Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)

K142280 · Healgen Scientific,, LLC · DJG · Oct 16, 2014 · Clinical Toxicology

Device Facts

• Record ID: K142280
• Device Name: Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)
• Applicant: Healgen Scientific,, LLC
• Product Code: DJG · Clinical Toxicology
• Decision Date: Oct 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

Healgen Oxazepam Test is an immunochromatographic assay for the qualitative determination of Oxazepam (a drug in the benzodiazepine class) in human urine at a Cut-Off concentration of 300 ng/m L. The test is available in a Strip format, a Cassette format, a Dip Card format and a 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 test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS 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. It is intended for over-the-counter and for prescription use. Healgen Morphine Test is an immunochromatographic assay for the qualitative determination of morphine (a drug in the opiate class) in human urine at a Cut-Off concentration of 2000 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the presult is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Device Story

Lateral flow immunochromatographic assays for qualitative detection of Oxazepam or Morphine in human urine; available in strip, cassette, dip card, or cup formats. Principle: competitive binding; target drugs in urine compete with drug-conjugate for limited antibody binding sites on colored particles. Absence of drug allows antibody-particle binding to immobilized conjugate, forming visible test line; presence of drug above cutoff saturates antibodies, preventing test line formation. Used in point-of-care or home settings by lay users or clinicians. Results are visual; interpreted by user. Preliminary positive results require confirmation via GC/MS. Benefits include rapid, accessible screening for drug presence.

Clinical Evidence

Bench testing only. Performance validated via precision studies (25 days, 2 runs/day), interference testing (no interference from common substances at 100µg/mL), specificity/cross-reactivity studies, and method comparison against GC/MS. Lay-user study (n=140 per test) confirmed ease of use and accuracy across diverse demographics (ages 21 to >50).

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: strip, cassette, dip card, cup. Components: monoclonal mouse antibody-coated particles, immobilized drug-conjugate. Stability: 24 months at 4-30°C. No electronic components or software.

Indications for Use

Indicated for qualitative detection of Oxazepam (300 ng/mL cutoff) or Morphine (2000 ng/mL cutoff) in human urine. Intended for over-the-counter and prescription use to provide preliminary drug screening results. Not intended to distinguish between prescription use and abuse. Requires confirmatory testing (GC/MS).

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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).

Submission Summary (Full Text)

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

October 16, 2014

HEALGEN SCIENTIFIC LLC C/O JOE SHIA LSI INTERNATIONAL INC. 504 EAST DIAMOND AVE., SUITE F GAITHERSBURG MD 20877

Re: K142280

Trade/Device Name: Healgen Oxazepam Test (Strip, Cassette, Cup, Dio Card): Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: II Product Code: JXM, DJG Dated: August 12, 2014 Received: August 15, 2014

Dear Mr. Joe Shia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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

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#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) k142280

#### Device Name

Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card) Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)

#### Indications for Use (Describe)

Healgen Oxazepam Test is an immunochromatographic assay for the qualitative determination of Oxazepam (a drug in the benzodiazepine class) in human urine at a Cut-Off concentration of 300 ng/m L. The test is available in a Strip format, a Cassette format, a Dip Card format and a 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 test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS 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. It is intended for over-the-counter and for prescription use.

Healgen Morphine Test is an immunochromatographic assay for the qualitative determination of morphine (a drug in the opiate class) in human urine at a Cut-Off concentration of 2000 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

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

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### 510(k) SUMMARY

| 1. Date: | October 6, 2014 |
|--------------------|---------------------------------------------------------------------------------------------------------|
| 2. Submitter: | HEALGEN SCIENTIFIC LLC<br>5213 Maple St<br>Bellaire, TX77401 |
| 3. Contact person: | Jianqiu Fang<br>HEALGEN SCIENTIFIC LLC<br>5213 Maple St<br>Bellaire, TX77401<br>Telephone: [phone] |

Telephone: [phone] Fax: [phone] Email: [e-mail]

- 4. Device Name: Healgen Oxazepam Test (Strip, Cassette. Cup, Dip Card) Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)
#### Classification:

| Product<br>Code | CFR # | Panel |
|-----------------|---------------------------------------------|------------|
| JXM | 21 CFR, 862.3170 Benzodiazepine Test System | Toxicology |
| DJG | 21 CFR, 862.3650 Opiate Test System | Toxicology |

- 5. Predicate Devices:
K052115 First Check Multi Drug Cup 12

- 6. Intended Use
Healgen Oxazepam Test is an immunochromatographic assay for the qualitative determination of Oxazepam (a drug in the benzodiazepine class) in human urine at a Cut-Off concentration of 300 ng/m L. The test is available in a Strip format, a Cassette format, a Dip Card format and a 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 test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and

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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. It is intended for over-the-counter and for prescription use.

