Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)

• K Number: K161214
• Device Name: Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)
• Manufacturer: GUANGZHOU WONDFO BIOTECH CO., LTD.
• Date Cleared: 2016-06-27 ( 59 days)
• Product Code: DIO DJC DKZ
• Regulation Number: 862.3250

Intended Use

Wondfo Amphetamine Urine Test AMP 500 Cup is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Amphetamine Urine Test AMP 500 DipCard is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Cocaine Urine Test COC 150 Cup is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. This test is callbrated to Benzoylecgonine (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Cocaine Urine Test COC 150 DipCard is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. This test is callbrated to Benzoylecgonine (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Methamphetamine Urine Test MET 500 Cup is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Amphetamine Urine Test MET 500 DipCard is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator). The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Device Description

WONDFO Urine Test devices are immunochromatographic assays for cocaine, amphetamine and Methamphetamine. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine, or D-amphetamine or D-methamphetamine (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: DipCards, or Cups. It contains a Test Device (in one of the two formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.

Predicate Devices

K122809

Reference Devices

K122961

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a standard immunochromatographic assay, with no mention of AI or ML technology. The analysis relies on chemical reactions and visual interpretation of results.

Therapeutic

No.
Explanation: The device is an in vitro diagnostic (IVD) test intended for qualitative determination of substances in human urine, providing preliminary test results for drug detection. It is not used for treatment or therapy.

Diagnostic

Yes

The text explicitly states "For in vitro diagnostic use only" in the "Intended Use / Indications for Use" section for each test listed.

SaMD (Software as a Medical Device)

No

The device is described as an immunochromatographic assay in the form of DipCards or Cups, which are physical hardware components used for in vitro diagnostic testing. The description focuses on the chemical and physical aspects of the test, not software.

IVD (In Vitro Diagnostic)

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

The intended use statement explicitly states: "For in vitro diagnostic use only."

Furthermore, the device description states: "The product is a single-use in vitro diagnostic device..."

These statements clearly indicate that the Wondfo Urine Test devices are intended for in vitro diagnostic use.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Wondfo Amphetamine Urine Test AMP 500 Cup is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Amphetamine Urine Test AMP 500 DipCard is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Cocaine Urine Test COC 150 Cup is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. This test is callbrated to Benzoylecgonine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Cocaine Urine Test COC 150 DipCard is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. This test is callbrated to Benzoylecgonine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Methamphetamine Urine Test MET 500 Cup is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Amphetamine Urine Test MET 500 DipCard is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

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

DIO, DKZ, DJC

Device Description

WONDFO Urine Test devices are immunochromatographic assays for cocaine, amphetamine and Methamphetamine. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine, or D-amphetamine or D-methamphetamine (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: DipCards, or Cups. It contains a Test Device (in one of the two formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-the-counter (OTC) consumer 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

