Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)

• K Number: K150791
• Device Name: Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
• Manufacturer: HEALGEN SCIENTIFIC LLC
• Date Cleared: 2015-04-24 ( 30 days)
• Product Code: DIS DJG DJR
• Regulation Number: 862.3150

Intended Use

Healgen Secobarbital Test is an immunochromatographic assay for the qualitative determination of Secobarbital 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 Secobarbital is ingescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Secobarbital in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use. Healgen Buprenorphine Test is an immunochromatographic assay for the qualitative determination of Buprenorplaine in human urine at a Cut-Off concentration of 10 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 Burrenorphine 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 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. 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 Methadone Test is an immunochromatographic assay for the qualitative determination of Methadone 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 Description

Healgen Secobarbital Test. Healgen Buprenorphine Test and Healgen Methadone Test are immunochromatographic assays for Secobarbital, Buprenorphine and Methadone. Each assay test is a lateral flow system for the qualitative detection of Secobarbital, Buprenorphine and Methadone (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.

Predicate Devices

K132812

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on immunochromatographic assay technology and comparison to GC/MS, with no mention of AI or ML.

Therapeutic

No
The device is an in vitro diagnostic test for the qualitative determination of substances in human urine; it is not used to treat or cure a disease.

Diagnostic

Yes

The document explicitly states "For in vitro diagnostic use only" multiple times for the Healgen Secobarbital Test, Healgen Buprenorphine Test, and Healgen Methadone Test.

SaMD (Software as a Medical Device)

No

The device is described as an immunochromatographic assay available in physical formats (Strip, Cassette, Dip Card, Cup) and involves the qualitative determination of substances in human urine, indicating a physical test kit rather than software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The document explicitly states multiple times:

• "For in vitro diagnostic use only."
• "The products are in vitro diagnostic devices..."

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Healgen Secobarbital Test is an immunochromatographic assay for the qualitative determination of Secobarbital 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 Secobarbital is ingescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Secobarbital in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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

Healgen Buprenorphine Test is an immunochromatographic assay for the qualitative determination of Buprenorplaine in human urine at a Cut-Off concentration of 10 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 Burrenorphine 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 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. 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 Methadone Test is an immunochromatographic assay for the qualitative determination of Methadone 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.

Product codes (comma separated list FDA assigned to the subject device)

DIS, DJR, DJG

Device Description

Healgen Secobarbital Test. Healgen Buprenorphine Test and Healgen Methadone Test are immunochromatographic assays for Secobarbital, Buprenorphine and Methadone. Each assay test is a lateral flow system for the qualitative detection of Secobarbital, Buprenorphine and Methadone (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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Human urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

prescription and for over-the-counter use.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

A lay user study was performed at three intended user sites with 560 lay persons testing each of the Secobarbital, the Buprenorphine and the Methadone devices. Total of 1680 individuals performed the study. A total of 190 females and 370 males tested the Secobarbital samples, 217 females and 343 males tested the Buprenorphine samples and 216 females and 344 males tested the Methadone samples. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Analytical Performance - 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.

Analytical Performance - 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 Secobarbital, Buprenorphine and Methadone. The cut-off values for the test devices have been verified.

Analytical Performance - Interference
Potential interfering substances found in human urine of physiological or pathological 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. There were no differences observed for different formats.

Analytical Performance - 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.

Analytical Performance - 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.

Comparison Studies
The method comparison studies for the Secobarbital Test, the Buprenorphine Test and the Methadone Test were performed in-house with three different laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to GC/MS results.

Lay-user study
A lay user study was performed at three intended user sites with 560 lay persons testing each of the Secobarbital, the Buprenorphine and the Methadone devices. Total of 1680 individuals performed the study. A total of 190 females and 370 males tested the Secobarbital samples, 217 females and 343 males tested the Buprenorphine samples and 216 females and 344 males tested the Methadone samples. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device.

Key Results from Lay-user study for Secobarbital
For Secobarbital, all formats (Strip, Cassette, DipCard, Cup) showed 100% correct results for samples at -100%, -75%, and -50% of the cut-off. At -25% cut-off, the correct result percentage was 95% (with 1 positive out of 20 samples). At +25% cut-off, the correct result percentage was 95% (with 19 positive and 1 negative out of 20 samples). For +50% and +75% cut-off, the correct result percentage was 100%.

