HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx
Device Facts
| Record ID | K220685 |
|---|---|
| Device Name | HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx |
| Applicant | Qingdao Hightop Biotech Co., Ltd. |
| Product Code | NFT · Clinical Toxicology |
| Decision Date | May 5, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Intended Use
Hightop® Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethy1-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of: [Table of drugs and cutoffs]. Hightop® Multi-Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may vield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
Device Story
Rapid, single-use, lateral flow immunochromatographic assay; detects drugs of abuse in human urine. Input: human urine sample added to test cup; capillary action moves sample through test strip. Principle: competitive binding antigen-antibody reaction. If drug concentration is below cutoff, target drug does not saturate antibody-coated particles, allowing capture by immobilized drug-conjugate to form visible colored test line. If drug concentration exceeds cutoff, binding sites are saturated, preventing test line formation. Control line forms regardless of drug presence. Used in OTC or clinical settings; operated by patients or healthcare providers. Output: visual qualitative result (positive/negative). Healthcare providers use results for preliminary screening; positive results require confirmatory testing via GC/MS or LC/MS. Benefits: rapid, preliminary identification of drug presence to guide clinical decision-making.
Clinical Evidence
Bench testing only. Analytical performance validated via precision studies (20 days, 3 lots), interference testing (100+ substances), and specificity/cross-reactivity. Method comparison study performed in-house with 80 samples compared to LC/MS. Lay-user study (n=280) conducted across three sites with diverse demographics; results showed high concordance with LC/MS and confirmed ease of use.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Single-use test cup format. Includes test device, desiccant, and package insert. No electronic components or software algorithms. Sterilization not specified. Materials: standard lateral flow membrane components.
Indications for Use
Indicated for qualitative, simultaneous detection of 15 specific drugs of abuse (Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, EDDP, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids) in human urine. Intended for OTC or prescription use. Not for distinguishing between prescription use and abuse. Requires confirmatory testing (GC/MS or LC/MS).
Regulatory Classification
Identification
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An amphetamine 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).
Related Devices
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- K180255 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup · Hangzhou Clongene Biotech Co., Ltd. · Feb 28, 2018
- K210327 — First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup · W.H.P.M., Inc. · Aug 12, 2021
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
May 5, 2022
Qingdao HIGHTOP Biotech Co., Ltd. % Joe Shia Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, Maryland 20877
Re: K220685
Trade/Device Name: Hightop® Multi-Drug Urine Test Cup, Hightop® Multi-Drug Urine Test Cup Rx Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT. NGL. PTH. NFV. NFY. PTG. NGG. OBF.OAW. NFW. LCM Dated: March 6, 2022 Received: March 8, 2022
Dear Joe Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, ple ase be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
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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 Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
k220685
#### Device Name Hightop® Multi-Drug Urine Test Cup
#### Indications for Use (Describe)
Hightop® Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethy1-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|----------------------------------------------------------|-------------------------|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethy1-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
Hightop® Multi-Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may vield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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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## Indications for Use
510(k) Number (if known)
#### Device Name
Hightop® Multi-Drug Urine Test Cup Rx
#### Indications for Use (Describe)
Hightoo® Multi-Drug Urine Test Cup Rx tests are competitive binding. lateral flow immunochromatographic assavs for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|----------------------------------------------------------|-------------------------|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
Hightop® Multi-Drug Urine Test Cup Rx offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use.
The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
{5}------------------------------------------------
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."