Healgen Morphine Test is an immunochromatographic assay for the qualitative determination of morphine (a drug in the opiate class) in human urine at a Cut-Off concentration of 2000 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS 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. It is intended for over-the-counter and for prescription use.

#### 7. Device Description

Healgen Oxazepam Test and Healgen Morphine Test are immunochromatographic assays for Oxazepam and Morphine. Each assay test is a lateral flow system for the qualitative detection of Oxazepam and Morphine (target analyte) in human urine. The products are in vitro diagnostic devices, which come in the form of: Strips, Cassettes, DipCards, or Cups. Each product contains a Test Device (in one of the four formats), and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

#### 8. Substantial Equivalence Information

A summary comparison of features of the Healgen Oxazepam Test and Healgen Morphine Test and the predicate device is provided in Table 1 & Table 2.

| Item | Device | Predicate -<br>K052115 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Intended Use | For the qualitative determination of drugs<br>of abuse in human urine. | Same |
| Drug Analyte | Oxazepam | Benzodiazepine<br>Drug Class |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on<br>the principle of antigen antibody<br>immunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 300 ng/mL | Same |

#### Table 1: Features Comparison of Healgen Oxazepam Test and the Predicate Device

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| Item | Device | Predicate -<br>K052115 |
|------------------------|------------------------------------------------|---------------------------------|
| Intended<br>Population | For over-the-counter and prescription<br>uses. | For<br>over-the-counter<br>use. |
| Configurations | Strip, Cassette, Cup, Dip Card | Cup |

| Table 2: Features Comparison of Healgen Morphine Test and the Predicate Device | | | | | | |
|--------------------------------------------------------------------------------|--|--|--|--|--|--|
|--------------------------------------------------------------------------------|--|--|--|--|--|--|

| Item | Device | Predicate - K052115 |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Intended Use | For the qualitative determination of<br>drugs of abuse in human urine. | Same |
| Drug Analyte | Morphine | Opiate Drug Class |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based<br>on the principle of antigen antibody<br>immunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 2000 ng/mL | Same |
| Intended<br>For over-the-counter and prescription | | For over-the-counter |
| Population | uses. | use. |
| Configurations | Strip, Cassette, Cup, Dip Card | Cup |

#### 9. Test Principle

Healgen Oxazepam Test and Healgen Morphine Test are rapid tests for the qualitative detection of Oxazepam and Morphine in urine samples. Each assay test is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs are present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific antibody (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 cut-off 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.

#### 10. Performance Characteristics

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#### 1. Analytical Performance

#### a.Precision

Precision studies were carried out for samples with concentrations of -100% cut-off, -50% cut-off, -25% cut-off, at the 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 blind labeled and randomized. For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following tables:

#### Oxazepam

| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|--------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot: 1201001 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: 1201002 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: 1201003 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

#### Strip Format

#### Cassette Format

| | Result -100% | -75% - | -50% | -25% | | +25% +50% +75% +100% | |
|--------------|---------------------------------------|--------|--------------------------------------------------------------------------------|------|---------|---------------------------------------|--|
| Drug | Cut-off Cut-off Cut-off Cut-off | | | | Cut-off | Cut-off Cut-off Cut-off Cut-off | |
| Lot: 1201004 | 50-10+ | | 50-/0+ 50-/0+ 50-/0+ 24-/26+ 50+/0- 50+/0- 50+/0- 50+/0- | | | | |
| Lot: 1201005 | 50-10+ | | 50-/0+ 50-/0+ 50-/0+ 24-/26+ 50+/0- 50+/0- 50+/0- 50+/0- | | | | |
| Lot: 1201006 | | | 50-/0+ 50-/0+ 50-/0+ 50-/0+ 24-/26+ 50+/0- 50+/0- 50+/0- 50+/0- | | | | |

