Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup

K232659 · Guangzhou Decheng Biotechnology Co., Ltd. · DJG · Dec 13, 2023 · Clinical Toxicology

Device Facts

• Record ID: K232659
• Device Name: Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
• Applicant: Guangzhou Decheng Biotechnology Co., Ltd.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Dec 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

Dochek® Multi-Drug Urine Test Cup Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table. Dochek® Multi-Drug Urine Test Cup Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for prescription use. For in vitro diagnostic use only. The test provides only preliminary results. 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 is needed. GC/MS or LC/MS is the recommended confirmatory method. Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table. Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.

Device Story

Lateral flow immunochromatographic assay for qualitative drug screening in human urine; cup format with integrated test strips. Urine sample collected directly into cup; capillary action draws sample across pre-coated membrane. Competitive binding mechanism: drug in sample competes with drug-protein conjugate for limited monoclonal antibody binding sites. Negative result: colored line in Test Region (T) indicates drug concentration below cutoff. Positive result: absence of colored line in Test Region (T) indicates drug concentration at or above cutoff. Control line (C) confirms proper test performance. Used in clinical or home settings; operated by healthcare professionals or lay users. Results are visual; preliminary only. Confirmatory testing via GC/MS or LC/MS required for positive results. Benefits: rapid, preliminary screening for drugs of abuse.

Clinical Evidence

No clinical diagnostic studies performed. Evidence includes analytical performance (precision, cross-reactivity, interference) and a lay user study (n=280) across three sites. Lay user study demonstrated high concordance with LC/MS confirmed samples across various drug concentrations relative to cutoffs. Bench testing confirmed performance across pH 4-9 and specific gravity 1.000-1.035.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Materials: test strips integrated into plastic cup. Energy source: none (capillary action). Connectivity: none. Sterilization: not stated. Software: none.

Indications for Use

Indicated for qualitative detection of single or multiple drugs in human urine for prescription or OTC use. Target population includes individuals requiring drug screening. Contraindications: None stated.

Regulatory Classification

Identification

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

Special Controls

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

Predicate Devices

• AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests (K201630)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Guangzhou Decheng Biotechnology Co., Ltd. % Joe Shia Director LSI International 504 E Diamond Ave., Suite H Gaithersburg, Maryland 20877

### Re: K232659

Trade/Device Name: Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, DKZ, PTH, NFT, NGL, DIS, NFV, JXM, DIO, NFY, PTG, DJR, NGG, DJC, NGM, LCM, QBF, JXN, QAW, LFG, LDJ, NFW Dated: November 6th, 2023 Received: November 6th, 2023

## 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 (the 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, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a

change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Joseph A. Kotarek -S Joseph A. Kotarek -S
Joseph A. Kotarek -S Date: 2023.12.13 14:33:39 -05'00 Joseph Kotarek Branch Chief for Toxicology Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known)

K232659

### Device Name

Dochek® Multi-Drug Urine Test Cup

### Indications for Use (Describe)

Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table.

| Drug(Identifier) | Cut-off level( ng/mL) |
|----------------------------------------------------------|-----------------------|
| Amphetamine(AMP) | 1000 or 500 |
| Secobarbital (BAR) | 300 |
| Buprenorphine (BUP) | 10 |
| Oxazepam (BZO) | 300 |
| Cocaine (COC) | 300 or 150 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 |
| Methylenedioxymethamphetamine (MDMA) | 500 |
| Methamphetamine (MET) | 1000 or 500 |
| Morphine (MOP300/OPI2000) | 2000 or 300 |
| Methadone (MTD) | 300 |
| Oxycodone (OXY) | 100 |
| Phencyclidine (PCP) | 25 |
| Propoxyphene(PPX) | 300 |
| Nortriptyline (TCA) | 1000 |
| Cannabinoids (THC) | 50 |
| 6-Monoacetylmorphine(6-MAM) | 10 |

Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device .

