Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)

K151348 · Healgen Scientific,, LLC · LFG · Aug 18, 2015 · Clinical Toxicology

Device Facts

• Record ID: K151348
• Device Name: Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)
• Applicant: Healgen Scientific,, LLC
• Product Code: LFG · Clinical Toxicology
• Decision Date: Aug 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3910
• Device Class: Class 2

Intended Use

Healgen Propoxyphene Test is an immunochromatographic assay for the qualitative determination of Propoxyphene in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format. The test may yield preliminary positive results even when the prescription drug Propoxyphene 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 Propoxyphene 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 prefered 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 prescription and for over-the-counter use. Healgen Nortriptyline Test is an immunochromatographic assay for the qualitative determination of Nortriptyline in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format. The test may yield preliminary positive results even when the prescription 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 Nortriptyline 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 prefered 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 prescription and for over-the-counter use. Healgen EDDP (Methadone Metabolite) Test is an immunochromatographic assay for the qualitative determination of EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) in human urine at a Cut-Off concentration of 300 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 prescription and for over-the-counter use.

Device Story

Lateral flow immunochromatographic assays for qualitative detection of Propoxyphene, Nortriptyline, and EDDP in human urine; competitive binding principle using monoclonal mouse antibodies. Available in strip, cassette, dip card, and cup formats. Used in clinical or home settings by healthcare professionals or lay users. Urine sample migrates via capillary action; target drug competes with drug-conjugate for antibody binding sites. Absence of test line indicates drug presence above cutoff; presence of line indicates drug absence or concentration below cutoff. Control line confirms proper test performance. Results are preliminary; require GC/MS confirmation. Assists in identifying potential drug use; clinical judgment required for interpretation.

Clinical Evidence

Bench testing only. Precision studies (25 days, 3 operators) and method comparison studies (80 clinical samples vs GC/MS) performed. Lay-user study (n=1680) conducted across three sites with diverse demographics (ages 21->50) confirmed performance across all formats. Interference and specificity testing verified no cross-reactivity with common substances.

Technological Characteristics

Lateral flow chromatographic immunoassay; monoclonal anti-mouse antibody-dye conjugate with gold chloride; fixed drug-protein conjugates; anti-mouse IgG polyclonal antibody; visual readout; no instrumentation required; shelf life 24 months at 4-30°C.

Indications for Use

Indicated for qualitative detection of Propoxyphene (300 ng/mL), Nortriptyline (1000 ng/mL), and EDDP (300 ng/mL) in human urine. Intended for prescription and OTC use to provide preliminary screening results. Not for distinguishing between prescription use and abuse.

Regulatory Classification

Identification

A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A tricyclic antidepressant drugs 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

• Co-Innovation Biotech One Step Single/Multi-drug Test (k140748)

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

August 18, 2015

HEALGEN SCIENTIFIC LLC C/O JOE XIA BUSINESS DIRECTOR 504 EAST DIAMOND AVE. SUITE I GAITHERSBURG MD 20877

Re: K151348

Trade/Device Name: Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) Regulation Number: 21 CFR 862.3910 Regulation Name: Tricyclic antidepressant drugs test system Regulatory Class: II Product Code: LFG, DJR, JXN Dated: July 6, 2015 Received: July 9, 2015

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 (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling 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/Resourcesfor You/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 H. Lias -S

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

Enclosure

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#### Indications for Use

510(k) Number (if known) k151348

#### Device Name

Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card) Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card) Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)

#### Indications for Use (Describe)

Healgen Propoxyphene Test is an immunochromatographic assay for the qualitative determination of Propoxyphene in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format.

The test may yield preliminary positive results even when the prescription drug Propoxyphene 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 Propoxyphene 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 prefered 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 prescription and for over-the-counter use.

Healgen Nortriptyline Test is an immunochromatographic assay for the qualitative determination of Nortriptyline in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format.