Not Found

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

1. Analytical Performance - Precision Study:

   • Samples with concentrations of -100%, -75%, -50%, -25%, at, +25%, +50%, +75%, and +100% of the cut-off were prepared by spiking drug in negative samples.
   • Each drug concentration was confirmed by GC/MS.
   • All sample aliquots were blinded labeled and randomized.
   • For each concentration, tests were performed two runs per day for 25 days.
   • Results:
     • Amphetamine (AMP) Dip Card Format:
       • Lot 1: 50-/0+ for -100% to -25% cut-off; 43+/7- at cut-off; 50+/0- for +25% to +100% cut-off.
       • Lot 2: 50-/0+ for -100% to -25% cut-off; 44+/6- at cut-off; 50+/0- for +25% to +100% cut-off.
       • Lot 3: 50-/0+ for -100% to -25% cut-off; 44+/6- at cut-off; 50+/0- for +25% to +100% cut-off.
     • Amphetamine (AMP) Cup Format:
       • Lot 1: 50-/0+ for -100% to -25% cut-off; 44+/6- at cut-off; 50+/0- for +25% to +100% cut-off.
       • Lot 2: 50-/0+ for -100% to -25% cut-off; 43+/7- at cut-off; 50+/0- for +25% to +100% cut-off.
       • Lot 3: 50-/0+ for -100% to -25% cut-off; 44+/6- at cut-off; 50+/0- for +25% to +100% cut-off.
     • Cocaine (COC) Dip Card Format:
       • Lot 1: 50-/0+ for -100% to -50% cut-off; 50-/0+ for -25% cut-off; 50-/0+ for +25%, +50% cut-off; 43+/7- at cut-off; 50+/0- for +75%, +100% cut-off.
       • Lot 2: 50-/0+ for -100% to -25% cut-off; 44+/6- at cut-off; 50+/0- for +25% to +100% cut-off.
       • Lot 3: 50-/0+ for -100% to -25% cut-off; 43+/7- at cut-off; 50+/0- for +25% to +100% cut-off.
     • COC Cup Format:
       • Lot 1: 50-/0+ for -100% to -25% cut-off; 44+/6- at cut-off; 50+/0- for +25% to +100% cut-off.
       • Lot 2: 50-/0+ for -100% to -25% cut-off; 43+/7- at cut-off; 50+/0- for +25% to +100% cut-off.
       • Lot 3: 50-/0+ for -100% to -25% cut-off; 43+/7- at cut-off; 50+/0- for +25% to +100% cut-off.
     • Methamphetamine precision data was reported in K122961.

2. Analytical Performance - Cut-off Study:

   • Sample Size: 150 samples equally distributed at concentrations of -50% cut-off; -25% cut-off; cut-off; +25% cut-off; +50% cut-off.
   • Study Design: Tested using three different lots of each device by three different operators.
   • Key Results: Results were all positive at and above +50% cut-off and all negative at and below -50% cut-off for Amphetamine, Cocaine and Methamphetamine (K122961).

3. Analytical Performance - Interference Study:

   • Study Design: Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentration at 25% above cut-off levels. These urine samples were tested using three batches of each device for all formats.
   • Key Results: Compounds listed in tables showed no interference at a concentration of 100µg/mL. No differences observed for different formats. MET interference data was reported in K122961.

4. Analytical Performance - Specificity Study:

   • Study Design: Drug metabolites and other components likely to interfere in urine samples were tested using three batches of each device for all formats.
   • Key Results: The lowest detectable concentration was used to calculate cross-reactivity. No differences observed for different formats.
     • AMP: D-Amphetamine (100% reactivity at 500 ng/mL), L-Amphetamine (2% at 25000), D,L-Amphetamine (33% at 1500), Phentermine (33% at 1500), Hydroxyamphetamine (6% at 8000), Methylenedioxyamphetamine (MDA) (20% at 2500). d-Methamphetamine, l-Methamphetamine, ephedrine, Methylenedioxyethylamphetamine (MDE), 3,4-methylenedioxy-methamphetamine(MDMA) showed

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

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

Summary

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

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

June 27, 2016

GUANGZHOU WONDFO BIOTECH CO., LTD. C/O JOE SHIA 504 E DIAMOND AVE., SUITE I GAITHERSBURG MD 20877

Re: K161214

Trade/Device Name: Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup. Dipcard). Wondfo Methamphetamine Urine Test MET 500 (Cup. Dipcard) Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: II Product Code: DIO, DKZ, DJC Dated: April 21, 2016 Received: April 29, 2016

Dear Mr. Shia:

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

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

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

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

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

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

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

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

Sincerely yours,

Courtney H. Lias -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K161214

Device Name Wondfo Amphetamine Urine Test AMP 500 (Cup, DipCard) Wondfo Cocaine Urine Test COC 150 (Cup, DipCard)

Wondfo Methamphetamine Urine Test MET 500 (Cup, DipCard)

Indications for Use (Describe)

Wondfo Amphetamine Urine Test AMP 500 Cup is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Amphetamine Urine Test AMP 500 DipCard is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Cocaine Urine Test COC 150 Cup is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. This test is callbrated to Benzoylecgonine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Cocaine Urine Test COC 150 DipCard is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. This test is callbrated to Benzoylecgonine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

