GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K984608 · Oxoid , Ltd. · JTN · Mar 9, 1999 · Microbiology

Device Facts

• Record ID: K984608
• Device Name: GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
• Applicant: Oxoid , Ltd.
• Product Code: JTN · Microbiology
• Decision Date: Mar 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Intended Use

Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Gentamicin 120µg these include Enterococcus spp. Gentamicin 120 Susceptibility Test Discs are for detection of 'high level antibiotic resistance'.

Device Story

Oxoid Gentamicin Antimicrobial Susceptibility Test Discs (120µg) are used in clinical microbiology laboratories for in vitro diagnostic testing. The device consists of paper discs impregnated with a specific concentration of gentamicin. In the agar diffusion procedure, discs are placed on inoculated agar plates; the antibiotic diffuses into the medium, inhibiting bacterial growth. The healthcare provider measures the zone of inhibition around the disc to determine the susceptibility of the microorganism. This semi-quantitative result assists clinicians in identifying high-level antibiotic resistance in Enterococcus spp., guiding appropriate antibiotic therapy selection for patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Antimicrobial susceptibility test disc; paper disc impregnated with 120µg gentamicin; agar diffusion principle; in vitro diagnostic use.

Indications for Use

Indicated for semi-quantitative susceptibility testing of rapidly growing microorganisms, specifically Enterococcus spp., to detect high-level antibiotic resistance using agar diffusion methods.

Regulatory Classification

Identification

An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR - 9 1000

Andy Hollingsworth Regulatory Affairs Manager Oxoid Limited Wade Road Basingstoke Hants RG24 8PW England

K984608 Re:

Trade Name: Oxoid Gentamicin Antimicrobial Susceptibility Test Disc Regulatory Class: II Product Code: JTN Dated: November 24, 1998 Received: December 28, 1998

Dear Mr. Hollingsworth:

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 OS 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.

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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 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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## 510(K) Submission for Oxoid Antimicrobial Susceptibility Test Disc

## GENTAMICIN

## OXOID LTD

Oxoid Gentamicin Susceptibility Test Disc Device Name :

## Indication for Use :

Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Gentamicin 120µg these include Enterococcus spp. Gentamicin 120 Susceptibility Test Discs are for detection of 'high level antibiotic resistance'.

Wooley Dubois

PRESCRIPTION USE X