The test may yield preliminary positive results even when the prescription 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 Nortriptyline 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 prefered 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 prescription and for over-the-counter use.

Healgen EDDP (Methadone Metabolite) Test is an immunochromatographic assay for the qualitative determination of EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) in human urine at a Cut-Off concentration of 300 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 prescription and for over-the-counter use.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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- 1. Date: July 6, 2015
- 2. Submitter: HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX 77401
- 3. Contact person: Jianqiu Fang HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX 77401 Telephone: [phone] Fax: [phone] Email: [e-mail]
- 4. Device Name: Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card) Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card) Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)

Classification: Class II

| Product Code | CFR # | Panel |
|--------------|-------------------------------------------------------------------------|------------|
| JXN | 21 CFR, 862.3700 Propoxyphene Test System | Toxicology |
| DJR | 21 CFR, 862.3620 Methadone Test System | Toxicology |
| LFG | 21 CFR, 862.3910 Tricyclic antidepressant drugs test system Test System | Toxicology |

- 5. Predicate Devices:
#### k140748

Co-Innovation Biotech One Step Single/Multi-drug Test.

- 6. Intended Use / Indications for Use
Healgen Propoxyphene Test is an immunochromatographic assay for the qualitative determination of Propoxyphene in human urine at a Cut-Off concentration of 300 ng/mL. 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 the prescription drug Propoxyphene 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 Propoxyphene 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 prescription and for over-the-counter use.

Healgen Nortriptyline Test is an immunochromatographic assay for the qualitative determination of Nortriptyline in human urine at a Cut-Off concentration of 1000 ng/mL. 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 the Nortriptyline 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 Nortriptyline 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 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 prescription and for over-the-counter use.

Healgen EDDP (Methadone Metabolite) Test is an immunochromatographic assay for the qualitative determination of EDDP (2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine) in human urine at a Cut-Off concentration of 300 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 prescription and for over-the-counter use.

### 7. Device Description

Healgen Propoxyphene Test, Healgen Nortriptyline Test and Healgen EDDP (Methadone Metabolite) Test are immunochromatographic assays for Propoxyphene, Nortriptyline and EDDP. Each assay test is a lateral flow system for the qualitative detection of Propoxyphene, Nortriptyline and EDDP (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 Propoxyphene Test, Healgen Nortriptyline Test and Healgen EDDP (Methadone Metabolite) Test and the predicate device is provided in Table 1, Table 2 and Table 3.

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

| Item | Device | Predicate -<br>k140748 | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------|--|--|
| Intended Use | For the qualitative determination of<br>Propoxyphene in human urine. | Same | | |
| Drug Analyte | Propoxyphene | Same | | |
| 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 | | |
| Intended<br>Population | For over-the-counter and prescription<br>Same<br>uses. | | | |
| Configurations | Strip, Cassette, Cup, Dip Card | Cup | | |

# Table 2: Features Comparison of Healgen Nortriptyline Test and the Predicate Device

| Item | Device | Predicate – k140748 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Intended Use | For the qualitative determination of<br>Nortriptyline in human urine. | Same |
| Drug Analyte | Nortriptyline | Same |
| 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 | 1000 ng/mL | Same |
| Intended<br>Population | For over-the-counter and prescription<br>uses. | Same |
| Configurations | Strip, Cassette, Cup, Dip Card | Cup |

Table 3: Features Comparison of Healgen EDDP (Methadone Metabolite)Test and the Predicate Device

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| Item | Device | Predicate – k140748 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------|
| Intended Use | For the qualitative determination of EDDP in human urine. | Same |
| Drug Analyte | EDDP | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 300 ng/mL | Same |
| Intended Population | For over-the-counter and prescription uses. | Same |
| Configurations | Strip, Cassette, Cup, Dip Card | Cup |

#### 9. Test Principle

Healgen Propoxyphene Test, Healgen Nortriptyline Test and Healgen EDDP (Methadone Metabolite) Test are rapid tests for the qualitative detection of Propoxyphene, Nortriptyline and EDDP 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 to indicate that the test has been performed properly.