Key Results from Lay-user study for Buprenorphine
For Buprenorphine, all formats (Strip, Cassette, DipCard, Cup) showed 100% correct results for samples at -100%, -75%, and -50% of the cut-off. At -25% cut-off, the correct result percentage was 95% (with 1 positive out of 20 samples) for Strip and Cassette formats, and 90% (with 2 positive out of 20 samples) for Dip Card and Cup formats. At +25% cut-off, the correct result percentage was 90% (with 18 positive and 2 negative out of 20 samples) for Strip, Dip Card, and Cup formats, and 95% for Cassette format. For +50% and +75% cut-off, the correct result percentage was 100%.

Key Results from Lay-user study for Methadone
For Methadone, all formats (Strip, Cassette, DipCard, Cup) showed 100% correct results for samples at -100%, -75%, and -50% of the cut-off. At -25% cut-off, the correct result percentage was 95% (with 1 positive out of 20 samples) for Strip, Cassette, and Dip Card formats, and 90% (with 2 positive out of 20 samples) for the Cup format. At +25% cut-off, the correct result percentage was 95% (with 19 positive and 1 negative out of 20 samples) for all formats. For +50% and +75% cut-off, the correct result percentage was 100%.

Lay-user surveys indicated that the device instructions are easily followed. Flesch-Kincaid reading analysis revealed a reading Grade Level of 7 for each package insert.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not directly stated in terms of sensitivity/specificity/PPV/NPV. However, the performance tables provide raw counts for true positive/negative and false positive/negative interpretations around the cut-off values as compared to GC/MS results and lay-user interpretations.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K132812 UCP Multi-Drug Test Key Cups

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.3150 Barbiturate test system.

(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).

Summary

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

April 24, 2015

HEALGEN SCIENTIFIC LLC C/O JOE SHIA REGULATORY CONSULTANT 504 EAST DIAMOND AVE. SUITE F GAITHERSBURG MD 20877

Re: K150791

Trade/Device Name: Healgen Secobarbital Test (Strip, Cassette, Cup, Dip Card), Healgen Buprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: II Product Code: DIS, DJR, DJG Dated: March 15, 2015 Received: March 25, 2015

Dear Mr. Joe Shia:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

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

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

Sincerely yours,

Katherine Serrano -S

For : 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

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

Indications for Use

510(k) Number (if known) K150791

Device Name Healgen Secobarbital Test (Strip, Cassette, Cup, Dip Card) Healgen Buprenorphine Test (Strip, Cassette, Cup, Dip Card) Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)

Indications for Use (Describe)

Healgen Secobarbital Test is an immunochromatographic assay for the qualitative determination of Secobarbital 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 Secobarbital is ingescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Secobarbital in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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

Healgen Buprenorphine Test is an immunochromatographic assay for the qualitative determination of Buprenorplaine in human urine at a Cut-Off concentration of 10 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 Burrenorphine 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 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. 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 Methadone Test is an immunochromatographic assay for the qualitative determination of Methadone 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)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☒ Over-The-Counter Use (21 CFR 801 Subpart C)

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PSC Publishing Services [phone]

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• 1. Date: April 21, 2015
• 2. Submitter: HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX 77401
• 3. Contact person: Jiangiu Fang HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX 77401 Telephone: [phone] Fax: [phone] Email: [e-mail]
• 4. Device Name: Healgen Secobarbital Test (Strip, Cassette, Cup, Dip Card) Healgen Buprenorphine Test (Strip, Cassette, Cup, Dip Card) Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)

Classification:

Product Code	CFR #	Panel
DIS	21 CFR, 862.3150
Barbiturate Test System	Toxicology
DJR	21 CFR, 862.3620
Methadone Test System	Toxicology
DJG	21 CFR, 862.3650
Opiate Test System	Toxicology

• 5. Predicate Devices: K132812 UCP Multi-Drug Test Key Cups
• 6. Intended Use / Indications for Use

