Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests

K153192 · Chemtron Biotech, Inc. · DJG · Apr 18, 2016 · Clinical Toxicology

Device Facts

• Record ID: K153192
• Device Name: Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests
• Applicant: Chemtron Biotech, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Apr 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

The Chemtrue® Multi-Panel Drug Screen Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

Device Story

Rapid lateral flow immunoassay for qualitative detection of drugs of abuse in human urine; utilizes competitive binding principle with drug-protein conjugates and anti-drug antibody-colloidal gold conjugates. Available in Dip Card or Cup formats. User (clinician or lay-user) collects urine; sample migrates via capillary action across membrane. Presence of drug above cutoff prevents formation of visible test line (preliminary positive); absence of drug allows formation of visible line (negative). Control line indicates proper test performance. Results are visual; intended for preliminary screening only. Confirmatory testing via GC/MS or LC/MS required for positive results. Clinical judgment required for interpretation.

Clinical Evidence

Consumer study with 130 lay-users across three sites; evaluated ability to interpret results using provided package insert; samples included negative, 50%, 75%, 125%, and 150% of cutoff concentrations; results showed high agreement with GC/MS reference method across all analytes.

Technological Characteristics

Lateral flow chromatographic immunoassay; visual readout; single-use test cup or dip card with 1-14 drug test strips; competitive binding principle; stable for 24 months at 2-30°C; no instrumentation required.

Indications for Use

Indicated for qualitative detection of drugs of abuse (Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene, TCA) in human urine. Intended for prescription and OTC use. Not for differentiating between illicit and prescription use of specific drugs.

Regulatory Classification

Identification

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

Special Controls

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

Predicate Devices

• Innovacon Spectrum II Test Card with Integrated Cups (k061718)
• QuickScreen™ Test (k103295)
• ONSite CupKit™ (k060896)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

April 18, 2016

CHEMTRON BIOTECH, INC. JANE ZHANG DIRECTOR OF QA/RA 9245 BROWN DEER ROAD SAN DIEGO CA 92121

Re: K153192

Trade/Device Name: Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests. Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, JXN, DKZ, LFG, DIO, LDJ, DNK, LAF, LCM, JXM, DIS, DJC, DJR Dated: April 1, 2016 Received: April 4, 2016

Dear Ms. Zhang:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

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

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

Sincerely yours,

Courtney 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) k153192

Device Name

Chemtrue® Multi-Panel Drug Screen Cup with OPI 2000 Tests

#### Indications for Use (Describe)

The Chemitrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunossays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
|------------------------------|--------------|---------------------------------------|------------------------------|
| Amphetamine | AMP | d-Amphetamine | 300 |
| Amphetamine | AMP | d-Amphetamine | 500 |
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 200 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Benzodiazepines | BZO | Oxazepam | 200 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxy<br>methamphetamine | 500 |
| Methamphetamine | MAMP | d-Methamphetamine | 300 |
| Methamphetamine | MAMP | d-Methamphetamine | 500 |
| Methamphetamine | MAMP | d-Methamphetamine | 1000 |
| Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Opiates | OPI | Morphine | 2000 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic<br>Antidepressants | TCA | Nortriptyline | 1000 |

The multi test panels can consist of up to fourteen (14) of the above issed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use.

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GCMS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodizepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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

{3}------------------------------------------------

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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{4}------------------------------------------------

#### Indications for Use

510(k) Number (if known) k153192

Device Name

Chemtrue® Multi-Panel Drug Screen Dip Card Tests

#### Indications for Use (Describe)

Indications on Ose (Docking) Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
|---------------------------|--------------|------------------------------------|------------------------------|
| Amphetamine | AMP | d-Amphetamine | 300 |
| Amphetamine | AMP | d-Amphetamine | 500 |
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 200 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Benzodiazepines | BZO | Oxazepam | 200 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxy methamphetamine | 500 |
| Methamphetamine | MAMP | d-Methamphetamine | 300 |
| Methamphetamine | MAMP | d-Methamphetamine | 500 |
| Methamphetamine | MAMP | d-Methamphetamine | 1000 |
| Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Morphine | MOR | Morphine | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1000 |

The multi test panels can consist of up to fourteen (14) of the above listed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use.