#### 10. Performance Characteristics

- 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, +75% 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 by the person who prepared samples and did not take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days by three different operators for each format of devices. Different set of operators tested each format. The results obtained are summarized in the following tables:

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# Propoxyphene

### 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 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+ | 27-/23+ | 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 | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|-------|--------|------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | |
| Lot 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- |

# Dip Card Format

| Drug | Result | Cut-off | | | | Cut-off | Cut-off | | | |
|-------|--------|---------|--------|--------|--------|---------|---------|--------|--------|--------|
| | | -100% | -75% | -50% | -25% | | +25% | +50% | +75% | +100% |
| Lot 1 | 50-/0+ | 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+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

# CUP Format

| Drug | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>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+ | 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+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

# Nortriptyline

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 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 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+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

### Cassette Format

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| | 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 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 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 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+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 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 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+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

# EDDP

# Strip Format

| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|-------|--------|------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | |
| Lot 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- |

# Cassette Format

| Drug | 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 |
|-------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| 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+ | 20-/30+ | 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- |

# Dip Card Format

| Drug | 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 |
|-------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| 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+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

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

| Drug | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|-------|--------|------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|------------------|
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- |

#### CUP Format

| Drug | 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 |
|-------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 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+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

### b. Linearity

Not applicable.

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

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; cutoff; +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 Propoxyphene, Nortriptyline and EDDP. The following cut-off values for the test devices have been verified.

| Test | Calibrator | Cut-off<br>(ng/mL) |
|--------------------|---------------|--------------------|
| Propoxyphene Test | Propoxyphene | 300 |
| Nortriptyline Test | Nortriptyline | 1000 |
| EDDP Test | EDDP | 300 |

### 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.

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

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.

| Acetophenetidin | Ethyl-p-aminobenzoate | Perphenazine |
|-----------------------------------|-------------------------------------------|------------------------------------|
| N-Acetylprocainamide | Fenoprofen | Phencyclidine |
| Acetylsalicylic Acid<br>(Aspirin) | Furosemide | Phenelzine |
| Aminopyrine | Gentisic acid | Phenobarbital |
| Amitriptyline | Hemoglobin | Phentermine |
| Amoxicillin | Hydralazine | Phenylephrine-L |
| Amobarbital | (+/-)-4-Hydroxyamphetamine<br>HCL | Phenylethylamine |
| D-Amphetamine | Hydrochlorothiazide | Phenylpropanolamine |
| L-Amphetamine | Hydrocodone | Prednisolone Acetate |
| Amphetamine Sulfate | Hydrocortisone | Prednisone |
| Ampicinine(Ampicillin) | a -Hydroxyhippuric acid | Procaine(Novocaine) |
| Apomorphine | p-Hydroxymethamphetamine | Promazine |
| L-Ascorbic Acid | Ibuprofen | Promethazine |
| Aspartame | Imipramine | Propranolol |
| Atropine | Isoxsuprine | Pseudoephedrine HCL |
| Benzilic acid | Isoproterenol-(+/-) | Quinidine |
| Benzphetamine | Ketamine | Quinine |
| Benzoic Acid | Labetalol | Ranitidine(Zantac) |
| Bilirubin | Levorphanol | Salicylic Acid |
| Caffeine | Loperamide | Secobarbital |
| Chloramphenicol | Maprotiline | Serotonin |
| Chlordiazepoxide HCL | Meprobamate | Sulfamethazine |
| Chloroquine | Methadone | Sulindac |
| Chlorothiazide | Methoxyphenamine | Temazepam |
| Chlorpheniramine | (+/-)- Methylenedioxyamphetamine<br>(MDA) | 11-Nor-A9-<br>Tetrahydrocannabinol |
| Chlorpromazine | Methylphenidate | Tetracycline |
| Cholesterol | Nalbuphine | Tetrahydrozoline |
| Clomipramine | Nalidixic acid | Thiamine |
| Clonidine hydrochloride | Naloxone hydrochloride | L-Thyroxine |
| Cortisone | Naltrexone hydrochloride | Thioridazine Hydrochloride |
| Cotinine(-) | Naproxen | Triamterene |
| Creatinine | Niacinamide | Triflupromazine<br>Hydrochloride |
| Deoxyepinephrine | Nifedipine | Trimethoprim |
| Dextromethorphan | Norethindrone | Trimipramine |
| Diazepam | Noscapine | Tryptamine |
| Diflunisal | Oxazepam | DL-Tryptophan |
| Digoxin | Oxymetazoline | Tyramine |
| Doxylamine | Papaverine | D/L-Tyrosine |
| Ecgonine methylester | Penicillin | Uric Acid |
| R(-)-Epinephrine | Pentobarbital | Verapamil |
| Erythromycin | Perphenazine | Zomepirac |
| Estrone-3-sulfate | Phencyclidine | |