It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positived analytical result, a more specific a termical method is needed. 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)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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### *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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FORM FDA 3881 (6/20)

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## Indications for Use

510(k) Number (if known)

K232659

### Device Name

Dochek® Multi-Drug Urine Test Cup Rx

### Indications for Use (Describe)

Dochek® Multi-Drug Urine Test Cup Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table.

| Drug(Identifier) | Cut-off level( ng/mL) |
|----------------------------------------------------------|-----------------------|
| Amphetamine(AMP) | 1000 or 500 |
| Secobarbital (BAR) | 300 |
| Buprenorphine (BUP) | 10 |
| Oxazepam (BZO) | 300 |
| Cocaine (COC) | 300 or 150 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 |
| Methylenedioxymethamphetamine (MDMA) | 500 |
| Methamphetamine (MET) | 1000 or 500 |
| Morphine (MOP300/OPI2000) | 2000 or 300 |
| Methadone (MTD) | 300 |
| Oxycodone (OXY) | 100 |
| Phencyclidine (PCP) | 25 |
| Propoxyphene(PPX) | 300 |
| Nortriptyline (TCA) | 1000 |
| Cannabinoids (THC) | 50 |
| 6-Monoacetylmorphine(6-MAM) | 10 |

Dochek® Multi-Drug Urine Test Cup Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device .

It is intended for prescription use. For in vitro diagnostic use only.

The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result , particularly in evaluating a preliminary positived analytical result , a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.

| 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

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

FORM FDA 3881 (6/20)

PSC Publishing Services [phone] EF

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# 510(k) SUMMARY

| | K232659 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Date: | December 8, 2023 |
| 2. Submitter: | Guangzhou Decheng Biotechnology Co., Ltd.<br>Room 107/218/212/405, Building 2, No.68, Nanxiang<br>1st Road, Science City, Huangpu District, Guangzhou<br>Guangdong, 510663, P.R. China |
| 3. Contact person: | Joe Shia<br>LSI International Inc.<br>504 East Diamond Ave., Suite H<br>Gaithersburg, MD 20877<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

- 4. Device Name: Dochek® Multi-Drug Urine Test Cup Rx Dochek® Multi-Drug Urine Test Cup
#### Classification: Class II 5.

| Product Code | Regulation Section | Panel |
|--------------------------------------------------------------|---------------------------------------------------------|------------|
| Target Drug | | |
| DKZ, NFT | 862.3100, Amphetamine Test System | Toxicology |
| Amphetamine (AMP) | | |
| DIS, PTH | 862.3150, Barbiturate Test System | Toxicology |
| Secobarbital (BAR) | | |
| DJG, NGL | 862.3650, Opiate Test System | Toxicology |
| Buprenorphine (BUP) | | |
| Morphine (MOP/OPI) | | |
| Oxycodone (OXY) | | |
| JXM, NFV | 862.3170, Benzodiazepine Test System | Toxicology |
| Oxazepam (BZO) | | |
| DIO, NFY | 862.3250, Cocaine and cocaine<br>metabolite test system | Toxicology |
| Cocaine (COC) | | |
| DJR, PTG | 862.3620, Methadone Test System | Toxicology |
| 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine (EDDP) | | |
| Methadone (MTD) | | |
| DJC, NGG | 862.3610,<br>Methamphetamine Test System | Toxicology |
| Methylenedioxymethamphetamine<br>(MDMA) | | |
| Methamphetamine (MET) | | |
| LCM, NGM | Unclassified | Toxicology |

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| Phencyclidine (PCP) | | |
|------------------------------------|--------------------------------------------------------|------------|
| JXN,QBF<br>Propoxyphene(PPX) | 862.3700 Propoxyphene test system. | Toxicology |
| LFG, QAW<br>Nortriptyline (TCA) | 862.3910 Tricyclic antidepressant drugs<br>test system | Toxicology |
| LDJ,NFW<br>Cannabinoids (THC 50) | 862.3870, Cannabinoids Test System | Toxicology |
| DJG<br>6-Monoacetylmorphine(6-MAM) | 862.3650, Opiate Test System | Toxicology |

#### 6. Predicate Devices:

AssureTech DOA Dipstick Screen Panel Tests and AssureTech DOA Integrated Cup Tests(K201630)

#### 7. Intended Use

Dochek® Multi-Drug Urine Test Cup Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table.