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## 510(k) SUMMARY K220685
- April 29, 2022 l Date Qingdao HIGHTOP Biotech Co., Ltd. 2 Submitter No.369 Hedong Road, Qingdao, Shandong 266112 China Contact Person Joe Shia 3 LSI International Inc. 504 East Diamond Ave., Suite J Gaithersburg, MD 20877 Telephone: 240-505-7880 Fax: 301-916-6213 Email: shiajl@yahoo.com
- Device Name Hightop® Multi-Drug Urine Test Cup 4 Hightop® Multi-Drug Urine Test Cup Rx
- 5 Classification
| Class II | | |
|----------------------------------------------------------------------------|------------------------------------------|------------|
| Product Code<br>Target Drug | Regulation Section | Cup |
| NFT<br>Amphetamine (AMP) | 862.3100, Amphetamine Test System | Toxicology |
| NGL<br>Buprenorphine (BUP) | 862.3650, Opiate Test System | Toxicology |
| PTH<br>Secobarbital (BAR) | 862.3150, Barbiturate Test System | Toxicology |
| NFV<br>Oxazepam (BZO) | 862.3170,<br>Benzodiazepine Test System | Toxicology |
| NFY<br>Cocaine (COC) | 862.3250, Cocaine Test System | Toxicology |
| PTG<br>2-ethylidene-1,5-<br>dimethyl-3,3-<br>diphenylpyrrolidine<br>(EDDP) | 862.3620, Methadone Test System | Toxicology |
| NGG<br>Methamphetamine<br>(MET) | 862.3610,<br>Methamphetamine Test System | Toxicology |
| NGG<br>Methylenedioxymethamphetamine (MDMA) | 862.3610,<br>Methamphetamine Test System | Toxicology |
| NGL | 862.3650, Opiate Test System | Toxicology |
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| Morphine (MOP/OPI) | | |
|------------------------------|-----------------------------------------------------|------------|
| PTG<br>Methadone (MTD) | 862.3620, Methadone Test System | Toxicology |
| NGL<br>Oxycodone (OXY) | 862.3650, Opiate Test System | Toxicology |
| LCM<br>Phencyclidine (PCP) | Unclassified | Toxicology |
| QBF<br>Propoxyphene (PPX) | 862.3700 Propoxyphene test system. | Toxicology |
| QAW<br>Nortriptyline (TCA) | 862.3910 Tricyclic antidepressant drugs test system | Toxicology |
| NFW<br>Cannabinoids (THC 50) | 862.3870, Cannabinoids Test System | Toxicology |
#### 6. Predicate Device K182701
Wondfo T-Cup® Multi-Drug Urine Test Cup
#### 7. Intended Use
Hightop® Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|----------------------------------------------------------|-------------------------|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
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Hightop® Multi-Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
Hightop® Multi-Drug Urine Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|----------------------------------------------------------|-------------------------|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
{9}------------------------------------------------
Hightop® Multi-Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use.
The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
#### Device Description 8.
The Hightop® Multi-Drug Urine Test Cup and Hightop® Multi-Drug Urine Test Cup Rx are rapid, single-use in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test Hightop® Cup and two desiccants, and a package insert. The Hightop® Multi-Drug Urine Test Cup is intended for over-the-counter use and the Hightop® Multi-Drug Urine Test Cup Rx is intended for prescription use.
| Item | Proposed Device | Predicate<br>(K182701) | |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------|
| Indication(s) for use | For the qualitative determination of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-<br>1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine. | Same | |
| Methodology | Competitive binding, lateral flow immunochromatographic assay based on antigen-antibody reaction | Same | |
| Type of Test | Qualitative | Same | |
| Specimen Type | Human urine | Same | |
| Target Drug and<br>Cut Off Values | Target Drug | Cutoff (ng/mL) | Same |
| | Amphetamine (AMP) | 1000 or 500 | |
| | Buprenorphine (BUP) | 10 | |
| | Secobarbital (BAR) | 300 | |
| | Oxazepam (BZO) | 300 | |
| | Cocaine (COC) | 300 or 150 | |
#### 9. Substantial Equivalence Information
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| | 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine (EDDP) | 300 | |
|----------------|--------------------------------------------------------------|-------------|--------------------------|
| | Methamphetamine (MET) | 1000 or 500 | |
| | Methylenedioxymethamphetamine (MDMA) | 500 | |
| | Morphine (MOP 300/OPI 2000) | 2000 or 300 | |
| | Methadone (MTD) | 300 | |
| | Oxycodone (OXY) | 100 | |
| | Phencyclidine (PCP) | 25 | |
| | Propoxyphene (PPX) | 300 | |
| | Nortriptyline (TCA) | 1000 | |
| | Cannabinoids (THC 50) | 50 | |
| Configurations | Test Cup | | Cup |
| Intended Use | Prescription Use and over-the-counter use | | For over-the-counter use |
#### 10. Test Principle
Hightop® Multi-Drug Urine Test Cup and Hightop® Multi-Drug Urine Test Cup Rx are rapid tests for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine.Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in urine samples. They are lateral flow chromatographic immunoassay. When urine sample is added to the cup device, urine is absorbed into the test strip and migrates upwards by capillary action. If the concentration of target drug presented in the urine sample is below the cutoff level, the target drug will not saturate the binding sites of its specific monoclonal antibody-coated particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored band will be formed on the test line region. If the concentration of target is beyond the cutoff level, the target drug will saturate the binding sites of its specific monoclonal antibody-particles, thus the antibody-coated particles will not be captured by immobilized drug-conjugate hence no colored band will be formed on the test line region.
