CEDIA VANCOMYCIN ASSAY

K032811 · Microgenics Corp. · LEH · Nov 24, 2003 · Clinical Toxicology

Device Facts

• Record ID: K032811
• Device Name: CEDIA VANCOMYCIN ASSAY
• Applicant: Microgenics Corp.
• Product Code: LEH · Clinical Toxicology
• Decision Date: Nov 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3950
• Device Class: Class 2

Intended Use

The CEDIA® Vancomycin Assay is a homogenous immunoassay intended for in vitro diagnostic use in the quantitative determination of vancomycin in human serum or plasma.

Device Story

The CEDIA Vancomycin Assay is a homogeneous enzyme immunoassay used for quantitative measurement of vancomycin in human serum or plasma. It utilizes recombinant DNA technology to produce bacterial β-galactosidase engineered into two inactive fragments: enzyme acceptor (EA) and enzyme donor (ED). In the assay, vancomycin in the patient sample competes with vancomycin conjugated to the ED fragment for antibody binding sites. If vancomycin is present, it binds to the antibody, allowing EA and ED to reassociate into active enzyme; the active enzyme cleaves a substrate, producing a color change measured spectrophotometrically. The absorbance change is directly proportional to the vancomycin concentration in the sample. The assay is performed in a clinical laboratory setting. Results assist healthcare providers in monitoring vancomycin levels to ensure appropriate therapy and avoid toxicity. The device is intended for in vitro diagnostic use.

Clinical Evidence

No clinical data provided; substantial equivalence demonstrated through comparison of intended use and physical properties to the predicate device.

Technological Characteristics

Homogeneous enzyme immunoassay; utilizes recombinant DNA-derived β-galactosidase fragments. Measurement via spectrophotometry. Liquid calibrators. Storage at 2°C to 8°C. In vitro diagnostic use.

Indications for Use

Indicated for the quantitative determination of vancomycin in human serum or plasma for patients requiring therapeutic drug monitoring of vancomycin levels.

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

• AxSYM® Vancomycin II (K955851)

Submission Summary (Full Text)

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K032811

# SECTION II

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

### 510(k) Number:

#### Submitter:

Microgenics Corporation 46360 Fremont Blvd Fremont, CA 94538 Telephone: [phone] Facsimile: [phone]

## Contact Person:

David Casal, Ph.D. Vice-President, Clinical, Regulatory and Quality Affairs Telephone: [phone] Facsimile: [phone]

## Preparation Date:

September 8, 2003

#### Device Information:

| Device Classification Name: | Radioimmunoassay, Vancomycin |
|-----------------------------|------------------------------------|
| Common/Usual Name: | Vancomycin Immunoassay Test System |
| Proprietary Name: | CEDIA® Vancomycin Assay |
| Regulation Number: | 21 CFR§862.3950 |
| Regulatory Name: | Vancomycin tesystem |
| Product Code: | LEH |
| Regulatory Class: | Class II |

## Predicate Devices:

The CEDIA® Vancomycin Assay is substantially equivalent to the AxSYM® Vancomycin II (Abbott Diagnostics, Abbott Park, IL) (K955851) for its stated intended use.

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## Device Description:

The CEDIA® Vancomycin Assay uses recombinant DNA technology (US Patent No. 4708929) to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-galactosidase, which has been genetically engineered into two inactive fragments i.e., enzyme acceptor (EA) and enzyme donor (ED). These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically.

In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment of B-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive 8-galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample.

## Intended Use:

The CEDIA® Vancomycin Assay is a homogenous enzyme immunoassay intended for in vitro diagnostic use in the quantitative determination of vancomycin in human serum or plasma for the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

## Comparison to Predicate Device(s):

The CEDIA® Vancomycin Assay is substantially equivalent to the Abbott AxSYM® Vancomycin II (K955851) in its intended use and principle of use.

| Device<br>Characteristics | Subject Device | Predicate Device<br>(K955851) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CEDIA® Vancomycin Assay is a<br>homogenous enzyme immunoassay<br>intended for in vitro diagnostic use in<br>the quantitative determination of<br>vancomycin in human serum or<br>plasma for the diagnosis and treatment<br>of vancomycin overdose and in<br>monitoring the level of vancomycin to<br>ensure appropriate therapy. | AxSYM® Vancomycin II (K955851)<br>is a reagent system for the quatitative<br>measurement of vancomycin, an<br>antibiotic drug, in serum or plasma.<br>The measurements obtained are used<br>in the diagnosis and treatment of<br>vancomycin overdose and in<br>monitoring levels of vancomycin to<br>ensure appropriate therapy. |
| Analyte | Vancomycin | Vancomycin |
| Matrix | Serum or plasma | Serum or plasma |
| Calibrator Form | Liquid | Liquid |
| Calibrator Levels | Two (2) Levels (0 and 50 µg/mL) | Six (6) Levels |
| Storage | 2°C to 8°C until expiration date | 2°C to 8°C until expiration date |
| Stability | Until expiration date noted on vial<br>label and Package Insert for Kit and<br>reconstituted reagents. | Until expiration date noted on vial<br>label. |

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### Summary:

The information provided in this pre-market notification demonstrates that the CEDIA® Vancomycin Assay is substantially equivalent to the Abbott AxSYM® Vancomycin II assay, the previously cleared predicate device (K955851). Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device. The information supplied in this pre-market notification provides reasonable assurance that the CEDIA® Vancomycin Assay is safe and effective for its stated intended use.

CEDIA® is a registered trademark of Roche Diagnostics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles. The profiles and lines are arranged to resemble a bird in flight. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

NOV 2 4 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

David Casal, Ph.D. VP, Clinical, Regulatory and Quality Affairs Microgenics Corporation 46360 Fremont Blvd. Fremont, CA 94538

Re: k032811

Trade/Device Name: CEDIA® Vancomycin Assay Regulation Number: 21 CFR 862.3950 Regulation Name: Vancomycin test system Regulatory Class: Class II Product Code: LEH Dated: September 8, 2003 Received: September 12, 2003

Dear Dr. Casal:

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 Putman

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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## SECTION III

# INDICATIONS FOR USE STATEMENT

#### 510(k) Number (if known):

CEDIA® Vancomycin Assay Device name:

#### Indications for Use:

The CEDIA® Vancomycin Assay is a homogenous enzyme immunoassay intended for in vitro diagnostic use in the quantitative determination of vancomycin in human serum or plasma for the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Alberto Sutz

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Division Sign-Off for Jean Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k032811

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Prescription Use __ V

OR

Over-the Counter Use

(per 21 CFR §801.109)

(Optional Format 1-2-96)