| Drug(Identifier) | Cut-off level( ng/mL) |
|----------------------------------------------------------|-----------------------|
| Amphetamine(AMP) | 1000 or 500 |
| Secobarbital (BAR) | 300 |
| Buprenorphine (BUP) | 10 |
| Oxazepam (BZO) | 300 |
| Cocaine (COC) | 300 or 150 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 |
| Methylenedioxymethamphetamine (MDMA) | 500 |
| Methamphetamine (MET) | 1000 or 500 |
| Morphine (MOP300/OPI2000) | 2000 or 300 |
| Methadone (MTD) | 300 |
| Oxycodone (OXY) | 100 |
| Phencyclidine (PCP) | 25 |
| Propoxyphene(PPX) | 300 |
| Nortriptyline (TCA) | 1000 |
| Cannabinoids (THC) | 50 |
| 6-Monoacetylmorphine(6-MAM) | 10 |

Dochek® Multi-Drug Urine Test Cup Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device .

It is intended for prescription use. For in vitro diagnostic use only.

The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result,particularly in evaluating a preliminary positive result.

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To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.

Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table.

| Drug(Identifier) | Cut-off level( ng/mL) |
|----------------------------------------------------------|-----------------------|
| Amphetamine(AMP) | 1000 or 500 |
| Secobarbital (BAR) | 300 |
| Buprenorphine (BUP) | 10 |
| Oxazepam (BZO) | 300 |
| Cocaine (COC) | 300 or 150 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 |
| Methylenedioxymethamphetamine (MDMA) | 500 |
| Methamphetamine (MET) | 1000 or 500 |
| Morphine (MOP300/OPI2000) | 2000 or 300 |
| Methadone (MTD) | 300 |
| Oxycodone (OXY) | 100 |
| Phencyclidine (PCP) | 25 |
| Propoxyphene(PPX) | 300 |
| Nortriptyline (TCA) | 1000 |
| Cannabinoids (THC) | 50 |
| 6-Monoacetylmorphine(6-MAM) | 10 |

Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device . It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result,particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.

#### 8. Device Description

Dochek® Multi-Drug Urine Test Cup Rx and Dochek® Multi-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The device is a cup format. The test strips are integrated into the cup provided and the urine sample is collected directly into the cup containing the strips. Each cup device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

#### Substantial Equivalence Information 9.

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| Similarities | | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Device | Predicate<br>(K201630) |
| Intended use | Qualitative detection of drugs of abuse in urine.<br>For prescription use or over-the-counter use | Same.<br>Only for prescription<br>use. |
| Methodology | Competitive binding, lateral flow immunochromatographic<br>assay based on antigen-antibody reaction | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Differences | | |
| Configurations | Test cup | Test panel and test<br>cup |
| Target Drug<br>and Cut Off<br>Values | Target Drugs | Cutoff (ng/mL) |
| | Amphetamine(AMP) | 1000 or 500 |
| | Secobarbital (BAR) | 300 |
| | Buprenorphine (BUP) | 10 |
| | Oxazepam (BZO) | 300 |
| | Cocaine (COC) | 300 or 150 |
| | 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine (EDDP) | 300 |
| | Methylenedioxymethamphetamine<br>(MDMA) | 500 |
| | Methamphetamine (MET) | 1000 or 500 |
| | Morphine (MOP300/OPI2000) | 2000 or 300 |
| | Methadone (MTD) | 300 |
| | Oxycodone (OXY) | 100 |
| | Phencyclidine (PCP) | 25 |
| | Propoxyphene(PPX) | 300 |
| | Nortriptyline (TCA) | 1000 |
| | Cannabinoids (THC) | 50 |
| | 6-Monoacetylmorphine(6-MAM) | 10 |
| | | Same except of<br>Amphetamine<br>(AMP): 500 ng/mL<br>Cocaine (COC): 150<br>ng/mL<br>Methamphetamine<br>(MET): 500 ng/mL<br>Cannabinoids<br>(THC): 20 ng/mL |

# 10. Standard/Guidance Document Reference (if applicable)

None referenced.