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Wondfo Methamphetamine Urine Test MET 500 Cup is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Amphetamine Urine Test MET 500 DipCard is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

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)

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• 1. Date: June 8, 2016

2. Submitter: Wondfo Biotech Co., Ltd. South China University of Technology Guangzhou, P.R. China 510641

• 3. Contact person: Joe Shia LSI International Inc. 504 East Diamond Ave., Suite I Gaithersburg, MD 20877 Telephone: [phone] Fax: [phone] Email:[e-mail]
• 4. Device Name: WONDFO Urine Test Amphetamine (Cup, DipCard) WONDFO Urine Test Cocaine (Cup, DipCard) WONDFO Urine Test Methamphetamine (Cup, DipCard)

Classification. Class II
Product
Code	CFR #	Panel
DIO	21 CFR, 862.3250 Cocaine Test System	Toxicology
DKZ	21 CFR, 862.3100 Amphetamine Test System	Toxicology
DJC	21 CFR, 862.3610 Methamphetamine Test System	Toxicology

Classification: Class II

• 5. Predicate Devices:
     K122809 Advin Multi-Drug Screen Test
• 6. Intended Use
     WONDFO Urine Test Amphetamine Cup is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator).

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

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For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

WONDFO Urine Test Amphetamine DipCard is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator).

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

For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

WONDFO Urine Test Cocaine Cup is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 150 ng/ml. This test is calibrated to Benzoylecgonine (calibrator).

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

For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

WONDFO Urine Test Cocaine DipCard is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 150 ng/ml. This test is calibrated to Benzoylecgonine (calibrator).

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

For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

6

WONDFO Urine Test Methamphetamine Cup is a rapid test for the qualitative detection of Methamphetamine in human urine at a cutoff concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator).

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

For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

WONDFO Urine Test Methamphetamine DipCard is a rapid test for the qualitative detection of Methamphetamine in human urine at a cutoff concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator).

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

For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

• 7. Device Description
     WONDFO Urine Test devices are immunochromatographic assays for cocaine, amphetamine and Methamphetamine. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine, or D-amphetamine or D-methamphetamine (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: DipCards, or Cups. It contains a Test Device (in one of the two formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.
• 8. Substantial Equivalence Information
     A summary comparison of features of the WONDFO Urine Test and the predicate device is provided in Table 1, Table 2 & Table 3.

Table 1: Features Comparison of WONDFO Cocaine Test and the Predicate Device

| Item | Device | Predicate -
K122809 |
|--------------------------|-------------------------------------------------------------------------|------------------------|
| Indication(s)
for Use | For the qualitative determination of
Benzoylecgonine in human urine. | Same |

7

| Item | Device | Predicate -
K122809 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Calibrator | Benzoylecgonine | Same |
| Methodology | Competitive binding, lateral flow
immunochromatographic assays based on
the principle of antigen antibody
immunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 150 ng/mL | Same |
| Intended
Population | For over-the-counter and prescription
uses. | Same |
| Configurations | Cup, Dip Card | Cup, Dip Card,
Cassette |

Table 2: Features Comparison of WONDFO Amphetamine Test and the Predicate Device

Item	Device	Predicate - K122809
Indication(s)
for Use	For the qualitative determination of
D-amphetamine in human urine.	Same
Calibrator	D-amphetamine	Same
Methodology	Competitive binding, lateral flow
immunochromatographic assays based
on the principle of antigen antibody
immunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	500 ng/mL	Same
Intended
Population	For over-the-counter and prescription
uses.	Same
Configurations	Cup, Dip Card	Cup, Dip Card,
Cassette

Table 3: Features Comparison of WONDFO Methamphetamine Test and the Predicate Device

Item	Device	Predicate - K122809
Indication(s)
for Use	For the qualitative determination of
D-methamphetamine in human urine.	Same
Calibrator	D-methamphetamine	Same