Healgen Secobarbital Test is an immunochromatographic assay for the qualitative determination of Secobarbital 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 Secobarbital 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 Secobarbital 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

5

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 Buprenorphine Test is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at a Cut-Off concentration of 10 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 Buprenorphine 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 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. 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 Methadone Test is an immunochromatographic assay for the qualitative determination of Methadone 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 Secobarbital Test. Healgen Buprenorphine Test and Healgen Methadone Test are immunochromatographic assays for Secobarbital, Buprenorphine and Methadone. Each assay test is a lateral flow system for the qualitative detection of Secobarbital, Buprenorphine and Methadone (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 Secobarbital Test, Healgen Buprenorphine Test and Healgen Methadone Test and the predicate device is provided in Table 1, Table 2 and Table 3.

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

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Item	Device	Predicate – K132812
Intended Use	For the qualitative determination of drugs
of abuse in human urine.	Same
Drug Analyte	Secobarbital	the class of
barbiturates
including
secobarbital
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

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

| Item | Device | Predicate -
K132812 | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------|--|--|
| Intended Use | For the qualitative determination of
drugs of abuse in human urine. | Same | | |
| Drug Analyte | Buprenorphine | 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 | 10 ng/mL
Same | | | |
| Intended
Population | For over-the-counter and prescription
uses. | Same | | |
| Configurations | Strip, Cassette, Cup, Dip Card
Cup | | | |

Table 3: Features Comparison of Healgen Methadone Test and the Predicate Device

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Item	Device	Predicate – K132812
Intended Use	For the qualitative determination of drugs of abuse in human urine.	Same
Drug Analyte	Methadone	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 Secobarbital Test, Healgen Buprenorphine Test and Healgen Methadone Test are rapid tests for the qualitative detection of Secobarbital, Buprenorphine and Methadone 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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Secobarbital

Strip Format

	Result
Drug	-100%
Cut-off	-75%
Cut-off	-50%
Cut-off	-25%
Cut-off	Cut-off	+25%
Cut-off	+50%
Cut-off	+75%
Cut-off	+100%
Cut-off
Lot: BAR1201001	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Lot: BAR1201002	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
Lot: BAR1201003	50-/0+	50-/0+	50-/0+	50-/0+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-

Cassette Format

Drug	Result	-100% Cut-off	-75% Cut-off	-50% Cut-off	-25% Cut-off	Cut-off	+25% Cut-off	+50% Cut-off	+75% Cut-off	+100% Cut-off
Lot: BAR1201004	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Lot: BAR1201005	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
Lot: BAR1201006	50-/0+	50-/0+	50-/0+	50-/0+	17-/33+	50+/0-	50+/0-	50+/0-	50+/0-

Dip Card Format

	Result -100% -75%	-50% -	-25%		+25%		+50% +75% +100%
Drug		Cut-off Cut-off Cut-off Cut-off		Cut-off			Cut-off Cut-off Cut-off Cut-off
Lot: BAR1201007				50-/0+ 50-/0+ 50-/0+ 50-/0+ 23-/27+ 50+/0- 50+/0- 50+/0-
Lot: BAR1201008				50-/0+ 50-/0+ 50-/0+ 50-/0+ 21-/29+ 50+/0- 50+/0- 50+/0- 50+/0-
Lot: BAR1201009				50-/0+ 50-/0+ 50-/0+ 50-/0+ 23-/27+ 50+/0- 50+/0- 50+/0- 50+/0-

CUP Format

	Result
Drug	-100%
Cut-off	-75%
Cut-off	-50%
Cut-off	-25%
Cut-off	Cut-off	+25%
Cut-off	+50%
Cut-off	+75%
Cut-off	+100%
Cut-off
Lot: BAR1201010	50-/0+	50-/0+	50-/0+	50-/0+	27-/23+	50+/0-	50+/0-	50+/0-	50+/0-
Lot: BAR1201011	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
Lot: BAR1201012	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-

Buprenorphine

Strip Format

| Drug | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|-----------------|--------|------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|------------------|
| Lot: BUP1204001 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: BUP1204002 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: BUP1204003 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Cassette Format

