CANNABINOIDS

K013247 · Abbott Laboratories · LDJ · Mar 13, 2002 · Clinical Toxicology

Device Facts

• Record ID: K013247
• Device Name: CANNABINOIDS
• Applicant: Abbott Laboratories
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Mar 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The Cannabinoids assay is used for the qualitative analysis of cannabinoids in human urine with a cutoff of 50 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoids use or overdose. The Cannabinoids assay is calibrated with 11-nor-Δ'-THC-9-COOH and will detect a variety of -Δ'-THC metabolites. The Cannabinoids assay 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 spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Story

In vitro diagnostic assay; homogeneous enzyme immunoassay; human urine input. Principle: competition between drug in specimen and G6PDH-labeled drug for antibody binding sites; enzyme activity inversely proportional to drug concentration. Active enzyme converts NAD to NADH; absorbance change measured spectrophotometrically. Used in clinical laboratories by trained personnel. Output: qualitative result (positive/negative based on 50 ng/mL cutoff). Results are preliminary; require confirmation via GC/MS. Assists clinicians in identifying cannabinoid use or overdose.

Clinical Evidence

Bench testing only. Method comparison studies on AEROSET System showed 100% agreement with Emit II Cannabinoid assay and 97% agreement with GC/MS (n=clinical specimens). Precision studies (within-run and total) performed using five control levels; total %CV ranged from 0.63% to 2.70%. Limit of detection (sensitivity) is 15 ng/mL.

Technological Characteristics

Homogeneous enzyme immunoassay; G6PDH-labeled drug; spectrophotometric detection. Calibrated with 11-nor-Δ'-THC-9-COOH. Cutoff 50 ng/mL. Designed for use on AEROSET System. No specific materials or software architecture details provided.

Indications for Use

Indicated for qualitative analysis of cannabinoids in human urine for clinical laboratory use to assist in diagnosis and treatment of cannabinoid use or overdose.

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

• Emit® II Cannabinoid assay (K904571)

Submission Summary (Full Text)

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MAR 1 3 2002

# 510(k) Summary

K013247

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive MS 1-8 Irving, Texas 75038

Contact Person Linda Morris Senior Regulatory Affairs Specialist Regulatory Affairs [phone] Fax [phone]

November 21, 2001 Date of Preparation of this Summary: Device Trade or Proprietary Name: Cannabinoids Device Common/Usual Name or Classification Name: Cannabinoids Classification Number/Class: LDJ/Class II

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K013247.

#### Test Description:

The Cannabinoids assay is an in vitro diagnostic assay for the qualitative analysis of cannabinoids in human urine. The assay is a homogeneous enzyme immunoassay with a 50 ng/mL cutoff. The ussay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activily. Active enzyme converts NAD to NADH, resulting in an absorbance change that can be measured spectrophotometrically.

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## Substantial Equivalence:

The Cannabinoids assay is substantially equivalent to the Emit® II Cannabinoid assay (K904571) on the SYVA®-30R Analyzer.

Both assays vield similar Performance Characteristics.

Similarities:

- Both assays are in vitro immunoassays. .
- Both assays can be used for the qualitative analysis of cannabinoids. .
- . Both assays vield similar results.
- Both assays are based on the competition between drug in the specimen and drug labeled with the . enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites.
- . Both assays have the same assay range

Differences:

- Cannabinoids is a qualitative assay. Emit II is a qualitative and semiquantitative assay. .
### Intended Use:

The Cannabinoids assay is used for the qualitative analysis of cannabinoids in human urine with a cutoff of 50 ng/mL. For use in clinical laboratories.

The Cannabinoids assay is calibrated with 11-nor-Δ'-THC-9-COOH and will detect a variety of -0 -THC metabolites.

### Performance Characteristics:

Comparative porformance studies were conducted using the AEROSET® System. The Cannabinoids assay method comparison yielded acceptable concordance with the Emit II Cannabinoid assay on the SYVA-30R Analyzer. The concordance table for the Cannabinoids assay shows 100% agreement. The Cannabinoids assay method comparison yielded acceptable concordance with GC/MS. The concordance table for the Cannabinoids assay shows 97% agreement with GC/MS. The clinical specimens tested ranged from 14.2 to 61.8 ng/mL. Precision studies were conducted using the

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Cannabinoids assay. A within-run and total precision study was performed using five levels of control material. The total %CV for Verifier I is 1.19%. The total %CV for the Cutoff Calibrator is 1.13%. The total %CV for Verifier II is 0.63%. The total %CV for the - 25% Control of Cutoff Calibrator and the + 25% Control of Cutoff Calibrator samples are 2.32% and 2.70%, respectively. The Cannabinoids assuy cutoff is 50 ng/mL. The limit of detection (sensitivity) of the Cannabinoids assay is 15 ng/mL. These data demonstrate that the performance of the Cannabinoids assay is substantially equivalent to the performance of the Emit II Cannabinoid assay on the SYVA-30R Analyzer.

## Conclusion:

The Cannabinoids assay is substantially equivalent to the Emit II Cannabinoids assay on the SYVA-30R Analyzer as demonstrated by results obtained in the studies.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Linda Morris Senior Regulatory Affairs Specialist Abbott Laboratories 1921 Hurd Dr. P.O. Box 152020 Irving. Texas 75015-2020

Re: k013247 Trade/Device Name: Cannabinoids Regulation Name: 21 CFR 862.3870 Regulatory Class: Class II Product Code: LDJ Dated: November 26, 2001 Received: November 28, 2001

Dear Ms. Morris:

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.

MAR 1 3 2002

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- . 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Steven Sutman

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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510(k) Number (if known): K013247

Device Name: ____ Cannabinoids

Indications For Use:

The Cannabinoids assay is used for the qualitative analysis of cannabinoids in human urine with a cutoff of 50 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoids use or overdose.

The Cannabinoids assay is calibrated with 11-nor-A -THC-9-COOH and will detect a variety of -A -THC metabolites.

The Cannabinoids assay 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 spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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vision Sinn- 399 vision of Children Caporatory Devices 510(k) Number

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

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