WUNDER TEST

K102428 · Hien Helen Nguyen · LDJ · Apr 18, 2012 · Clinical Toxicology

Device Facts

• Record ID: K102428
• Device Name: WUNDER TEST
• Applicant: Hien Helen Nguyen
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Apr 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

A competitive binding immunoassay used for the qualitative determination of Cannabinoids in human urine. The device is visually read and intended for over-the-counter single use. The test has a cutoff of 50 ng/mL of Cannabinoids. 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

Wunder Test is a qualitative, visually-read immunochromatographic lateral flow assay for detecting 9-COOH-11-norΔ⁹-THC in human urine. Device consists of a nitrocellulose membrane strip coated with THC-BSA conjugate and a wicking pad with anti-THC monoclonal antibody-colloid gold conjugate. User submerges absorbent tip into urine sample; sample migrates across membrane. If THC is absent, anti-THC conjugate binds to THC-BSA, forming a visible colored test band (negative result). If THC is present at ≥50 ng/mL, it saturates antibody binding sites, preventing test band formation (positive result). A control band confirms proper flow. Intended for OTC home use; results are preliminary and require GC/MS confirmation. Provides rapid screening to assist in identifying potential cannabinoid presence.

Clinical Evidence

No clinical data provided; device relies on analytical performance characteristics typical of competitive binding immunoassays for drug screening.

Technological Characteristics

Immunochromatographic lateral flow assay. Components: nitrocellulose membrane, THC-BSA conjugate, anti-THC monoclonal goat anti-mouse antibody-colloid gold conjugate, mouse IgG control. Form factor: dipstick with absorbent tip. Storage: 4-30°C. Shelf life: 2 years. Qualitative visual readout. No electronic components or software.

Indications for Use

Indicated for qualitative detection of Cannabinoids in human urine for over-the-counter (OTC) use. Cutoff concentration: 50 ng/mL. Results are preliminary; requires confirmatory testing (GC/MS preferred).

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).

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Hien Helen Nguyen 1810 Oakland Rd Ste E San Jose, CA 95131

Re:

APR 1 8 2012

k102428 Trade Name: Wunder Test™ Regulation Number: 21 CFR §862.3870 Regulation Name: Cannabinoid Test System Regulatory Class: Class II Product Codes: LDJ Dated: April 12, 2012 Received: April 17, 2012

Dear Ms. Nguyen:

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 Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

N

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

. Enclosure

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## Indications for Use

510(k) Number (if known): K102428

Device Name: Wunder Test

Indications For Use:

A competitive binding immunoassay used for the qualitative determination of Cannabinoids in human urine. The device is visually read and intended for over the counter single use. The test has a cutoff of 50 ng/mL of Cannabinoids.

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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k). K102428

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