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

# Nortriptyline

| Acetophenetidin | Ethyl-p-aminobenzoate | Phencyclidine |
|------------------------|------------------------------------|------------------------------------|
| N-Acetylprocainamide | Fenoprofen | Phenelzine |
| Acetylsalicylic Acid | Furosemide | Phenobarbital |
| (Aspirin) | | |
| Aminopyrine | Gentisic acid | Phentermine |
| Amoxicillin | Hemoglobin | Phenylephrine-L |
| Amobarbital | Hydralazine | Phenylethylamine |
| D-Amphetamine | (+/-)-4-Hydroxyamphetamine<br>HCL | Phenylpropanolamine |
| L-Amphetamine | Hydrochlorothiazide | Prednisolone Acetate |
| Amphetamine Sulfate | Hydrocodone | Prednisone |
| Ampicinine(Ampicillin) | Hydrocortisone | Procaine(Novocaine) |
| Apomorphine | a -Hydroxyhippuric acid | Propoxyphene,d- |
| L-Ascorbic Acid | p-Hydroxymethamphetamine | Propranolol |
| Aspartame | Ibuprofen | Pseudoephedrine HCL |
| Atropine | Isoxsuprine | Quinidine |
| Benzilic acid | Isoproterenol-(+/-) | Quinine |
| Benzphetamine | Ketamine | Ranitidine(Zantac) |
| Bezoic Acid | Labetalol | Salicylic Acid |
| Bilirubin | Levorphanol | Secobarbital |
| Caffeine | Loperamide | Serotonin |
| Chloramphenicol | Meprobamate | Sulfamethazine |
| Chlordiazepoxide HCL | Methadone | Sulindac |
| Chloroquine | Methoxyphenamine | Temazepam |
| Chlorothiazide | (+/-)- | 11-Nor-Δ9-<br>Tetrahydrocannabinol |
| | Methylenedioxyamphetamine<br>(MDA) | |
| Chlorpheniramine | Methylphenidate | Tetracycline |

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

| Chlorpromazine | Nalbuphine | Tetrahydrozoline |
|-------------------------|--------------------------|----------------------------------|
| Cholesterol | Nalidixic acid | Thiamine |
| Clonidine hydrochloride | Naloxone hydrochloride | L-Thyroxine |
| Cortisone | Naltrexone hydrochloride | ThioridazineHydrochloride |
| Cotinine(-) | Naproxen | Triamterene |
| Creatinine | Niacinamide | Triflupromazine<br>Hydrochloride |
| Deoxyepinephrine | Nifedipine | Trimethoprim |
| Dextromethorphan | Norethindrone | Tryptamine |
| Diazepam | Norpropoxyphene | DL-Tryptophan |
| Diflunisal | Noscapine | Tyramine |
| Digoxin | Oxazepam | D/L-Tyrosine |
| Doxylamine | Oxymetazoline | Uric Acid |
| Ecgonine methylester | Papaverine | Verapamil |
| R(-)-Epinephrine | Penicillin | Zomepirac |
| Erythromycin | Pentobarbital | |
| Estrone-3-sulfate | Perphenazine | |

