COBAS INTEGRA ONLINE DAT II METHADONE II

K021512 · Roche Diagnostics Corp. · DJR · Jul 16, 2002 · Clinical Toxicology

Device Facts

• Record ID: K021512
• Device Name: COBAS INTEGRA ONLINE DAT II METHADONE II
• Applicant: Roche Diagnostics Corp.
• Product Code: DJR · Clinical Toxicology
• Decision Date: Jul 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

Intended Use

The cassette COBAS INTEGRA Methadone II contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of methadone in human urine at a cutoff concentration of 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 methadone in human urine. Uses Kinetic Interaction of Microparticles in Solution (KIMS) technology; drug in sample competes with drug-polymer conjugate for microparticle-bound antibody; aggregation inhibited by presence of drug. Absorbance changes measured photometrically; inverse relationship between drug concentration and light transmission/absorbance. Provides semiquantitative and qualitative results to clinicians for drug screening. Used in clinical laboratory settings; operated by laboratory personnel. Benefits patient by providing rapid, automated assessment of methadone presence.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent system; KIMS (Kinetic Interaction of Microparticles in Solution) technology; photometric detection of light transmission changes; utilizes methadone monoclonal antibody on microparticles and soluble drug-polymer conjugate; designed for use on COBAS INTEGRA automated systems.

Indications for Use

Indicated for the semiquantitative and qualitative detection of methadone in human urine at a 300 ng/ml cutoff concentration. Intended for laboratory use.

Regulatory Classification

Identification

A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

Special Controls

*Classification.* Class II (special controls). A methadone 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 Methadone (K951595)

Submission Summary (Full Text)

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510(k) Summary According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. 1) Submitter Roche Diagnostics Corporation name, address, 9115 Hague Rd. contact Indianapolis, IN 46250-0457 [phone] Contact Person: Kerwin Kaufman Date Prepared: May 8, 2002 Proprietary name: COBAS INTEGRA ONLINE DAT II Methadone II 2) Device name Common name: Methadone Test System Classification name: Enzyme immunoassay, methadone We claim substantial equivalence to the currently marketed Roche COBAS 3) Predicate device INTEGRA Methadone assay (K951595). のお気になっています。 この時間のお店は、 2007年には、 2007年には、 2007年には、 2005年には、 2008年の 2007年に、 2007年( 2008年) 2007年( 2008年) 2007年( 2008年) 2007年( 2008年) 2007年( 2008年) 2007年( 2008年) 2007年( 2008年) 2

JUL 1 6 2002

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# 510(k) Summary, Continued

The cassette COBAS INTEGRA Methadone II contains an in vitro diagnostic 4) Device Description reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of methadone in human urine at a cutoff concentration of 300 ng/ml.

### Principal of procedure

The COBAS INTEGRA ONLINE DAT II Methadone 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

| 5.) Intended<br>Use | The cassette COBAS INTEGRA Methadone II contains an in vitro diagnostic<br>reagent system intended for use on COBAS INTEGRA systems for the semi-<br>quantitative and qualitative detection of methadone in human urine at a cutoff<br>of 300 ng/ml. |
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| 6.) Comparison<br>to the Predicate<br>Device | The Roche COBAS INTEGRA ONLINE DAT II Methadone II assay is<br>substantially equivalent to other products in commercial distribution intended<br>for similar use. Most notably, it is substantially equivalent to the currently<br>marketed Roche COBAS INTEGRA Methadone (K951595).<br><br>The Roche COBAS INTEGRA ONLINE DAT II Methadone II assay utilizes<br>a modified KIMS technology relative to the currently marketed COBAS<br>INTEGRA Methadone assay. Differences between this application and the<br>cleared assay include:<br>use of a methadone monoclonal antibody attached to<br>microparticles in solution, a soluble drug-polymer conjugate, and use of new calibrators and unassayed controls. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road JE - JE - JE - JE - JE - JE - JE - JE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Rockville MD 20850

JUL 1 6 2002

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

Re: k021512

> Trade/Device Name: Roche Diagnostics COBAS INTEGRA DAT II Methadone II Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR Dated: May 8, 2002 Received: May 9, 2002

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 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 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.

Page 2 Station and Parties and portugues and port and more and mind the first and

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" (21CFR 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 Butman

無意識を見てきる。しているのは、との出来ました。

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): | K021512 |
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| Device Name: | Roche Diagnostics COBAS INTEGRA ONLINE DAT II Methadone II |
| Indications for Use: | The cassette COBAS INTEGRA Methadone II contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of methadone in human urine at a cutoff concentration of 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) | OR Over-the-Counter Use |
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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021512

(Optional format 1-2-96)

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