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

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)

{5}------------------------------------------------

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

This section applies only to requirements of the Paperwork Reduction Act of 1995,

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{6}------------------------------------------------

#### Indications for Use

510(k) Number (if known) k153192

#### Device Name

Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests

#### Indications for Use (Describe)

The Chemtrue® Drug Screen Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
|------------------------------|--------------|---------------------------------------|------------------------------|
| Amphetamine | AMP | d-Amphetamine | 300 |
| Amphetamine | AMP | d-Amphetamine | 500 |
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 200 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Benzodiazepines | BZO | Oxazepam | 200 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxy<br>methamphetamine | 500 |
| Methamphetamine | MAMP | d-Methamphetamine | 300 |
| Methamphetamine | MAMP | d-Methamphetamine | 500 |
| Methamphetamine | MAMP | d-Methamphetamine | 1000 |
| Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Opiates | OPI | Morphine | 2000 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic<br>Antidepressants | TCA | Nortriptyline | 1000 |

The multi test panels can consist of up to fourteen (14) of the above listed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use.

The tests provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

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)

{7}------------------------------------------------

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{8}------------------------------------------------

#### Indications for Use

510(k) Number (if known) k153192

Device Name

Chemtrue® Multi-Panel Drug Screen Cup Tests

#### Indications for Use (Describe)

The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
|------------------------------|--------------|---------------------------------------|------------------------------|
| Amphetamine | AMP | d-Amphetamine | 300 |
| Amphetamine | AMP | d-Amphetamine | 500 |
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 200 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Benzodiazepines | BZO | Oxazepam | 200 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxy<br>methamphetamine | 500 |
| Methamphetamine | MAMP | d-Methamphetamine | 300 |
| Methamphetamine | MAMP | d-Methamphetamine | 500 |
| Methamphetamine | MAMP | d-Methamphetamine | 1000 |
| Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Morphine | MOR | Morphine | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic<br>Antidepressants | TCA | Nortriptyline | 1000 |

The multi test panels can consist of up to fourteen (14) of the above listed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use.

The tests provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

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

IX Prescription Use (Part 21 CFR 801 Subpart D)

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

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

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

.

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

# 510(k) Summary

### AS REQUIRED BY 21 CFR 807.92(c)

#### SUBMITTER: Chemtron Biotech, Inc. 9245 Brown Deer Road, Suite B, San Diego, CA 92121. A. TEL: [phone];

FAX: [phone]

Contact Person: Jane Zhang, Director of QA/RA

Official FDA Correspondent 9245 Brown Deer Road, Suite B San Diego, CA 92121 Office: [phone]; FAX: [phone] Email: [e-mail]

Date Prepared: April 12, 2016

#### DEVICE B.

Trade or Proprietary Name: Chemtrue® Multi-Panel Drug Screen Cup Tests, Chemtrue® Multi-Panel Drug Screen Cup with OPI2000 Tests, Chemtrue® Drug Screen Dip Card Tests, Chemtrue® Drug Screen Dip Card with OPI2000 Tests Common Name: Single/Multi-Drug Urine Test Panel

Regulatory Class: Class II

# Regulatory Information:

| Drug of Abuse | Product Code | Panel | Regulation Section |
|-----------------|--------------|---------------|------------------------------------------------------|
| Amphetamine | DKZ | Toxicology 91 | 21CFR 862.3100, Amphetamine Test System |
| Benzodiazepines | JXM | Toxicology 91 | 21 CFR 862.3170, Benzodiazepines Test System |
| Barbiturates | DIS | Toxicology 91 | 21 CFR 862.3150, Barbiturates Test System |
| Cocaine | DIO | Toxicology 91 | 21 CFR 862.3250, Cocaine and metabolites Test System |
| Methamphetamine | LAF | Toxicology 91 | 21 CFR 862.3610, Methamphetamine Test System |
| Propoxyphene | JXN | Toxicology 91 | 21 CFR 862.3700 Propoxyphene test system |

