AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

K152025 · Assure Tech. Co., Ltd. · DJR · Oct 5, 2015 · Clinical Toxicology

Device Facts

• Record ID: K152025
• Device Name: AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
• Applicant: Assure Tech. Co., Ltd.
• Product Code: DJR · Clinical Toxicology
• Decision Date: Oct 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

Intended Use

The AssureTech Buprenorphine Strip test is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at a Cut-Off concentration of 10ng/mL. This test is calibrated to Buprenorphine (calibrator). The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine 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. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use. The AssureTech Methadone Strip test is an immunochromatographic assay for the qualitative determination of Methadone in human urine at a Cut-Off concentration of 300ng/mL. This test is calibrated to Methadone (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use. The AssureTech Buprenorphine/Methadone Panel Dip test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators). The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine 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. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. The AssureTech Buprenorphine/Methadone Quick Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators). The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine 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. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. The AssureTech BuprenorphineMethadone Turn Key-Split Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators). The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine 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. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

Device Story

Lateral flow immunochromatographic assays for qualitative detection of Buprenorphine and Methadone in human urine; competitive binding principle; monoclonal mouse antibody-coated particles; target analytes compete with immobilized drug-conjugate for binding sites; visible colored line indicates negative result (drug below cutoff); absence of line indicates positive result (drug above cutoff); control line confirms proper test performance. Used in point-of-care or home settings by lay users or professionals. Results are visual; preliminary only; require confirmatory GC/MS testing. Benefits include rapid, accessible screening for drug presence to inform clinical or personal decision-making.

Clinical Evidence

No clinical trials performed. Evidence consists of analytical bench testing (precision, interference, specificity, stability, cut-off verification) and a lay-user study (n=1113) across three sites. Lay-user study demonstrated high concordance with GC/MS results across various drug concentrations relative to cut-offs. Flesch-Kincaid analysis of instructions yielded a 7th-grade reading level.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding; monoclonal mouse antibody; visual readout; urine specimen; 10ng/mL (Buprenorphine) and 300ng/mL (Methadone) cut-offs; stable at 4-30°C for 24 months.

Indications for Use

Indicated for qualitative detection of Buprenorphine (10ng/mL) and/or Methadone (300ng/mL) in human urine. Intended for over-the-counter and prescription use in individuals requiring drug of abuse screening. Provides preliminary results; requires confirmatory testing via GC/MS.

Regulatory Classification

Identification

A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

Special Controls

*Classification.* Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

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

Submission Summary (Full Text)

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

October 5, 2015

ASSURE TECH. CO., LTD. C/O JOE SHIA MANAGER 504 E DIAMOND AVE., SUITE I GAITHERSBURG MD 20877

Re: K152025

Trade/Device Name: Assuretech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turnkey Split Cup), Assuretech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-key Split Cup) Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: II Product Code: DJR, DJG Dated: July 17, 2015 Received: July 22, 2015

Dear Mr. Shia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of 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) k152025

#### Device Name

AssureTech Buprenorphine Strip; AssureTech Methadone Strip AssureTech Buprenorphine/Methadone Panel Dip AssureTech Buprenorphine/Methadone Turn Key-Split Cup; AssureTech Buprenorphine/Methadone Quick Cup

#### Indications for Use (Describe)

The AssureTech Buprenorphine Strip test is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at a Cut-Off concentration of 10ng/mL. This test is calibrated to Buprenorphine (calibrator).

The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine 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. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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

The AssureTech Methadone Strip test is an immunochromatographic assay for the qualitative determination of Methadone in human urine at a Cut-Off concentration of 300ng/mL. This test is calibrated to Methadone (calibrator).

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

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

The AssureTech Buprenorphine/Methadone Panel Dip test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators).

The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine 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. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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

The AssureTech Buprenorphine/Methadone Quick Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL, and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators).

The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed

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analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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

The AssureTech BuprenorphineMethadone Turn Key-Split Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators).

