ROCHE COBAS INTEGRA OPIATES 300/2000

K992890 · Roche Diagnostics Corp. · DJG · Nov 23, 1999 · Clinical Toxicology

Device Facts

• Record ID: K992890
• Device Name: ROCHE COBAS INTEGRA OPIATES 300/2000
• Applicant: Roche Diagnostics Corp.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Nov 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

The cassette COBAS INTEGRA Opiates contains an in vitro diagnostic reagent test system intended for use on the COBAS INTEGRA 700 for the semiquantitative and qualitative detection of morphine and its metabolites at cutoff concentrations of 300 and 2000 ng/mL in human urine.

Device Story

The Roche COBAS INTEGRA Opiates is an in vitro diagnostic reagent system used on the COBAS INTEGRA 700 analyzer. It detects morphine and its metabolites in human urine samples. The device utilizes Kinetic Interaction of Microparticles in Solution (KIMS) technology. In the absence of drug, soluble drug-polymer conjugates bind to antibody-coated microparticles, causing aggregation and increased light absorbance. When drug is present in the urine, it competes with the conjugate for antibody binding, inhibiting aggregation and reducing the absorbance increase. The system compares sample absorbance to a known cutoff concentration to provide qualitative or semiquantitative results. It is intended for professional use in clinical laboratory settings to assist in drug testing. The output allows healthcare providers to identify the presence of opiates, aiding in clinical decision-making regarding patient drug status.

Clinical Evidence

No clinical data provided; substantial equivalence is based on performance characteristics and technological similarities to the predicate device.

Technological Characteristics

In vitro diagnostic reagent system; KIMS (Kinetic Interaction of Microparticles in Solution) technology; measures changes in light transmission/absorbance; designed for use on COBAS INTEGRA 700 analyzer; semiquantitative and qualitative detection of morphine and metabolites.

Indications for Use

Indicated for the semiquantitative and qualitative detection of morphine and its metabolites in human urine at cutoff concentrations of 300 and 2000 ng/mL.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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 Abuscreen OnLine II for Opiates (K974840)

Submission Summary (Full Text)

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K992890

# NOV 2 3 1999

# 510(k) Summary

[

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><br>Contact person: Lisa M. Gerard<br><br>Date prepared August 26, 1999 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name | Proprietary name: Roche COBAS INTEGRA Opiates<br>Common name: Opiates test system<br>Classification name: Enzymatic Immunoassay, Opiate |
| 3) Predicate device | We claim substantial equivalence to the currently marketed Roche Abuscreen OnLine II for Opiates (K974840). |

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### 510(k) Summary, Continued

The cassette COBAS INTEGRA Opiates contains an in vitro diagnostic 4) Device description reagent test system intended for use on the COBAS INTEGRA 700 for the semiquantitative and qualitative detection of morphine and its metabolites at cutoff concentrations of 300 and 2000 ng/mL in human urine. The cassette COBAS INTEGRA Opiates is based on the kinetic interaction of microparticles in a solutions (KIMS) as a measured by changes in light transmission. In the absence of sample drug, soluble drug-polymer conjugate binds to antibody bound microparticle, causing the formation of particle aggregates. When a urine sample containing the dug in question is present, this drug competes with the drug conjugate 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 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

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#### 510(k) Summary, Continued

The cassette COBAS INTEGRA Opiates contains an in vitro diagnostic 5) Intended use reagent test system intended for use on the COBAS INTEGRA 700 for the semiquantitative and qualitative detection of morphine and its metabolites at cutoff concentrations of 300 and 2000 ng/mL in human urine. The Roche COBAS INTEGRA Opiates 300/2000 and the predicate device 6) Comparison to the predicate use the same reagents, and have similar performance characteristics. Modifications to the Roche COBAS INTEGRA Opiates 300/2000 include the device, similarities addition of: a 300 ng/mL semiquantitative cutoff and .

- an application for the Integra family of analyzers. .

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 3 1999

Ms. Lisa M. Gerard Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457

Re: K992890

> Trade Name: COBAS INTEGRA Opiates 300/2000 Regulatory Class: II Product Code: DJG Dated: November 8, 1999 Received: November 9, 1999

Dear Ms. Gerard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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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## Indications for Use Statement

| 510(k) Number (if known): | K992890 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Roche COBAS INTEGRA Opiates |
| Indications for Use: | The cassette COBAS INTEGRA Opiates contains an in vitro diagnostic reagent test system intended for use on the COBAS INTEGRA 700 for the semiquantitative and qualitative detection of morphine and its metabolites at cutoff concentrations of 300 and 2000 ng/mL in human urine. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use <span style="text-decoration:underline;">✓</span> (Per 21 CFR 801.109) | OR | Over-the-Counter Use ______ |
|-----------------------------------------------------------------------------------------|----|-----------------------------|
|-----------------------------------------------------------------------------------------|----|-----------------------------|

(Optional format 1-2-96)

Jean Cooper

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number K992890

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