# 11. Test Principle

Dochek® Multi-Drug Urine Test Cup Rx or Dochek® Multi-Drug Urine Test Cup is a competitive immunoassay that is used to screen for the presence of various drugs and drug metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites. When the test is activated, the urine is absorbed into each test strip by capillary action, mixes with

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the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test strip. This produces a colored Test line in the Test Region (T) of the strip, which, regardless of its intensity, indicates a negative test result.

When sample drug levels are at or above the detection level of the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.

To serve as a procedure control, a colored line will appear at the Control Region (C) of each strip, if the test has been performed properly.

# 12. Performance Characteristics

## A. Analytical performance

## a. Precision/Reproducibility:

Precision studies were carried out for samples with concentrations of +100% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Other samples were prepared by spiked target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups. The results obtained are summarized in the following tables:

| Drug | Lot<br>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 |
|-------------|---------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| AMP<br>1000 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 1000 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BAR<br>300 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BUP<br>10 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 10 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 16-/34+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BZO<br>300 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| COC<br>300 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| EDDP | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MDM | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| A 500 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MET | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 1000 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| OPI | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 9-/41+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 2000 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MTD | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| OXY | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 100 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| PCP | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 16-/34+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 25 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| PPX | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| TCA | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 1000 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| THC | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 50 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 6- | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MAM | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| AMP | Lot IV | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 500 | Lot V | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot VI | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| COC | Lot IV | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 150 | Lot V | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot VI | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MET | Lot IV | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 500 | Lot V | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot VI | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MOP<br>300 | Lot IV | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot V | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot VI | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

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

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

## b. Linearity/assay reportable range:

Not applicable. This device is intended for qualitative use only.

## c. Stability:

The device is stable at 2-30℃ for 24 months based on real time stability study.

## d. Analytical specificity/Interference:

To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine samples were tested using three lots of the 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.