A band should be formed on the control line region regardless of target drug or metabolite in the sample to indicate that the tests have been performed properly.
#### 11. Performance Characteristics
#### 1. Analytical Performance
- a. Precision
Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cutoff, +25% cut off, +50% cut off, +75% cut off and +100% cut off. Samples with concentration of -100% cutoff were drug-free urines samples. Other samples were prepared by spiking target drug in drug-free urine samples. Each drug concentration was confirmed by LC/MS. For each concentration, tests were performed two runs per day for 20 days using three lots of test Cups. The results obtained are summarized in the following tables:
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| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 20.639 | 18.961 | 16.144 | 12.894 | 10.931 | 7.847 | 4.699 | 2.372 | 0 |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 12-/28+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 11-/29+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 13-/27+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
Hightop® Multi-Drug Urine Test Cup BUP 10
Hightop® Multi-Drug Urine Test Cup PCP 25
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|----------------------------------------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| Lot I | 45.873 | 40.806 | 34.745 | 28.986 | 23.342 | 17.475 | 11.980 | 6.035 | 0 |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 10-/30+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 12-/28+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 12-/28+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
Hightop® Multi-Drug Urine Test Cup THC 50
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| 91.719 | 77.980 | 68.828 | 56.254 | 44.616 | 33.999 | 23.206 | 11.577 | 0 | |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 14-/26+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 15-/25+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 16-/24+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
Hightop® Multi-Drug Urine Test Cup OXY 100
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 190.930 | 166.80 | 145.48 | 121.95 | 97.199 | 74.091 | 48.055 | 23.512 | 0 |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 11-/29+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 13-/27+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 10-/30+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
{12}------------------------------------------------
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 521.930 | 478.35 | 432.76 | 355.67 | 310.579 | 237.31 | 142.88 | 73.822 | 0 |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 13-/27+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 12-/28+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 14-/26+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
Hightop® Multi-Drug Urine Test Cup BAR 300
Hightop® Multi-Drug Urine Test Cup BZO 300
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 565.071 | 480.34 | 416.67 | 354.25 | 273.078 | 202.73 | 136.25 | 69.388 | 0 |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 15-/25+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 13-/27+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 16-/24+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
Hightop® Multi-Drug Urine Test Cup EDDP 300
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 554.757 | 487.55 | 420.46 | 343.50 | 283.163 | 214.94 | 144.88 | 71.416 | 0 |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 11-/29+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 13-/27+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 14-/26+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
Hightop® Multi-Drug Urine Test Cup MTD 300
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 560.075 | 460.6 | 436.87 | 359.45 | 281.504 | 215.81 | 152.45 | 73.320 | 0 |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 12-/28+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 14-/26+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 11-/29+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
{13}------------------------------------------------
### Hightop® Multi-Drug Urine Test Cup MOP 300
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|---------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 647.611 | 559.70 | 492.4 | 402.2 | 318.962 | 210.61 | 163.37 | 81.274 | 0 |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 10-/30+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 11-/29+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 13-/27+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
Hightop® Multi-Drug Urine Test Cup PPX 300
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 605.886 | 527.60 | 448.738 | 394.47 | 314.961 | 233.98 | 153.15 | 79.325 | 0 |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 12-/28+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 11-/29+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 14-/26+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
Hightop® Multi-Drug Urine Test Cup COC 150