These devices also incorporate the assays previously cleared under 510(k) numbers k142396 and k143599, which consist of any combinations of the following drug tests:

| Drug of Abuse | Product Code | Panel | Regulation Section |
|---------------------------------|--------------|---------------|--------------------------------------------------------------|
| Buprenorphine (BUP) | DJG | Toxicology 91 | 21CFR 862.3650, Opiate Test System |
| Ecstasy (MDMA) | DJC | Toxicology 91 | 21 CFR 862.3610, Methamphetamine Test System |
| Methadone | DJR | Toxicology 91 | 21 CFR 862.3620, Methadone Test System |
| Morphine | DNK | Toxicology 91 | 21 CFR 862.3640, Morphine Test System |
| Opiates | DJG | Toxicology 91 | 21 CFR 862.3650, Opiate Test System |
| Oxycodone | DJG | Toxicology 91 | 21 CFR 862.3650, Opiate Test System |
| Phencyclidine | LCM | Toxicology 91 | Unclassified, Enzyme immunoassay Phencyclidine |
| Marijuana | LDJ | Toxicology 91 | 21 CFR 862.3870, Cannabinoids Test System |
| Tricyclic Antidepressants (TCA) | LFG | Toxicology 91 | 21 CFR 862.3910, Tricyclic antidepressant drugs test system. |

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### C. PREDICATE DEVICES

C-1. k061718: Innovacon Spectrum II Test Card with Integrated Cups, applicant: Innovacon Laboratories, Inc.

C-2. k10329: QuickScreen™ Test. The applicant: Phamatech. Inc.

C-3. k060896: ONSite CupKit™. The applicant: Variance, Inc.

# D. INDICATIONS FOR USE:

# Chemtrue® Multi-Panel Drug Screen Cup with OPI 2000 Tests

The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
|------------------------------|--------------|---------------------------------------|------------------------------|
| Amphetamine | AMP | d-Amphetamine | 300 |
| Amphetamine | AMP | d-Amphetamine | 500 |
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 200 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Benzodiazepines | BZO | Oxazepam | 200 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxy<br>methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 300 |
| Methamphetamine | MET | d-Methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 1000 |
| Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Opiates | OPI | Morphine | 2000 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic<br>Antidepressants | TCA | Nortriptyline | 1000 |

The multi test panels can consist of up to fourteen (14) of the above listed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use.

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods.

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

Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

# Chemtrue® Multi-Panel Drug Screen Cup Tests

The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
|------------------------------|--------------|---------------------------------------|------------------------------|
| Amphetamine | AMP | d-Amphetamine | 300 |
| Amphetamine | AMP | d-Amphetamine | 500 |
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 200 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Benzodiazepines | BZO | Oxazepam | 200 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxy<br>methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 300 |
| Methamphetamine | MET | d-Methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 1000 |
| Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Morphine | MOR | Morphine | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic<br>Antidepressants | TCA | Nortriptyline | 1000 |

The multi test panels can consist of up to fourteen (14) of the above listed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use.

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

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The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

# Chemtrue® Multi-Panel Drug Screen Dip Card with OPI2000 Tests

The Chemtrue® Multi-Panel Drug Screen Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
|------------------------------|--------------|---------------------------------------|------------------------------|
| Amphetamine | AMP | d-Amphetamine | 300 |
| Amphetamine | AMP | d-Amphetamine | 500 |
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 200 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Benzodiazepines | BZO | Oxazepam | 200 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxy<br>methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 300 |
| Methamphetamine | MET | d-Methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 1000 |
| Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Opiates | OPI | Morphine | 2000 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic<br>Antidepressants | TCA | Nortriptyline | 1000 |

The multi test panels can consist of up to fourteen (14) of the above listed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use.

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic

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

Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

# Chemtrue® Multi-Panel Drug Screen Dip Card Tests

The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
|------------------------------|--------------|---------------------------------------|------------------------------|
| Amphetamine | AMP | d-Amphetamine | 300 |
| Amphetamine | AMP | d-Amphetamine | 500 |
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 200 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Benzodiazepines | BZO | Oxazepam | 200 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxy<br>methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 300 |
| Methamphetamine | MET | d-Methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 1000 |
| Marijuana | THC | 11-nor-A9-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Morphine | MOR | Morphine | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic<br>Antidepressants | TCA | Nortriptyline | 1000 |

The multi test panels can consist of up to fourteen (14) of the above listed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use.

