INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST

K994410 · Alfa Scientific Designs, Inc. · LDJ · Jun 21, 2000 · Clinical Toxicology

Device Facts

• Record ID: K994410
• Device Name: INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST
• Applicant: Alfa Scientific Designs, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Jun 21, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The Instant-View™ Marijuana (THC) Urine Dip Strip 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

Instant-View Marijuana (THC) Urine Dip Strip Test is a lateral flow, competitive binding immunoassay for professional use in clinical or physician office settings. Device utilizes immunochemical sandwich assay principle to detect THC metabolites in human urine. Operator dips test strip into urine sample; results appear visually as lines on the strip. Two lines (C and T) indicate negative result (THC < 50 ng/ml); absence of T line indicates positive result (THC ≥ 50 ng/ml). Output is a preliminary qualitative result requiring confirmation by GC/MS. Healthcare providers use results to inform clinical judgment regarding drug abuse. Benefits include rapid, point-of-care screening for marijuana metabolites.

Clinical Evidence

Accuracy evaluation performed at one clinical laboratory and three physician office laboratories. Results demonstrated an overall agreement of >95.9% compared to the predicate device. Correlation of results between subject device and predicate was >98.8%.

Technological Characteristics

One-step lateral flow, competitive binding immunoassay. Utilizes immunochemical sandwich assay principle for THC/Antibody/THC complex formation. Visual readout via test and control lines. Professional use, point-of-care diagnostic.

Indications for Use

Indicated for health care professional use to qualitatively detect 11-nor-delta-9-THC-carboxylic acid (THC) in human urine at a 50 ng/ml cutoff. Provides 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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K99441°

11494 Sorrento Valley Road, Suite 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 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>Dip Strip Test<br>Common Name: Cannabinoid Test<br>Classification Name: 21 CFR 862.3870, Class II |
| Predicate Device | The Instant-View™ Marijuana (THC) Urine Dip Strip Test<br>is 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 Dip Strip Test<br>is a qualitative immunoassay device intended to detect THC,<br>a 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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K994410

## 11494 Sorrento Valley Road, Suite M Alfa Scientific Designs, Inc. San Diego, CA 92121 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 Dip Strip Test, and the Conclusion legally marketed test device compared, is higher than 98.8 %. · The results of the accuracy evaluation from the clinical laboratory & three physician's office laboratory demonstrated an overall agreement of greater than 95.9 %. · Based on the results of the Performance Characteristics and Comparison Studies, it may be concluded that the Instant-View™ Marijuana (THC) Urine Dip Strip Test is suitable for professional use, and is substantially equivalent to the existing legally marketed product.

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## JUN 2 1 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K994410 Re:

> Trade Name: Instant-View Marijuana (THC) Urine Dip Strip Test Regulatory Class: II Product Code: LDJ Dated: June 6, 2000 Received: June 8, 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 packeted predicate device results in a classification for your device and thus, permits your drying 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 regulations entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other green 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 ins internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Routman

Steven I. 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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K994410 510(k) Number (if known):

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

Indications For Use:

Instant-View Marijuana (THC) Urine Dip StripTest 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.

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510(k) Number

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_V (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)