#### Dip Card Format

| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|------|--------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot: 1201007 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot: 1201008 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot: 1201009 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

#### CUP Format

| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|--------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot: 1201010 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: 1201011 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: 1201012 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

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#### Morphine

## Strip Format

| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|------|--------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot: 1112001 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot: 1112002 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot: 1112003 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

#### Cassette Format

| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|------|--------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot: 1112004 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:1112005 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot: 1112006 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

#### Dip Card Format

| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|--------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot: 1112007 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: 1112008 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: 1112009 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

#### CUP Format

| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|--------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot: 1112010 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: 1112011 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: 1112012 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 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℃ and real time stability determination at both 4 ℃ and 30℃.

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Control materials are not provided with the device. The labeling provides information on how to obtain control materials.

#### 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 both Oxazepam and Morphine. The following cut-off values for the test devices have been verified.

| Test | Calibrator | Cut-off<br>(ng/mL) |
|---------------|------------|--------------------|
| Oxazepam Test | Oxazepam | 300 |
| Morphine Test | Morphine | 2000 |

#### e. Interference

Potential interfering substances found in human urine of physiological conditions were added to drug-free urine and target drugs urine with concentration at 25% above cut-off levels. These urine samples were tested using three batches of each device for all formats.

Compounds that showed no interference at a concentration of 100µg/mL are summarized in the following tables. There were no differences observed for different formats.

| 4-Acetamidophenol | Doxylamine | Oxolinic acid |
|----------------------|-------------------------------|---------------------|
| Acetophenetidin | Ecaonine dydrochloride | Pentobarbital |
| N-Acetylprocainamide | Ecgonine methylester | Perphenazine |
| Acetylsalicylic acid | (-)-Ψ-Ephedrine | Phencyclidine |
| Aminoprine | Fenoprofen | Phenelzine |
| Amitriptyline | Furosemide | Phenobarbital |
| Amorbarbital | Gentisic acid | Phentermine |
| Amoxicillin | Hemoglobin | L-Phenylephrine |
| Ampicillin | Hydrocortisone | Phenylethylamine |
| 1-Ascorbic Acid | O-Hydroxyhippuric acid | Phenylpropanotamine |
| D.L-Amphetamine | p-Hydroxy-<br>methamphetamine | Prednisone |
| Aporphine | 3-Hydroxytyramine | D.L-Propanolol |

#### Oxazepam

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| Aspartame | Ibuprofen | D-Propoxyphene |
|-----------------------|-------------------------------------------|------------------------------------------|
| Atropine | Imipramine | D-Pseudoephedrine |
| Benzillic acid | Iproniazid | Quinine |
| Benzoic acid | (±)Isoproterenol | Ranitidine |
| Benzoylecaonine | Isoxsuprine | Salicylic acid |
| Benzphetamine | Ketamine | Secobarbital |
| Bilirubin | Ketoprofen | Serotonin<br>(5-Hydroxytyramine) |
| (±) Chlorpheniramine | Labetalol | Sertraline |
| Caffeine | Loperamide | Sulfamethazine |
| Cannabidiol | Maprotiline | Sulindac |
| Chloralhydrate | Meperidine | Tetrahydrocortisone,3 Acetate |
| Chloramphenicol | Meprobamate | Tetrahydrocortisone,(β-D<br>glucuronide) |
| Chlorothiazide | Methadone | Tetrahydrozoline |
| (±)Chlorpheniramine | Methoxyphenamine | Thiamine |
| Chlorpromazine | (+) 3,4-Methylenedioxy-<br>amphetamine | Thioridazine |
| Chlorquine | (+)3,4-Methylenedioxy-<br>methamphetamine | D.L-Tyrosine |
| Cholesterol | Nalidixic acid | Tolbutamide |
| Clomipramine | Nalorphine | Triamterene |
| Clonidine | Naloxone | Trifluoperazine |
| Cocaine hydrochloride | Naltrexone | Trimethoprim |
| Cortisone | Naproxen | Tryptamine |
| (-)cotinine | Niacinamide | D.L-Tryptophan |
| Creatinine | Nifedipine | Tyramine |
| Dextromethlorphan | Norethindrone | Uric acid |
| Diclolrfenac | D-Norpropoxyphene | Verapamil |
| Diflunisal | Noscapine | Zomepirac |
| Diaoxin | D.L-Octopamine | |
| Diphenhydramine | Oxalic acid | |