9

| | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|-----------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot: BUP1204004 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: BUP1204005 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: BUP1204006 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Dip Card Format

| | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|-----------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot: BUP1204007 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: BUP1204008 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: BUP1204009 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

CUP Format

| | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|------|-----------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot: BUP1204010 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot: BUP1204011 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot: BUP1204012 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Methadone

Strip Format

| | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|-----------------|--------|------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | |
| Lot: MTD1202001 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- |
| Lot: MTD1202002 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- |
| Lot: MTD1202003 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- |

Cassette Format

| Drug | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|-----------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot: MTD1202004 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 19-/31+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: MTD1202005 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: MTD1202006 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Dip Card Format

| Drug | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|-----------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot: MTD1202007 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: MTD1202008 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

10

| Drug | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|-----------------|--------|------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|------------------|
| Lot: MTD1202009 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- |

CUP Format

| | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|-----------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot: MTD1202010 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: MTD1202011 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: MTD1202012 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 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; -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 Secobarbital, Buprenorphine and Methadone. The following cut-off values for the test devices have been verified.

| Test | Calibrator | Cut-off
(ng/mL) |
|--------------------|---------------|--------------------|
| Secobarbital Test | Secobarbital | 300 |
| Buprenorphine Test | Buprenorphine | 10 |
| Methadone Test | 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 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	Phencyclidine
N-Acetylprocainamide	Fenoprofen	Phenelzine
Acetylsalicylic Acid
(Aspirin)	Furosemide	Phentermine
Aminopyrine	Gentisic acid	Phenylephrine-L
Amitriptyline	Hemoglobin	Phenylethylamine
Amoxicillin	Hydralazine	Phenylpropanolamine
D-Amphetamine	(+/-)-4-Hydroxyamphetamine
HCL	Prednisolone Acetate
L-Amphetamine	Hydrochlorothiazide	Prednisone
Amphetamine Sulfate	Hydrocodone	Procaine(Novocaine)
Ampicinine(Ampicillin)	Hydrocortisone	Promazine
Apomorphine	a -Hydroxyhippuric acid	Promethazine
L-Ascorbic Acid	p-Hydroxymethamphetamine	Propoxyphene,d-
Aspartame	Ibuprofen	Propranolol
Atropine	Imipramine	Pseudoephedrine HCL
Benzilic acid	Isoxsuprine	Quinidine
Benzphetamine	Isoproterenol-(+/-)	Quinine
Bezoic Acid	Ketamine	Ranitidine(Zantac)
Bilirubin	Labetalol	Salicylic Acid
Caffeine	Levorphanol	Secobarbital
Chloramphenicol	Loperamide	Serotonin
Chlordiazepoxide
HCL	Maprotiline	Sulfamethazine
Chloroquine	Meprobamate	Sulindac
Chlorothiazide	Methadone	Temazepam
Chlorpheniramine	Methoxyphenamine	11-Nor-△9-Tetrahydrocannab
inol
Chlorpromazine	(+/-)-Methylenedioxyampheta
mine(MDA)	Tetracycline
Cholesterol	Methylphenidate	Tetrahydrozoline
Clomipramine	Nalbuphine	Thiamine
Clonidine hydrochloride	Nalidixic acid	L-Thyroxine
Cortisone	Naloxone hydrochloride	ThioridazineHydrochloride
Cotinine(-)	Naltrexone hydrochloride	Triamterene
Creatinine	Naproxen	Triflupromazine
Hydrochloride

Secobarbital

12

Deoxyepinephrine	Niacinamide	Trimethoprim
Dextromethorphan	Nifedipine	Trimipramine
Diazepam	Norethindrone	Tryptamine
Diflunisal	Norpropoxyphene	DL-Tryptophan
Digoxin	Noscapine	Tyramine
Doxylamine	Oxazepam	D/L-Tyrosine
Ecgonine methylester	Oxymetazoline	Uric Acid
R(-)-Epinephrine	Papaverine	Verapamil
Erythromycin	Penicillin	Zomepirac
Estrone-3-sulfate	Perphenazine