# EDDP

| Acetophenetidin | Ethyl-p-aminobenzoate | Phencyclidine |
|-----------------------------------|-----------------------------------|----------------------|
| N-Acetylprocainamide | Fenoprofen | Phenelzine |
| Acetylsalicylic Acid<br>(Aspirin) | Furosemide | Phenobarbital |
| Aminopyrine | Gentisic acid | Phentermine |
| Amitriptyline | Hemoglobin | Phenylephrine-L |
| Amoxicillin | Hydralazine | Phenylethylamine |
| Amobarbital | (+/-)-4-Hydroxyamphetamine<br>HCL | Phenylpropanolamine |
| D-Amphetamine | Hydrochlorothiazide | Prednisolone Acetate |
| L-Amphetamine | Hydrocodone | Prednisone |
| Amphetamine Sulfate | Hydrocortisone | Procaine(Novocaine) |
| Ampicinine(Ampicillin) | a -Hydroxyhippuric acid | Promazine |
| Apomorphine | p-Hydroxymethamphetamine | Promethazine |
| L-Ascorbic Acid | Ibuprofen | Propoxyphene,d- |
| Aspartame | Imipramine | Propranolol |
| Atropine | Isoxsuprine | Pseudoephedrine HCL |
| Benzilic acid | Isoproterenol-(+/-) | Quinidine |
| Benzphetamine | Ketamine | Quinine |
| Benzoic Acid | Labetalol | Ranitidine(Zantac) |

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

| Bilirubin | Levorphanol | Salicylic Acid |
|-------------------------|-------------------------------------------|------------------------------------|
| Caffeine | Loperamide | Secobarbital |
| Chloramphenicol | Maprotiline | Serotonin |
| Chlordiazepoxide HCL | Meprobamate | Sulfamethazine |
| Chloroquine | Methadone | Sulindac |
| Chlorothiazide | Methoxyphenamine | Temazepam |
| Chlorpheniramine | (+/-)- Methylenedioxyamphetamine<br>(MDA) | 11-Nor-Δ9-<br>Tetrahydrocannabinol |
| Chlorpromazine | Methylphenidate | Tetracycline |
| Cholesterol | Nalbuphine | Tetrahydrozoline |
| Clomipramine | Nalidixic acid | Thiamine |
| Clonidine hydrochloride | Naloxone hydrochloride | L-Thyroxine |
| Cortisone | Naltrexone hydrochloride | ThioridazineHydrochloride |
| Cotinine(-) | Naproxen | Triamterene |
| Creatinine | Niacinamide | Triflupromazine<br>Hydrochloride |
| Deoxyepinephrine | Nifedipine | Trimethoprim |
| Dextromethorphan | Norethindrone | Trimipramine |
| Diazepam | Norpropoxyphene | Tryptamine |
| Diflunisal | Noscapine | DL-Tryptophan |
| Digoxin | Oxazepam | Tyramine |
| Doxylamine | Oxymetazoline | D/L-Tyrosine |
| Ecgonine methylester | Papaverine | Uric Acid |
| R(-)-Epinephrine | Penicillin | Verapamil |
| Erythromycin | Pentobarbital | Zomepirac |
| Estrone-3-sulfate | Perphenazine | |

- 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.

| Propoxyphene<br>(Cut-off=300 ng/mL) | Result | % Cross-Reactivity |
|-------------------------------------|-----------------------|--------------------|
| Propoxyphene | Positive at 300 ng/mL | 100% |
| Norpropoxyphene | Positive at 300 ng/mL | 100% |