The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine 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. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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### 510(k) SUMMARY

| 1. Date: | September 17, 2015 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Submitter: | Assure Tech. Co., Ltd.<br>Building 1, No.10, Xiyuansan Road, Westlake<br>Economic Zone<br>Hangzhou, China, 310030 |
| 3. Contact person: | Eric Lin<br>Assure Tech. Co., Ltd.<br>Building 1, No.10, Xiyuansan Road, Westlake<br>Economic Zone<br>Hangzhou, China, 310030<br>Telephone: [phone]<br>Email: [e-mail]. |
| 4. Device Name: | AssureTech Buprenorphine Strip<br>AssureTech Methadone Strip<br>AssureTech Buprenorphine/Methadone Panel Dip<br>AssureTech Buprenorphine/Methadone Quick Cup<br>AssureTech Buprenorphine/Methadone Turn Key-Split Cup |

#### Classification:

| Product Code | CFR | Panel |
|--------------|----------------------------------------|------------|
| DJR | 21 CFR, 862.3620 Methadone Test System | Toxicology |
| DJG | 21 CFR, 862.3650 Opiate Test System | Toxicology |

- 5. Predicate Devices: K142396
The Chemtrue® Multi-Panel Drug Screen Dip Card Tests

- 6. Intended Use
The AssureTech Buprenorphine Strip test is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at a Cut-Off concentration of 10ng/mL. This test is calibrated to Buprenorphine (calibrator).

The test may vield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine 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. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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

The AssureTech Methadone Strip test is an immunochromatographic assay for the qualitative

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determination of Methadone in human urine at a Cut-Off concentration of 300ng/mL. This test is calibrated to Methadone (calibrator).

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

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

The AssureTech Buprenorphine/Methadone Panel Dip test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators).

The test may vield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine 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. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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

The AssureTech Buprenorphine/Methadone Quick Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators).

The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine 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. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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

The AssureTech Buprenorphine/Methadone Turn Key-Split Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators).

The test may yield preliminary positive results when prescription drug Buprenorphine is

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ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine 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. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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

- 7. Device Description
Strip. AssureTech Methadone The AssureTech Bunrenorphine Strip. AssureTech Buprenorphine/Methadone Panel Dip, AssureTech Buprenorphine/Methadone Quick Cup and AssureTech Buprenorphine/Methadone Turn Key-Split Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Buprenorphine and/or Methadone (target analytes) in human urine. The Quick Cup format does not contain a turn-key for device activation. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

- 8. Substantial Equivalence Information
A summary comparison of features of the AssureTech Buprenorphine Tests and AssureTech Methadone Tests and the predicate devices is provided in Table 1 & Table 2.

| Item | Device | Predicate - K142396 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of drugs of<br>abuse in human urine. | Same (but the number of<br>drugs detected is different) |
| Calibrator | Buprenorphine | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 10 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Strip | Dip Card |

Table 1: Features Comparison of AssureTech Buprenorphine Strip and the Predicate Devices

Table 2: Features Comparison of AssureTech Methadone Strip and the Predicate Devices

| Item | Device | Predicate - K142396 |
|------|--------|---------------------|
|------|--------|---------------------|

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| Indication(s)<br>for Use | For the qualitative determination of<br>drugs of abuse in human urine. | Same (but the number of<br>drugs detected is different) |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Calibrator | Methadone | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 300 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Strip | Dip Card |

## Table 3: Features Comparison of AssureTech Buprenorphine/Methadone Panel Dip and the Predicate Devices

| Item | Device | Predicate - K142396 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of<br>drugs of abuse in human urine. | Same (but the number of<br>drugs detected is different) |
| Calibrator | Buprenorphine and Methadone | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 10ng/mL for Buprenorphine and 300 ng/mL for<br>Methadone | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Panel Dip | Same |

Table 4: Features Comparison of AssureTech Buprenorphine/Methadone Cup and the Predicate Devices

| Item | Device | Predicate - K142396 |
|--------------------------|------------------------------------------------------------------------|---------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of<br>drugs of abuse in human urine. | Same (but the number of<br>drugs detected is different) |