8

Item	Device	Predicate - K122809
Methodology	Competitive binding, lateral flow
immunochromatographic assays based
on the principle of antigen antibody
immunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	500 ng/mL	Same
Intended
Population	For over-the-counter and prescription
uses.	Same
Configurations	Cup, Dip Card	Cup, Dip Card,
Cassette

9. Test Principle

WONDFO Urine Tests are rapid tests for the qualitative detection of Benzoylecgonine, or D-amphetamine or D-methamphetamine in urine samples. Each assay test is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs are present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific antibody (monoclonal mouse antibody) coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample.

10. Performance Characteristics

• 1. Analytical Performance
  • a. Precision

Precision studies were carried out for samples with concentrations of -100% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +75% cut-off, +75% cut-off and +100% cut-off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blinded labeled and randomized. For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following tables:

| Drug | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|-------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Amphetamine (AMP) Dip Card Format

9

| | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|------------------------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Drug | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Amphetamine (AMP) Cup Format | | | | | | | | | | |
| | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
| Drug | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Drug | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Drug | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Cocaine (COC) Dip Card Format

| Drug | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|-------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| | | Lot 1 | | 50-/0+ | 50-/0+ | | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

COC Cup Format

| Drug | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|-------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| | | | | | | | | | | |
| Lot 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

The Methamphetamine precision data was reported in K122961.

• b. Linearity
  Not applicable, these are visually read devices.

• c. Stability

10

The devices are stable at 4-30°C (39-86°F) for 24 months based on the accelerated stability study at 50°C. Control materials are not provided with the device. The labeling provides information on how to obtain control materials.

• d. Cut-off
  A total of 150 samples equally distributed at concentrations of -50% cut-off; -25% cut-off; cut-off; +25% cut-off; +50% cut-off were tested using three different lots of each device by three different operators. Results were all positive at and above +50% cut-off and all negative at and below -50% cut-off for Amphetamine, Cocaine and Methamphetamine (K122961). The following cut-off values for the test devices have been verified.

Test	Calibrator	Cut-off (ng/mL)
WONDFO Urine Test Amphetamine
Cup (DipCard)	D-amphetamine	500
WONDFO Urine Test Cocaine Cup
(DipCard)	Benzoylecogonine	150
WONDFO Urine Test
Methamphetamine Cup (DipCard)	D-methamphetamine	500

e. Interference

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

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

4-Acetamidophenol	L-Ephedrine	Oxycodone
Acetophenetidin	(-) Y Ephedrine	Oxymetazoline
N-Acetylprocainamide	Erythromycin	Papaverine
Acetylsalicylic acid	ß-Estradiol	Penicillin-G
Aminopyrine	Estrone-3-sulfate	Pentazocaine
Amitryptyline	Ethyl aminobenzoate	Pentobarbital
Amobarbital	Fenfluramine	Perphenazine
Amoxicillin	Fenoprofen	Phencyclidine
Ampicillin	Furosemide	Phenelzine
Ascorbic acid	Gentisic acid	Phenobarbital
Aspartame	Hemoglobin	Phetoin
Atropine	Hydralazine	L-Phenylephrine
Benzilic acid	Hydrochlorothiazide	Phenylpropanolamine