| Concentration by<br>LC/MS<br>(ng/mL) | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 319.266 | 272.97 | 241.8 | 201.02 | 158.168 | 117.53 | 79.916 | 41.227 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 10-/30+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 12-/28+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 13-/27+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
Hightop® Multi-Drug Urine Test Cup MDMA 500
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|------------------|--------|--------|--------|---------|---------|--------|--------|--------|---------|
| LC/MS<br>(ng/mL) | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| 1064.78 | 933.69 | 805.91 | 656.18 | 532.253 | 405.34 | 264.48 | 130.38 | 0 | |
| Lot Number | | | | | | | | | |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 14-/26+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 11-/29+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 11-/29+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
{14}------------------------------------------------
| Concentration by<br>LC/MS<br>(ng/mL) | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 1826.46 | 1582.9 | 1356.8 | 1146.2 | 913.883 | 676.01 | 456.57 | 242.25 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 12-/28+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 12-/28+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 11-/29+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
# Hightop® Multi-Drug Urine Test Cup TCA 1000
Hightop® Multi-Drug Urine Test Cup AMP 500
| Concentration<br>by LC/MS<br>(ng/mL) | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| Lot Number | 916.094 | 807.506 | 689.93 | 577.14 | 462.436 | 347.06 | 225.67 | 124.313 | 0 |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 11-/29+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 13-/27+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 14-/26+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
Hightop® Multi-Drug Urine Test Cup MET 500
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 952.643 | 814.24 | 679.94 | 578.75 | 476.642 | 357.6 | 241.67 | 131.18 | 0 |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 10-/30+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 12-/28+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 11-/29+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
Hightop® Multi-Drug Urine Test Cup OPI 2000
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|------------------|---------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS<br>(ng/mL) | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| | 4047.51 | 3667.3 | 3241.0 | 2611.8 | 1966.56 | 1548.3 | 1080.0 | 535.72 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 13-/27+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 12-/28+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 11-/29+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
{15}------------------------------------------------
# Hightop® Multi-Drug Urine Test Cup COC 300
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 624.542 | 542.14 | 479.71 | 402.03 | 319.266 | 241.8 | 158.17 | 79.916 | 0 |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 11-/29+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 10-/30+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 13-/27+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
Hightop® Multi-Drug Urine Test Cup AMP 1000
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|---------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 1814.57 | 1583.3 | 1396.3 | 1157.0 | 916.094 | 689.93 | 462.44 | 225.67 | 0 |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 12-/28+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 11-/29+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 12-/28+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
Hightop® Multi-Drug Urine Test Cup MET 1000
| Concentration by<br>LC/MS<br>(ng/mL) | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 1837.1 | 1593.0 | 1378.7 | 1155.5 | 952.643 | 679.94 | 476.64 | 241.67 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 13-/27+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot II | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 10-/30+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
| Lot III | 0-/40+ | 0-/40+ | 0-/40+ | 0-/40+ | 11-/29+ | 40-/0+ | 40-/0+ | 40-/0+ | 40-/0+ |
The following cutoff values are verified:
| Target Drug | Cut-off level |
|----------------------------------------------------------|-------------------------|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
{16}------------------------------------------------
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
|--------------------------------------|-------------------------|
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Cannabinoids (THC 50) | 50 ng/mL |
#### b. Linearity
Not applicable
#### c. Stability
The devices are stable at 4-30℃ for 24 months based on real-time stability studies.
- d. Interference
Potential interfering substances were added to drug-free urine samples with target drugs of -25% cutoff and +25% cutoff level.