Buprenorphine

Acetophenetidin	Ethyl-p-aminobenzoate	Phencyclidine
N-Acetylprocainamide	Fenoprofen	Phenelzine
Acetylsalicylic Acid
(Aspirin)	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)	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
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	(+/-)-Methylenedioxyamphetamine (MDA)	11-Nor-△9-Tetrahydrocannabinol

13

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
		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

Methadone
Acetophenetidin	Ethyl-p-aminobenzoate	Phenelzine
N-Acetylprocainamide	Fenoprofen	Phenobarbital
Acetylsalicylic Acid
(Aspirin)	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
Atropine	Isoxsuprine	Quinidine
Benzilic acid	Isoproterenol-(+/-)	Quinine
Benzphetamine	Ketamine	Ranitidine(Zantac)

14

Bezoic Acid	Labetalol	Salicylic Acid
Bilirubin	Levorphanol	Secobarbital
Caffeine	Loperamide	Serotonin
Chloramphenicol	Maprotiline	Sulfamethazine
Chlordiazepoxide HCL	Meprobamate	Sulindac
Chloroquine	Methoxyphenamine	Temazepam
Chlorothiazide	(+/-)-Methylenedioxyamphetamine(MDA)	11-Nor-△9-Tetrahydrocannabinol
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
Hydrochloride
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 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.

| Secobarbital

(Cut-off=300 ng/mL)	Result	% Cross-Reactivity
Secobarbital	Positive at 300 ng/mL	100%
Amobarbital	Positive at 300 ng/mL	100%

15

Alphenol	Positive at 750 ng/mL	40%
Aprobarbital	Positive at 250 ng/mL	120%
Butabarbital	Positive at 2500 ng/mL	12%
Butathal	Positive at 2500 ng/mL	12%
Butalbital	Positive at 2500 ng/mL	12%
Cyclopentobarbital	Positive at 500 ng/mL	60%
Pentobarbital	Positive at 2500 ng/mL	12%
Phenobarbital	Positive at 25000 ng/mL	1%

| Buprenorphine

(Cut-off=10 ng/mL)	Result	% Cross-Reactivity
Buprenorphine	Positive at 10 ng/mL	100%
Buprenorphine -3-D-Glucuronide	Positive at 10 ng/mL	100%
Norbuprenorphine	Positive at 20 ng/mL	50%
Norbuprenorphine
-3-D-Glucuronide	Positive at 20 ng/mL	50%
Morphine	Negative at 100000	Not detected
Oxymorphone	Negative at 100000	Not detected
Hydromorphone	Negative at 100000	Not detected

| Methadone

(Cut-off=300 ng/mL)	Result	% Cross-Reactivity
Methadone	Positive at 300 ng/mL	100%
Doxylamine	Positive at 5000 ng/mL	6%
EDDP	Negative at 100000	Not detected
EMDP	Negative at 100000	Not detected
LAAM HCI	Negative at 100000	Not detected
Alpha Methadol	Negative at 100000	Not detected

• 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 Secobarbital Test, the Buprenorphine Test and the Methadone Test were performed in-house with three different laboratory assistants for each format

16

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

Secobarbital
Strip
format		Negative	Low
Negative
by GC/MS
(less than
-50%)	Near Cutoff
Negative by
GC/MS
(Between
-50% and
cut-off)	Near
Cutoff
Positive by
GC/MS
(Between
the cut-off
and +50%)	High
Positive by
GC/MS
(greater
than +50%)
Viewer A	Positive	0	0	0	14	24
	Negative	10	15	15	2	0
Viewer B	Positive	0	0	0	14	24
	Negative	10	15	15	2	0
Viewer C	Positive	0	0	0	15	24
	Negative	10	15	15	1	0

Discordant Results of Secobarbital Strip

| Viewer | Sample Number | GC/MS Result | Strip Format
Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | BAR06 | 303 | Negative |
| Viewer A | BAR72 | 302 | Negative |
| Viewer B | BAR06 | 303 | Negative |
| Viewer B | BAR72 | 302 | Negative |
| Viewer C | BAR06 | 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 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |

