ROCHE ONLINE THEOPHYLLINE

K020740 · Roche Diagnostics Corp. · KLS · Apr 16, 2002 · Clinical Toxicology

Device Facts

• Record ID: K020740
• Device Name: ROCHE ONLINE THEOPHYLLINE
• Applicant: Roche Diagnostics Corp.
• Product Code: KLS · Clinical Toxicology
• Decision Date: Apr 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3880
• Device Class: Class 2

Intended Use

For the quantitative determination of theophylline in human serum or plasma on automated clinical chemistry analyzers.

Device Story

In vitro diagnostic reagent system for automated clinical chemistry analyzers (Roche/Hitachi 911, 912, 917, and Modular P). Analyzes human serum or plasma samples to quantify theophylline levels. Used by clinical laboratory professionals to assist in diagnosing overdose and monitoring therapeutic drug levels. Provides quantitative results to healthcare providers for clinical decision-making regarding patient medication dosage and safety.

Clinical Evidence

Bench testing only. Performance evaluated via method comparison (n=103) against predicate, yielding R=0.996 and y=0.976x+0.011. Precision studies showed total CV% ranging from 1.7% to 2.1% across three concentration levels. No clinical patient trials reported.

Technological Characteristics

In vitro diagnostic reagent system for automated clinical chemistry analyzers. Utilizes established biochemical assay principles for theophylline quantification. Compatible with Roche/Hitachi 911, 912, 917, and Modular P analyzer platforms.

Indications for Use

Indicated for quantitative determination of theophylline in human serum or plasma for patients with asthma, apnea, or other obstructive lung diseases. Used for diagnosis/treatment of theophylline overdose and monitoring therapeutic levels.

Regulatory Classification

Identification

A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.

Predicate Devices

• COBAS INTEGRA Theophylline assay

Submission Summary (Full Text)

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## APR 1 6 2002

K020740

# Roche ONLINE Theophylline Assay

# 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: Mike Flis<br><br>Date Prepared: April 2, 2002 |
| 2) Device name | Roche ONLINE Theophylline |
| 3) Predicate device | We claim substantial equivalence to the COBAS INTEGRA Theophylline assay. |
| 4) Device Description | The Roche ONLINE Theophylline assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of theophylline, a bronchodilator, widely used to treat patients with asthma, apnea (temporary asphyxia), and other obstructive lung diseases, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure appropriate therapy. The proposed labeling indicates that the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Theophylline reagent kits. |
| 5) Intended use | For the quantitative determination of theophylline in human serum or plasma on automated clinical chemistry analyzers. |

Continued on next page

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### 510(k) Summary, continued

The Roche ONLINE Theophylline was evaluated for several performance 6) Comparison characteristics, including precision, lower detection limit, method to predicate comparison, specificity, and interfering substances. All of the evaluation device studies gave acceptable results compared to the predicate device. These experiments provide evidence that the Roche ONLINE Theophylline Assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Theophylline Assay. The following table presents the precision and method comparison results.

| Roche ONLINE Theophylline | | | | Roche COBAS INTEGRA<br>Theophylline (Predicate) | | |
|---------------------------------------------|---------|---------|---------|-------------------------------------------------|---------|---------|
| Roche/Hitachi 917 versus Theophylline assay | | | | Versus COBAS FARA II Theophylline | | |
| on the COBAS INTEGRA 700 | | | | assay | | |
| n = 103 | | | | n = 138 | | |
| $y = 0.976x + 0.011$ | | | | $y = 0.963x + 0.065$ | | |
| R = 0.996 | | | | R = 0.998 | | |
| Range = 0.62 to 39.6 μg/mL | | | | Range = 0.16 to 36.3 μg/mL | | |
| Precision: | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Mean (μg/mL) | 4.87 | 14.51 | 24.31 | 5.4 | 14.2 | 22.5 |
| CV% (within run) | 1.0 | 0.5 | 0.9 | 1.6 | 1.9 | 1.8 |
| CV% (total) | 1.9 | 1.7 | 2.1 | 2.6 | 2.6 | 2.8 |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Mike Flis Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457

Re: k020740

> Trade/Device Name: Roche ONLINE Theophylline Regulation Number: 21 CFR § 862.3880 Regulation Name: Theophylline Test System Regulatory Class: II Product Code: KLS Dated: March 1, 2002 Received: March 6, 2002

Dear Mr. Flis:

This letter corrects the letter dated April 9, 2002. The indications for use, was amended by Roche and a copy of new indications for use has been added to the file. 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.

APR 2 4 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 (OS) 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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Page 2

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" (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 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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### Roche Diagnostics Corporation

510(k) Number (if known): K020740 Device Name: Roche ONLINE Theophylline Assay Indications for Use:

The Roche ONLINE Theophylline assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of theophylline, a broncodilator, widely used to treat patients with asthma, apnea (temporary asphyxia), and other obstructive lung diseases. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.

Dan Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number K020740

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use √
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)