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

| Nortriptyline<br>(Cut-off=1000 ng/mL) | Result | % Cross-<br>Reactivity |
|---------------------------------------|--------------------------|------------------------|
| Nortriptyline | Positive at 1000 ng/mL | 100% |
| Amitriptyline | Positive at 1500 ng/mL | 67% |
| Clomipramine | Positive at 50000 ng/mL | 2% |
| Desipramine | Positive at 5000 ng/mL | 20% |
| Doxepine | Positive at 10000 ng/mL | 10% |
| Imipramine | Positive at 10000 ng/mL | 10% |
| Maprotiline | Positive at 100000 ng/mL | 1% |
| Nordoxepin | Positive at 10000 ng/mL | 10% |
| Promazine | Positive at 50000 ng/mL | 2% |
| Promethazine | Positive at 2500 ng/mL | 40% |
| Trimipramine | Positive at 50000 ng/mL | 2% |
| Cyclobenzaprine Hydrochloride | Positive at 5000 ng/mL | 20% |
| Norclomipramine | Positive at 50000 ng/mL | 2% |

| EDDP<br>(Cut-off=300 ng/mL) | Result | % Cross-<br>Reactivity |
|--------------------------------------------------------------|-------------------------|------------------------|
| EDDP (2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine) | Positive at 300 ng/mL | 100% |
| EMDP (2-Ethyl-5-methyl-3,3-<br>diphenylpyrroline) | Positive at 500 ng/mL | 60% |
| Disopyramide | Positive at 50000 ng/mL | 1% |
| Methadone | Negative at 100000 | <0.3 |
| LAAM (Levo-alpha-acetylmethadol) HCl | Negative at 100000 | <0.3 |
| Alpha Methadol | Negative at 100000 | <0.3 |
| Doxylamine | Negative at 100000 | <0.3 |

- 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 Propoxyphene Test, the Nortriptyline Test and the EDDP Test were performed in-house with three different laboratory assistants for each format of the device.

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

Operators ran 80 (40 negative and 40 positive) unaltered clinical samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:

| Propoxyphene | | | | | | |
|-----------------|----------|----------|-----------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------|
| 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<br>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 +50%) |
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |

### Discordant Results of Propoxyphene Strip

| Viewer | Sample Number | GC/MS Result | Strip Format<br>Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | PPX67 | 301 | Negative |
| Viewer A | PPX66 | 304 | Negative |
| Viewer B | PPX67 | 301 | Negative |
| Viewer C | PPX67 | 301 | Negative |
| Viewer C | PPX66 | 304 | Negative |

| Cassette 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 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |

Discordant Results of Propoxyphene Cassette

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

| Viewer | Sample Number | GC/MS Result | Cassette Format<br>Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | PPX67 | 301 | Negative |
| Viewer A | PPX66 | 304 | Negative |
| Viewer B | PPX67 | 301 | Negative |
| Viewer C | PPX67 | 301 | Negative |
| Viewer C | PPX66 | 304 | Negative |

| 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 Propoxyphene Cup

| Viewer | Sample Number | GC/MS Result | Cup Format Viewer Results |
|----------|---------------|--------------|---------------------------|
| Viewer A | PPX67 | 301 | Negative |
| Viewer A | PPX66 | 304 | Negative |
| Viewer B | PPX67 | 301 | Negative |
| Viewer B | PPX66 | 304 | Negative |
| Viewer C | PPX67 | 301 | Negative |
| Viewer C | PPX66 | 304 | Negative |

| Dip Card<br>format | | 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 cut-<br>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 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |

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

| | Negative | 10 | ﮯ ﻟﻠ | ﮯ ﻟﻠ | |
|----------|----------|----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|----|
| Viewer C | Positive | | | | 24 |
| | Negative | | ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ | ﻟﻠ | |

