K Number
K242428
Device Name
Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus
Date Cleared
2025-02-06

(175 days)

Product Code
Regulation Number
862.3650
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dochek® Fentanyl Urine Test Strip Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentany] Urine Test Card Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Cup Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Strip is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Card is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Device Description
Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentany1 Urine Test Card, Dochek® Fentany] Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus are immunochromatographic assays that use a lateral flow system for the qualitative detection of fentanyl in human urine. Test Strip, Test Card and Test Cup use identical test strips made with same chemical formulation and manufacturing procedures.
More Information

Not Found

No
The device is described as a lateral flow immunochromatographic assay, which is a traditional biochemical test method. There is no mention of AI, ML, image processing, or any computational analysis of the test results. The performance studies focus on the analytical and clinical performance of the immunoassay itself.

No
This device is for in vitro diagnostic use, specifically for the qualitative detection of Fentanyl in human urine, which is a diagnostic purpose, not a therapeutic one.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only," which directly indicates it is a diagnostic device.

No

The device is described as an immunochromatographic assay using a lateral flow system, which is a physical test strip/card/cup that detects the presence of a substance in a sample. This involves hardware components and chemical reactions, not solely software.

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

The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only." This phrase is a clear indicator that the device is intended for use outside of the body to diagnose or detect a condition.

Furthermore, the device is designed to detect Fentanyl in human urine, which is a biological specimen analyzed in vitro for diagnostic purposes.

N/A

Intended Use / Indications for Use

Dochek® Fentanyl Urine Test Strip is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

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

Dochek® Fentany] Urine Test Card is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentany] (FTY) in human urine at the cut-off concentration of 1 ng/mL.

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

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

Dochek® Fentanyl Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentany] (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

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

Dochek® Fentanyl Urine Test Strip Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

For in vitro diagnostic use only.

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

Dochek® Fentany] Urine Test Card Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

For in vitro diagnostic use only.

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

Dochek® Fentanyl Urine Test Cup Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

For in vitro diagnostic use only.

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

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

NGL

Device Description

Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentany1 Urine Test Card, Dochek® Fentany] Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus are immunochromatographic assays that use a lateral flow system for the qualitative detection of fentanyl in human urine.

Test Strip, Test Card and Test Cup use identical test strips made with same chemical formulation and manufacturing procedures.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter Use

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

Not Found

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

  • Precision/Reproducibility Study:

    • Sample Size: 30 determinations were made for each concentration, and a total of 60 results were obtained per concentration per lot (each result was read in duplicate by two different operators). For each of the three device types (Strip, Card, Cup) and three lots, this means 60 determinations per concentration, across 9 concentrations (0ng/mL to 2ng/mL).
    • Data Source: Drug-free specimens spiked with Fentanyl at different concentrations: 0ng/mL, 0.25ng/mL, 0.75ng/mL, 1ng/mL, 1.25ng/mL, 1.5ng/mL, 1.75ng/mL, and 2ng/mL. All concentrations were confirmed with LC-MS/MS.
    • Annotation Protocol: The study was performed 3 runs per day and lasted for 10 non-consecutive days using three different lots of Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Card and Dochek® Fentany] Urine Test Cup.
  • Analytical Specificity/Interference Study:

    • Data Source: Drug-free urine or drug positive urine containing Fentanyl with the concentration 50% below the cutoff and the concentration 50% above the cutoff, respectively. Various opioid compounds and commonly ingested medications or substances were added at a concentration of 100µg/mL or specified concentrations.
    • Annotation Protocol: The urine specimens were tested with 3 lots of Dochek® Fentanyl Urine Test.
  • Method Comparison Study:

    • Sample Size: 80 clinical urine specimens.
    • Data Source: Clinical urine specimens.
    • Annotation Protocol: Samples were divided by concentration into five categories: drug free, less than half the cutoff negative, near cutoff negative, near cutoff positive, and high positive. The study was conducted by 3 laboratory professionals at the manufacturer site. LC/MS was used for confirmation.
  • Lay Person Study:

    • Sample Size: 980 lay persons.
    • Data Source: Urine samples prepared at the following concentrations: 0ng/mL, 0.25 ng/mL, 0.75ng/mL, 1.25ng/mL, 1.5ng/mL, 1.5ng/mL, 1.75ng/mL, cutoff by spiking target drug fentanyl into drug free urine specimens. The concentrations of samples were confirmed by LC/MS. Each sample was aliquoted into individual containers, blind-labeled and randomized.
    • Annotation Protocol: Each participant was provided with the English package insert, 1 blind labeled sample, and a device.