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

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# E. DEVICE DESCRIPTION

The Chemtrue® Drug Screen Tests are colloidal gold based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in Dip Card or Cup formats, as indicated by the test name.

# F. SUBSTANTIAL EQUIVALENCE INFORMATION:

Comparison with the predicate devices is outlined below:

| | Similarities and Differences | |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Item | Candidate Devices | Predicate Devices<br>(k061718, k103295 and k060896) |
| Indication(s) for use | Same | For qualitative detection of drugs of abuse in<br>human urine |
| Specimen Type | Same | Human urine |
| Methodology/Technological<br>Characteristics | Same | Lateral flow, competitive binding immunoassay<br>based on the principle of antigen and antibody<br>immunochemistry. |
| Results | Same | Qualitative |
| Cut Off | Propoxyphene – Same | K061718<br>Propoxyphene – 300 |
| | Cocaine – 150 | Cocaine – 150 / 300 |
| | Amphetamine – 500 / 300 | Amphetamine – 300 / 1000 |
| | Methamphetamine – 500 / 300 | Methamphetamine – 500 / 1000 |
| | Methamphetamine – Same<br>Barbiturates - Same<br>Benzodiazepines – Same<br>Methamphetamine 300 – Same | k103295<br>Methamphetamine – 500<br>Barbiturates – 200<br>Benzodiazepines – 200<br>K060896<br>Methamphetamine – 300 |
| Configurations | Dip Card and Cup | K061718<br>Dip Card and Cup<br>K103295<br>Dipcard and Cassette<br>K060896<br>Cup Only |
| Intended Use | Same | Prescription / OTC Use |

# G. TEST PRINCIPLE

These devices are rapid lateral flow immunoassays in which chemically modified drugs (drugprotein conjugates) compete with drugs that may be present in urine. On each test strip, a drugprotein conjugate is striped on the test band of the membrane - known as the test region (T) and the anti-drug antibody-colloidal gold conjugate pads are placed at the forward end of the

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membrane. If target drugs are present in the urine specimen below its cut-off concentration, the solution of the colored antibody-colloidal gold conjugates moves along with the sample solution by capillary action across the membrane to the immobilized drug-protein conjugate zone on the test band region. The colored antibody-gold conjugates then complexes with the drug-protein conjugates to form visible lines. Therefore, the formation of the visible precipitant in the test band indicates a negative result. If the target drug level exceeds its cut-off concentration, the drug/metabolite antigen competes with drug-protein conjugates on the test band region for the limited antibody on the colored drug antibody-colloidal gold conjugate pad. The drug will saturate the limited antibody binding sites and the colored antibody-colloidal gold conjugate cannot bind to the drug-protein conjugate at the test region of the test strip. Therefore, absence of the color band on the test region indicates a preliminary positive result.

A band should form in the control region (C) of the devices regardless of the presence of drug in the sample to indicate that the test has been performed properly.

Monoclonal anti-drug antibodies are used on the AMP/ BAR/COC/MET/PPX Test devices which are derived from mouse. The polyclonal and monoclonal anti-drug antibodies which are used on BZO Test devices are derived from sheep/mouse.

# H. PERFORMANCE CHARACTERISTICS

Performance data is only provided for AMP300/500, BAR200/BZO200, COC150, MET300/500 and PPX as the new analytes in this submission. AMP1000, BAR3000, BZO300, BUP, COC300, MET1000, MOR, PCP, THC, MDMA, MTD, OPI2000, OXY and TCA analytes were previously cleared under k143599 and k142396.

