CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET

K092269 · Randox Laboratories, Ltd. · LDJ · Apr 8, 2011 · Clinical Toxicology

Device Facts

• Record ID: K092269
• Device Name: CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET
• Applicant: Randox Laboratories, Ltd.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Apr 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The Randox Laboratories Ltd. Cannabinoid Assay is an in vitro diagnostic test for the detection of 11-nor-Δ9-THC-9-COOH (THC) in human urine with a cut off concentration of 50ng/ml, for use on the Rx Imola and Rx Daytona analyzers in qualitative or semi-quantitative mode. This in vitro diagnostic device is intended for prescription use only. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures. This assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatograph/mass spectrometry (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. The Randox Cannabinoid Calibrator Set consists of liquid calibrators containing 11-nor-Δ9-THC-9-COOH (THC). There are 5 levels of calibrator. They have been developed for use in the calibration of THC assays on the Rx Imola and Rx Daytona analyzers. This in vitro diagnostic device is intended for prescription use only. The Randox Cannabinoid Controls, level 1 and 2 are liquid controls containing 11-nor-Δ9-THC-9-COOH (THC). There are 2 levels of controls. They have been developed for use in the quality control of the THC assay on the Rx Imola and Rx Daytona analyzers. This in vitro diagnostic device is intended for prescription use only.

Device Story

Randox Cannabinoids Assay is an in vitro diagnostic test for detecting 11-nor-d-THC-9-COOH in human urine. Used on Rx imola and Rx Daytona analyzers in clinical laboratory settings by trained personnel. Assay provides preliminary results; requires confirmation via GC/MS. Includes liquid calibrators (5 levels) and controls (2 levels) for system calibration and quality control. Healthcare providers use results to guide clinical decisions, necessitating professional judgment for positive findings. Benefits include rapid preliminary screening for cannabinoids to facilitate subsequent confirmatory testing.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

In vitro diagnostic assay for human urine. Analyte: 11-nor-d-THC-9-COOH. Cutoff: 50ng/ml. Form factor: Liquid reagents, calibrators, and controls. Analyzers: Rx imola and Rx Daytona. Principle: Immunochemical detection. Intended for prescription use.

Indications for Use

Indicated for the detection of 11-nor-Δ9-THC-9-COOH in human urine at a 50ng/ml cutoff. Intended for prescription use in clinical laboratories on Rx Imola and Rx Daytona analyzers. Provides preliminary results requiring 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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting and promoting the health and well-being of Americans.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Randox Laboratories, LTD c/o Dr. Pauline Armstrong Regulatory Affairs 55 Diamond Road Crumlin, County Antrim, United Kingdom BT29 4QY

Re: k092269

> Trade Name: Randox Cannabinoids Assay, Cannabinoid Calibrator Set, Cannabinoid Controls, Level 1 & 2 Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid Test System. Regulatory Class: Class II Product Codes: LDJ, JIT, JJX Dated: March 29, 2011 Received: March 31, 2011

APR C 3 2511

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); 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 (OS) regulation (21 CFR Part 820).

{1}------------------------------------------------

Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/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/cdrh/industry/support/index.html.

Sincerely yours,

CJC.

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

Enclosure

{2}------------------------------------------------

## Indication for Use

510(k) Number (if known):

Device Name:

CANNABINQIDS ASSAY, CALIBRATOR SET AND CONTROLS LEVEL 1 & 2

Indication For Use:

## Randox Cannabinoids Assay

The Randox Laboratories Ltd. Cannabinoid Assay is an in vitro diagnostic test for the detection of 11-nor-d -THC-9-COOH (THC) in human urine on the Rx imola and Rx Daytona. The cut off for 11-nor-A-THC-9-COOH (THC) is 50ng/ml, This in vitro diagnostic device is intended for prescription use only.

The semi-quantitative mode is for purposes of

- (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS
or

- (2) permitting laboratories to establish quality control procedures.
k092269

This assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatograph/mass spectrometry (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.

## Randox Cannabinoid Calibrator Set

The Randox Cannabinoid Calibrator Set consists of liquid calibrators containing 11-nor-Δ2-THC-9-COOH (THC). There are 5 levels of calibrator. They have been developed for use in the calibration of THC assays on the X day to na™ and Anmond analysers. This in vitro diagnostic device is intended for prescription use only.

## Randox Cannabinoid Controls, Level 1 & 2

The Randox Cannabinoid Controls, level 1 and 2 are liquid controls containing 11-nor-A -THC-9-COOH (THC). There are 2 levels of controis. They have been developed for use in the quality control of the THC assay on the X day to na™ and Amond analysers. This in vitro diagnostic device is intended for prescription use only.

Prescription Use (21 CFR Part 801 Subpart D)

Over the Coun
(21 CE)

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

And/Or

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K092269

Page 1 of 1