# Discordant Results of Propoxyphene Dip Card

| Viewer | Sample Number | GC/MS Result | Dip Card Format<br>Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | PPX67 | 301 | Negative |
| Viewer A | PPX66 | 304 | Negative |
| Viewer B | PPX67 | 301 | Negative |
| Viewer B | PPX66 | 304 | Negative |
| Viewer C | PPX67 | 301 | Negative |
| Viewer C | PPX66 | 304 | Negative |

# Nortriptyline

| 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 cut-<br>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 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 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 Nortriptyline Strip

| Viewer | Sample Number | GC/MS Result | Strip Format<br>Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | TCA27 | 1011 | Negative |
| Viewer B | TCA51 | 1025 | Negative |
| Viewer B | TCA27 | 1011 | Negative |
| Viewer C | TCA51 | 1025 | Negative |
| Viewer C | TCA27 | 1011 | Negative |

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

| 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 cut-<br>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 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |

# Discordant Results of Nortriptyline Cassette

| Viewer | Sample Number | GC/MS Result | Cassette Format<br>Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | TCA51 | 1025 | Negative |
| Viewer A | TCA34 | 1232 | Negative |
| Viewer A | TCA52 | 1123 | Negative |
| Viewer B | TCA51 | 1025 | Negative |
| Viewer B | TCA34 | 1232 | Negative |
| Viewer C | TCA51 | 1025 | Negative |
| Viewer C | TCA34 | 1232 | Negative |
| Viewer C | TCA52 | 1123 | Negative |

| Dip Card 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 Nortriptyline Dip Card

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

| Viewer | Sample Number | GC/MS Result | Dip Card Format<br>Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | TCA51 | 1025 | Negative |
| Viewer A | TCA27 | 1011 | Negative |
| Viewer B | TCA51 | 1025 | Negative |
| Viewer B | TCA27 | 1011 | Negative |
| Viewer C | TCA51 | 1025 | Negative |
| Viewer C | TCA27 | 1011 | Negative |

| 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 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |

# Discordant Results of Nortriptyline Cup

| Viewer | Sample Number | GC/MS Result | Cup Format<br>Viewer Results |
|----------|---------------|--------------|------------------------------|
| Viewer A | TCA51 | 1025 | Negative |
| Viewer A | TCA27 | 1011 | Negative |
| Viewer A | TCA38 | 1097 | Negative |
| Viewer B | TCA51 | 1025 | Negative |
| Viewer B | TCA27 | 1011 | Negative |
| Viewer B | TCA38 | 1097 | Negative |
| Viewer C | TCA51 | 1025 | Negative |
| Viewer C | TCA27 | 1011 | Negative |
| Viewer C | TCA38 | 1097 | Negative |

# EDDP

| Strip format | Negative | Low Negative by GC/MS<br>(less than - 50%) | Near Cutoff Negative by GC/MS<br>(Between - 50% and cut-off) | Near Cutoff Positive by GC/MS<br>(Between the cut-off and +50%) | High Positive by GC/MS<br>(greater than +50%) |
|--------------|----------|--------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------|
|--------------|----------|--------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------|

{21}------------------------------------------------

| Viewer A | Positive | 0 | 0 | 0 | 13 | 24 |
|----------|----------|----|----|----|----|----|
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |

# Discordant Results of EDDP Strip

| Discordant Results of EDDP Strip | | | |
|----------------------------------|---------------|--------------|--------------------------------|
| Viewer | Sample Number | GC/MS Result | Strip Format<br>Viewer Results |
| Viewer A | EDDP28 | 308 | Negative |
| Viewer A | EDDP02 | 302 | Negative |
| Viewer A | EDDP72 | 303 | Negative |
| Viewer B | EDDP02 | 302 | Negative |
| Viewer B | EDDP72 | 303 | Negative |
| Viewer C | EDDP28 | 308 | Negative |
| Viewer C | EDDP02 | 302 | Negative |
| Viewer C | EDDP72 | 303 | Negative |

| Cassette 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 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0…