- 1. Reproducibility (Precision) Studies:
The precision study was conducted by three (3) Operators with three (3) lots in replicates of 10 devices/lot of each device format at each concentration level of Negative, 50%, 75%, cut-off, 125% and 150% of the cutoff which are GC/MS confirmed drug spiked urine controls. The study was conducted over a ten (10) nonconsecutive days. The samples were blind coded according to a random table and randomly distributed to three operators by the research coordinator. The data is analyzed and summarized in the tables below:

| Concentration Level | n | TOTAL | |
|---------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 16 | 14 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |

### Table 1a. AMP Dip Card Test: Cutoff: 300 ng/mL

# Table 1b. AMP Dip Card Test: Cutoff: 500 ng/mL

| Concentration Level | n | TOTAL | |
|---------------------|----|----------|-----------|
| | | + | - |
| Negative | 30 | <b>0</b> | <b>30</b> |

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| 50% of cutoff | 30 | <b>0</b> | <b>30</b> |
|----------------|----|-----------|-----------|
| 75% of cutoff | 30 | <b>0</b> | <b>30</b> |
| Cutoff | 30 | <b>14</b> | <b>16</b> |
| 125% of cutoff | 30 | <b>30</b> | <b>0</b> |
| 150% of cutoff | 30 | <b>30</b> | <b>0</b> |

# Table 1c. BAR Dip Card Test: Cutoff: 200 ng/mL

| Concentration Level | n | TOTAL | |
|---------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 14 | 16 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |

# Table 1d. BZO Dip Card Test: Cutoff: 200 ng/mL

| Concentration Level | n | TOTAL | |
|---------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 16 | 14 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |

# Table 1e. COC Dip Card Test: Cutoff: 150 ng/mL

| Concentration Level | n | TOTAL | |
|---------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 16 | 14 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |

Table 1f. MET Dip Card Test: Cutoff: 300 ng/mL

| Concentration Level | n | TOTAL | |
|---------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 14 | 16 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |

Table 1g. MET Dip Card Test: Cutoff: 500 ng/mL

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| Concentration Level | n | TOTAL | |
|---------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 14 | 16 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |

# Table 1h. Propoxyphene Dip Card Test: Cutoff: 300 ng/mL

| Concentration Level | n | TOTAL | |
|---------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 15 | 15 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |

# Table 1i. AMP Cup Test: Cutoff: 300 ng/mL

| Concentration Level | n | TOTAL | |
|---------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 13 | 17 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |

# Table 1j. AMP Cup Test: Cutoff: 500 ng/mL

| Concentration Level | n | TOTAL | |
|---------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 14 | 16 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |

# Table 1k. BAR Cup Test: Cutoff: 200 ng/mL

| Concentration Level | n | TOTAL | |
|---------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |

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| Cutoff | 30 | <b>15</b> | <b>15</b> |
|----------------|----|-----------|-----------|
| 125% of cutoff | 30 | <b>30</b> | <b>0</b> |
| 150% of cutoff | 30 | <b>30</b> | <b>0</b> |

Table 11. BZO Cup Test: Cutoff: 200 ng/mL

| Concentration Level | n | TOTAL | |
|---------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 15 | 15 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |

# Table 1m. COC Cup Test: Cutoff: 150 ng/mL

| Concentration Level | n | TOTAL | |
|---------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 17 | 13 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |

# Table 1n. MET Cup Test: Cutoff: 300 ng/mL

| Concentration Level | n | TOTAL | |
|---------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 15 | 15 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |

Table 10. MET Cup Test: Cutoff: 500 ng/mL

| Concentration Level | n | TOTAL | |
|---------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 17 | 13 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |

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| | | + | - |
|----------------|----|----|----|
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 15 | 15 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |

- 2. Specificity Study: These studies were conducted by adding various drugs, drug metabolites, and other structurally-similar compounds likely to be present in the actual urine specimen.
The following structurally-related compounds were tested for cross-reactivity and found to be positive if the levels were greater than the following listed concentrations:

Amphetamine 500 related compounds:

| Substances | Concentration (ng/mL) | % Cross Reactivity |
|-------------------------|-----------------------|--------------------|
| d-Amphetamine | 500 | 100 |
| d,l-Amphetamine | 800 | 62.5 |
| l-Amphetamine | >50,000 | <1 |
| d-Methamphetamine | >50,000 | <1 |
| l-Methamphetamine | >50,000 | <1 |
| d,l-Methamphetamine | >50,000 | <1 |
| d,l-MDMA | >50,000 | <1 |
| Ephedrine | >50,000 | <1 |
| Pseudoephedrine | 50,000 | <1 |
| (d,l)-(MDA) | 800 | 62.5 |
| Phentermine | 5,000 | 10 |
| MDEA | >50,000 | <1 |
| d,l-Phenylpropanolamine | >50,000 | <1 |
| Phenylephrine | >50,000 | <1 |
| Phenylethlylamine | 50,000 | <1 |
| Tyramine | >50,000 | <1 |

Amphetamine 300 related compounds:

| Substances | Concentration (ng/mL) | % Cross Reactivity |
|----------------------------------------|-----------------------|--------------------|
| d-Amphetamine | 300 | 100 |
| d,l-Amphetamine | 600 | 50 |
| l-Amphetamine | >30,000 | <1 |
| d-Methamphetamine | >30,000 | <1 |
| l-Methamphetamine | >30,000 | <1 |
| d,l-Methamphetamine | >30,000 | <1 |
| d,l-MDMA | >30,000 | <1 |
| Ephedrine | >30,000 | <1 |
| | | |
| Pseudoephedrine | >30,000 | <1 |
| (d,l)-(MDA) | 300 | 100 |
| Phentermine | 4,000 | 7.5 |
| MDEA | >30,000 | <1 |
| d,l-Phenylpropanolamine | >30,000 | <1 |
| Phenylephrine | >30,000 | <1 |
| Phenylethlylamine | >30,000 | <1 |
| Tyramine | >30,000 | <1 |
| Barbiturates 200 related compounds: | | |
| Substances | Concentration (ng/mL) | % Cross Reactivity |
| Secobarbital | 200 | 100 |
| Pentobarbital | 200 | 100 |
| Alphenal | 300 | 67 |
| Amobarbital | 400 | 50 |
| Aprobarbital | 400 | 50 |
| Barbital | 6,000 | 3.3 |
| Butabarbital Butisol | 300 | 67 |
| Butalbital | 1,000 | 20 |
| Cyclopentobarbital | 240 | 83 |
| Phenobarbital | 1,200 | 16.7 |
| Benzodiazepines 200 related compounds: | | |
| Substances | Concentration (ng/mL) | % Cross Reactivity |
| Oxazepam | 200 | 100 |
| Alprazolam | 200 | 100 |
| Alpha-Hydroxyalprazolam | 200 | 100 |
| Bromazepam | 200 | 100 |
| Chlordiazepoxide | 400 | 50 |
| Clobazam | 600 | 33 |
| Clonazepam | 20,000 | <1 |
| Clorazepate | 1,800 | 11 |
| Desalkylflurazepam | 800 | 25 |
| Diazepam | 300 | 67 |
| Estazolam | 200 | 100 |
| Flunitrazepam | 4,600 | 4.4 |
| Flurazepam | 200 | 100 |
| Lorazepam | 600 | 33.3 |
| Lormetazepam | 2,800 | 7 |
| Midazolam | 8,000 | 2.5 |
| Nitrazepam | 800 | 25 |
| Nordiazepam | 5,200 | 3.9 |
| Temazepam | 400 | 50 |
| Triazolam | 1,200 | 16.7 |
| Cocaine 150 related compounds: | | |
| Substances | Concentration (ng/mL) | % Cross Reactivity |
| | | |
| Benzoylecgonine | 150 | 100 |
| Cocaine | 180 | 83 |
| Cocaethylene | 150 | 100 |
| Ecgonine Hcl | >15,000 | <1 |
| Ecgonine Methylester | >15,000 | <1 |