# Morphine

| 4-Acetamidophenol | Ecgonine methylester | Oxolinic acid |
|------------------------|-------------------------------------------|-------------------------------------------|
| Acetophenetidin | (-) -Y -Ephedrine | Oxymetazoline |
| N-Acetylprocainamide | Erythromycin | Papaverine |
| Acetylsalicylic acid | β-Estradiol | Penicillin-G |
| Aminopyrine | Estrone-3-sulfate | Pentazocine |
| Amitryptyline | Ethyl-p-aminobenzoate | Pentobarbital |
| Amobarbital | Fenoprofen | Perphenazine |
| Amoxicillin | Furosemide | Phencyclidine |
| Ampicillin | Gentisic acid | Phenelzine |
| Ascorbic acid | Hemoglobin | Phenobarbital |
| D,L-Amphetamine | Hydralazine | Phentermine |
| Apomorphine | Hydrochlorothiazide | L-Phenylephrine |
| Aspartame | Hydrocortisone | β-Phenylethylamine |
| Atropine | O-Hydroxyhippuric acid | Phenylpropanolamine |
| Benzilic acid | p-Hydroxy methamphetamine | Prednisone |
| Benzoic acid | 3-Hydroxytyramine | D,L-Propanolol |
| Benzoylecgonine | Ibuprofen | D-Propoxyphene |
| Benzphetamine | Imipramine | D-Pseudoephedrine |
| Bilirubin (±) | Iproniazid | Quinidine |
| Brompheniramine | Isoproterenol | Quinine |
| Caffeine | Isoxsuprine | Ranitidine |
| Cannabidiol | Ketamine | Salicylic acid |
| Chloralhydrate | Ketoprofen | Secobarbital |
| Chloramphenicol | Labetalol | Serotonin (5-<br>Hydroxytyramine) |
| Chlordiazepoxide | Loperamide | Sulfamethazine |
| Chlorothiazide | Maprotiline | Sulindac |
| (±) Chlorpheniramine | Meperidine | Temazepam |
| Chlorpromazine | Meprobamate | Tetracycline |
| Chlorquine | Methadone | Tetrahydrocortisone, 3<br>Acetate |
| Cholesterol | Methoxyphenamine | Tetrahydrocortisone3 (ß-D<br>glucuronide) |
| Clomipramine | (+) 3,4-Methylenedioxy-<br>amphetamine | Tetrahydrozoline |
| Clonidine | (+)3,4-Methylenedioxy-<br>methamphetamine | Thiamine |
| Cocaine hydrochloride | Nalidixic acid | Thioridazine |
| Cortisone | Nalorphine | D, L-Tyrosine |
| (-) Cotinine | Naloxone | Tolbutamide |
| Creatinine | Naltrexone | Triamterene |
| Deoxycorticosterone | Naproxen | Trifluoperazine |
| Dextromethorphan | Niacinamide | Trimethoprim |
| Diazepam | Nifedipine | Trimipramine |
| Diclofenac | Norethindrone | Tryptamine |
| Diflunisal | D-Norpropoxyphene | D, L-Tryptophan |
| Digoxin | Noscapine | Tyramine |
| Diphenhydramine | D,L-Octopamine | Uric acid |
| Doxylamine | Oxalic acid | Verapamil |
| Ecgonine hydrochloride | Oxazepam | Zomepirac |

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

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

#### f. Specificity

To test the specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device for all formats. The obtained lowest detectable concentration was used to calculate the cross-reactivity. There were no differences observed for different formats.

