ROCHE ONLINE TDM PHENYTOIN

K030428 · Roche Diagnostics Corp. · DIP · Apr 28, 2003 · Clinical Toxicology

Device Facts

• Record ID: K030428
• Device Name: ROCHE ONLINE TDM PHENYTOIN
• Applicant: Roche Diagnostics Corp.
• Product Code: DIP · Clinical Toxicology
• Decision Date: Apr 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3350
• Device Class: Class 2

Intended Use

The Roche ONLINE Phenytoin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of phenytoin, an anti-convulsant drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.

Device Story

In vitro diagnostic reagent system for quantitative phenytoin measurement in human serum or plasma; used on automated clinical chemistry analyzers (Roche/Hitachi 911, 912, 917, and Modular P). Operates via automated laboratory workflow; results provided to clinicians for monitoring anti-convulsant therapy and managing phenytoin overdose. Benefits include optimized drug dosing and toxicity prevention.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (N=106) and method comparison against Abbott TDx Phenytoin Assay. Precision (CV%) ranged from 1.3% to 6.1% across three levels. Method comparison yielded R=0.992, slope=0.99, and range 1.68–40.0 µg/mL, demonstrating equivalence to predicate.

Technological Characteristics

In vitro diagnostic reagent system for automated clinical chemistry analyzers. Quantitative assay principle. Compatible with Roche/Hitachi 911, 912, 917, and Modular P platforms.

Indications for Use

Indicated for quantitative determination of phenytoin in human serum or plasma for patients requiring monitoring of anti-convulsant therapy or diagnosis/treatment of phenytoin overdose.

Regulatory Classification

Identification

A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.

Predicate Devices

• Roche CEDIA Phenytoin II Assay (K963840)

Reference Devices

• Abbott TDx Phenytoin Assay

Submission Summary (Full Text)

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# APR 2 8 2003

K030428

### Roche ONLINE Phenytoin 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 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Date Prepared: February 6, 2003 |
| 2) Device name | Roche ONLINE Phenytoin |
| 3) Predicate device | We claim substantial equivalence to the Roche CEDIA Phenytoin II Assay [K963840]. |
| 4) Device Description | The Roche ONLINE Phenytoin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of phenytoin, an anti-convulsant drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Phenytoin reagent kits. |

Continued on next page

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K030428

and the comments of the country

# 510(k) Summary, Continued

| 5) Intended use | For the quantitative determination of phenytoin in human serum or plasma on<br>automated clinical chemistry analyzers. | | | | | | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|------------------------------------------|---------|---------|---------|---------|
| 6) Comparison<br>to predicate<br>device | The Roche ONLINE Phenytoin was evaluated for several performance<br>characteristics, including precision, lower detection limit, method<br>comparison, specificity, and interfering substances. All of the evaluation<br>studies gave acceptable results compared to the predicate device. These<br>experiments provide evidence that the Roche ONLINE Phenytoin Assay is<br>substantially equivalent to the currently marketed Roche CEDIA Phenytoin<br>II Assay. The following table presents the precision and method comparison results. | | | | | | |
| | | Roche ONLINE Phenytoin | Roche CEDIA Phenytoin II,<br>(Predicate) | | | | |
| | | Versus Abbott TDx Phenytoin Assay | Versus Abbott TDx Phenytoin Assay | | | | |
| | | N = 106 | N= 108 | | | | |
| | | Y = 0.99X-0.865 | Y=0.99X-1.43 | | | | |
| | | R = 0.992 | R=0.993 | | | | |
| | | Range = 1.68 to 40.0 µg/mL | Range = 1.1 to 40.0 µg/mL | | | | |
| | NCCLS<br>Precision: | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| | Mean (µg/mL) | 6.49 | 13.39 | 22.87 | 6.3 | 14.8 | 26.8 |
| | CV% (within run) | 2.7 | 1.4 | 1.5 | 3.2 | 2.0 | 1.3 |
| | CV% (total) | 6.1 | 4.5 | 4.3 | 5.1 | 3.1 | 2.3 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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APR 2 8 2003

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, IN 46250-0457

Re: k030428

> Trade/Device Name: Roche ONLINE Phenytoin Assay Regulation Number: 21 CFR 862.3350 Regulation Name: Diphenlhydantoin Test System Regulatory Class: Class II Product Code: DIP Dated: February 6, 2003 Received: February 10, 2003

Dear Mr. Flis:

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 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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### Roche Diagnostics Corporation

Ko30428 510(k) Number (if known): Device Name: Roche ONLINE Phenytoin Assay Indications for Use:

The Roche ONLINE Phenytoin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of phenytoin, an anti-convulsant drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.

Franc

(Division Sign-Off)
Division Minical Laboratory Dev
510(k) K030428

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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)