Discordant Results of Secobarbital Cassette

17

| Viewer | Sample Number | GC/MS Result | Cassette Format
Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | BAR06 | 303 | Negative |
| Viewer A | BAR16 | 308 | Negative |
| Viewer A | BAR72 | 302 | Negative |
| Viewer B | BAR06 | 303 | Negative |
| Viewer B | BAR72 | 302 | Negative |
| Viewer C | BAR72 | 302 | Negative |
| Viewer C | BAR06 | 303 | Negative |
| Viewer C | BAR16 | 308 | 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	14	24
	Negative	10	15	15	2	0

Discordant Results of Secobarbital Cup

Viewer	Sample Number	GC/MS Result	Cup Format Viewer Results
Viewer A	BAR06	303	Negative
Viewer A	BAR16	308	Negative
Viewer A	BAR72	302	Negative
Viewer B	BAR06	303	Negative
Viewer B	BAR16	308	Negative
Viewer B	BAR72	302	Negative
Viewer C	BAR06	303	Negative
Viewer C	BAR72	302	Negative

18

| 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 | 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 Secobarbital Dip Card

| Viewer | Sample Number | GC/MS Result | Dip Card Format
Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | BAR06 | 303 | Negative |
| Viewer A | BAR16 | 308 | Negative |
| Viewer A | BAR72 | 302 | Negative |
| Viewer B | BAR06 | 303 | Negative |
| Viewer B | BAR16 | 308 | Negative |
| Viewer B | BAR72 | 302 | Negative |
| Viewer C | BAR06 | 303 | Negative |
| Viewer C | BAR16 | 308 | Negative |
| Viewer C | BAR72 | 302 | Negative |

Buprenorphine

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

Discordant Results of Buprenorphine Strip

19

| Viewer | Sample Number | GC/MS Result | Strip Format
Viewer Results | |
|----------|---------------|--------------|--------------------------------|--|
| Viewer A | BUP23 | 10.2 | Negative | |
| Viewer A | BUP67 | 10.6 | Negative | |
| Viewer A | BUP12 | 10.4 | Negative | |
| Viewer B | BUP23 | 10.2 | Negative | |
| Viewer B | BUP67 | 10.6 | Negative | |
| Viewer B | BUP12 | 10.4 | Negative | |
| Viewer C | BUP23 | 10.2 | Negative | |
| Viewer C | BUP12 | 10.4 | 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 | 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 Buprenorphine Cassette

Viewer	Sample Number	GC/MS Result	Cassette Format Viewer Results
Viewer A	BUP23	10.2	Negative
Viewer A	BUP12	10.4	Negative
Viewer B	BUP23	10.2	Negative
Viewer B	BUP12	10.4	Negative
Viewer C	BUP23	10.2	Negative
Viewer C	BUP12	10.4	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%) |
|--------------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| | | | 0 | 0 | 13 | 24 |
| Viewer A | Positive | 0 | | | | |

20

	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 Buprenorphine Dip Card

| Viewer | Sample Number | GC/MS Result | Dip Card Format
Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | BUP23 | 10.2 | Negative |
| Viewer A | BUP67 | 10.6 | Negative |
| Viewer A | BUP12 | 10.4 | Negative |
| Viewer B | BUP23 | 10.2 | Negative |
| Viewer B | BUP12 | 10.4 | Negative |
| Viewer C | BUP23 | 10.2 | Negative |
| Viewer C | BUP67 | 10.6 | Negative |
| Viewer C | BUP12 | 10.4 | 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 | 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 Buprenorphine Cup

| Viewer | Sample Number | GC/MS Result | Cup Format
Viewer Results |
|----------|---------------|--------------|------------------------------|
| Viewer A | BUP23 | 10.2 | Negative |
| Viewer A | BUP67 | 10.6 | Negative |
| Viewer A | BUP12 | 10.4 | Negative |
| Viewer B | BUP23 | 10.2 | Negative |
| Viewer B | BUP12 | 10.4 | Negative |
| Viewer C | BUP23 | 10.2 | Negative |
| Viewer C | BUP12 | 10.4 | Negative |

