Antimicrobial Susceptibility Test Discs are indicated for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriacae, Pseud. aeruginosa, Acinetobacter spp., and Staphylococcus spp.

Device Description

Oxoid Compound Sulphonamide Antimicrobial Susceptibility Test Discs

AI/ML Overview

The provided document is a 510(k) summary for the Oxoid Compound Sulphonamides Susceptibility Test Disc. It states that the device performs in accordance with NCCLS (National Committee for Clinical Laboratory Standards, now Clinical and Laboratory Standards Institute - CLSI) Approved Performance Standards. However, it does not provide specific details of a study with acceptance criteria and results.

The document states: "Performance Data: Oxoid Compound Sulphonamide Antimicrobial Susceptibility Test Discs perform in accordance with NCCLS Approved Performance Standard. Product performance is in accordance with NCCLS Performance Standard for Antimicrobial Disk Susceptibility Tests - Fifth Edition Approved Standard - M2-A5 Vol. 13 No.24, and Performance Standards for Antimicrobial Susceptibility Testing M100 - S6 Vol 15 No.14."

This indicates that the device's performance was evaluated against the established NCCLS standards for antimicrobial disk susceptibility testing. These standards define the methodology for testing, zone size interpretive criteria, and acceptable ranges for quality control organisms. The 510(k) submission asserts that the device meets these standards, but the actual data and specific acceptance criteria tables are not included in the provided text. The document states, "Data provided in this submission will be made available to any person within 30 days of a written request," implying the detailed study data is part of the full submission but not present in this summary.

Therefore,Based on the provided information:

Table of acceptance criteria and reported device performance:
The document states that the Oxoid Compound Sulphonamide Antimicrobial Susceptibility Test Disc performs "in accordance with NCCLS Approved Performance Standard." Specifically, it references:
- NCCLS Performance Standard for Antimicrobial Disk Susceptibility Tests - Fifth Edition Approved Standard - M2-A5 Vol. 13 No.24
- Performance Standards for Antimicrobial Susceptibility Testing M100 - S6 Vol 15 No.14.
These NCCLS/CLSI standards define the acceptance criteria including:
- Zone diameter interpretive criteria: Specific zone diameter ranges (in mm) that classify an isolate as Susceptible, Intermediate, or Resistant to the antimicrobial.
- Quality Control (QC) ranges: Acceptable zone diameter ranges for specified QC strains tested with the antimicrobial disc.
- Essential agreement (EA): Agreement between the test method and a reference method (e.g., broth microdilution or agar dilution) within +/- 1 dilution for MIC, or within a specified number of mm for zone diameters.
- Category agreement (CA): Agreement in the interpretive category (Susceptible, Intermediate, Resistant) between the test method and the reference method.
However, the document does not provide the specific acceptance criteria values from the NCCLS standards nor the reported performance data (e.g., specific zone diameter ranges, QC results, or agreement rates) that were observed in the study. It only states that the product performs "in accordance" with these standards.
Sample size used for the test set and the data provenance:
This information is not provided in the document. The general claim is that the device "performs in accordance with NCCLS Approved Performance Standard," which typically involves testing a defined number of clinical isolates and QC strains. Data provenance (e.g., country of origin, retrospective/prospective) is also not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. For antimicrobial susceptibility testing, the "ground truth" (or reference method) is usually an established laboratory method like broth microdilution or agar dilution, interpreted by trained microbiologists following standard guidelines, rather than a consensus of external experts on individual cases.
Adjudication method for the test set:
This information is not provided.
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 is not applicable to an antimicrobial susceptibility test disc. This device is a diagnostic reagent for laboratory use, not an AI-assisted diagnostic tool that would involve human readers interpreting images or complex data with or without AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable for this type of device. The device itself is a disc containing an antimicrobial agent, and its performance is assessed by measuring zones of inhibition, which is a standardized laboratory procedure, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For antimicrobial susceptibility test discs, the ground truth is established by a reference susceptibility testing method, typically broth microdilution or agar dilution, as defined by organizations like NCCLS/CLSI. These methods determine the Minimum Inhibitory Concentration (MIC) for an antimicrobial against a microorganism, from which the interpretive category (S/I/R) is derived. The document does not explicitly state which reference method was used but cites adherence to NCCLS standards, which would imply the use of such a reference method.
The sample size for the training set:
This is not applicable as this device does not involve a "training set" for an algorithm. Its performance is chemical and biological, assessed through adherence to standardized laboratory protocols.
How the ground truth for the training set was established:
This is not applicable for the reasons stated above.