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

{22}------------------------------------------------

Methamphetamine 300 related compounds:

| Substances | Concentration (ng/mL) | % Cross Reactivity |
|---------------------|-----------------------|--------------------|
| d-Methamphetamine | 300 | 100 |
| d,l-Methamphetamine | 1,600 | 18.8 |
| l-Methamphetamine | 2,000 | 15 |
| d-Amphetamine | >30,000 | <1 |
| d,l-Amphetamine | >30,000 | <1 |
| l-Amphetamine | >30,000 | <1 |
| Ephedrine | >30,000 | <1 |
| Phenylephrine | >30,000 | <1 |
| Phenylethylamine | >30,000 | <1 |
| Pseudoephedrine | >30,000 | <1 |
| d,l-(MDA) | >30,000 | <1 |
| d,1-MDEA | 20,000 | 1.5 |
| d,1-MDMA | 2,000 | 15 |
| Phentermine | >30,000 | <1 |

Methamphetamine 500 related compounds:

| Substances | Concentration (ng/mL) | % Cross Reactivity |
|---------------------|-----------------------|--------------------|
| d-Methamphetamine | 500 | 100 |
| d,l-Methamphetamine | 2,000 | 25 |
| l-Methamphetamine | 2,500 | 20 |
| d-Amphetamine | >50,000 | <1 |
| d,l-Amphetamine | >50,000 | <1 |
| l-Amphetamine | >50,000 | <1 |
| Ephedrine | >50,000 | <1 |
| Phenylephrine | >50,000 | <1 |
| Phenylethylamine | >50,000 | <1 |
| Pseudoephedrine | >50,000 | <1 |
| d,l-(MDA) | >50,000 | <1 |
| d,1-MDEA | 25,000 | 2 |
| d,l-MDMA | 2,600 | 19 |
| Phentermine | >50,000 | <1 |

Propoxyphene 300 related compounds:

| Substances | Concentration (ng/mL) | % Cross Reactivity |
|-----------------|-----------------------|--------------------|
| Propoxyphene | 300 | 100 |
| Norpropoxyphene | 300 | 100 |

{23}------------------------------------------------

### 3. Interference:

One hundred and three (103) potential interferents were tested with one lot each of the test device format. It was found not to cross-react when tested at concentrations of 100 µg/mL at ±25% of the drug cut-off concentrations.

Table 3. The following compounds do not interfere with the tests:

| Endogenous Compounds: | | |
|-----------------------|------------|-----------------|
| Albumin | Creatinine | Riboflavin |
| Bilirubin | Glucose | Sodium Chloride |
| Cholesterol | Hemoglobin | Uric Acid |

### Endogenous Compounds:

# Non-structurally related compound:

| Non-structurally related compound: | | |
|------------------------------------|------------------------|-----------------------|
| Acetaminophen | 5, 5-Diphenylhydantoin | Octopamine |
| Acetone | Dopamine | Oxalic Acid |
| Acetylsalicylic Acid | 1-Erythromycin, | Papaverine |
| Amoxicillin | Estradiol | Penicillin-G |
| Ampicillin | Estrone | Perphenazine |
| R-(-)-Apomorphine | Ethanol | Phenelzine |
| L-Ascorbic Acid | Fenofibrate | Phenylethylamine |
| Aspirin | Fentanyl | Prednisone |
| Aspartame | Fotemustine | Promazine |
| Atropine | Furosemide | Promethazine |
| Baclofen | Gemfibrozil | d-Propoxyphene |
| Benzocaine | Guaiacolglyceryl ether | d,l-Propranolol |
| Benzoic Acid | Gentisic acid | Pyridoxine |
| Carisoprodol | Hydralazine | Pyrilamine |
| Chloramphenicol | Hydrocortisone | Pyrogallol |
| Chlordiazepoxide | 3-Hydroxytyramine | Quinidine |
| d-Chlorpheniramine | d,l-Isoproterenol | Quinine |
| Chlorpromazine | Ketamine | Quinolinic Acid |
| Clofibrate | Meprobamate | Ranitidine |
| Clonidine | Methapyrilene | Salicylic Acid |
| Cortisone | Methylphenidate | Sulfamethazine |
| 1-Cotinine | Nalidixic Acid | Sulindac |
| Creatine Hydrate | Naloxone | Tetracycline |
| Cyclobenzaprine | Naltrexone | Tetrahydrozoline |
| Cyclodextrin-r | d-Naproxen | Thiamine |
| Cyproheptadine | Niacinamide | Thioridazine |
| Deoxycorticosterone | Nicotinic Acid | Tramadol |
| Dextromethorphan | Nifedipine | Trifluoperazine |
| Diclofenac | 19-Norethindrone | Tryptamine |
| Diflunisal | Norpropoxyphene | Tyramine |
| 4-Dimethyl-aminoantipyrine | Noscapine | Zomepirac sodium salt |

