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

Device Description

Oxoid Cefprozil Susceptibility Test Disc

AI/ML Overview

This document does not contain the detailed information needed to describe acceptance criteria and a study proving device performance in the way requested. The provided text is a 510(k) clearance letter from the FDA for a Cefprozil Antimicrobial Susceptibility Test Disc. It confirms that the device is substantially equivalent to a predicate device and can be marketed.

While it mentions "performance" in a general sense within the context of device regulation, it does not include:

A table of acceptance criteria and reported device performance.
Details about a specific study, sample sizes, data provenance, expert qualifications, or adjudication methods.
Information on MRMC comparative effectiveness studies or standalone algorithm performance.
Specifics on how ground truth was established for training or test sets.

Essentially, the FDA clearance letter indicates the device met the requirements for substantial equivalence, but it does not present the data from the study that led to that determination. To answer your questions, one would need access to the actual 510(k) submission document itself, which would contain the performance data and study details.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

0 1998 SEP

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

Re: K982517

Trade Name: Cefprozil Antimicrobial Susceptibility Test Disc Regulatory Class: II Product Code: JTN Dated: July 15, 1998 Received: July 20, 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 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.

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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 (770)488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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

CEFPROZIL

OXOID LTD

510(K) Number : Unknown

Oxoid Cefprozil Susceptibility Test Disc Device Name :

Indication for Use :

Woody Dubois

atory Devices 510(k) Number

PRESCRIPTION USE X

Regulation Number and Section

§ 866.1620 Antimicrobial susceptibility test disc.

(a)
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.(b)
Classification. Class II (performance standards).