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

  • Precision/Reproducibility Study:

    • Study type: Precision/Reproducibility
    • Sample Size: 30 determinations per lot for each of 9 concentrations, tested across 3 lots and read in duplicate by two different operators.
    • Key results:
      • Dochek® Fentanyl Urine Test Strip: At 0.75ng/mL (-25% cutoff), positive percentages ranged from 4% to 8%. At 1ng/mL (cutoff), positive percentages ranged from 34% to 38%. At 1.25ng/mL (+25% cutoff), positive percentages ranged from 54% to 58%. At 1.5ng/mL (+50% cutoff) and above, all results were positive.
      • Dochek® Fentanyl Urine Test Card: At 0.75ng/mL (-25% cutoff), positive percentages ranged from 2% to 6%. At 1ng/mL (cutoff), positive percentages ranged from 32% to 34%. At 1.25ng/mL (+25% cutoff), positive percentages ranged from 54% to 58%. At 1.5ng/mL (+50% cutoff) and above, all results were positive.
      • Dochek® Fentanyl Urine Test Cup: At 0.75ng/mL (-25% cutoff), positive percentages ranged from 2% to 4%. At 1ng/mL (cutoff), positive percentages ranged from 34% to 36%. At 1.25ng/mL (+25% cutoff), positive percentages ranged from 56% to 58%. At 1.5ng/mL (+50% cutoff) and above, all results were positive.
  • Analytical Specificity/Interference Study:

    • Study type: Analytical Specificity/Interference
    • Key results: Various fentanyl analogs showed cross-reactivity at different concentrations. For example, Acetyl fentanyl and Isobutyryl fentanyl showed 100% cross-reactivity at 1.0 ng/mL. Many other compounds (Opioids compounds, Commonly ingested medications or substances) were tested at specified concentrations and none were shown to interfere.
  • Method Comparison Study:

    • Study type: Method Comparison
    • Sample Size: 80 clinical urine specimens.
    • Key results: For all three products (Strip, Card, Cup) across all 3 lots and operators, the overall agreement rate with LC/MS was 97.5% (87.1%-99.6%). Discordant results occurred predominantly near the cutoff concentration (e.g., test positive when LC/MS was slightly below cutoff, or test negative when LC/MS was slightly above cutoff).
  • Lay Person Study:

    • Study type: Lay Person Study
    • Sample Size: 980 lay persons.
    • Key results:
      • Dochek® Fentanyl Urine Test Strip (Lay User Study): Agreement was 100% for 0, 0.25, 0.5, 1.5, and 1.75 ng/mL. At 0.75 ng/mL (-25% cutoff), agreement was 95%. At 1.25 ng/mL (+25% cutoff), agreement was 95%.
      • Dochek® Fentanyl Urine Test Card (cassette method) (Lay User Study): Agreement was 100% for 0, 0.25, 0.5, 1.5, and 1.75 ng/mL. At 0.75 ng/mL (-25% cutoff), agreement was 96.7%. At 1.25 ng/mL (+25% cutoff), agreement was 93.3%.
      • Dochek® Fentanyl Urine Test Card (dipcard method) (Lay User Study): Agreement was 100% for 0, 0.25, 0.5, 1.5, and 1.75 ng/mL. At 0.75 ng/mL (-25% cutoff), agreement was 93.3%. At 1.25 ng/mL (+25% cutoff), agreement was 96.7%.
      • Dochek® Fentanyl Urine Test Cup (Lay User Study): Agreement was 100% for 0, 0.25, 0.5, 1.5, and 1.75 ng/mL. At 0.75 ng/mL (-25% cutoff), agreement was 92.5%. At 1.25 ng/mL (+25% cutoff), agreement was 92.5%.