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Additional interference study: In addition to the cross-reactivity and interference studies presented in this submission, the drug tests were tested with each of all the drug analytes at 150% and 50% of the drug cut-off urine samples. The results confirmed that the no interference or crossreactivity among these drug tests and the Chemtrue® Drug Screen Tests are safe and equivalent to the similar test devices that were FDA cleared.

- 4. Effect of Urine pH and Specific Gravity Studies: The testing results demonstrate that the urine pH ranges from 2.0 to 9.0 at ±25% of the drug cut-off concentrations do not affect the test performance. The specific gravity (SG) ranges of 1.001, 1.015, 1.020, 1.025 and 1.030 at ±25% of the drug cut-off concentrations do not affect the test results.
- 5. Stability Study: To establish and support the shelf life and expiration date, stability studies were conducted under accelerated temperature (at 60°C and real time (2°C to 30°C) with three (3) lots of each device format. The stability study results support two (2) years shelf-life of the products at (2℃ to 30℃). The real time stability study is still on going.
- 6. Method Comparison (Accuracy) Studies:

Chemtrue® DOA Low Cutoff with PPX Drug Screen Tests were compared to the GC/MS Reference Method. The accuracy of the Chemtrue® Test devices were evaluated against the confirmed GC/MS values in this blind-labeled clinical specimen correlation study (On average of 85 clinical specimens for each drug test and a total of 685 samples were tested). Three operators performed the testing. Each blind-labeled sample was randomly distributed to each operator by the Clinical Research Cooperator. The results are summarized in the tables below:

| | Concentration By GC/MS (ng/mL) | | | | |
|---------------|--------------------------------|----------------------------|------------------------|-----------------------|-----------|
| Chemtrue® | | (-) | (+) | | % |
| Drug Screen | No drug | Near cutoff | Near cutoff positive | GC/MS Positive | Agreement |
| Dip Card | present | negative | (Cutoff to 150% of the | (>150% of the cutoff) | |
| | | (50% of the C/O to cutoff) | C/O) | | |
| AMP300<br>(+) | 0 | 0 | 14 | 27 | 100% |
| (-) | 31 | 11 | 0 | 0 | 100% |
| BAR200<br>(+) | 0 | 1 | 26 | 14 | 100% |
| (-) | 34 | 9 | 0 | 0 | 98.2% |
| BZO200<br>(+) | 0 | 0 | 26 | 14 | 100% |
| (-) | 31 | 16 | 0 | 0 | 100% |
| COC150<br>(+) | 0 | 0 | 15 | 28 | 100% |
| (-) | 31 | 10 | 0 | 0 | 100% |
| MET300 (+) | 0 | 1 | 14 | 34 | 100% |
| (-) | 31 | 9 | 0 | 0 | 97.6% |
| PPX<br>(+) | 0 | 0 | 12 | 33 | 100% |
| (-) | 31 | 10 | 0 | 0 | 100% |
| AMP500 (+) | 0 | 0 | 12 | 31 | 100% |
| (-) | 31 | 14 | 0 | 0 | 100% |

### 6-1. Test Result Summary:

Table 6a. Method comparison study summary: Chemtrue® Drug Screen Dip Card Test results vs GC/MS

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| MET500 | 0 | 1 | 11 | 30 | 100% |
|--------|----|----|----|----|-------|
| (-) | 31 | 11 | 0 | 0 | 97.8% |

Table 6b. Method comparison study summary - Chemtrue® Drug Screen Cup Test results vs GC/MS

| | Concentration By GC/MS (ng/mL) | | | | |
|---------------------------------|--------------------------------|-------------------------------------------------------|--------------------------------------------------------|-----------------------------------------|----------------|
| Chemtrue®<br>Drug Screen<br>Cup | No drug<br>present…