RANDOX CANNABINOIDS ASSSAY

K041142 · Randox Laboratories, Ltd. · LDJ · Nov 23, 2004 · Clinical Toxicology

Device Facts

• Record ID: K041142
• Device Name: RANDOX CANNABINOIDS ASSSAY
• Applicant: Randox Laboratories, Ltd.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Nov 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The evidence®Cannabinoids test has been designed for use only on the evidence® analyser to detect cannabinoids in urine, using a cut-off of 50ng/ml. Qualitative results obtained can be utilised in the diagnosis of cannabinoid use or abuse. This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS. The Cannabinoids Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions. The evidence® Drugs of Abuse Calibrators. The evidence®Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone and 11-nor-D9-THC-9 carboxylic acid. There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system. The evidence®Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Device Story

The evidence® Cannabinoids Assay is an in vitro diagnostic test for use on the evidence® analyser. It detects cannabinoids in urine samples at a 50ng/ml cut-off. The system utilizes liquid calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone, and 11-nor-D9-THC-9 carboxylic acid for system calibration. The device is intended for use by qualified laboratory personnel in a clinical laboratory setting. The output is a qualitative result indicating the presence or absence of cannabinoids, which serves as a preliminary analytical finding. Clinicians must confirm positive results using a more specific method, such as GC/MS, before making final clinical decisions regarding drug use or abuse.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic assay for use on the evidence® analyser. Includes liquid calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone, and 11-nor-D9-THC-9 carboxylic acid. Designed for qualitative urine analysis at a 50ng/ml cut-off.

Indications for Use

Indicated for the qualitative detection of cannabinoids in human urine at a 50ng/ml cut-off to assist in the diagnosis of cannabinoid use or abuse. For use by qualified laboratory personnel only. Preliminary results require confirmation by 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).

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The logo is simple and monochromatic.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV ຂໍ້ 3ໍ້ 2004

Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories, Ltd. 55 Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY

Re: k041142

Trade/Device Name: evidence® Cannabinoids Assay and evidence® Drugs of Abuse Calibrators Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ, DKB Dated: October 26, 2004 Received: October 28, 2004

Dear Dr. Armstrong:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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/dsma/dsmamain.html.

Sincerely yours,

Sincerely yours,

Cornelia B. Lohs

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology 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):_

| Device Name: | evidence® CANNABINOIDS ASSAY AND<br>evidence® DRUGS OF ABUSE CALIBRATORS |
|--------------|--------------------------------------------------------------------------|
|--------------|--------------------------------------------------------------------------|

Indications For Use:

The evidence®Cannabinoids test has been designed for use only on the evidence® analyser to detect cannabinoids in urine, using a cut-off of 50ng/ml. Qualitative results obtained can be utilised in the diagnosis of cannabinoid use or abuse.

This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS.

The Cannabinoids Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

The evidence® Drugs of Abuse Calibrators.

The evidence®Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone and 11-nor-D9-THC-9 carboxylic acid.

There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system.

The evidence®Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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Office of In Vitro Diagne

510(k) K041192