AMP

11

Benzoic acid	Hydrocodone	Prednisolone
Benzoylecgonine	Hydrocortisone	Prednisone
Bilirubin	O-Hydroxyhippuric acid	Procaine
Brompheniramine	3-Hydroxytyramine	Promazine
Caffeine	Ibuprofen	Promethazine
Cannabidiol	Imipramine	D,L-Propanolol
Cannabinol	(-) Isoproterenol	D-Propoxyphene
Chloralhydrate	Isoxsuprine	Quinidine
Chloramphenicol	Ketamine	Quinine
Chlordiazepoxide	Ketoprofen	Ranitidine
Chlorothiazide	Labetalol	Salicylic acid
(±)-Chlorpheniramine	Levorphanol	Secobarbital
Chlorpromazine	Loperamide	Sulfamethazine
Chloroquine	Maprotiline	Sulindac
Cholesterol	Meperidine	Temazepam
Clomipramine	Meprobamate	Tetracycline
Clonidine	Methadone	Tetrahydrocortisone
Cocaine hydrochloride	Methylphenidate	Tetrahydrozoline
Codeine	Morphine-3-Dglucuronide	Δ9-THC-COOH
Cortisone	Nalidixic acid	Thebaine
(-) Cotinine	Naloxone	Thiamine
Creatinine	Naltrexone	Thioridazine
Deoxycorticosterone	Naproxen	D,L-Thyroxine
Dextromethorphan	Niacinamide	Tolbutamide
Diazepam	Nifedipine	Triamterene
Diclofenac	Norcodein	Trifluoperazine
Diflunisal	Norethindrone	Trimethoprim
Digoxin	D-Norpropoxyphene	Trimipramine
Diphenhydramine	Noscapine	Tryptamine
Doxylamine	D,L-Octopamine	D, L-Tyrosine
Ecgonine hydrochloride	Oxalic acid	Uric acid
Ecgonine methylester	Oxazepam	Verapamil
(1R,2S)-(-)-Ephedrine	Oxolinic acid	Zomepirac

COC

Acetaminophen	Estrone-3-sulfate	Oxymetazoline
Acetophenetidin	Ethyl-p-aminobenzoate	Papaverine
N-Acetylprocainamide	Fenoprofen	Penicillin-G
Acetylsalicylic acid	Furosemide	Pentobarbital
Aminopyrine	Gentisic acid	Perphenazine
Amitryptyline	Hemoglobin	Phencyclidine
Amobarbital	Hydralazine	Phenelzine
Amoxicillin	Hydrochlorothiazide	Phenobarbital
Ampicillin	Hydrocodone	Phentermine
L-Ascorbic acid	Hydrocortisone	L-Phenylephrine
DL-Amphetamine Sulfate	O-Hydroxyhippuric acid	β-Phenylethylamine
Apomorphine	p-Hydroxymethamphetamine	Phenylpropanolamine
Aspartame	3-Hydroxytyramine	Prednisolone
Atropine	Ibuprofen	Prednisone
Benzilic acid	Imipramine	Procaine
Benzoic acid	Iproniazid	Promazine
Benzphetamine	(±) - Isoproterenol	Promethazine
(±) -Brompheniramine	Isoxsuprine	DL-Propranolol
Caffeine	Ketamine	D-Propoxyphene
Cannabidiol	Ketoprofen	D-Pseudoephedrine
Cannabinol	Labetalol	Quinidine
Chloralhydrate	Levorphanol	Quinine
Chloramphenicol	Loperamide	Ranitidine
Chlordiazepoxide	Maprotiline	Salicylic acid
Chlorothiazide	Meperidine	Secobarbital
(±) -Chlorpheniramine	Meprobamate	Serotonin
Chlorpromazine	Methadone	Sulfamethazine
Chloroquine	Methoxyphenamine	Sulindac
Cholesterol	(±) -3,4-Methylene
dioxyamphetamine	Temazepam
Clomipramine	Methylene-
dioxymethamphetamine	Tetracycline
Clonidine	Morphine-3-B-D glucuronide	Tetrahydrocortisone
3-(β-D glucuronide)
Codeine	Morphine Sulfate	Tetrahydrozoline
Cortisone	Nalidixic acid	Thebaine
(-) Cotinine	Naloxone	Thiamine
Creatinine	Naltrexone	Thioridazine
Deoxycorticosterone	Naproxen	DL-Tyrosine
Dextromethorphan	Niacinamide	Tolbutamide
Diazepam	Nifedipine	Triamterene
Diclofenac	Norcodein	Trifluoperazine
Diflunisal	Norethindrone	Trimethoprim
Digoxin	D-Norpropoxyphene	Trimipramine
Diphenhydramine	Noscapine	Tryptamine
Doxylamine	DL-Octopamine	DL-Tryptophan
Ecgonine methylester	Oxalic acid	Tyramine
(-) - Ψ-Ephedrine	Oxazepam	Uric acid
Erythromycin	Oxolinic acid	Verapamil
ß-Estradiol	Oxycodone	Zomepirac

12

13

MET: The MET interference data was reported in K122961.