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

Not Found. The data presented are positive/negative counts at specified concentrations or agreement rates.

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

K231698

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

Not Found

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

Not Found

§ 862.3650 Opiate test system.

(a)
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.(b)
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).

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 6, 2025

Guangzhou Decheng Biotechnology Co., Ltd. Jenny Mao Regulatory Affairs Supervisor Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road Science City, Huangpu District Guangzhou, Guangdong 510663 China

Re: K242428

Trade/Device Name: Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus Dochek® Fentanyl Urine Test Cup, Dochek® Fentanyl Urine Test Cup Plus Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: NGL Dated: December 20, 2024 Received: December 20, 2024

Dear Jenny Mao:

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.

1

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).

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 QS 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 (QS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 mediation-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-regulatory

2

assistance/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,

Digitally signed by Joseph A. Joseph A. Kotarek -S Kotarek -S Date: 2025.02.06 09:05:30 -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

Enclosure

3

Indications for Use

510(k) Number (if known) K242428

Device Name

Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup Plus

Indications for Use (Describe)

Dochek® Fentanyl Urine Test Strip Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

For in vitro diagnostic use only.

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

Dochek® Fentany] Urine Test Card Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only.

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

Dochek® Fentanyl Urine Test Cup Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

For in vitro diagnostic use only.

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

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.

4

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."

5

Indications for Use

510(k) Number (if known) K242428

Device Name

Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Cup

Indications for Use (Describe)

Dochek® Fentanyl Urine Test Strip is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

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

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

Dochek® Fentanyl Urine Test Card is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

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

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

Dochek® Fentanyl Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

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

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

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.

6

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."

7

Section 5- 510(k) SUMMARY

K242428

1.Date:2025/2/5
2.Submitter:Guangzhou Decheng Biotechnology Co., Ltd.
Address: Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road, Science City,
Huangpu District, Guangzhou, Guangdong, 510663, P.R. China
Contact Person: Jenny Mao
Contact Email Address: jenny.mao@dochekbio.com
Telephone: +86-020-82557192
3.Correspondent:Guangzhou Decheng Biotechnology Co., Ltd.
Address: Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road, Science City,
Huangpu District, Guangzhou, Guangdong, 510663, P.R. China
Contact Person: Jenny Mao
Contact Email Address: jenny.mao@dochekbio.com
Telephone: +86-020-82557192
4.Device Name
Common Name:Fentanyl (FTY) Test System
Proprietary names:Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus
Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus
Dochek® Fentanyl Urine Test Cup, Dochek® Fentanyl Urine Test Cup Plus

ട്. Classification: Class II

Product CodeRegulation SectionPanel
NGL21 CFR 862.3650, Opiate Test SystemToxicology

Predicate Devices: 6.

AllTest Fentanyl Rapid Test (Urine) (K231698)

7. Intended Use

Dochek® Fentanyl Urine Test Strip is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

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

Dochek® Fentany] Urine Test Card is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentany] (FTY) in human urine at the cut-off concentration of 1 ng/mL.

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

The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result,

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particularly when the preliminary result is positive.

Dochek® Fentanyl Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentany] (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

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

Dochek® Fentanyl Urine Test Strip Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

For in vitro diagnostic use only.

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

Dochek® Fentany] Urine Test Card Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

For in vitro diagnostic use only.

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

Dochek® Fentanyl Urine Test Cup Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

For in vitro diagnostic use only.

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

Device Description 8.

Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentany1 Urine Test Card, Dochek® Fentany] Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus are immunochromatographic assays that use a lateral flow system for the qualitative detection of fentanyl in human urine.

Test Strip, Test Card and Test Cup use identical test strips made with same chemical formulation and manufacturing procedures.