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| Calibrator | Buprenorphine and Methadone | Same |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------|----------|
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 10ng/mL for Buprenorphine and 300 ng/mL for<br>Methadone | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Cup with or without turn-key | Dip Card |

## 9. Test Principle

AssureTech Buprenorphine Strip, AssureTech Methadone Strip, AssureTech Buprenorphine/Methadone Panel Dip, AssureTech Buprenorphine/Methadone Quick Cup and AssureTech Buprenorphine/Methadone Turn Key-Split Cup are rapid tests for the qualitative detection of Buprenorphine and/or Methadone in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.

### 10. Performance Characteristics

- 1. Analytical Performance
- a. Precision

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

## Buprenorphine

AssureTech Buprenorphine Strip

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|--|-----------------|-----------------|-----------------|------------------|
|---------------|------------------|-----------------|-----------------|----------------|--|-----------------|-----------------|-----------------|------------------|

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| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
|-------|--------|--------|--------|--------|--------|--------|--------|--------|--------|
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 1-/49+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

AssureTech Buprenorphine /Methadone Panel Dip

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- |

AssureTech Buprenorphine/Methadone Turn-Key Split Cup

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

#### AssureTech Buprenorphine/Methadone Quick Cup

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- |

## Methadone

AssureTech Methadone Strip

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
|------------|---------------|--------------|--------------|-------------|---------|--------------|--------------|--------------|---------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

AssureTech Buprenorphine/Methadone Panel Dip

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- |

AssureTech Buprenorphine/Methadone Turn-Key Split Cup

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 1-/49+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

## AssureTech Buprenorphine/Methadone Quick Cup

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

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

| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
|-------|--------|--------|--------|--------|--------|--------|--------|--------|--------|
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

#### b. Linearity

Not applicable.

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

d. Cut-off

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

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

| Calibrator | Cut-off (ng/mL) |
|---------------|-----------------|
| Buprenorphine | 10 |
| Methadone | 300 |

### e. Interference

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

#### Buprenorphine:

| Acetophenetidin | Ethyl-p-aminobenzoate | Phencyclidine |
|------------------------|--------------------------------|----------------------|
| N-Acetylprocainamide | Fenoprofen | Phenelzine |
| Acetylsalicylic Acid | Furosemide | Phenobarbital |
| Aminopyrine | Gentisic acid | Phentermine |
| Amitriptyline | Hemoglobin | Phenylephrine-L |
| Amoxicillin | Hydralazine | Phenylethylamine |
| Amobarbital | (+/-)-4-Hydroxyamphetamine HCL | Phenylpropanolamine |
| D-Amphetamine | Hydrochlorothiazide | Prednisolone Acetate |
| L-Amphetamine | Hydrocodone | Prednisone |
| Amphetamine Sulfate | Hydrocortisone | Procaine(Novocaine) |
| Ampicinine(Ampicillin) | 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 |

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

| Bezoic 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 | (+/-)-<br>Methylenedioxyamphetamine(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 | |

### Methadone

| Acetophenetidin | Ethyl-p-aminobenzoate | Phenelzine |
|------------------------|--------------------------------|----------------------|
| N-Acetylprocainamide | Fenoprofen | Phenobarbital |
| Acetylsalicylic Acid | Furosemide | Phentermine |
| Aminopyrine | Gentisic acid | Phenylephrine-L |
| Amitriptyline | Hemoglobin | Phenylethylamine |
| Amoxicillin | Hydralazine | Phenylpropanolamine |
| Amobarbital | (+/-)-4-Hydroxyamphetamine HCL | Prednisolone Acetate |
| D-Amphetamine | Hydrochlorothiazide | Prednisone |
| L-Amphetamine | Hydrocodone | Procaine(Novocaine) |
| Amphetamine Sulfate | Hydrocortisone | Promazine |
| Ampicinine(Ampicillin) | a -Hydroxyhippuric acid | Promethazine |
| Apomorphine | p-Hydroxymethamphetamine | Propoxyphene,d- |
| L-Ascorbic Acid | Ibuprofen | Propranolol |
| Aspartame | Imipramine | Pseudoephedrine HCL |