| Drug/Cutoff | Compound | Minimum<br>concentration<br>required to obtain<br>a positive result<br>(ng/mL) | % Cross-<br>Reactivity |
|---------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------|------------------------|
| | d-Amphetamine | 1,000 | 100% |
| | d/l-Amphetamine | 3,000 | 33.3% |
| | l-Amphetamine | 50,000 | 2% |
| AMP 1000 | (+/-) 3,4-<br>methylenedioxyamphetamine<br>(MDA) | 5,000 | 20% |
| | Phentermine | 3,000 | 33.3% |
| | Hydroxyamphetamine | 10,000 | 10% |
| | d-Methamphetamine | 100,000(Negative) | Not detected |
| | l-Methamphetamine | 100,000(Negative) | Not detected |
| | (+/-)3,4-<br>Methylenedioxyethylamphetamine<br>(MDEA) | 100,000(Negative) | Not detected |
| | (+/-)3,4-<br>Methylenedioxymethamphetamine | 100,000(Negative) | Not detected |
| | (MDMA) | | |
| | (1R,2S)-(-)-Ephedrine | 100,000(Negative) | Not detected |
| | β-Phenylethylamine | 100,000 | 1% |
| | Tyramine | 100,000 | 1% |
| | p-Hydroxynorephedrine | 100,000 | 1% |
| | Phenylpropanolamine | 100,000(Negative) | Not detected |
| | (±)Phenylpropanolamine | 100,000(Negative) | Not detected |
| | p-Hydroxyamphetamine | 100,000 | 1% |
| | d/l-Norephedrine | 100,000 | 1% |
| | Benzphetamine | 100,000(Negative) | Not detected |
| | l-Epinephrine | 100,000(Negative) | Not detected |
| | d/l-Epinephrine | 100,000(Negative) | Not detected |
| | Secobarbital | 300 | 100% |
| | Amobarbital | 1,000 | 3% |
| | Alphenal | 75 | 400% |
| | Aprobarbital | 250 | 120% |
| | Butabarbital | 100 | 300% |
| BAR 300 | Butalbital | 5,000 | 6% |
| | Butethal | 500 | 60% |
| | Cyclopentobarbital | 500 | 60% |
| | Pentobarbital | 200 | 150% |
| | Phenobarbital | 300 | 100% |
| | Buprenorphine | 10 | 100% |
| | Norbuprenorphine | 50 | 20% |
| | Buprenorphine 3-D-glucuronide | 10 | 100% |
| BUP 10 | Norbuprenorphine 3-D-<br>glucuronide | 10 | 100% |
| | | | |
| | Morphine | 100000 (Negative) | Not Detected |
| | Oxymorphone | 100000 (Negative) | Not Detected |
| | Hydromorphone | 100000 (Negative) | Not Detected |
| | Oxazepam | 300 | 100% |
| BZO 300 | Alprazolam | 150 | 200% |
| | α-Hydroxyalprazolam | 1,500 | 20% |
| | | | |
| | Bromazepam | 100 | 300% |
| | Chlordiazepoxide | 500 | 60% |
| | Clobazam | 750 | 40% |
| | Clonazepam | 1,500 | 20% |
| | Clorazepate dipotassium | 100 | 300% |
| | Diazepam | 500 | 60% |
| | Estazolam | 500 | 60% |
| | Flunitrazepam | 2,500 | 12% |
| | Midazolam | 2,000 | 15% |
| | Nitrazepam | 2,000 | 15% |
| | Nordiazepam | 500 | 60% |
| | Temazepam | 250 | 120% |
| | Triazolam | 1,000 | 30% |
| | Desalkylflurazepam | 500 | 60% |
| | Lorazepam | 5,000 | 6% |
| | Norchlordiazepoxide | 500 | 60% |
| | Nordazepam | 1,000 | 30% |
| | Delorazepam | 2,000 | 15% |
| | Demoxepam | 5,000 | 6% |
| | Flurazepam | 500 | 60% |
| | Benzoylecgonine | 300 | 100% |
| | Cocaine HCl | 750 | 40% |
| COC 300 | Cocaethylene | 12,500 | 2.4% |
| | Ecgonine | 30,000 | 1% |
| | Ecgonine methyl ester | 100,000(negative) | Not detected |
| | Norcocaine | 100,000(negative) | Not detected |
| | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 | 100% |
| EDDP 300 | Methadone | 100,000(negative) | Not detected |
| | EMDP | 100,000(negative) | Not detected |
| | Doxylamine | 100,000(negative) | Not detected |
| | Levacetylmethadol (LAAM) | 100,000(negative) | Not detected |
| | Disopyramide | 100,000(negative) | Not detected |
| | Alpha Methadol | 100,000(negative) | Not detected |
| MDMA 500 | (+/-)3,4-<br>Methylenedioxymethamphetamine<br>HCl(MDMA) | 500 | 100% |
| | (+/-)3,4-<br>Methylenedioxyamphetamine HCl<br>(MDA) | 3,000 | 17% |
| | (+/-)3,4-<br>Methylenedioxyethylamphetamine<br>(MDEA) | 300 | 167% |