Summary

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

14971637

510(K) Submission for Oxoid Antimicrobial Susceptibility Test Disc

COMPOUND SULPHONAMIDES

OXOID LTD

이 로

510(K) Summary

DEC 2 3 1997

510(K) Number : K971637

Compound Sulphonamides Susceptibility Test Disc Product Name :

Manufacturer : Oxoid Limited Wade Road Basingstoke Hants RG24 8PW England

Substantial Equivalence :

Oxoid Compound Sulphonamide Antimicrobial Susceptibility Test Discs are substantially equivalent to other antimicrobial susceptibility test discs on the market.

Product :	BBL Sensi-Disc Sulphonamides 300µg/mLSensi -Disc - Antimicrobial Susceptibility Test Disc
Manufacturer :	Becton Dickinson Microbiology SystemsBecton Dickinson and Company250 Schilling CircleCockeysville, MD
Performance Data :	Oxoid Compound Sulphonamide Antimicrobial Susceptibility Test Discperform in accordance with NCCLS Approved Performance Standard.
Code Number :	S3 300

Antimicrobial Content :

Product performance is in accordance with NCCLS Performance Standard for Antimicrobial Disk Susceptibility Tests - Fifth Edition Approved Standard - M2-A5 Vol. 13 No.24, and Performance Standards for 24, and Performance Standards for Antimicrobial Susceptibility Testing M100 - S6 Vol 15 No.14.

300ug

Data provided in this submission will be made available to any person within 30 days of a written request.

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

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and three human figures are visible within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 3 1997

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

Re: K971637

Trade Name: Oxoid Compound Sulphonamides Susceptibility Test Disc Regulatory Class: II Product Code: JTN Dated: November 17, 1997 Received: November 20, 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 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.

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

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 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

{3}------------------------------------------------

14971637

510(K) Submission for Oxoid Antimicrobial Susceptibility Test Disc

COMPOUND SULPHONAMIDES

OXOID LTD

이 역할 때 높은 일을 일을 일을 보고 있는 일부 일로 일까지 이러 이유 이러 이어 이러

510(K) Summary

DEC 2 3 1997

510(K) Number : K971637

Compound Sulphonamides Susceptibility Test Disc Product Name :

Oxoid Limited Manufacturer : Wade Road Basingstoke Hants RG24 8PW England

Substantial Equivalence :

Oxoid Compound Sulphonamide Antimicrobial Susceptibility Test Discs are substantially equivalent to other antimicrobial susceptibility test discs on the market.

Product :	BBL Sensi-Disc Sulphonamides 300µg/mLSensi -Disc - Antimicrobial Susceptibility Test Disc
Manufacturer :	Becton Dickinson Microbiology SystemsBecton Dickinson and Company250 Schilling CircleCockeysville, MD
Performance Data :	Oxoid Compound Sulphonamide Antimicrobial Susceptibility Test Discsperform in accordance with NCCLS Approved Performance Standard.
	Code Number :	S3 300

Antimicrobial Content :

300ug

Data provided in this submission will be made available to any person within 30 days of a written request.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. The text is written in all capital letters.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 3 1997

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

Re: K971637

Trade Name: Oxoid Compound Sulphonamides Susceptibility Test Disc Regulatory Class: II Product Code: JTN Dated: November 17, 1997 Received: November 20, 1997

Dear Mr. Hollingsworth:

{5}------------------------------------------------

Page 2

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

{6}------------------------------------------------

510(K) Submission for Oxoid Antimicrobial Susceptibility Test Disc

COMPOUND SULPHONAMIDES

OXOID LTD

510(K) Number : K971637

Device Name : Oxoid Compound Sulphonamide Susceptibility Test Disc

Indication for Use :

ﻧﺘﺎﺭ : : : : :

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

12/22/97
John Tickhurst MD Interim Chief,

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K971637

Prescription Use ﺳﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩ (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).