ENZYME IMMUNOASSAY, VANCOMYCIN

K060586 · Roche Diagnostics Corp. · LEH · May 11, 2006 · Clinical Toxicology

Device Facts

• Record ID: K060586
• Device Name: ENZYME IMMUNOASSAY, VANCOMYCIN
• Applicant: Roche Diagnostics Corp.
• Product Code: LEH · Clinical Toxicology
• Decision Date: May 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3950
• Device Class: Class 2

Intended Use

The ONLINE TDM Vancomycin assay is for the quantitative determination of vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Device Story

ONLINE TDM Vancomycin is a homogeneous enzyme immunoassay for quantitative vancomycin measurement in human serum or plasma. Operates on Roche automated clinical chemistry analyzers (Hitachi 911, 912, 917, Modular P). Principle: competition between sample drug and enzyme-labeled drug (G6PDH) for antibody binding sites; enzyme activity inversely proportional to drug concentration. Active enzyme converts NAD to NADH, measured spectrophotometrically via absorbance change. Used in clinical laboratories by technicians/physicians to monitor therapeutic levels and manage overdose. Results assist clinicians in adjusting vancomycin dosing to ensure therapeutic efficacy and patient safety.

Clinical Evidence

Bench testing only. Precision studies (CLSI EP5-T2) showed total CVs ranging from 2.7% to 5.8% across concentrations. Linearity confirmed from 1.7 to 80 μg/mL. Method comparison (n=55) against predicate yielded Passing-Bablok slope 1.038, r=0.99, y-intercept 0.094. Analytical specificity testing showed no cross-reactivity with 34 tested compounds or interference from common serum components (bilirubin, hemoglobin, lipemia, rheumatoid factor, total protein).

Technological Characteristics

Homogeneous enzyme immunoassay; reagents include G6PDH-labeled vancomycin, mouse monoclonal anti-vancomycin antibodies, NAD, G6P, and buffers. Operates on Roche/Hitachi 911, 912, 917, and MODULAR P automated analyzers. Measures absorbance change spectrophotometrically. Storage 2–8°C. Traceable to USP reference standards.

Indications for Use

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

Regulatory Classification

Identification

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

Predicate Devices

• Roche COBAS INTEGRA Vancomycin assay (k954992)

Submission Summary (Full Text)

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Ko60586

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MAY 11 2006

## 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] |
|-------------------------------------|------------------------------------------------------------------------------------------------|
| | Contact Person: Dimitris Demirtzoglou |
| | Date Prepared: February 28, 2006 |
| 2) Device name | Proprietary name: ONLINE TDM Vancomycin |
| | Common name: Enzyme Immunoassay, Vancomycin |
| | Classification name: RADIOIMMUNOASSAY, VANCOMYCIN |
| 3) Predicate device | We claim substantial equivalence to the currently marketed COBAS INTEGRA Vancomycin (K954992). |

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## 510(k) Summary, Continued

4) Device The ONLINE TDM Vancomycin assay is for the quantitative Description determination of vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Vancomycin reagent kits. The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of vancomycin in human serum or plasma.8 The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroids) enzyme employed in the assay. 5.) Intended The ONLINE TDM Vancomycin assay is for the quantitative Use determination of vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers. Continued on next page

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## 510(k) Summary, Continued

The Roche ONLINE TDM Vancomycin 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 Vancomycin assay (K954992).

> The Roche ONLINE TDM Vancomycin 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 Vancomycin assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Vancomycin assay. The following table summarizes the precision and method comparison results.

| | Roche ONLINE TDM Vancomycin | | | Roche COBAS INTEGRA Vancomycin<br>(Predicate) | | |
|--------------------------------|--------------------------------------------------------------------------------------------------|-----------|-----------|----------------------------------------------------------------------------|-----------|-----------|
| NCCLS Precision,<br>Within run | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Mean (µg/ml) | 6.8 | 21.0 | 39.1 | 3.8 | 8.6 | 14.7 |
| SD (µg/ml) | 0.34 | 0.29 | 0.45 | 0.08 | 0.17 | 0.31 |
| CV% | 4.9 | 1.4 | 1.1 | 2.2 | 1.9 | 2.1 |
| NCCLS Precision,<br>Total | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Mean (µg/ml) | 6.8 | 21.0 | 39.1 | 3.8 | 8.6 | 14.7 |
| SD (µg/ml) | 0.40 | 0.60 | 1.04 | 0.12 | 0.24 | 0.52 |
| CV% | 5.8 | 2.9 | 2.7 | 3.0 | 2.8 | 3.6 |
| Method<br>Comparison | Linear Regression: ONLINE TDM<br>Carbamazepine Vs. COBAS INTEGRA<br>Carbamazepine (FPIA) method. | | | Linear Regression: COBAS INTEGRA<br>Carbamazepine (FPIA) Vs. COBAS FARA II | | |
| | N=55, Range = 5.0-67.2 µg/ml<br>y=1.038x - 0.094<br>r=0.991 | | | N=193, Range = 1.41-68.1 µg/ml<br>y=0.958x - 0.386<br>r=0.995 | | |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Dimitris Demirtzoglou Regulatory Affairs Consultant Roche Diagnostic Corp. 9115 Hague Rd. Indianapolis, IN 46250

MAY 1 1 2006

Re: k060586

> Trade/Device Name: ONLINE TDM Vancomycin Regulation Number: 21 CFR8862.3950 Regulation Name: Vancomycin test system Regulatory Class: Class II Product Code: LEH Dated: March 6, 2006 Received: March 7. 2006

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 no 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 mber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Alberto G
Alberto Gutie PhD

Alberto Gutierrez, Ph.D. 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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## Indications for Use

510(k) Number (if known):

60586

Device Name: ONLINE TDM Vancomycin

Indications For Use:

The ONLINE TDM Vancomycin assay is for the quantitative determination of vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

A.C.W.

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Office of In Vitro Diagnostic Device Brunnerion and Salery

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