21

Methadone

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

Discordant Results of Methadone Strip

Viewer	Sample Number	GC/MS Result	Strip Format Viewer Results
Viewer A	MTD80	302	Negative
Viewer A	MTD67	303	Negative
Viewer B	MTD80	302	Negative
Viewer B	MTD67	303	Negative
Viewer B	MTD59	306	Negative
Viewer C	MTD80	302	Negative
Viewer C	MTD67	303	Negative
Viewer C	MTD59	306	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 | 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 Methadone Cassette

22

Viewer	Sample Number	GC/MS Result	Cassette Format Viewer Results
Viewer A	MTD80	302	Negative
Viewer A	MTD67	303	Negative
Viewer B	MTD80	302	Negative
Viewer B	MTD67	303	Negative
Viewer C	MTD80	302	Negative
Viewer C	MTD67	303	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 Methadone Dip Card

| Viewer | Sample Number | GC/MS Result | Dip Card Format
Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | MTD80 | 302 | Negative |
| Viewer A | MTD67 | 303 | Negative |
| Viewer B | MTD80 | 302 | Negative |
| Viewer B | MTD67 | 303 | Negative |
| Viewer C | MTD80 | 302 | Negative |
| Viewer C | MTD67 | 303 | 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 |

23

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

| Viewer | Sample Number | GC/MS Result | Cup Format
Viewer Results |
|----------|---------------|--------------|------------------------------|
| Viewer A | MTD80 | 302 | Negative |
| Viewer A | MTD67 | 303 | Negative |
| Viewer A | MTD59 | 306 | Negative |
| Viewer B | MTD80 | 302 | Negative |
| Viewer B | MTD67 | 303 | Negative |
| Viewer C | MTD80 | 302 | Negative |
| Viewer C | MTD67 | 303 | Negative |

Discordant Results of Methadone Cup

Lay-user study

A lay user study was performed at three intended user sites with 560 lay persons testing each of the Secobarbital, the Buprenorphine and the Methadone devices. Total of 1680 individuals performed the study. A total of 190 females and 370 males tested the Secobarbital samples, 217 females and 343 males tested the Buprenorphine samples and 216 females and 344 males tested the Methadone samples. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.

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

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

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

24

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

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

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

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

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

% of Cutoff	Number	Buprenorphine	Lay person results	The
-------------	--------	---------------	--------------------	-----

25

| | of
samples | Concentration by GC/MS
(ng/mL) | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
|--------------|---------------|-----------------------------------|--------------------|--------------------|-----------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 2.5 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 5 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 7.5 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 12.5 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 15 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 17.5 | 20 | 0 | 100% |

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

% of Cutoff	Number of samples	Buprenorphine Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100%Cutoff	20	0	0	20	100%
-75% Cutoff	20	2.5	0	20	100%
-50% Cutoff	20	5	0	20	100%
-25% Cutoff	20	7.5	1	19	95%
+25% Cutoff	20	12.5	19	1	95%
+50% Cutoff	20	15	20	0	100%
+75% Cutoff	20	17.5	20	0	100%

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

% of Cutoff	Number of samples	Buprenorphine Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	2.5	0	20	100%
-50% Cutoff	20	5	0	20	100%
-25% Cutoff	20	7.5	2	18	90%
+25% Cutoff	20	12.5	18	2	90%
+50% Cutoff	20	15	20	0	100%
+75% Cutoff	20	17.5	20	0	100%

Comparison between GC/MS and Lav Person Results (Buprenorphine Cup)
---------------------------------------------------------------------	--	--	--	--	--

% of Cutoff	Number	Buprenorphine	Lay person results	The
-------------	--------	---------------	--------------------	-----

26

| | of
samples | Concentration by GC/MS
(ng/mL) | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
|--------------|---------------|-----------------------------------|--------------------|--------------------|-----------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 2.5 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 5 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 7.5 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 12.5 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 15 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 17.5 | 20 | 0 | 100% |

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

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

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

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

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

% of Cutoff	Number	Methadone	Lay person results	The
-------------	--------	-----------	--------------------	-----

27

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

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

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

Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

• 3. Clinical Studies
     Not applicable.

• 11.Conclusion
  Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and method comparison of the devices, it's concluded that the Healgen Secobarbital Test, Healgen Buprenorphine Test and Healgen Methadone Test are substantially equivalent to the predicate.