9

ItemDevicePredicate (K231698)
Indication for useQualitative detection of fentanyl in urineSame
Intended UseProfessional/HCP Use and Over-The-Counter UsePrescription Use
SpecimenUrineSame
Cutoff1 ng/mLSame
ResultsQualitativeSame
MethodologyCompetitive binding, lateral flow
immunochromatographic assay based on the
principle of antigen antibody immunochemistrySame
ConfigurationStrip, card and cupCassette
Storage2-30°CSame

Substantial Equivalence Information: 9.

10. Standard/Guidance Document Reference (if applicable)

Draft Guidance for Industry and FDA Staff: Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests

11. Test Principle

The Fentanyl (FTY) Test System is an immunoassay based on the principle of competitive binding that is used to screen for the presence of Fentanyl in urine. It is a chromatographic absorbent device in which Fentanyl in a sample competitively combined to a limited number of antibody-dye conjugate binding sites.

During testing, the urine specimen migrates upward by capillary action. Fentanyl, if present in the urine specimen below 1 ng/mL, will not saturate the binding sites of antibody-coated particles in the test device. The antibody-coated particles will then be captured by immobilized FTY conjugate and a visible colored line will appear in the test region (T) to indicate a negative result. The colored line will not appear in the test region (T) if the Fentanyl level exceeds 1 ng/mL because it will saturate all the binding sites of anti-FTY antibodies and prevent the development of a distinct colored line, which indicating a positive result.

To serve as a procedure control, a colored line will always appear at the control region (C), if the test has been performed properly.

12. Performance Characteristics

A. Analytical performance

a. Precision/Reproducibility

Precision study was performed using drug-free specimens spiked with Fentanyl at different concentrations: 0ng/mL, 0.25ng/mL, 0.75ng/mL, 1ng/mL, 1.25ng/mL, 1.5ng/mL, 1.75ng/mL, and 2ng/mL. All concentrations were confirmed with LC-MS/MS. The study was performed 3 runs per day and lasted for 10 non-consecutive days using three different lots of Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Card and Dochek® Fentany] Urine Test Cup. 30 determinations were made for each concentration, and a total of 60 results were obtained per concentration per lot (each result was read in duplicate by two different operators).

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| Approximate
concentration
of sample | % of cutoff | Number of
determinations
per lot | Lot 1 | | Lot 2 | | Lot 3 | |
|-------------------------------------------|--------------|----------------------------------------|----------|----------|----------|----------|----------|----------|
| | | | Positive | Negative | Positive | Negative | Positive | Negative |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.25ng/mL | -75% cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.5ng/mL | -50% cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.75ng/mL | -25% cutoff | 60 | 8 | 52 | 4 | 56 | 4 | 56 |
| 1ng/mL | cutoff | 60 | 38 | 22 | 34 | 26 | 34 | 26 |
| 1.25ng/mL | +25% cutoff | 60 | 54 | 6 | 58 | 2 | 56 | 4 |
| 1.5ng/mL | +50% cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1.75ng/mL | +75% cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2ng/mL | +100% cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Dochek® Fentanyl Urine Test Strip

Dochek® Fentany1 Urine Test Card

| Approximate
concentration
of sample | % of cutoff | Number of
determinations
per lot | Lot 1 | | Lot 2 | | Lot 3 | |
|-------------------------------------------|--------------|----------------------------------------|----------|----------|----------|----------|----------|----------|
| | | | Positive | Negative | Positive | Negative | Positive | Negative |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.25ng/mL | -75% cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.5ng/mL | -50% cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.75ng/mL | -25% cutoff | 60 | 6 | 54 | 2 | 58 | 4 | 56 |
| 1ng/mL | cutoff | 60 | 32 | 28 | 34 | 26 | 34 | 26 |
| 1.25ng/mL | +25% cutoff | 60 | 58 | 2 | 58 | 2 | 54 | 6 |
| 1.5ng/mL | +50% cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1.75ng/mL | +75% cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2ng/mL | +100% cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Dochek® Fentanyl Urine Test Cup