| | Result | %<br>Cross-Reactivity |
|---------------------------------|-------------------------|-----------------------|
| Oxazepam<br>(Cut-off=300 ng/mL) | Positive at 300 ng/mL | 100% |
| Alprazolam | Positive at 200 ng/mL | 150% |
| Bromazepam | Positive at 1560 ng/mL | 19% |
| Chlordiazepoxide HCL | Positive at 1560 ng/mL | 19% |
| Clobazam | Positive at 100 ng/mL | 300% |
| Clonazepam | Positive at 780 ng/mL | 38% |
| Clorazepate Dipotassium | Positive at 200 ng/mL | 150% |
| Delorazepam | Positive at 1560 ng/mL | 19% |
| Desalkylflurazepam | Positive at 400 ng/mL | 75% |
| Diazepam | Positive at 200 ng/mL | 150% |
| Estazolam | Positive at 2500 ng/mL | 12% |
| Flunitrazepam | Positive at 400 ng/mL | 75% |
| a-Hydroxyalprazolam | Positive at 1260 ng/mL | 24% |
| (±) Lorazepam | Positive at 1560 ng/mL | 19% |
| RS-Lorazepam glucuronide | Positive at 160 ng/mL | 188% |
| Midazolam | Positive at 12500 ng/mL | 2.4% |
| Nitrazepam | Positive at 100 ng/mL | 300% |
| Norchlordiazepoxide | Positive at 200 ng/mL | 150% |
| Nordiazepam | Positive at 400 ng/mL | 75% |
| Temazepam | Positive at 100 ng/mL | 300% |
| Triazolam | Positive at 2500 ng/mL | 12% |

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

| | Result | % Cross-Reactivity |
|----------------------------------|--------------------------|----------------------------|
| Morphine<br>(Cut-off=2000 ng/mL) | Positive at 2000 ng/mL | 100% |
| O6-Acetylmorphine | Positive at 2500 ng/mL | 80% |
| Codeine | Positive at 1000 ng/mL | 200% |
| EthylMorphine | Positive at 250 ng/mL | 800% |
| Heroin | Positive at 5000 ng/mL | 40% |
| Hydromorphone | Positive at 2500 ng/mL | 80% |
| Hydrocodone | Positive at 5000 ng/mL | 40% |
| Oxycodone | Positive at 75000 ng/mL | 3% |
| Thebaine | Positive at 13,000 ng/mL | 15% |

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

To investigate the effect of urine specific gravity and urine pH, urine samples with of 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 batches of each device for all formats. 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 formats.

#### 2. Comparison Studies

The method comparison studies for the Oxazepam Test, and the Morphine Test were performed in-house with three different laboratory assistants for each format of the 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:

| Oxazepam | | | | | | |
|--------------|----------|----------|----------------------------------------|----------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------|
| Strip format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |

Oxazepam

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

| Viewer | Sample Number | GC/MS Result | Strip Format<br>Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | 549 | 306 | Negative |
| Viewer A | 523 | 303 | Negative |
| Viewer B | 549 | 306 | Negative |
| Viewer B | 523 | 303 | Negative |
| Viewer B | 579 | 312 | Negative |
| Viewer C | 549 | 306 | Negative |
| Viewer C | 523 | 303 | Negative |

Discordant Results of Oxazepam Strip

| Cassette<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than<br>-50%) | Near<br>Cutoff<br>Negative<br>by GC/MS<br>(Between<br>-50% and<br>cut-off) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than<br>+50%) |
|--------------------|----------|----------|----------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| | Positive | 0 | 0 | 0 | 13 | 24 |
| Viewer A | Negative | 10 | ાં ર | ાં ર | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | ા ર | ા ર | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | ા ર | ા ર | 3 | 0 |

## Discordant Results of Oxazepam Cassette

| Viewer | Sample Number | GC/MS Result | Cassette Format<br>Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | 549 | 306 | Negative |
| Viewer A | 523 | 303 | Negative |
| Viewer A | 579 | 312 | Negative |
| Viewer B | 549 | 306 | Negative |
| Viewer B | 523 | 303 | Negative |
| Viewer B | 579 | 312 | Negative |
| Viewer C | 549 | 306 | Negative |
| Viewer C | 523 | 303 | Negative |
| Viewer C | 579 | 312 | Negative |

