ONLINE DAT II CANNABINOIDS II

K030213 · Roche Diagnostics Corp. · LDJ · Apr 11, 2003 · Clinical Toxicology

Device Facts

• Record ID: K030213
• Device Name: ONLINE DAT II CANNABINOIDS II
• Applicant: Roche Diagnostics Corp.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Apr 11, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

Cannabinoids II (THC II) is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/ml, 50 ng/ml and 100 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

Device Story

The ONLINE DAT II Cannabinoids II assay is an in vitro diagnostic test for human urine. It utilizes Kinetic Interaction of Microparticles in Solution (KIMS) technology to detect cannabinoids. In the absence of drug, drug-polymer conjugates bind to antibody-coated microparticles, causing aggregation and increased light absorbance. In the presence of cannabinoids, the drug competes for the antibody, inhibiting aggregation and reducing absorbance. The assay is performed on automated clinical chemistry analyzers in a laboratory setting. Results are qualitative or semi-quantitative, determined relative to known cutoff concentrations (20, 50, 100 ng/ml). Healthcare providers use these results to screen for cannabinoid presence; semi-quantitative data assists in laboratory quality control programs.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

In vitro diagnostic assay using Kinetic Interaction of Microparticles in Solution (KIMS) technology. Components include mouse monoclonal cannabinoids antibody, soluble drug-polymer conjugate, and microparticles. Operates via light transmission measurement on automated clinical chemistry analyzers. Qualitative and semi-quantitative detection at 20, 50, and 100 ng/ml cutoffs.

Indications for Use

Indicated for the qualitative and semi-quantitative detection of cannabinoids in human urine using automated clinical chemistry analyzers. Intended for laboratory use to assess assay performance via semi-quantitative results.

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

• Abuscreen OnLine Cannabinoids assay (K983701)

Submission Summary (Full Text)

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K030213

| 510(k) Summary | APR 11 2003 |
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|----------------|-------------|

Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

| 1) Submitter name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone]<br>Contact Person: Kerwin Kaufman<br>Date Prepared: January 17, 2003 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name | Proprietary name: ONLINE DAT II Cannabinoids II<br>Common name: Cannabinoids test system<br>Classification name: Enzyme immunoassay, cannabinoids |
| 3) Predicate device | We claim substantial equivalence to the currently marketed Abuscreen OnLine Cannabinoids assay (K983701). |

,

Continued on next page

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# 510(k) Summary. Continued

4) Device The ONLINE DAT II Cannabinoids II (THC II) assay is an in vitro diagnostic Description test for the qualitative and semi-quantitative detection of cannabinoids in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/ml, 50 ng/ml and 100 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

#### Principal of procedure

The ONLINE DAT II Cannabinoids II assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission. In the absence of sample drug, soluble drug-polymer conjugates bind to antibody-bound microparticles, causing the formation of particle aggregates.

When a urine sample containing the drug in question is present, this drug competes with the conjugate-bound drug derivative for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited.

As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. Conversely, the presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.

#### Negative Sample

drug-polymer conjugate + antibody-bound microparticle = particle aggregates (↑ absorbance)

#### Positive Sample

sample drug + antibody-bound microparticle = particle aggregation inhibited drug-polymer conjugate + antibody bound microparticle = particle aggregates

Continued on next page

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### 510(k) Summary, Continued

The ONLINE DAT II Cannabinoids II (THC II) assay is an in vitro 5.) Intended Use diagnostic test for the qualitative and semi-quantitative detection of cannabinoids in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/ml, 50 ng/ml and 100 ng/ml. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. 6.) Comparison The Roche ONLINE DAT II Cannabinoids II assay is substantially equivalent to the Predicate to other products in commercial distribution intended for similar use. Most Device notably, it is substantially equivalent to the currently marketed Roche Abuscreen OnLine Cannabinoids assay (K983701). The Roche ONLINE DAT II Cannabinoids II assay utilizes a modified KIMS technology relative to the currently marketed Abuscreen OnLine Cannabinoids assay. Differences between this application and the cleared assay include: use of a new cannabinoids monoclonal antibody (mouse) attached . to microparticles in solution, . a soluble drug-polymer conjugate, and . use of new calibrators and unassayed controls.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# APR 1 1 2003

Mr. Kerwin Kaufman Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: k030213

Trade/Device Name: Roche Diagnostics ONLINE DAT II Cannabinoids II Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ Dated: January 17, 2003 Received: January 21, 2003

Dear Mr. Kaufman:

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,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

| 510(k) Number (if known): | K030213 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Roche Diagnostics ONLINE DAT II Cannabinoids II |
| Indications for Use: | Cannabinoids II (THC II) is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/ml, 50 ng/ml and 100 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | OR Over-the-Counter Use ______ |
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(Optional format 1-2-96)

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number K030213