| Approximate
concentration | % of cutoff | Number of
determinations
per lot | Lot 1 | | Lot 2 | | Lot 3 | |
|------------------------------|-------------|----------------------------------------|----------|----------|----------|----------|----------|----------|
| of sample | | | Positive | Negative | Positive | Negative | Positive | Negative |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.25ng/mL | -75% cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.5ng/mL | -50% cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.75ng/mL | -25% cutoff | 60 | 4 | 56 | 2 | 58 | 2 | 58 |
| lng/mL | cutoff | 60 | 34 | 26 | 34 | 26 | 36 | 24 |

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1.25ng/mL+25% cutoff60564582564
1.5ng/mL+50% cutoff60600600600
1.75ng/mL+75% cutoff60600600600
2ng/mL+100% cutoff60600600600

b. Linearity/assay reportable range:

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

c. Stability:

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

d. Analytical specificity/Interference:

The following table lists the lowest concentration (ng/mL) of compounds that gave a positive result on the Dochek® Fentanyl Urine Test identified positive results.

| Compound | Lowest Concentration
(ng/mL) | % Cross-Reactivity |
|------------------------------------|---------------------------------|--------------------|
| Acetyl fentanyl | 1.0 | 100 |
| Acetyl norfentanyl | 10,000 | 0.01 |
| Acrylfentanyl | 1.5 | 66.7 |
| Butyryl fentanyl | 2.5 | 40 |
| Carfentanil | 50 | 2 |
| (±)-3-cis-methylfentanyl | 50 | 2 |
| 4-Fluoro-isobutyrylfentanyl | 5 | 20 |
| Furanyl fentanyl | 2.8 | 35.7 |
| ω-1-Hydroxyfentanyl | 20,000 | 0.005 |
| (±) ß-hydroxythiofentanyl | 1.5 | 66.7 |
| Isobutyryl fentanyl | 1.0 | 100 |
| Ocfentanil | 1.8 | 55.6 |
| Para-fluorobutyrylfentanyl (p-FBF) | 4 | 25 |
| Para-fluoro fentanyl | 3 | 33.3 |
| Sufentanil | 20 | 5 |
| Valeryl fentanyl | 5 | 20 |
| Alfentanil | 5,000 | 0.02 |
| Despropionyl fentanyl (4-ANPP) | 20,000 | 0.005 |
| Remifentanil | 10,000 | 0.01 |
| Norcarfentanil | 10,000 | 0.01 |
| Norfentanyl | 10,000 | 0.01 |

e. Interference

Clinical urine samples may contain substances that could potentially interfere with the test. The following compounds were added to drug-free urine or drug positive urine containing Fentanyl with the concentration 50% below the cutoff and the concentration 50% above the cutoff, respectively. All potential interfering substances were added at a concentration of 100µg/mL or specified concentrations are summarized in the following tables. The urine specimens were tested with 3 lots of Dochek® Fentanyl Urine Test. None of the substances listed below were shown to interfere.

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Opioids compounds

6-Acetyl morphineAmphetamineBuprenorphineBuprenorphineglucuronide
CodeineDextromethorphanDihydrocodeineEDDP
EMDPFluoxetineHeroinHydrocodone
HydromorphoneKetamine,LevorphanolMeperidine
MethadoneMorphineMorphine-3-
glucuronideNaloxone
NaltrexoneNorbuprenorphineNorcodeineNorketamine
NormeperidineNormorphineNoroxycodoneOxycodone
OxymorphonePentazocine (Talwin)PipamperoneRisperidone
TapentadolThioridazineTilidineTramadol
Tramadol-O-DesmethylTramadol-N-DesmethylTrazodone