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

AMP	Result	Reactivity
(D- Amphetamine, Cut-off=500 ng/mL)	Positive at 500 ng/mL	100%
L - Amphetamine	25000	2%
D,L - Amphetamine	1500	33%
Phentermine	1500	33%
Hydroxyamphetamine	8000	6%
Methylenedioxyamphetamine (MDA)	2500	20%
d-Methamphetamine	Negative at 100000	50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.

| % of Cutoff | Number
of
samples | d-Amphetamine
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|----------------------------------------------------|--------------------|--------------------|------------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 126.3 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 248.6 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 377.1 | 1 | 19 | 95.0 |
| +25% Cutoff | 20 | 625.8 | 18 | 2 | 90.0 |
| +50% Cutoff | 20 | 753.2 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 874.3 | 20 | 0 | 100 |

Comparison between GC/MS and Lay Person Results AMP Cup

Comparison between GC/MS and Lay Person Results AMP Dip Card

| % of Cutoff | Number
of
samples | d-Amphetamine
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results |
|-------------|-------------------------|----------------------------------------------------|--------------------|--------|-----------------------------------------|
| | | | No. of | No. of | |

18

			Positive	Negative	(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	126.3	0	20	100
-50% Cutoff	20	248.6	0	20	100
-25% Cutoff	20	377.1	2	18	90.0
+25% Cutoff	20	625.8	18	2	90.0
+50% Cutoff	20	753.2	20	0	100
+75% Cutoff	20	874.3	20	0	100

Comparison between GC/MS and Lay Person Results COC Cup

| | Number
of
samples | Benzoylecgonine
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|------------------------------------------------------|--------------------|--------------------|------------------------------------------------|
| % of Cutoff | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 38.1 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 75.6 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 113.4 | 2 | 18 | 90.0 |
| +25% Cutoff | 20 | 186.7 | 18 | 2 | 90.0 |
| +50% Cutoff | 20 | 226.3 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 259.8 | 20 | 0 | 100 |

Comparison between GC/MS and Lay Person Results COC Dip Card

| % of Cutoff | Number
of
samples | Benzoylecgonine
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|------------------------------------------------------|--------------------|--------------------|------------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 38.1 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 75.6 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 113.4 | 2 | 18 | 90.0 |
| +25% Cutoff | 20 | 186.7 | 18 | 2 | 90.0 |
| +50% Cutoff | 20 | 226.3 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 259.8 | 20 | 0 | 100 |

Comparison between GC/MS and Lay Person Results MET Cup

| % of Cutoff | Number
of
samples | Methamphetamine
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|-------------|-------------------------|------------------------------------------------------|--------------------|--------------------|------------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |

19

-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	124.8	0	20	100
-50% Cutoff	20	251.3	0	20	100
-25% Cutoff	20	377.6	2	18	90.0
+25% Cutoff	20	625.9	18	2	90.0
+50% Cutoff	20	748.3	20	0	100
+75% Cutoff	20	878.1	20	0	100

Comparison between GC/MS and Lay Person Results MET Dip Card

| % of Cutoff | Number
of
samples | Methamphetamine
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|------------------------------------------------------|--------------------|--------------------|------------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 124.8 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 251.3 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 377.6 | 2 | 18 | 90.0 |
| +25% Cutoff | 20 | 625.9 | 18 | 2 | 90.0 |
| +50% Cutoff | 20 | 748.3 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 878.1 | 20 | 0 | 100 |

Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

• 3. Clinical Studies
     Not applicable.

11.Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and method comparison of the devices, it's concluded that the WONDFO Urine Test devices are substantially equivalent to the predicate.