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

| Atropine | Isoxsuprine | Quinidine |
|-------------------------|--------------------------|---------------------------|
| Benzilic acid | Isoproterenol-(+/-) | Quinine |
| Benzphetamine | Ketamine | Ranitidine(Zantac) |
| Bezoic Acid | Labetalol | Salicylic Acid |
| Bilirubin | Levorphanol | Secobarbital |
| Caffeine | Loperamide | Serotonin |
| Chloramphenicol | Maprotiline | Sulfamethazine |
| Chlordiazepoxide HCL | Meprobamate | Sulindac |
| Chloroquine | Methoxyphenamine | Temazepam |
| Chlorothiazide | (+/-)- | 11-Nor-49- |
| Chlorpheniramine | Methylphenidate | Tetracycline |
| Chlorpromazine | Nalbuphine | Tetrahydrozoline |
| Cholesterol | Nalidixic acid | Thiamine |
| Clomipramine | Naloxone hydrochloride | L-Thyroxine |
| Clonidine hydrochloride | Naltrexone hydrochloride | ThioridazineHydrochloride |
| Cortisone | Naproxen | Triamterene |
| Cotinine(-) | Niacinamide | Triflupromazine |
| Creatinine | Nifedipine | Trimethoprim |
| Deoxyepinephrine | Norethindrone | Trimipramine |
| Dextromethorphan | Norpropoxyphene | Tryptamine |
| Diazepam | Noscapine | DL-Tryptophan |
| Diflunisal | Oxazepam | Tyramine |
| Digoxin | Oxymetazoline | D/L-Tyrosine |
| Doxylamine | Papaverine | Uric Acid |
| Ecgonine methylester | Penicillin | Verapamil |
| R(-)-Epinephrine | Pentobarbital | Zomepirac |
| Erythromycin | Perphenazine | |
| Estrone-3-sulfate | Phencyclidine | |

#### f. Specificity

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

| Buprenorphine<br>(Cut-off=10 ng/mL) | Result | %<br>Cross-Reactivity |
|-------------------------------------|-----------------------|-----------------------|
| Buprenorphine | Positive at 10 ng/mL | 100% |
| Buprenorphine -3-D- | Positive at 10 ng/mL | 100% |
| Norbuprenorphine | Positive at 50 ng/mL | 20% |
| Norbuprenorphine-3-D- | Positive at 100 ng/mL | 10% |
| Morphine | Negative at 100,000 | <0.01% |

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

| Oxymorphone | Negative at 100,000 | <0.01% |
|---------------|---------------------|--------|
| Hydromorphone | Negative at 100,000 | <0.01% |

| Methadone<br>(Cut-off=300 ng/mL) | Result | %<br>Cross-Reactivity |
|----------------------------------|-------------------------|-----------------------|
| Methadone | Positive at 300 ng/mL | 100% |
| Doxylamine | Positive at 5000 ng/mL | 6% |
| LAAM HCl | Positive at 10000 ng/mL | 3% |
| Alpha Methadol | Positive at 2000 ng/mL | 15% |
| EDDP | Negative at 100,000 | <0.3% |
| EMDP | Negative at 100,000 | <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 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different devices.

## 2. Comparison Studies

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

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

### Discordant Results of Buprenorphine Strip

| Viewer | Sample Number | GC/MS Result | Strip<br>Viewer Results |
|----------|---------------|--------------|-------------------------|
| Viewer A | 11178 | 9.8 | Positive |
| Viewer A | 20805 | 9.6 | Positive |
| Viewer B | 20805 | 9.6 | Positive |
| Viewer C | 20805 | 9.6 | Positive |

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

| Viewer A | 31718 | 10.9 | Negative |
|----------|-------|------|----------|
| Viewer B | 18342 | 10.6 | Negative |

