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

• K Number: K151348
• Device Name: Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)
• Manufacturer: HEALGEN SCIENTIFIC LLC
• Date Cleared: 2015-08-18 ( 90 days)
• Product Code: LFG DJR JXN
• Regulation Number: 862.3910

Intended Use

Healgen Propoxyphene Test is an immunochromatographic assay for the qualitative determination of Propoxyphene in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format. The test may yield preliminary positive results even when the prescription drug Propoxyphene is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Propoxyphene in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the prefered confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use. Healgen Nortriptyline Test is an immunochromatographic assay for the qualitative determination of Nortriptyline in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format. The test may yield preliminary positive results even when the prescription is ingested, at prescribed doses, it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Nortriptyline in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the prefered confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use. Healgen EDDP (Methadone Metabolite) Test is an immunochromatographic assay for the qualitative determination of EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.

Device Description

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

Predicate Devices

K140748

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is described as an immunochromatographic assay (lateral flow system) for qualitative determination, which is a standard biochemical test method and does not involve AI/ML. The summary also explicitly states "Mentions AI, DNN, or ML: Not Found".

Therapeutic

No.
Explanation: The device is an in vitro diagnostic (IVD) test for the qualitative determination of substances in human urine, used for preliminary screening. It does not provide any form of therapy or treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only." This phrase directly indicates that the device is intended for the diagnosis of conditions, in this case, the presence of specific substances in human urine.

SaMD (Software as a Medical Device)

No

The device is described as an immunochromatographic assay available in physical formats (Strips, Cassettes, Dip Cards, Cups) and involves the qualitative determination of substances in human urine, indicating a hardware component for the test itself.

IVD (In Vitro Diagnostic)

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

The document explicitly states "For in vitro diagnostic use only" multiple times for each of the described tests (Healgen Propoxyphene Test, Healgen Nortriptyline Test, and Healgen EDDP Test).

Furthermore, the "Device Description" section also refers to the products as "in vitro diagnostic devices".

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

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

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

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

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

Healgen EDDP (Methadone Metabolite) Test is an immunochromatographic assay for the qualitative determination of EDDP (2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine) in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

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

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

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

LFG, DJR, JXN

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

For in vitro diagnostic use only. It is intended for 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 Propoxyphene, the Nortriptyline and the EDDP devices. Total of 1680 individuals performed the study. A total of 204 females and 356 males tested the Propoxyphene samples, 213 females and 347 males tested the Nortriptyline samples and 209 females and 351 males tested the EDDP 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%, +/-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)

Precision Studies: Conducted for samples with concentrations of -100% cut-off, -75% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +50% cut-off, +75% cut-off, and +100% cut-off. Samples were prepared by spiking drug in negative samples, and confirmed by GC/MS. All sample aliquots were blind labeled and randomized. For each concentration, tests were performed two runs per day for 25 days by three different operators for each format (Strip, Cassette, Dip Card, Cup).
Key Results for Propoxyphene:

• Strip Format: At cut-off, Lot 1: 25-/25+, Lot 2: 21-/29+, Lot 3: 27-/23+. For +25% cut-off and above, all results were 50+/0-. For -25% cut-off and below, all results were 50-/0+.
• Cassette Format: At cut-off, Lot 1: 27-/23+, Lot 2: 22-/28+, Lot 3: 22-/28+. For +25% cut-off and above, all results were 50+/0-. For -25% cut-off and below, all results were 50-/0+.
• Dip Card Format: At cut-off, Lot 1: 26-/24+, Lot 2: 26-/24+, Lot 3: 23-/27+. For +25% cut-off and above, all results were 50+/0-. For -25% cut-off and below, all results were 50-/0+.
• CUP Format: At cut-off, Lot 1: 25-/25+, Lot 2: 21-/29+, Lot 3: 29-/21+. For +25% cut-off and above, all results were 50+/0-. For -25% cut-off and below, all results were 50-/0+.

Key Results for Nortriptyline:

• Strip Format: At cut-off, Lot 1: 20-/30+, Lot 2: 24-/26+, Lot 3: 21-/29+. For +25% cut-off and above, all results were 50+/0-. For -25% cut-off and below, all results were 50-/0+.
• Cassette Format: At cut-off, Lot 1: 20-/30+, Lot 2: 22-/28+, Lot 3: 18-/32+. For +25% cut-off and above, all results were 50+/0-. For -25% cut-off and below, all results were 50-/0+.
• Dip Card Format: At cut-off, Lot 1: 22-/28+, Lot 2: 26-/24+, Lot 3: 18-/32+. For +25% cut-off and above, all results were 50+/0-. For -25% cut-off and below, all results were 50-/0+.
• CUP Format: At cut-off, Lot 1: 26-/24+, Lot 2: 24-/26+, Lot 3: 21-/29+. For +25% cut-off and above, all results were 50+/0-. For -25% cut-off and below, all results were 50-/0+.