Compounds that show no interference at a concentration of 100µg/mL are summarized in the following table.
| Acetaminophen | Acetophenetidin | Acetylsalicylic Acid |
|-----------------------------|-------------------------------|----------------------|
| Acyclovir | Amiodarone Hydrochloride | Apomorphine |
| Afrin | Albumin (100mg/dL) | Amlodipine Mesylate |
| Aminophylline | Amoxicillin | Aripiprazole |
| Aminopyrine | Ampicillin | Aspartame |
| Benzilic Acid | Atropine | Atomoxetine |
| Benzoic Acid | Carbamazepine | Atorvastatin Calcium |
| Bilirubin | Cefradine | Chloramphenicol |
| Bupropion | Cephalexin | Chlorothiazide |
| Captopril | Chloral Hydrate | Chloroquine |
| Ciprofloxacin Hydrochloride | Clonidine | Cholesterol |
| Citalopram | Clopidogrel Hydrogen Sulphate | (-) Cotinine |
| Clarithromycin | Clozapine | chlorpheniramine |
| Deoxy- corticosterone | D,L-Tyrosine | D,L-Octopamine |
| Dextromethorphan | Digoxin | D,L-Propranolol |
| Diclofenac | Diphenhydramine | D-Norpropoxy- phene |
| Diflunisal | Dirithromycin | Domperidone |
{17}------------------------------------------------
| D-Pseudo- ephedrine | Ecgonine Methyl Ester | Doxylamine |
|--------------------------|----------------------------|-----------------------------------------|
| Duloxetine | Effexor | Epinephrine Hydrochloride |
| Dicyclomine | Enalapril Maleate | Erythromycin |
| ẞ-Estradiol | Fentanyl Citrate | Esomeprazole Magnesium |
| Ethanol (1%) | Fluoxetine Hydrochloride | Furosemide |
| Fenofibrate | Fluvoxamine | Gabapentin |
| Fenoprofen | Glucose | Gentisic Acid |
| Glibenclamide | Haloperidol | 3-Hydroxy- tyramine |
| Gliclazide | Hemoglobin | Isosorbide Dinitrate |
| Glipizide | Ketamine | Isoxsuprine |
| Ibuprofen | Kratom powder | Lamotrigine |
| Ketoconazole | Labetalol | Levofloxacin Hydrochloride |
| Ketoprofen | Liverite | Levonorgestrel |
| Lidocaine Hydrochloride | Loperamide | Levothyroxine Sodium |
| Lisinopril | Loratadine | Minocycline |
| Lithium Carbonate | Naproxen | Nalidixic Acid |
| Metoprolol Tartrate | Mifepristone | Niacinamide |
| Magnesium | Mirtazapine | Nifedipine |
| Meperidine | Montelukast Sodium | Nikethamide |
| Meprobamate | Phenelzine | Sulfamethazine |
| Mosapride Citrate | Pioglitazone Hydrochloride | Sulindac |
| Maprotiline | Piracetam | Tetrahydrocortisone 3 -acetate |
| Nimodipine | Pravastatin Sodium | Tetrahydrocortisone 3-(β-D-glucuronide) |
| Norethindrone | Prednisone | Tetrahydrozoline |
| N-Acetylprocain-amide | Propylthiouracil | Tetracycline |
| O-Hydroxyhippu-ric Acid | Promethazine | Thiamine |
| Olanzapine | Quetiapine Fumarate | Thioridazine |
| Omeprazole | Quinine | Topiramate |
| Oxalic Acid | Ranitidine | Tramadol Hydrochloride |
| Oxolinic Acid | Rifampicin | Trazodone Hydrochloride |
| Oxymetazoline | Risperidone | Triamterene |
| Ondansetran | Salicylic Acid | Trifluoperazine |
| Paliperidone | Serotonin | Trimethoprim |
| Pantoprazole | Sertraline Hydrochloride | Uric Acid |
| Papaverine | Sildenafil Citrate | Valproate |
| Paroxetine Hydrochloride | Simvastatin | Verapamil |
| Penfluridol | Sodium Valproate | Vitamin B2 |
| PenicillinV Potassium | Spironolactone | Vitamin C |
{18}------------------------------------------------
- Specificity e.