Commonly ingested medications or substances

AcetaminophenDoxepin (50 ug/mL)Nortriptyline (25 ug/mL)
Acetone (1000 mg/dL)Ecgonine methyl esterNoscapine
AcetophenetidinEphedrineO-Hydroxyhippuric acid
Acetylsalicylic acidErythromycinOctopamine
Albumin (100 mg/dL)Ethanol (1%)Oxalic acid (100 mg/dL)
AlbuterolFenoprofenOxazepam
AminopyrineFluphenazineOxolinic acid
Amitriptyline (35 ug/mL)FurosemideOxymetazoline
AmobarbitalGalactose (10 mg/dL)Papaverine
AmoxicillinGamma Globulin (500mg/dL)Penicillin G
AmpicillinGentisic acidPerphenazine
ApomorphineGlucose (3000 mg/dL)Phencyclidine
Ascorbic acidHemoglobinPhenelzine
AspartameDL-TyrosinePrednisone
AtropineHydralazinePropoxyphene (50 ug/mL)
Benzilic acidHydrochlorothiazidePropranolol
Benzoic acidHydrocortisonePseudoephedrine
BenzoylecgonineHydroxytyramineQuinine
BilirubinIbuprofenRanitidine
Boric Acid (1%)Imipramine (30 ug/mL)Riboflavin (7.5 mg/dL)
Bupropion (50 ug/mL)IsoproterenolSalicylic acid
CaffeineIsoxsuprineSecobarbital
CarbamazepineKetoprofenSerotonin (5-Hydroxytyramine)
Chloral hydrateLabetalolSulfamethazine
ChloramphenicolLidocaine (50 ug/mL)Sulindac
ChlorothiazideLoperamideTetrahydrocortisone 3-(ß-Dglucuronide)
ChlorpromazineMaprotiline (50 ug/mL)Tetrahydrocortisone 3-acetate
CholesterolMeprobamateTetrahydrozoline
Clomipramine (50 ug/mL)Methapyrilene (10 ug/mL)Thiamine
ClonidineMethaqualone (50 ug/mL)Triamterene
CortisoneMethoxyphenamineTrifluoperazine
CotinineMetronidazole (300 ug/mL)Trimethoprim
CreatinineN-AcetylprocainamideTyramine
Cyclobenzaprine (10 ug/mL)NaCl (4000 mg/dL)Urea (2000 mg/dL)
DeoxycorticosteroneNalidixic acidUric acid
Desipramine (50 ug/mL)NaproxenValproic acid (250 ug/mL)
DiclofenacNiacinamideVenlafaxine
DiflunisalNicotine (10 ug/mL)Verapamil
DigoxinNifedipineZomepirac
DiphenhydramineNorethindroneß-Estradiol
DL-TryptophanPhenobarbital

B. Method comparison study

80 clinical urine specimens were analyzed by LC/MS and by 3 lots of the corresponding Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Card and Dochek® Fentanyl Urine Test Cup. Samples were

13

divided by concentration into five categories: drug free, less than half the cutoff negative, near cutoff positive, and high positive. The study was conducted by 3 laboratory professionals at the manufacturer site. Results were as follows.

| Dochek® Fentanyl Urine Test

StripLC/MSAgreement Rate
Neg.
(drug free)Neg.
(+50%
cutoff)
Lot 1, operator 1Positive001
Negative1014151097.5%
(87.1%-99.6%)
Lot 2, operator 2Positive001261397.5%
(87.1%-99.6%)
Negative1014151097.5%
(87.1%-99.6%)
Lot 3, operator 3Positive001261397.5%
(87.1%-99.6%)
Negative1014151097.5%
(87.1%-99.6%)

Comparison data of Dochek® Fentanyl Urine Test Strip

Analysis of Discordant Results (Strip)

Dochek® Fentanyl Urine Test StripLC/MS Analysis
Lot No. and OperatorTest ResultConcentration rangeFentanyl Concentration
(ng/mL)
Lot 1, operator 1PositiveNear cutoff neg. (-50% cutoff to cutoff)0.945
Lot 1, operator 1NegativeNear cutoff pos. (cutoff to +50% cutoff)1.012
Lot 2, operator 2PositiveNear cutoff neg. (-50% cutoff to cutoff)0.894
Lot 2, operator 2NegativeNear cutoff pos. (cutoff to +50% cutoff)1.012
Lot 3, operator 3PositiveNear cutoff neg. (-50% cutoff to cutoff)0.920
Lot 3, operator 3NegativeNear cutoff pos. (cutoff to +50% cutoff)1.077

