INSTANT-VIEW MARIJUANA URINE CASSETTE TEST

K994405 · Alfa Scientific Designs, Inc. · DKE · Jun 2, 2000 · Clinical Toxicology

Device Facts

• Record ID: K994405
• Device Name: INSTANT-VIEW MARIJUANA URINE CASSETTE TEST
• Applicant: Alfa Scientific Designs, Inc.
• Product Code: DKE · Clinical Toxicology
• Decision Date: Jun 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The Instant-View™ Marijuana (THC) Urine Cassette Test is a qualitative immunoassay device intended to detect THC, a major metabolite of marijuana, in human urine at a cutoff level of 50 ng/ml. It is intended for health care professional use only.

Device Story

Lateral flow chromatographic immunoassay; detects THC metabolite in human urine. Principle: competitive binding immunoassay; utilizes THC/Antibody/THC complex formation. Input: human urine sample. Output: visual qualitative result (two lines = negative; one line = positive). Used in clinical laboratories and physician office laboratories by healthcare professionals. Provides preliminary screening; requires GC/MS confirmation for definitive diagnosis. Assists clinicians in identifying potential marijuana use.

Clinical Evidence

Performance evaluated via accuracy studies comparing subject device to predicate. Clinical laboratory and three physician office laboratory sites demonstrated >96.4% overall agreement. Correlation with legally marketed test device >96.7%.

Technological Characteristics

One-step lateral flow chromatographic immunoassay; competitive binding format. Utilizes immunochemical sandwich assay principle. Qualitative visual readout.

Indications for Use

Indicated for the qualitative detection of 11-nor-delta-9-THC-carboxylic acid in human urine at a 50 ng/ml cutoff. Intended for healthcare professional use to provide preliminary analytical results. Requires confirmatory testing via GC/MS.

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

• QuikStrip One Step Marijuana Test (K963654)

Submission Summary (Full Text)

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## Alfa Scientific Designs, Inc.

11494 Sorrento Valley Road, Suite F&M San Diego, CA 92121

## 510(K) Summary

In accordance with the Safe Medical Devices Act of 1990, a 510(K) summary is provided as outlined in 21 CFR 807.92.

| Submitter | Name: Alfa Scientific Designs, Inc.<br>Address: 11494 Sorrento Valley Road, Suite F&M<br>San Diego, CA 92121<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Trade Name: Instant-View™ Marijuana (THC) Urine<br>Cassette Test |
| | Common Name: Cannabinoid Test |
| | Classification Name: 21 CFR 862.3870, Class II |
| Predicate Device | The Instant-View™ Marijuana (THC) Urine Cassette Test is<br>substantially equivalent to other legally marketed devices<br>for the similar intended use. The device used for<br>comparison study is QuikStrip One Step Marijuana Test,<br>manufactured by Syntron Bioresearch, Inc. with 510(K) #:<br>K963654, Date of Approval: 02/28/97. |
| Device Description | This test is a one-step lateral flow chromatographic<br>immunoassay. |
| Intended Use | The Instant-View™ Marijuana (THC) Urine Cassette Test is<br>a qualitative immunoassay device intended to detect THC, a<br>major metabolite of marijuana, in human urine at a cutoff<br>level of 50 ng/ml. It is intended for health care professional<br>use only. |
| Summary of the<br>Similarities to the<br>Predicate Device | • Intended Use:<br>Both devices are intended to detect THC in human urine<br>at a cutoff level of 50 ng/ml.<br>• Interpretation of results:<br>The appearance of two lines - both C and T lines<br>Indicates a negative result. The THC level in the urine is<br>below 50 ng/ml. The absence of the T line indicates a |

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positive result, and the THC level in the urine is at a cutoff level of 50 ng/ml or higher. · Technological Characteristics: Both devices are one step, qualitative, competitive binding immunoassay test, utilizing the basic immunochemical sandwich assay principle of recognition and formation of the specific THC/Antibody/ THC complexes. · The correlation of results from the Instant-View ™ Discussion and Marijuana (THC) Urine Cassette Test, and the Conclusion legally marketed test device compared, is higher than 96.7 %. · The results of the accuracy evaluation from the clinical laboratory & three physician's office laboratory demonstrated an overall agreement of greater than 96.4 %. · Based on the results of the Performance Characteristics and Comparison Studies, it may be concluded that the Instant-View™ Marijuana (THC) Urine Cassette Test is suitable for professional use, and is substantially equivalent to the existing legally marketed product.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is oriented to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUN = 2 2000

Ms. Rhoda Filipina OA Manager Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road Suite M San Diego, California 92121

K994405 Re:

Trade Name: Instant-View Marijuana (THC) Urine Test (Cassette) Regulatory Class: II Product Code: DKE Dated: April 26, 2000 Received: April 28, 2000

Dear Ms. Filipina:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrls/dsmamain.html".

Sincerely yours,

Steven Routman

Steven 1. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K994405 510(k) Number (if known):

Instant-View Marijuana (THC) Urine Test (Cassette) Device Name:

Indications For Use:

Instant-View Marijuana (THC) Urine Test (Cassette) is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect 11-nor-delta-9, THC-carboxylic acid (THC), a major metabolites of marijuana in human urine at a cutoff level of 50 ng/ml. It is intended for health care professional use only.

The test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.

Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994405

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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