To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine. These urine samples were tested using three lots of each device.
Percent cross-reactivity, provided in the below table, was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100; compounds that did not yield a positive result at the highest concentration tested have relative cross reactivity results represented by a dash in the table below:
| BUP 10 (Buprenorphine,<br>Cutoff=10 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|--------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Buprenorphine -3-D-Glucuronide | 15 | 66.67% |
| Norbuprenorphine | 20 | 50% |
| Norbuprenorphine-3-D-Glucuronide | 250 | 4% |
| Morphine | >100000 | - |
| Oxymorphone | >100000 | - |
| Hydromorphone | >100000 | - |
| PCP (Phencyclidine)<br>(Phencyclidine,<br>Cutoff=25 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 4-Hydroxyphencyclidine | 12500 | 0.2% |
| THC 50<br>(11-nor-Δ9-THC-9-COOH,<br>Cutoff=50 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| (-)-11-nor-9-carboxy-Δ9-THC | 500 | 10% |
| 11-nor-Δ8-THC-9-COOH | 30 | 166.67% |
| 11-nor-Δ9-THC-carboxy glucuronide | 100000 | 0.05% |
| Cannabidiol | 100000 | 0.05% |
| Cannabinol | 100000 | 0.05% |
| Δ8- Tetrahydrocannabinol | 20000 | 0.25% |
| Δ9- Tetrahydrocannabinol | 20000 | 0.25% |
| 11-hydroxy-Δ9-Tetrahydrocannabinol | 100000 | 0.05% |
| OXY 100<br>(Oxycodone, Cutoff=100 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Dihydrocodeine | 10000 | 1% |
| Hydrocodone | 10000 | 1% |
| Oxymorphone | 500 | 20% |
{19}------------------------------------------------
| Codeine | 10000 | 1% |
|----------------|---------|------|
| Hydromorphone | 50000 | 0.2% |
| Morphine | 50000 | 0.2% |
| Acetylmorphine | >100000 | - |
| Buprenorphine | >100000 | - |
| Ethylmorphine | 10000 | 1% |
| Thebaine | >100000 | - |
| COC 150<br>(Benzoylecgonine, Cutoff=150 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Cocaine | 500 | 30% |
| Cocaethylene | 6000 | 2.5% |
| Ecgonine | 40000 | 0.375% |
| Ecgonine methyl ester | >100000 | - |
| Norcocaine | >100000 | - |
| BAR 300<br>(Secobarbital, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|--------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Amobarbital | 300 | 100% |
| Alphenol | >100000 | - |
| Aprobarbital | 300 | 100% |
| Butabarbital | 300 | 100% |
| Butethal | 300 | 100% |
| Butalbital | 2500 | 12% |
| Cyclopentobarbital | 300 | 100% |
| Pentobarbital | 300 | 100% |
| Phenobarbital | 300 | 100% |
| BZO 300<br>(Oxazepam, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Alprazolam | 200 | 150% |
| a-Hydroxyalprazolam | 1250 | 24% |
| Bromazepam | 500 | 60% |
| Chlordiazepoxide | 1250 | 24% |
| Clobazam | 100 | 300% |
| Clonazepam | 2500 | 12% |
| Clorazepate dipotassium | 200 | 150% |
| Delorazepam | 1250 | 24% |
| Desalkylflurazepam | 100 | 300% |
{20}------------------------------------------------
| Diazepam | 100 | 300% |
|---------------------|-------|------|
| Estazolam | 5000 | 6% |
| Flunitrazepam | 50000 | 0.6% |
| Midazolam | 12500 | 2.4% |
| Nitrazepam | 100 | 300% |
| Norchlordiazepoxide | 200 | 150% |
| Nordiazepam | 500 | 60% |
| Temazepam | 50 | 600% |
| Triazolam | 2500 | 12% |
| Demoxepam | 2000 | 15% |
