CANNABINOIDS URINE TEST

K110182 · Guangzhou Wondfo Biotech Co., Ltd. · LDJ · May 20, 2011 · Clinical Toxicology

Device Facts

• Record ID: K110182
• Device Name: CANNABINOIDS URINE TEST
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: May 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

Wondfo Cannabinoids Urine Test is an immunochromatographic assay for the qualitative determination of Cannabinoids in human urine. The test is available in a cassette format and a strip format. The test has a cutoff of 50 ng/mL of Cannabinoids. It is intended for prescription use and over the counter use. 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.

Device Story

Wondfo Cannabinoids Urine Test is a lateral flow immunochromatographic assay for qualitative detection of cannabinoids in human urine. Available in strip or cassette formats. Principle: competitive binding; urine sample migrates via capillary action; mixes with anti-mouse IgG polyclonal antibody-dye conjugate. If cannabinoids are below 50 ng/mL, conjugate binds to drug-protein conjugate on membrane, producing a colored test line (negative). If cannabinoids are at or above 50 ng/mL, free drug binds conjugate, preventing test line formation (positive). Control line confirms proper wicking. Used in home or clinical settings by patients or professionals. Provides preliminary results; requires GC/MS confirmation. Benefits: rapid, visual screening for drug abuse.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical performance data (precision, specificity, cross-reactivity, and cutoff verification) and a lay-user study. Lay-user study (n=242) demonstrated 95.8% agreement for strip format and 96.7% for cassette format compared to GC/MS. Bench testing confirmed 100% positive agreement and 97.5% negative agreement with GC/MS.

Technological Characteristics

Lateral flow immunochromatographic assay; utilizes gold chloride, monoclonal antibody-dye conjugate, and anti-mouse IgG polyclonal antibody. Cassette form factor. Qualitative detection at 50ng/mL cutoff.

Indications for Use

Indicated for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50ng/mL. Intended for both prescription and over-the-counter use. Provides preliminary results only; requires confirmatory testing (e.g., GCMS).

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

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

Predicate Devices

• Step Drug Screen Test Card (K020771)

Submission Summary (Full Text)

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Premarket Notification - Guangzhou Wond

Co. Ltd. K110182

## TABLE 4

Submitter's name: Address:

Phone:

SUMMARY

December 13, 2010

Guangzhou Wondfo Biotech Co., Ltd. South China University of Technology Guangzhou, P.R. China 510641 012-86-20-32296069

MAY 2 0 2011

Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: [phone] Fax: [phone]

Date the summary was prepared:

Name of the device: Trade or proprietary name: Common or usual name:

Cannabinoids Urine Test Cannabinoids Urine Test lmmunochromatographic test for the qualitative detection of Cannabinoids

Classification: Class II medical device with the product codes with Code of Federal Regulation references:

> CFR # Product Code 862.3870 LDJ

The legally marketed device to which we are claiming equivalence [807.92((3)]: illy marketed device to which Step Drug Screen Test Card, K020771.

Description of the device:

Assay Principle: Immunochromatographic assay for Cannabinoids urine test using a lateral Assay Principle: Immunochromation of Cannabinoids in human urine. Each assay uses a
flow system for the qualitative detection of Cannabinoids in human note ableside and fixed flow system for the qualitative detection of ourinament thrug with gold chloride and fixed monoclonal antibody-dye congugate from medio against any
drug-protein conjugate and anti-mouse lgG polyclonal antibody in membrane.

Intended use of the device:

The Cannabinoids Urine Test is intended for the qualitative determination of Cannabinoids in human i he Cannabilioius Unite Test is intended for the qualities and over the counter use.

Summary of the technological characteristics of our device compared to the predicate device:

The Wondfo Biotech Co., Ltd. Cannabinoids have similar technological characteristics and performance to the predicate and are equivalent.

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Image /page/1/Picture/12 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - GSA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with outstretched wings. The eagle's body is formed by three curved lines, giving it a modern and abstract appearance. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

MAY 20 2011

Guangzhou Wondfo Biotech Co., LTD. c/o Joe Shia, LSI International Inc. 504 East Diamond Ave. Suite F Gaithersburg, MD 20877

Re: k110182

> Trade Name: Wondfo Cannabinoids Urine Test Regulation Number: 21 CFR §862.3870 Regulation Name: Cannabinoid Test System Regulatory Class: Class II Product Codes: LDJ Dated: May 16, 2011 Received: May 19, 2011

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

CJC.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

: Vijs

Enclosure

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## INDICATIONS FOR USE FORM

510(k) Number (if known): K110182

Device Name: Wondfo Cannabinoids Urine Test

Indications for Use:

Wondfo Cannabinoids Urine Test is an immunochromatographic assay for the qualitative determination of Cannabinoids in human urine. The test is available in a cassette format. The test has a cutoff of 50ng/mL of Cannabinoids. It is intended for prescription use and over the counter use.

The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a conformed analytical result. GCMS 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.

Prescription Use __ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ X (21 CFR Part 801 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110182