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

# Discordant Results of Buprenorphine Panel Dip

| Viewer | Sample Number | GC/MS Result | Panel Dip<br>Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer A | 11178 | 9.8 | Positive |
| Viewer A | 20805 | 9.6 | Positive |
| Viewer B | 11178 | 9.8 | Positive |
| Viewer B | 20805 | 9.6 | Positive |
| Viewer C | 11178 | 9.8 | Positive |
| Viewer C | 20805 | 9.6 | Positive |
| Viewer A | 18342 | 10.6 | Negative |
| Viewer B | 31718 | 10.9 | Negative |
| Viewer C | 31718 | 10.9 | Negative |

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

Discordant Results of Buprenorphine Turn-Key Split Cup

| Viewer | Sample Number | GC/MS Result | Turn-Key Split<br>Cup |
|----------|---------------|--------------|-----------------------|
| Viewer A | 20805 | 9.6 | Positive |
| Viewer B | 11178 | 9.8 | Positive |

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

| Viewer C | 11178 | 9.8 | Positive |
|----------|-------|------|----------|
| Viewer A | 31718 | 10.9 | Negative |
| Viewer B | 18342 | 10.6 | Negative |
| Viewer C | 18342 | 10.6 | Negative |
| Viewer C | 31718 | 10.9 | Negative |

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

Discordant Results of Buprenorphine Quick Cup

| Viewer | Sample Number | GC/MS Result | Quick Cup<br>Viewer Results |
|----------|---------------|--------------|-----------------------------|
| | | | |
| Viewer A | 20805 | 9.6 | Positive |
| Viewer B | 11178 | 9.8 | Positive |
| Viewer C | 11178 | 9.8 | Positive |
| Viewer C | 20805 | 9.6 | Positive |
| Viewer A | 31718 | 10.9 | Negative |
| Viewer C | 18342 | 10.6 | Negative |

## Methadone (MTD)

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

# Discordant Results of MTD Strip

| Viewer | Sample Number | GC/MS Result | Strip Viewer Results |
|----------|---------------|--------------|----------------------|
| Viewer A | 36406 | 293 | Positive |

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

| Viewer A | 15168 | 291 | Positive |
|----------|-------|-----|----------|
| Viewer B | 15168 | 291 | Positive |
| Viewer C | 15168 | 291 | Positive |
| Viewer A | 82949 | 305 | Negative |
| Viewer B | 82949 | 305 | Negative |
| Viewer C | 82949 | 305 | Negative |

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

## Discordant Results of MTD Panel Dip

| Viewer | Sample Number | GC/MS Result | Panel Dip<br>Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer A | 36406 | 293 | Positive |
| Viewer A | 15168 | 291 | Positive |
| Viewer B | 15168 | 291 | Positive |
| Viewer C | 15168 | 291 | Positive |
| Viewer B | 82949 | 305 | Negative |

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

# Discordant Results of MTD Turn-Key Split Cup

| Viewer | Sample Number | GC/MS Result | Split Cup<br>Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer A | 15168 | 291 | Positive |
| Viewer B | 15168 | 291 | Positive |

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

| Viewer C | 36406 | 293 | Positive |
|----------|-------|-----|----------|
| Viewer A | 82949 | 305 | Negative |
| Viewer C | 82949 | 305 | Negative |

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

#### Discordant Results of MTD Quick Cup

| Viewer | Sample Number | GC/MS Result | Quick Cup<br>Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer A | 36406 | 293 | Positive |
| Viewer B | 36406 | 293 | Positive |
| Viewer B | 15168 | 291 | Positive |
| Viewer C | 36406 | 293 | Positive |
| Viewer A | 82949 | 305 | Negative |
| Viewer B | 82949 | 305 | Negative |

#### Lay-user study

A lay user study was performed at three intended user sites with 1113 lay persons. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) 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. Each device was tested.

