ROCHE ONLINE GENTAMICIN

K020704 · Roche Diagnostics Corp. · LCD · Jul 12, 2002 · Clinical Toxicology

Device Facts

• Record ID: K020704
• Device Name: ROCHE ONLINE GENTAMICIN
• Applicant: Roche Diagnostics Corp.
• Product Code: LCD · Clinical Toxicology
• Decision Date: Jul 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3450
• Device Class: Class 2

Intended Use

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

Device Story

In vitro diagnostic reagent system for quantitative measurement of gentamicin in human serum or plasma; used on automated clinical chemistry analyzers (Roche/Hitachi 911, 912, 917, and Modular P). Operates via automated laboratory workflow; clinician orders test; laboratory technician processes patient sample on analyzer; analyzer performs assay and provides numerical concentration output. Results used by physicians to monitor therapeutic drug levels and manage potential overdose. Benefits include optimized antibiotic dosing and improved patient safety.

Clinical Evidence

Bench testing only. Performance evaluated via method comparison against predicate (N=112, R=0.984, range 0.17–7.81 µg/mL) and precision studies. Within-run CV% ranged 0.7–1.0%; total CV% ranged 2.7–3.2%. Specificity and interfering substances also assessed.

Technological Characteristics

In vitro diagnostic reagent system for automated clinical chemistry analyzers. Utilizes automated photometric/turbidimetric sensing principle. Compatible with Roche/Hitachi 911, 912, 917, and Modular P platforms. Reagent-based assay.

Indications for Use

Indicated for quantitative determination of gentamicin in human serum or plasma for patients requiring monitoring of antibiotic levels or diagnosis/treatment of gentamicin overdose.

Regulatory Classification

Identification

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

Predicate Devices

• COBAS INTEGRA Gentamicin Assay

Submission Summary (Full Text)

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KC020704

# JUL 12 2002

# Roche ONLINE Gentamicin 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>Contact Person: Mike Flis<br>Date Prepared: Februray 27, 2002 |
| 2) Device name | Roche ONLINE Gentamicin |
| 3) Predicate device | We claim substantial equivalence to the COBAS INTEGRA Gentamicin Assay. |
| 4) Device Description | The Roche ONLINE Gentamicin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin 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 Gentamicin reagent kits. |

Continued on next page

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### 510(k) Summary, Continued

comparison results.

1 - 12

| 5) Intended use | For the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6) Comparison to predicate device | The Roche ONLINE Gentamicin 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 Gentamicin Assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA |

| Roche ONLINE Gentamicin | | | | Roche COBAS INTEGRA Gentamicin,<br>(Predicate) | | |
|-----------------------------------------------------------------------|---------|---------|---------|------------------------------------------------|---------|---------|
| Roche/Hitachi 917 versus Gentamicin assay on<br>the COBAS INTEGRA 700 | | | | Versus COBAS FARA II Gentamicin<br>assay | | |
| N = 112 | | | | N= 145 | | |
| Y = $1.104x - 0.022$ | | | | Y = $1.025x - 0.029$ | | |
| R = 0.984 | | | | R = 0.998 | | |
| Range = 0.17 to 7.81 µg/mL | | | | Range = 0.5 to 10.0 µg/mL | | |
| Precision: | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Mean (µg/mL) | 3.36 | 6.26 | 7.96 | 1.4 | 4.0 | 4.9 |
| CV% (within run) | 1.0 | 0.9 | 0.7 | 3.0 | 1.9 | 2.1 |
| CV% (total) | 2.9 | 3.2 | 2.7 | 3.4 | 1.8 | 2.1 |

Gentamicin Assay. The following table presents the precision and method
comparison results.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three curved lines representing the eagle's head and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

.JUI 12 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Mike Flis Regulatory Affairs Principle 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

k020704 Re:

> Trade/Device Name: Roche ONLINE Gentamicin Assay Regulation Number; 21 CFR 862.3450 Regulation Name: Gentamicin test system Regulatory Class: Class II Product Code: LCD Dated: June 7, 2002 Received: June 10, 2002

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 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.

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

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): Device Name: Roche ONLINE Gentamicin Assay Indications for Use:

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

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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020704

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) \$\checkmark\$

OR

Over-The-Counter Use

(Optional Format 1-2-96)