Key Results for EDDP:

• Strip Format: At cut-off, Lot 1: 27-/23+, Lot 2: 23-/27+, Lot 3: 28-/22+. For +25% cut-off and above, all results were 50+/0-. For -25% cut-off and below, all results were 50-/0+.
• Cassette Format: At cut-off, Lot 1: 28-/22+, Lot 2: 20-/30+, Lot 3: 23-/27+. For +25% cut-off and above, all results were 50+/0-. For -25% cut-off and below, all results were 50-/0+.
• Dip Card Format: At cut-off, Lot 1: 21-/29+, Lot 2: 26-/24+, Lot 3: 22-/28+. For +25% cut-off and above, all results were 50+/0-. For -25% cut-off and below, all results were 50-/0+.
• CUP Format: At cut-off, Lot 1: 29-/21+, Lot 2: 24-/26+, Lot 3: 18-/32+. For +25% cut-off and above, all results were 50+/0-. For -25% cut-off and below, all results were 50-/0+.

Cut-off Verification: 150 samples equally distributed at concentrations of -50% cut-off; cutoff; +25% cut-off; +50% cut-off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% cut-off and all negative at and below -25% cut-off for Propoxyphene, Nortriptyline and EDDP.

Interference Study: Potential interfering substances were added to drug-free urine and target drug urine at 25% above cut-off levels. Tested using three batches of each device for all formats. No interference observed for compounds listed at 100 µg/mL.

Specificity Study: Cross-reactivity was calculated from the lowest detectable concentration.

• Propoxyphene: Propoxyphene (100%), Norpropoxyphene (100%)
• Nortriptyline: Nortriptyline (100%), Amitriptyline (67%), Clomipramine (2%), Desipramine (20%), Doxepine (10%), Imipramine (10%), Maprotiline (1%), Nordoxepin (10%), Promazine (2%), Promethazine (40%), Trimipramine (2%), Cyclobenzaprine Hydrochloride (20%), Norclomipramine (2%).
• EDDP: EDDP (100%), EMDP (60%), Disopyramide (1%), Methadone (

Regulation Number and Section

§ 862.3910 Tricyclic antidepressant drugs test system.

(a)
Identification. A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.(b)
Classification. Class II (special controls). A tricyclic antidepressant drugs test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Summary

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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

August 18, 2015

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

Re: K151348

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

Dear Mr. Xia:

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

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

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

1

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

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

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

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

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

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

Sincerely yours,

Courtney H. Lias -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K151348

Device Name

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

Indications for Use (Describe)

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

The test may yield preliminary positive results even when the prescription drug Propoxyphene is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Propoxyphene in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the prefered confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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

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

The test may yield preliminary positive results even when the prescription is ingested, at prescribed doses, it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Nortriptyline in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the prefered confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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

Healgen EDDP (Methadone Metabolite) Test is an immunochromatographic assay for the qualitative determination of EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

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

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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

Classification: Class II

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

• 5. Predicate Devices:

K140748

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

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

The test may yield preliminary positive results even when the prescription drug Propoxyphene is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Propoxyphene in urine. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and

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

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

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

Healgen EDDP (Methadone Metabolite) Test is an immunochromatographic assay for the qualitative determination of EDDP (2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine) in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

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

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

7. Device Description

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

8. Substantial Equivalence Information

A summary comparison of features of the Healgen Propoxyphene Test, Healgen Nortriptyline Test and Healgen EDDP (Methadone Metabolite) Test and the predicate device is provided in Table 1, Table 2 and Table 3.

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

| Item | Device | Predicate -
K140748 | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------|--|--|
| Intended Use | For the qualitative determination of
Propoxyphene in human urine. | Same | | |
| Drug Analyte | Propoxyphene | 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
Same
uses. | | | |
| Configurations | Strip, Cassette, Cup, Dip Card | Cup | | |

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

Item	Device	Predicate – K140748
Intended Use	For the qualitative determination of
Nortriptyline in human urine.	Same
Drug Analyte	Nortriptyline	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	1000 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 EDDP (Methadone Metabolite)Test and the Predicate Device

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Item	Device	Predicate – K140748
Intended Use	For the qualitative determination of EDDP in human urine.	Same
Drug Analyte	EDDP	Same
Methodology	Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	300 ng/mL	Same
Intended Population	For over-the-counter and prescription uses.	Same
Configurations	Strip, Cassette, Cup, Dip Card	Cup

9. Test Principle

Healgen Propoxyphene Test, Healgen Nortriptyline Test and Healgen EDDP (Methadone Metabolite) Test are rapid tests for the qualitative detection of Propoxyphene, Nortriptyline and EDDP in urine samples. Each assay test is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs are present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific antibody (monoclonal mouse antibody) coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cut-off concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the test has been performed properly.