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

| Cup format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
|------------|----------|----------|----------------------------------------|----------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |

## Discordant Results of Oxazepam Cup

| Viewer | Sample Number | GC/MS Result | Cup Format<br>Viewer Results |
|----------|---------------|--------------|------------------------------|
| Viewer A | 549 | 306 | Negative |
| Viewer A | 523 | 303 | Negative |
| Viewer B | 523 | 303 | Negative |
| Viewer B | 579 | 312 | Negative |
| Viewer C | 549 | 306 | Negative |
| Viewer C | 523 | 303 | Negative |

| Dip Card<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cut-off) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than<br>+50%) |
|--------------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 12 | 24 |
| | Negative | 10 | 15 | 15 | 4 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 12 | 24 |
| | Negative | 10 | 15 | 15 | 4 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |

# Discordant Results of OxazepamDip Card

| Discordant Results of OxazepamDip Card | | | | | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|---------------------------------------------------|--|--|
| Viewer | Sample Number | | Dip Card Format<br>GC/MS Result<br>Viewer Results | | |
| Viewer A | રે રેણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ | 315 | Negative | | |
| Viewer A | 549 | 306 | Negative | | |

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

| Viewer | Sample Number | GC/MS Result | Dip Card Format<br>Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | 523 | 303 | Negative |
| Viewer A | 579 | 312 | Negative |
| Viewer B | 505 | 315 | Negative |
| Viewer B | 549 | 306 | Negative |
| Viewer B | 523 | 303 | Negative |
| Viewer B | 579 | 312 | Negative |
| Viewer C | 549 | 306 | Negative |
| Viewer C | 523 | 303 | Negative |

## Morphine

| Strip<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cut-off) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than<br>+50%) |
|-----------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 13 | 23 |
| | Negative | 10 | 16 | 14 | 4 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 23 |
| | Negative | 10 | 16 | 14 | 4 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 15 | 23 |
| | Negative | 10 | 16 | 14 | 2 | 0 |

# Discordant Results of Morphine Strip

| Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer A | 468 | 2036 | Negative |
| Viewer A | 466 | 2019 | Negative |
| Viewer A | 453 | 2066 | Negative |
| Viewer A | 449 | 2005 | Negative |
| Viewer B | 468 | 2036 | Negative |
| Viewer B | 466 | 2019 | Negative |
| Viewer B | 453 | 2066 | Negative |
| Viewer B | 449 | 2005 | Negative |
| Viewer C | 466 | 2019 | Negative |

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

| Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer C | 449 | 2005 | Negative |

| Cassette<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cut-off) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than<br>+50%) |
|--------------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 14 | 23 |
| | Negative | 10 | 16 | 14 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 23 |
| | Negative | 10 | 16 | 14 | 4 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 23 |
| | Negative | 10 | 16 | 14 | 4 | 0 |

# Discordant Results of Morphine Cassette

| Viewer | Sample Number | GC/MS Result | Cassette Format Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | 468 | 2036 | Negative |
| Viewer A | 466 | 2019 | Negative |
| Viewer A | 449 | 2005 | Negative |
| Viewer B | 405 | 2053 | Negative |
| Viewer B | 468 | 2036 | Negative |
| Viewer B | 466 | 2019 | Negative |
| Viewer B | 449 | 2005 | Negative |
| Viewer C | 405 | 2053 | Negative |
| Viewer C | 468 | 2036 | Negative |
| Viewer C | 466 | 2019 | Negative |
| Viewer C | 449 | 2005 | Negative |

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

| Dip Card<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cut-off) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than<br>+50%) |
|--------------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 13 | 23 |
| Viewer A | Negative | 10 | 16 | 14 | 4 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 12 | 23 |
| Viewer B | Negative | 10 | 16 | 14 | 5 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 12 | 23 |
| Viewer C | Negative | 10 | 16 | 14 | 5 | 0 |