Comparison data of Dochek® Fentanyl Urine Test Card

LC/MS
Dochek® Fentanyl Urine Test
CardNeg.
(drug
free)Neg.
(+50%
cutoff)Agreement Rate
Lot 1, operator 1Positive001261397.5%
(87.1%-99.6%)
Negative1014151097.5%
(87.1%-99.6%)
Lot 2, operator 2Positive001261397.5%
(87.1%-99.6%)
Negative1014151097.5%
(87.1%-99.6%)
Lot 3, operator 3Positive001261397.5%
(87.1%-99.6%)
Negative1014151097.5%
(87.1%-99.6%)

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Dochek® Fentanyl Urine Test CardLC/MS Analysis
Lot No. and OperatorTest ResultConcentration rangeFentanyl Concentration
(ng/mL)
Lot 1, operator 1PositiveNear cutoff neg. (-50% cutoff to cutoff)0.885
Lot 1, operator 1NegativeNear cutoff pos. (cutoff to +50% cutoff)1.012
Lot 2, operator 2PositiveNear cutoff neg. (-50% cutoff to cutoff)0.894
Lot 2, operator 2NegativeNear cutoff pos. (cutoff to +50% cutoff)1.020
Lot 3, operator 3PositiveNear cutoff neg. (-50% cutoff to cutoff)0.945
Lot 3, operator 3NegativeNear cutoff pos. (cutoff to +50% cutoff)1.012

Comparison data of Dochek® Fentanyl Urine Test Cup

| Dochek® Fentanyl Urine Test

CupLC/MSAgreement Rate
Neg.
(drug free)Neg.
(+50%
cutoff)
Lot 1, operator 1Positive001261397.5%
(87.1%-99.6%)
Negative1014151097.5%
(87.1%-99.6%)
Lot 2, operator 2Positive001261397.5%
(87.1%-99.6%)
Negative1014151097.5%
(87.1%-99.6%)
Lot 3, operator 3Positive001261397.5%
(87.1%-99.6%)
Negative1014151097.5%
(87.1%-99.6%)

Analysis of Discordant Results (Cup)

Dochek® Fentanyl Urine Test CupLC/MS Analysis
Lot No. and OperatorTest ResultConcentration rangeFentanyl Concentration
(ng/mL)
Lot 1, operator 1PositiveNear cutoff neg. (-50% cutoff to cutoff)0.894
Lot 1, operator 1NegativeNear cutoff pos. (cutoff to +50% cutoff)1.044
Lot 2, operator 2PositiveNear cutoff neg. (-50% cutoff to cutoff)0.945
Lot 2, operator 2NegativeNear cutoff pos. (cutoff to +50% cutoff)1.044
Lot 3, operator 3PositiveNear cutoff neg. (-50% cutoff to cutoff)0.920
Lot 3, operator 3NegativeNear cutoff pos. (cutoff to +50% cutoff)1.012

C. Lay person study

Lay user studies were performed at three intended user sites with 980 lay persons. They had diverse educational and professional backgrounds and ranged in age from 20 to 65 years. Urine samples were prepared at the following concentrations: 0ng/mL, 0.25 ng/mL, 0.75ng/mL, 1.25ng/mL, 1.5ng/mL, 1.5ng/mL, 1.75ng/mL, cutoff by spiking target drug fentanyl into drug free urine specimens. The concentrations of samples were confirmed by