#### Comparison between GC/MS and Lay Person Results for Buprenorphine Strip

| % of Cutoff | Number<br>of<br>samples | Buprenorphine<br>Concentration by GC/MS<br>(ng/mL) | Lay person results | | The<br>percentage of<br>correct results<br>(%) |
|--------------|-------------------------|----------------------------------------------------|--------------------|----|------------------------------------------------|
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 2.2 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 5.5 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 7.6 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 12.6 | 21 | 0 | 100 |
| +50% Cutoff | 21 | 16.2 | 21 | 0 | 100 |

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

| +75% Cutoff | 21 | 17.8 | 21 | 0 | 100 |
|-------------|----|------|----|---|-----|
|-------------|----|------|----|---|-----|

| % of Cutoff | Number<br>of<br>samples | Methadone Concentration<br>by GC/MS (ng/mL) | Lay person results | | The<br>percentage of<br>correct results<br>(%) |
|--------------|-------------------------|---------------------------------------------|--------------------|--------------------|------------------------------------------------|
| | | | No. of<br>Positive | No. of<br>Negative | |
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 69 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 162 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 251 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 389 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 463 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 510 | 21 | 0 | 100 |

## Comparison between GC/MS and Lay Person Results for MTD Strip

### Comparison between GC/MS and Lay Person Results for BUP/MTD Panel DipCard

| % Cutoff | No of samples | Concentration by GC/MS(ng/mL) | | Lay person results | | Correct Results (%) | |
|----------|---------------|-------------------------------|-----------|--------------------|--------|---------------------|-----|
| | | Buprenorphine | Methadone | BUP | MTD | BUP | MTD |
| -100% | 21 | 0 | 0 | 0+/21- | 0+/21- | 100 | 100 |
| -75% | 21 | 2.2 | 69 | 0+/21- | 0+/21- | 100 | 100 |
| -50% | 21 | 5.5 | 162 | 0+/21- | 0+/21- | 100 | 100 |
| -25% | 21 | 7.6 | 251 | 1+/20- | 2+/19- | 95 | 90 |
| +25% | 21 | 12.6 | 389 | 20+/1- | 20+/1- | 95 | 95 |
| +50% | 21 | 16.2 | 463 | 21+/0- | 21+/0- | 100 | 100 |
| +75% | 21 | 17.8 | 510 | 21+/0- | 21+/0- | 100 | 100 |

## Comparison between GC/MS and Lay Person Results for BUP/MTD Turn-Key Split Cup

| % Cutoff | No of<br>samples | Concentration by<br>GC/MS(ng/mL) | | Lay person<br>results | | Correct Results<br>(%) | |
|----------|------------------|----------------------------------|-----------|-----------------------|--------|------------------------|-----|
| | | Buprenorphine | Methadone | BUP | MTD | BUP | MTD |
| -100% | 21 | 0 | 0 | 0+/21- | 0+/21- | 100 | 100 |
| -75% | 21 | 2.2 | 69 | 0+/21- | 0+/21- | 100 | 100 |
| -50% | 21 | 5.5 | 162 | 0+/21- | 0+/21- | 100 | 100 |
| -25% | 21 | 7.6 | 251 | 2+/19- | 0+/21- | 90 | 100 |
| +25% | 21 | 12.6 | 389 | 20+/1- | 20+/1- | 95 | 95 |
| +50% | 21 | 16.2 | 463 | 21+/0- | 21+/0- | 100 | 100 |
| +75% | 21 | 17.8 | 510 | 21+/0- | 21+/0- | 100 | 100 |

## Comparison between GC/MS and Lay Person Results for BUP/MTD Quick Cup

| % Cutoff | No of<br>samples | Concentration by<br>GC/MS(ng/mL) | | Lay person<br>results | | Correct Results<br>(%) | |
|----------|------------------|----------------------------------|-----------|-----------------------|--------|------------------------|-----|
| | | Buprenorphine | Methadone | BUP | MTD | BUP | MTD |
| -100% | 21 | 0 | 0 | 0+/21- | 0+/21- | 100 | 100 |
| -75% | 21 | 2.2 | 69 | 0+/21- | 0+/21- | 100 | 100 |

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

| -50% | 21 | ર્ . રે | 162 | 0+/21- | 0+/21- | 100 | 100…