| | d-Methamphetamine | 100,000(Negative) | Not detected |
| | d-Amphetamine | 100,000(Negative) | Not detected |
| | l-Methamphetamine | 100,000(Negative) | Not detected |
| | l-Amphetamine | 100,000(Negative) | Not detected |
| | d-Methamphetamine | 1,000 | 100% |
| | d-Amphetamine | 50,000 | 2% |
| | Chloroquine | 50,000 | 2% |
| | (1R,2S)-(-)-Ephedrine | 50,000 | 2% |
| | (-)-Methamphetamine | 25,000 | 4% |
| MET 1000 | (+/-)3,4-<br>methylenedioxumethamphetamine<br>(MDMA) | 4,000 | 25% |
| | β-Phenylethylamine | 50,000 | 2% |
| | Trimethobenzamide | 10,000 | 10% |
| | l-Amphetamine | 75,000 | 1.3% |
| | (+/-)3,4-<br>Methylenedioxyethylamphetamine<br>(MDEA) | 30,000 | 3.3% |
| | Mephentermine | 50,000 | 2% |
| | Methoxyphenamine | 50,000 | 2% |
| | Fenfluramine | 75,000 | 1.3% |
| | Procaine | 100,000(Negative) | Not detected |
| | d/l-Amphetamine | 100,000(Negative) | Not detected |
| | p-Hydroxymethamphetamine | 30,000 | 3.3% |
| | l-Phenylephrine | 100,000(Negative) | Not detected |
| | d/l-Methamphetamine | 1,000 | 100% |
| | (+/-) 3,4-<br>Methylenedioxyamphetamine<br>(MDA) | 100,000(Negative) | Not detected |
| | Morphine | 2,000 | 100% |
| | Codeine | 2,000 | 100% |
| | Hydrocodone | 12,500 | 16% |
| | Hydromorphone | 5,000 | 40% |
| | 6-Monoacetylmorphine | 1,500 | 133% |
| | Morphine 3- <b>β</b> -D-glucuronide | 2,000 | 100% |
| | Ethylmorphine | 1,500 | 133% |
| | Diacetylmorphine (heroin) | 2,000 | 100% |
| OPI 2000 | Levorphanol | 75,000 | 2.7% |
| | Norcodeine | 12,500 | 16% |
| | Oxycodone | 100,000(Negative) | Not detected |
| | Thebaine | 5,000 | 40% |
| | Normorphine | 50,000 | 4% |
| | Oxymorphone | 100,000(Negative) | Not detected |
| | Procaine | 100,000(Negative) | Not detected |
| | Codeine-6- <b>β</b> -D-glucuronide | 3,000 | 67% |
| | d-Norpropoxyphene hydrochloride | 5,000 | 40% |
| | Methadone | 300 | 100% |
| | EDDP | 100,000(Negative) | Not detected |
| | Doxylamine | 50,000 | 0.6% |
| MTD 300 | Levacetylmethadol (LAAM) | 100,000(Negative) | Not detected |
| | EMDP | 100,000(Negative) | Not detected |
| | Alpha Methadol | 100,000(Negative) | Not detected |
| OXY 100 | Oxycodone | 100 | 100% |
| | Hydrocodone | 5,000 | 2% |
| | Hydromorphone | 50,000 | 0% |
| | Oxymorphone | 1,000 | 10% |
| | Codeine | >100,000 | Not detected |
| | Ethylmorphine | >100,000 | Not detected |
| | Dihydrocodeine | 20,000 | 0.5% |
| | Oxymorphone-3β-D- glucuronide | 5,000 | 2% |
| | Morphine | 100,000(negative) | Not detected |
| | 6-Monoacetylmorphine | 100,000(negative) | Not detected |
| | Buprenorphine | 100,000(negative) | Not detected |
| | Thebaine | 100,000(negative) | Not detected |
| PCP 25 | Phencyclidine | 25 | 100% |
| | 4-Hydroxy Phencyclidine | 1500 | 1.7% |
| PPX 300 | d-Propoxyphene | 300 | 100% |
| | d-Norpropoxyphene | 300 | 100% |
| TCA 1000 | Notriptyline | 1,000 | 100% |
| | Nordoxepin | 1,000 | 100% |
| | Trimipramine | 3,000 | 33.3% |
| | Promazine | 1,500 | 66.7% |
| | Desipramine | 200 | 500% |
| | Imipramine | 750 | 133% |
| | Clomipramine | 10,000 | 10% |
| | Doxepin | 1,250 | 80% |
| | Maprotiline | 2,000 | 50% |
| | Amitriptyline | 1,500 | 66.7% |
| | Promethazine | 25,000 | 4% |
| | Cyclobenzaprine | 1,000 | 100% |
| | Norclomipramine | 12,500 | 8% |
| THC 50 | 11-nor-Δ9-THC-9-COOH | 50 | 100% |
| | 11-nor-Δ8-THC-9-COOH | 30 | 167% |
| | (±)-11-Hydroxy-Δ9-THC | 2,500 | 2% |
| | Δ8- Tetrahydrocannabinol | 2,000 | 2.5% |
| | Δ9- Tetrahydrocannabinol | 5,000 | 1% |
| | Cannabinol | 10,000 | 0.5% |
| | Cannabidiol(CBD) | 100,000 | 0.05% |
| | (±)-11-nor-9-carboxy-Δ 9-THC | 100 | 50% |
| | 11-nor-Δ9-THC-carboxy | 100 | 50% |
| | glucuronide | | |
| 6-MAM 10 | 6-Monoacetylmorphine | 10 | 1…