CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K971631 · Oxoid , Ltd. · JTN · Jul 3, 1997 · Microbiology

Device Facts

• Record ID: K971631
• Device Name: CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
• Applicant: Oxoid , Ltd.
• Product Code: JTN · Microbiology
• Decision Date: Jul 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Intended Use

Antimicrobial Susceptibility Test Discs are indicated for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriaceae, Enterococcus spp., and modified by procedures, Haemophilus influenzae and Neisseria gonorthoeae. The technical product insert details the Quality Control organisms to be use with this disc.

Device Story

Device consists of antimicrobial susceptibility test discs impregnated with Cefotetan. Used in clinical microbiology laboratories by trained technicians to perform agar diffusion susceptibility testing. Discs are placed on agar plates inoculated with patient-derived rapidly growing microorganisms. As antibiotic diffuses into agar, it inhibits bacterial growth, creating a zone of inhibition. Technicians measure zone diameter to determine susceptibility profile. Results assist clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections. Device provides semi-quantitative data to guide clinical decision-making regarding antimicrobial treatment.

Clinical Evidence

No clinical data provided; device relies on established agar diffusion susceptibility testing principles.

Technological Characteristics

Antimicrobial susceptibility test discs for agar diffusion. Principle: Kirby-Bauer or similar agar diffusion method. Standalone diagnostic consumable. No software or electronic components.

Indications for Use

Indicated for semi-quantitative susceptibility testing of rapidly growing microorganisms, including Enterobacteriaceae, Enterococcus spp., Haemophilus influenzae, and Neisseria gonorrhoeae, via agar diffusion.

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

Andy Hollingsworth Quality Systems Manager Oxoid Limited ... . . .......... Wade Road Basingstoke Hants RG24 8PW England

JUL - 3 1997

Re: K971631

Trade Name: Cefotetan Antimicrobial Susceptibility Test Disc Regulatory Class: II Product Code: JTN Dated: June 10, 1997 Received: June 12, 1997

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to complv 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 vours.

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) Submission for Oxoid Antimicrobial Susceptibility Test Disc

## CEFOTETAN

## OXOID LTD

510(K) Number : K971631

Device Name : Oxoid Cefotetan Susceptibility Test Disc

## Indication_for Use :

Antimicrobial Susceptibility Test Discs are indicated for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriaceae, Enterococcus spp., and modified by procedures, Haemophilus influenzae and Neisseria gonorthoeae.

The technical product insert details the Quality Control organisms to be use with this disc.

Arlen Perla

(Division Sign-Off Division of Clinical I aboratory Dev 510(k) Number

✓ For prescription use