ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620

K071644 · Roche Diagnostics Corp. · DLZ · Sep 12, 2007 · Clinical Toxicology

Device Facts

• Record ID: K071644
• Device Name: ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620
• Applicant: Roche Diagnostics Corp.
• Product Code: DLZ · Clinical Toxicology
• Decision Date: Sep 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3660
• Device Class: Class 2

Intended Use

The ONLINE TDM Phenobarbital assay is for the quantitative determination of phenobarbital in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital.

Device Story

The ONLINE TDM Phenobarbital assay is an in vitro diagnostic reagent kit used on Roche automated clinical chemistry analyzers (Hitachi 912, 917, and Modular P). It measures phenobarbital concentrations in human serum or plasma samples. The assay utilizes enzyme immunoassay technology to quantify drug levels. Clinicians use these quantitative results to individualize patient dosage, achieve maximal seizure control, minimize side effects, and diagnose potential overdose. The device is intended for use in clinical laboratory settings by trained laboratory personnel. By providing accurate, automated monitoring of serum drug levels, the device assists healthcare providers in optimizing therapeutic regimens for patients with epilepsy.

Clinical Evidence

Bench testing only. Precision studies (within-run and total) performed on Hitachi 917 showed CVs < 5% at high concentrations. Linearity assessed across 2.4–60 µg/mL range with recoveries 89.39%–113.75%. Method comparison against predicate (n=53) yielded a correlation of R=0.996 and slope of 1.047. Interference studies confirmed no significant impact from bilirubin, hemolysis, lipemia, proteins, or common drugs.

Technological Characteristics

Quantitative homogeneous enzyme immunoassay (KIMS). Reagents: phenobarbital conjugate, mouse monoclonal anti-phenobarbital antibody, latex microparticles, MOPS buffer, stabilizers, preservatives. Measuring range: 2.4–60 µg/mL. Instrumentation: Roche/Hitachi 912, 917, and MODULAR P analyzers. Connectivity: Automated clinical chemistry analyzer integration. Storage: 2-8°C.

Indications for Use

Indicated for quantitative determination of phenobarbital in human serum or plasma for patients requiring monitoring of phenobarbital levels for the diagnosis and treatment of phenobarbital use or overdose, including management of grand mal, psychomotor, and focal epilepsy.

Regulatory Classification

Identification

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

Predicate Devices

• Roche COBAS INTEGRA Phenobarbital assay (k951595)

Submission Summary (Full Text)

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K071644

| 510(k) Summary | SEP 12 2007 |
|----------------|-------------|
|----------------|-------------|

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: Dimitris Demirtzoglou |
| 2) Device name | Proprietary name: ONLINE TDM Phenobarbital |
| | Common name: Enzyme Immunoassay, Phenobarbital |
| | Classification name: Enzyme Immunoassay, Phenobarbital |
| 3) Predicate device | We claim substantial equivalence to the currently marketed COBAS INTEGRA Phenobarbital (K951595). |
| 4) Device Description | The ONLINE TDM Phenobarbital assay is for the quantitative determination of phenobarbital in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital. The proposed labeling indicates the Roche Hitachi 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Phenobarbital reagent kits. |

Phenobarbital is one of the most commonly used drugs for the treatment of grand mal, psychomotor epilepsy, and other forms of focal epilepsy. Monitoring of the serum level of the drug is essential in order to achieve maximal seizure control while maintaining minimal blood levels to avoid negative side effects. As with other anti-convulsant drugs, it is imperative that each patient's dosage be individualized.

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The ONLINE TDM Phenobarbital assay is for the quantitative determination 5.) Intended Use of phenobarbital in human serum or plasma on Roche automated clinical chemistry analyzers.

## 510(k) Summary, Continued

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

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

Continued on next page

| | Roche COBAS Integra Phenobarbital<br>(Predicate) | | | Roche ONLINE TDM Phenobarbital | | |
|--------------------------------|------------------------------------------------------------|-----------|-----------|------------------------------------------------------------------------------|-----------|-----------|
| NCCLS Precision,<br>Within run | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Mean (µg/ml) | 12.0 | 23.4 | 52.0 | 9.6 | 24.1 | 45.2 |
| SD (µg/ml) | 0.25 | 0.51 | 1.52 | 0.13 | 0.18 | 0.37 |
| CV% | 2.1 | 2.2 | 2.9 | 1.3 | 0.7 | 0.8 |
| NCCLS Precision,<br>Total | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Mean (µg/ml) | 12.0 | 23.4 | 52.0 | 9.6 | 24.1 | 45.2 |
| SD (µg/ml) | 0.26 | 0.62 | 2.04 | 0.34 | 0.59 | 0.82 |
| CV% | 2.2 | 2.7 | 3.9 | 3.5 | 2.4 | 1.8 |
| Method<br>Comparison | Linear Regression: COBAS Integra<br>Phenobarbital Vs. FPIA | | | Linear Regression: ONLINE TDM<br>Phenobarbital Vs. COBAS FP<br>Phenobarbital | | |
| | N=206, Range = 0.8 - 60 µg/ml | | | N=53, Range = 3.0 - 52.4 µg/ml | | |
| | y = 1.036x - 1.236 | | | y= 1.047x - 0.339 | | |
| | r = 0.995 | | | r=0.996 | | |

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines forming the body and wings.

SEP 1 2 2007

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Roche Diagnostics Corporation c/o Mr. Dimitris Demirtzoglou Regulatory Affairs Consultant 9115 Hague Road Indianapolis, IN 46250

Re: k071644 Trade/Device Name: Online TDM Phenobarbital Regulation Number: 21 CFR 862.3660 Regulation Name: Phenobarbital test system Regulatory Class: Class II Product Code: DLZ Dated: June 14, 2007 Received: June 15, 2007

Dear Mr. Demirtzoglou:

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indication for Use

KO71644 510(k) Number (if known):

Device Name: ONLINE TDM Phenobarbital

Indication For Use:

The ONLINE TDM Phenobarbital assay is for the quantitative determination of phenobarbital in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Carol C. Benson
Revision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

071644

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