Amphetamine Easy Cup

| Discordant Results of Amphetamine Easy Cup | | | |
|--------------------------------------------|---------------|--------------|-------------------------|
| Viewer | Sample Number | GC/MS Result | Easy Cup Viewer Results |
| Viewer B | AMP30 | 963 | Positive |
| Viewer C | AMP30 | 963 | Positive |
| Viewer C | AMP18 | 952 | Positive |
| Viewer A | AMP59 | 1005 | Negative |
| Viewer A | AMP78 | 1037 | Negative |
| Viewer B | AMP59 | 1005 | Negative |

# Cocaine

| Cassette | | 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 | 20 | 20 |
| Viewer A | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 19 | 20 |
| Viewer B | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 20 | 20 |
| Viewer C | Negative | 10 | 15 | 15 | 0 | 0 |

# Discordant Results of Cocaine Cassette

| Viewer | Sample Number | GC/MS Result | Cassette Viewer Results |
|----------|---------------|--------------|-------------------------|
| Viewer A | COC45 | 284 | Positive |
| Viewer B | COC45 | 284 | Positive |
| Viewer B | COC66 | 307 | Negative |

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

| Panel<br>Dip | | 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 | 2 | 20 | 20 |
| | Negative | 10 | 15 | 13 | 0 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 19 | 20 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 19 | 20 |
| | Negative | 10 | 15 | 15 | 1 | 0 |

# Discordant Results of Cocaine Panel Dip

| Viewer | Sample Number | GC/MS Result | Panel Dip<br>Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer B | COC35 | 311 | Negative |
| Viewer C | COC35 | 311 | Negative |
| Viewer A | COC16 | 296 | Positive |
| Viewer A | COC45 | 284 | Positive |

| Split-<br>Key<br>Cup | | Negative | Low Negative<br>by 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 | 0 | 20 | 20 |
| | Negative | 10 | 15 | 15 | 0 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 18 | 20 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 20 | 20 |
| | Negative | 10 | 15 | 14 | 0 | 0 |

| Discordant Results of Cocaine Split-Kev Cup | | |
|---------------------------------------------|--|--|
|---------------------------------------------|--|--|

| Viewer | Sample Number | GC/MS Result | Split Cup Viewer Results |
|----------|---------------|--------------|--------------------------|
| Viewer C | COC45 | 284 | Positive |
| Viewer B | COC35 | 311 | Negative |
| Viewer B | COC66 | 307 | Negative |

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

| Easy<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 | 0 | 18 | 20 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 19 | 20 |
| | Negative | 10 | 15 | 15 | 1 | 0 |

# Discordant Results of Cocaine Easy Cup

| Viewer | Sample Number | GC/MS Result | Easy Cup<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer B | COC45 | 284 | Positive |
| Viewer A | COC35 | 311 | Negative |
| Viewer A | COC66 | 307 | Negative |
| Viewer B | COC66 | 307 | Negative |
| Viewer C | COC35 | 311 | Negative |

## Oxazepam

| Cassette | | 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 | 0 | 19 | 20 |
| A | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 19 | 20 |
| B | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 0 | 19 | 20 |
| C | Negative | 10 | 15 | 15 | 1 | 0 |

# Discordant Results of Oxazepam Cassette

| Viewer | Sample Number | GC/MS Result | Cassette<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer B | BZ077 | 291 | Positive |
| Viewer A | BZ013 | 309 | Negative |
| Viewer B | BZO26 | 311 | Negative |
| Viewer C | BZO61 | 308 | Negative |

{20}------------------------------------------------

| Panel<br>Dip | | 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 | 19 | 20 |
| Viewer<br>A | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 20 | 20 |
| Viewer<br>B | Negative | 10 | 15 | 15 | 0 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 20 | 20 |
| Viewer<br>C | Negative | 10 | 15 | 14 | 0 | 0…