15

LC/MS. Each sample was aliquoted into individual containers, blind-labeled and randomized. Each participant was provided with the English package insert, 1 blind labeled sample, and a device. Results were as follows:

| Approximate
concentration
of sample | % of cutoff | Number of
determinations
per lot | Layer user Results | | Agreement
(%) |
|-------------------------------------------|-------------|----------------------------------------|--------------------|----|------------------|
| Positive | Negative | | | | |
| 0ng/mL | Negative | 40 | 0 | 40 | 100% |
| 0.25ng/mL | -75% cutoff | 40 | 0 | 40 | 100% |
| 0.5ng/mL | -50% cutoff | 40 | 0 | 40 | 100% |
| 0.75ng/mL | -25% cutoff | 40 | 2 | 38 | 95% |
| 1.25ng/mL | +25% cutoff | 40 | 38 | 2 | 95% |
| 1.5ng/mL | +50% cutoff | 40 | 40 | 0 | 100% |
| 1.75ng/mL | +75% cutoff | 40 | 40 | 0 | 100% |

Lay user study data of Dochek® Fentanyl Urine Test Strip

Lay user study data of Dochek® Fentanyl Urine Test Card (cassette method)

| Approximate
concentration
of sample | % of cutoff | Number of
determinations
per lot | Layer user Results | | Agreement
(%) |
|-------------------------------------------|-------------|----------------------------------------|--------------------|----------|------------------|
| | | | Positive | Negative | |
| 0ng/mL | Negative | 30 | 0 | 30 | 100% |
| 0.25ng/mL | -75% cutoff | 30 | 0 | 30 | 100% |
| 0.5ng/mL | -50% cutoff | 30 | 0 | 30 | 100% |
| 0.75ng/mL | -25% cutoff | 30 | 1 | 29 | 96.7% |
| 1.25ng/mL | +25% cutoff | 30 | 28 | 2 | 93.3% |
| 1.5ng/mL | +50% cutoff | 30 | 30 | 0 | 100% |
| 1.75ng/mL | +75% cutoff | 30 | 30 | 0 | 100% |

Lay user study data of Dochek® Fentanyl Urine Test Card (dipcard method)

| Approximate
concentration
of sample | % of cutoff | Number of
determinations
per lot | Layer user Results | | Agreement
(%) |
|-------------------------------------------|-------------|----------------------------------------|--------------------|----------|------------------|
| | | | Positive | Negative | |
| 0ng/mL | Negative | 30 | 0 | 30 | 100% |
| 0.25ng/mL | -75% cutoff | 30 | 0 | 30 | 100% |
| 0.5ng/mL | -50% cutoff | 30 | 0 | 30 | 100% |
| 0.75ng/mL | -25% cutoff | 30 | 2 | 28 | 93.3% |
| 1.25ng/mL | +25% cutoff | 30 | 29 | 1 | 96.7% |
| 1.5ng/mL | +50% cutoff | 30 | 30 | 0 | 100% |
| 1.75ng/mL | +75% cutoff | 30 | 30 | 0 | 100% |

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| Approximate
concentration
of sample | % of cutoff | Number of
determinations
per lot | Layer user Results | | Agreement
(%) |
|-------------------------------------------|-------------|----------------------------------------|--------------------|----------|------------------|
| | | | Positive | Negative | |
| 0ng/mL | Negative | 40 | 0 | 40 | 100% |
| 0.25ng/mL | -75% cutoff | 40 | 0 | 40 | 100% |
| 0.5ng/mL | -50% cutoff | 40 | 0 | 40 | 100% |
| 0.75ng/mL | -25% cutoff | 40 | 3 | 37 | 92.5% |
| 1.25ng/mL | +25% cutoff | 40 | 37 | 3 | 92.5% |
| 1.5ng/mL | +50% cutoff | 40 | 40 | 0 | 100% |
| 1.75ng/mL | +75% cutoff | 40 | 40 | 0 | 100% |

Lay user study data of Dochek® Fentanyl Urine Test Cup

13. Conclusion

Based on the test principle and performance characteristics of the device including precision, cut-off, interference, specificity, method comparison and lay-user studies of the devices, it's concluded a substantial equivalence decision.