LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC by OXOID, LTD.

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, Neisseria gonorrhoeae.

Device Description

Oxoid Lomefloxacin Susceptibility Test Disc

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device, specifically the Oxoid Lomefloxacin Antimicrobial Susceptibility Test Disc. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain the detailed study information required to answer your request regarding "acceptance criteria and the study that proves the device meets the acceptance criteria." The letter is a regulatory approval, not a scientific study report. It states that the device is "substantially equivalent" for the indications for use, but it doesn't describe the studies that led to that determination, nor does it list specific performance criteria or results.

Therefore, most of the information requested in your prompt cannot be extracted from this document.

Here's what can be inferred or stated based on the document's content:

Device Name: Oxoid Lomefloxacin Susceptibility Test Disc
Indication for Use: For the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms, including Enterobacteriaceae, Staphylococcus spp., and by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae.
Regulatory Class: II
Product Code: JTN
Type of Device: Antimicrobial Susceptibility Test Disc

Information NOT available in the provided text:

A table of acceptance criteria and the reported device performance: Not present. The letter indicates substantial equivalence, implying general performance parity with predicate devices, but doesn't list specific metrics or acceptance thresholds.
Sample size used for the test set and the data provenance: Not present.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
Adjudication method: Not present.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is an antimicrobial susceptibility test disc, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device type.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical test disc and not an algorithm.
The type of ground truth used: Not explicitly stated, but for antimicrobial susceptibility testing, the ground truth typically involves reference broth microdilution methods (e.g., CLSI breakpoints) or other established laboratory methods. This would have been part of the underlying data submitted for the 510(k).
The sample size for the training set: Not applicable and not present, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable and not present.

To obtain the detailed study information you're looking for, you would need to access the full 510(k) submission (K973488) which would contain the preclinical and clinical data submitted by Oxoid Limited to the FDA.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the caduceus symbol in a circular fashion. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

OCT 1 0 1997

K973488 Re:

Trade Name: Lomefloxacin Antimicrobial Susceptibility Test Disc Regulatory Class: II Product Code: JTN Dated: September 9, 1997 Received: September 15, 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 current Good Manufacturing Practice requirement, 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.

{1}------------------------------------------------

Page 2

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

{2}------------------------------------------------

510(K) Submission for Oxoid Antimicrobial Susceptibility Test Disc

Lomefloxacin

OXOID LTD

e not dogs are

510(K) Number : Unknown

Device Name : Oxoid Lomefloxacin Susceptibility Test Disc

Indication for Use :

. 178. P

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number K973488

Prescription Use √
(Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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).