| Flurazepam | 500 | 60% |
| D,L-Lorazepam | 2000 | 15% |
| EDDP 300<br>(2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine, Cutoff = 300 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Methadone | >100000 | - |
| EMDP | >100000 | - |
| Doxylamine | >100000 | - |
| Disopyramide | >100000 | - |
| LAAM (Levo-alpha-acetylmethadol) HCl | >100000 | - |
| Alpha Methadol | >100000 | - |
| MTD 300<br>(Methadone, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Doxylamine | >100000 | - |
| EDDP | >100000 | - |
| EMDP | >100000 | - |
| LAAM | >100000 | - |
| Alpha Methadol | >100000 | - |
| MOP 300<br>(Morphine, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Normorphine | >100000 | - |
| Codeine | 300 | 100% |
| s-Monoacetylmorphine | 300 | 100% |
| Ethyl Morphine | 200 | 150% |
| Heroin | 1250 | 24% |
| Hydrocodone | 10000 | 3% |
| Hydromorphone | 5000 | 6% |
{21}------------------------------------------------
| Morphinie-3-β-d-glucuronide | 2500 | 12% |
|------------------------------|---------|------|
| Oxycodone | >100000 | - |
| Oxymorphone | >100000 | - |
| Thebaine | 20000 | 1.5% |
| Levorphanol | 10000 | 3% |
| 6-Monoacetylmorphine (6-MAM) | 300 | 100% |
| Norcodeine | 100000 | 0.3% |
| Procaine | >100000 | - |
| PPX 300<br>(d-Propoxyphene, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|----------------------------------------------|--------------------------------------------------------------------------|------------------------|
| d-Norpropoxyphene | 5000 | 6% |
| MDMA 500<br>(3,4-Methylenedioxymethamphetamine HCl,<br>Cutoff=500ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 3,4-Methylenedioxyamphetamine HCl (MDA) | 50000 | 1% |
| 3,4-Methylenedioxyethylamphetamine (MDE) | 2500 | 20% |
| d-methamphetamine | >100000 | - |
| d-amphetamine | >100000 | - |
| l-methamphetamine | 50000 | 1% |
| l-amphetamine | >100000 | - |
| AMP (Amphetamine) (Amphetamine,<br>Cutoff=500ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-----------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| l-Amphetamine | 500 | 100% |
| dl- Amphetamine | 500 | 100% |
| (+/-) 3,4-Methylenedioxyamphetamine (MDA) | 1000 | 50% |
| Phentermine | 5000 | 10% |
| Hydroxyamphetamine | 100000 | 0.5% |
| d-Methamphetamine | >100000 | - |
| l-Methamphetamine | >100000 | - |
| (+/-) 3,4-Methylenedioxyethylamphetamine (MDE) | >100000 | - |
| (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | >100000 | - |
| β-Phenylethylamine | 100000 | 0.5% |
| Tyramine | 100000 | 0.5% |
| p-Hydroxynorephedrine | 100000 | 0.5% |
| Phenylpropanolamine | 100000 | 0.5% |
{22}------------------------------------------------
| (±)Phenylpropanolamine | >100000 | - |
|------------------------|---------|------|
| p-Hydroxyamphetamine | 100000 | 0.5% |
| d/l-Norephedrine | 100000 | 0.5% |
| Benzphetamine | >100000 | - |
| l-Ephedrine | 100000 | 0.5% |
| l-Epinephrine | >100000 | - |
| d/l-Epinephrine | >100000 | - |
| MET 500<br>(D(+)-Methamphetamine, Cutoff=500ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-----------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| (+/-)3,4-Methylenedioxy-n-<br>ethylamphetamine(MDE) | 25000 | 2% |
| D/L-Methamphetamine | 500 | 100% |
| p-Hydroxymethamphetamine | 12500 | 4%…
