VANCOMYCIN EIA ASSAY

K983280 · Diagnostic Reagents, Inc. · LEH · Nov 6, 1998 · Clinical Toxicology

Device Facts

• Record ID: K983280
• Device Name: VANCOMYCIN EIA ASSAY
• Applicant: Diagnostic Reagents, Inc.
• Product Code: LEH · Clinical Toxicology
• Decision Date: Nov 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3950
• Device Class: Class 2

Intended Use

The Vancomycin Enzyme Immunoassay is intended for in vitro diagnostic use for quantitative determination of vancomycin in human serum or plasma.

Device Story

Vancomycin Enzyme Immunoassay; in vitro diagnostic test for quantitative measurement of vancomycin levels in human serum or plasma. Used in clinical laboratory settings by trained personnel. Provides concentration data to assist clinicians in therapeutic drug monitoring of vancomycin, ensuring appropriate dosing and minimizing toxicity. Operates via enzyme immunoassay principle.

Technological Characteristics

Enzyme immunoassay (EIA) for quantitative analysis of vancomycin in serum/plasma samples.

Indications for Use

Indicated for the quantitative determination of vancomycin in human serum or plasma for in vitro diagnostic use.

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.

Submission Summary (Full Text)

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6 1998 NOV

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Yuh-geng Tsay, Ph.D. President Diagnostic Reagents, Inc. 601 California Avenue Sunnyvale, CA 94086

Re: K983280 Trade Name: Vancomycin EIA Assay Regulatory Class: II Product Code: LEH Dated: September 16, 1998 Received: September 18, 1998

Dear Dr. Tsay:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Image /page/0/Picture/9 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines representing hair or clothing. The overall design is simple and recognizable, representing the department's focus on health and human well-being.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

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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510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________ VANCOMYCIN ENZTME IMMUNOASSAY Device Name:

Indications For Use:

The Vancomycin Enzyme Immunoassay is intended for in vitro diagnostic use for quantitative determination of vancomycin in human serum or plasma.

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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) | |

| (Division Sign-Off) | |
|-----------------------------------------|----------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | 47983288 |