BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST

K971841 · Bionike Laboratories, Inc. · LDJ · Jun 25, 1997 · Clinical Toxicology

Device Facts

• Record ID: K971841
• Device Name: BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
• Applicant: Bionike Laboratories, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Jun 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The Bionike AQ™ One Step Cannabinoids Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of Cannabinoids and its metabolites at a cutoff concentration of 50ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.

Device Story

Bionike AQ™ One Step Cannabinoids Test is a rapid immunochromatographic competitive assay. Input: human urine sample. Principle: competitive binding immunoassay for detection of Cannabinoids/metabolites at 50ng/mL cutoff. Output: qualitative preliminary analytical result. Used in clinical settings by healthcare professionals. Requires confirmation of positive results via GC/MS. Benefits: provides rapid preliminary screening for drug presence to guide clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunochromatographic competitive assay; lateral flow format. Qualitative detection of Cannabinoids in urine. Cutoff concentration: 50ng/mL.

Indications for Use

Indicated for screening human urine for Cannabinoids and metabolites at 50ng/mL cutoff. For use by healthcare professionals only. Not for over-the-counter use.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 25 1997

Janis Freestone Director, Requlatory Affairs Bionike, Inc. 1015 Grandview Drive So. San Francisco, California 94080-4910

Re : K971841 Bionike AQ™ Cannabinoid (THC) Test Regulatory Class: II Product Code: LDJ Dated: May 16, 1997 Received: May 19, 1997

Dear Ms. Freestone:

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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 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/cdrh/dsmamain.html".

sincerely yours,
Steven Litman

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

Enclosure

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INDICATION FOR USE STATEMENT.

## Intended Use Statement

510k Number:

Device Name: Bionike AQ™ One Step Cannabinoids(THC) Test

Indications for Use:

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The Bionike AQ™ One Step Cannabinoids Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of Cannabinoids and its metabolites at a cutoff concentration of 50ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.

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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 6971841

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_ over-the-counter

AST ANDRESS

Bionike AQ Cannabinoid 510(k)