Discordant Results of Morphine Dip Card

| Viewer | Sample Number | GC/MS Result | Dip Card Format<br>Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | 405 | 2053 | Negative |
| Viewer A | 468 | 2036 | Negative |
| Viewer A | 466 | 2019 | Negative |
| Viewer A | 449 | 2005 | Negative |
| Viewer B | 405 | 2053 | Negative |
| Viewer B | 468 | 2036 | Negative |
| Viewer B | 466 | 2019 | Negative |
| Viewer B | 449 | 2005 | Negative |
| Viewer B | 429 | 2067 | Negative |
| Viewer C | 405 | 2053 | Negative |
| Viewer C | 468 | 2036 | Negative |
| Viewer C | 466 | 2019 | Negative |
| Viewer C | 449 | 2005 | Negative |
| Viewer C | 429 | 2067 | Negative |

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

| Cup<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cut-off) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than<br>+50%) |
|---------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 15 | 23 |
| | Negative | 10 | 16 | 14 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 23 |
| | Negative | 10 | 16 | 14 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 23 |
| | Negative | 10 | 16 | 14 | 4 | 0 |

#### Discordant Results of Morphine Cup

| Viewer | Sample Number | GC/MS Result | Cup Format Viewer Results |
|----------|---------------|--------------|---------------------------|
| Viewer A | 466 | 2019 | Negative |
| Viewer A | 449 | 2005 | Negative |
| Viewer B | 468 | 2036 | Negative |
| Viewer B | 466 | 2019 | Negative |
| Viewer B | 449 | 2005 | Negative |
| Viewer C | 405 | 2053 | Negative |
| Viewer C | 468 | 2036 | Negative |
| Viewer C | 466 | 2019 | Negative |
| Viewer C | 449 | 2005 | Negative |

Lay-user study

A lay user study was performed at three intended user sites with 140 lay persons testing the Oxazepam devices and another set of 140 persons testing the morphine devices. A total of 44 females and 96 males tested the Oxazepam samples, and 41 females and 99 males tested the Morphine samples. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.

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

| % of Cutoff | Number of samples | Oxazepam Concentration by GC/MS (ng/mL) | Lay person results No. of Positive | Lay person results No. of Negative | The percentage of correct results (%) |
|--------------|-------------------|-----------------------------------------|------------------------------------|------------------------------------|---------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |

Comparison between GC/MS and Lay Person Results (Oxazepam Strip)

Comparison between GC/MS and Lay Person Results (Oxazepam Cassette)

| | Number | Oxazepam Concentration | Lay person results | | The |
|--------------|---------------|------------------------|--------------------|--------------------|-----------------------------------------|
| % of Cutoff | of<br>samples | by GC/MS<br>(ng/mL) | No. of<br>Positive | No. of<br>Negative | percentage of<br>correct results<br>(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |

Comparison between GC/MS and Lay Person Results (Oxazepam DipCard)

| | Number<br>of<br>samples | Oxazepam Concentration<br>by GC/MS<br>(ng/mL) | Lay person results | | The |
|--------------|-------------------------|-----------------------------------------------|--------------------|--------------------|-----------------------------------------|
| % of Cutoff | | | No. of<br>Positive | No. of<br>Negative | percentage of<br>correct results<br>(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |

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

| | Number<br>of<br>samples | Oxazepam Concentration<br>by GC/MS<br>(ng/mL) | Lay person results | | The |
|--------------|-------------------------|-----------------------------------------------|--------------------|--------------------|-----------------------------------------|
| % of Cutoff | | | No. of<br>Positive | No. of<br>Negative | percentage of<br>correct results<br>(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |

Comparison between GC/MS and Lay Person Results (Oxazepam Cup)

#### Comparison between GC/MS and Lay Person Results (Morphine Strip)

| % of Cutoff | Number of samples | MOP Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
|--------------|-------------------|------------------------------------|--------------------|----|---------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 500 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 1000 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 1500 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 2500 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 3000 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 3500 | 20 | 0 | 100% |

Comparison between GC/MS and Lay Person Results (Morphine Cassette)

| | Number<br>of<br>samples | MOP Concentration by<br>GC/MS<br>(ng/mL) | Lay person results | | The |
|-------------|-------------------------|------------------------------------------|--------------------|--------------------|-----------------------------------------|
| % of Cutoff | | | No. of<br>Positive | No. of<br>Negative | percentage of<br>correct results<br…