COBAS INTEGRA ONLINE DAT II COCAINE II

K023296 · Roche Diagnostics Corp. · DIO · Nov 25, 2002 · Clinical Toxicology

Device Facts

• Record ID: K023296
• Device Name: COBAS INTEGRA ONLINE DAT II COCAINE II
• Applicant: Roche Diagnostics Corp.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Nov 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Intended Use

The cassette COBAS INTEGRA Cocaine II contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine at cutoff concentrations of 150 ng/ml and 300 ng/ml. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

Device Story

In vitro diagnostic reagent system for COBAS INTEGRA analyzers; detects benzoylecgonine in human urine. Uses Kinetic Interaction of Microparticles in Solution (KIMS) technology; measures changes in light transmission. In absence of drug, drug-polymer conjugates bind to antibody-coated microparticles, forming aggregates; presence of drug in sample competes for antibody, inhibiting aggregation. Absorbance increases as aggregation proceeds; drug presence diminishes absorbance increase proportionally. Results used by laboratory professionals for qualitative/semiquantitative drug screening and quality control. Benefits include rapid, automated detection of cocaine use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent system; KIMS (Kinetic Interaction of Microparticles in Solution) technology; utilizes mouse monoclonal anti-benzoylecgonine antibody attached to microparticles and soluble drug-polymer conjugate. Designed for use on COBAS INTEGRA systems. Measures light transmission changes.

Indications for Use

Indicated for the semiquantitative and qualitative detection of benzoylecgonine (cocaine metabolite) in human urine at 150 ng/ml and 300 ng/ml cutoffs. For professional laboratory use.

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite 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

• Roche COBAS INTEGRA Cocaine Metabolite assay (K951595)

Submission Summary (Full Text)

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K023296

| 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] |
| | Contact Person: Kerwin Kaufman |
| | Date Prepared: October 1, 2002 |
| 2) Device name | Proprietary name: COBAS INTEGRA ONLINE DAT II Cocaine II |
| | Common name: Cocaine and cocaine metabolite test system |
| | Classification name: Enzyme immunoassay, cocaine and cocaine metabolites |
| 3) Predicate device | We claim substantial equivalence to the currently marketed Roche COBAS INTEGRA Cocaine Metabolite assay (K951595). |

510(k) Summary

NOV 2 5 2002

Continued on next page

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4) Device

Description

The cassette COBAS INTEGRA Cocaine II contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine at cutoff concentrations of 150 ng/ml and 300 ng/ml. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

# Principal of procedure

The COBAS INTEGRA ONLINE DAT II Cocaine 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 drugpolymer 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 (1 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 cassette COBAS INTEGRA Cocaine II contains an in vitro diagnostic 5.) Intended Use reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine at cutoff concentrations of 150 ng/ml and 300 ng/ml. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

The Roche COBAS INTEGRA ONLINE DAT II Cocaine II assay is 6.) Comparison to the Predicate substantially equivalent to other products in commercial distribution intended Device for similar use. Most notably, it is substantially equivalent to the currently marketed Roche COBAS INTEGRA Cocaine Metabolite (K951595).

> The Roche COBAS INTEGRA ONLINE DAT II Cocaine II assay utilizes a modified KIMS technology relative to the currently marketed Roche COBAS INTEGRA Cocaine Metabolite assay. Differences between this application and the cleared assay include:

- . use of a benzoylecgonine monoclonal antibody (mouse) attached to microparticles in solution,
- . a soluble drug-polymer conjugate,
- addition of a cutoff concentration of 150 ng/ml, and
- . use of new calibrators and unassayed controls.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

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

> k023296 Trade/Device Name: Roche Diagnostics ONLINE DAT II Cocaine II Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: October 1, 2002 Received: October 2, 2002

Dear Mr. Kaufman:

Re:

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. Iisting 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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Page 2.

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). 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

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| 510(k) Number (if known): | K023296 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Roche Diagnostics ONLINE DAT II Cocaine II |
| Indications for Use: | The cassette COBAS INTEGRA Cocaine II contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine at cutoff concentrations of 150 ng/ml and 300 ng/ml. Semiquantitative 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) | <div> <img alt="Checkmark" src=""/> </div> |
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OR Over-the-Counter Use ______

(Optional format 1-2-96)

Sean Croger

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number: K023296