10. Performance Characteristics

• 1. Analytical Performance
  • a. Precision

Precision studies were carried out for samples with concentrations of -100% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +75% cut-off, +75% cut-off and +100% cut-off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blind labeled and randomized by the person who prepared samples and did not take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days by three different operators for each format of devices. Different set of operators tested each format. The results obtained are summarized in the following tables:

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Propoxyphene

Strip Format

| | Result | -100%
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 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Cassette Format

| | Result | -100%
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 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- |

Dip Card Format

Drug	Result	Cut-off				Cut-off	Cut-off
		-100%	-75%	-50%	-25%		+25%	+50%	+75%	+100%
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	50-/0+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-

CUP Format

| Drug | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|-------|--------|------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Nortriptyline

Strip Format

| | Result | -100%
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 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Cassette Format

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

Dip Card Format

| | Result | -100%
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 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

CUP Format

| | Result | -100%
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 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

EDDP

Strip Format

| | Result | -100%
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 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- |

Cassette Format

| Drug | Result | -100%
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 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Dip Card Format

| Drug | Result | -100%
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 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

10

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

CUP Format

| Drug | Result | -100%
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 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

b. Linearity

Not applicable.

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

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

• d. Cut-off
  A total of 150 samples equally distributed at concentrations of -50% cut-off; cutoff; +25% cut-off; +50% cut-off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% cut-off and all negative at and below -25% cut-off for Propoxyphene, Nortriptyline and EDDP. The following cut-off values for the test devices have been verified.

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

e. Interference

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

11

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

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

12

Nortriptyline

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

13

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

EDDP

Acetophenetidin	Ethyl-p-aminobenzoate	Phencyclidine
N-Acetylprocainamide	Fenoprofen	Phenelzine
Acetylsalicylic Acid
(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
Benzoic Acid	Labetalol	Ranitidine(Zantac)

14

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

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

| Propoxyphene

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

15

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

| EDDP
(Cut-off=300 ng/mL) | Result | % Cross-
Reactivity |
|--------------------------------------------------------------|-------------------------|------------------------|
| EDDP (2-ethylidene-1,5-dimethyl-3,3-
diphenylpyrrolidine) | Positive at 300 ng/mL | 100% |
| EMDP (2-Ethyl-5-methyl-3,3-
diphenylpyrroline) | Positive at 500 ng/mL | 60% |
| Disopyramide | Positive at 50000 ng/mL | 1% |
| Methadone | Negative at 100000 | 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-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.

| | Number
of
samples | Propoxyphene
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 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |

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

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

| % of Cutoff | Number
of
samples | Propoxyphene
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% |

24

-50% Cutoff	20	150		20	100%
-25% Cutoff	20	225	2	18	90%
+25% Cutoff	20	375	19		તે તે જે જે જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલત
+50% Cutoff	20	450	20		100%
+75% Cutoff	20	525	20		100%

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

% of Cutoff	Number of samples	Propoxyphene Concentration by GC/MS (ng/mL)	Lay person results		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	18	2	90%
+50% Cutoff	20	450	20	0	100%
+75% Cutoff	20	525	20	0	100%

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

| % of Cutoff | Number
of
samples | Propoxyphene
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 (Nortriptyline Strip)

| % of Cutoff | Number
of
samples | Nortriptyline
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 | 250 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 750 | 2 | 18 | 90% |

25

+25% Cutoff	20	1250	18	2	90%
+50% Cutoff	20	1500	20	0	100%
+75% Cutoff	20	1750	20	0	100%

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

| | Number | Nortriptyline
Concentration by GC/MS
(ng/mL) | Lay person results | | The |
|--------------|---------------|----------------------------------------------------|--------------------|--------------------|-----------------------------------------|
| % of Cutoff | of
samples | | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 250 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 750 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 1250 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100% |

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

| % of Cutoff | Number
of
samples | Nortriptyline
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|----------------------------------------------------|--------------------|----|------------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 250 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 750 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 1250 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100% |

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

| % of Cutoff | Number
of
samples | Nortriptyline
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 | 250 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 750 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 1250 | 18 | 2 | 90% |

26

+50% Cutoff	20	1500	20	0	100%
+75% Cutoff	20	1750	20	0	100%

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

| % of Cutoff | Number
of
samples | EDDP 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 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 375 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |

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

| | Number
of
samples | EDDP 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 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |

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

| % of Cutoff | Number
of
samples | EDDP 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% |

27

+75% Cutoff	20	525	20	0	100%
-------------	----	-----	----	---	------

| % of Cutoff | Number | EDDP Concentration by
GC/MS
(ng/mL) | Lay person results | | The |
|-------------|---------------|-------------------------------------------|--------------------|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | of
samples | | 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 | તે તે જે જ જીરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય |
| +25% Cutoff | 20 | 375 | 19 | 1 | તે તે જે જ જીરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | રેટર | 20 | 0 | 100% |

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

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 Propoxyphene Test, Healgen Nortriptyline Test and Healgen EDDP (Methadone Metabolite) Test are substantially equivalent to the predicate.