(235 days)
Not Found
Not Found
No
The summary describes a standard antimicrobial susceptibility test disc and does not mention any AI or ML components or capabilities.
No
Explanation: The device is an antimicrobial susceptibility test disc used for in-vitro diagnostic purposes to determine the susceptibility of microorganisms to antimicrobial agents. It is not intended to treat or prevent disease, which are characteristics of a therapeutic device.
Yes.
The device is used for semi-quantitative susceptibility testing of microorganisms, which is a diagnostic procedure to determine if a microorganism is susceptible to an antimicrobial.
No
The device description clearly states "Antimicrobial Susceptibility Test Discs," which are physical components used in laboratory testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms." This describes a test performed in vitro (outside the body) on biological samples (micro-organisms) to provide information about their susceptibility to antimicrobial agents.
- Device Description: The device is an "Antimicrobial Susceptibility Test Disc," which is a common component used in in vitro diagnostic tests for determining microbial susceptibility.
- Performance Standard: The mention of performing "in accordance with NCCLS Approved Performance Standard" further indicates that this device is intended for use in a standardized laboratory testing procedure, typical of IVDs.
- Predicate Device: The listing of a "Predicate Device" which is also an "Antimicrobial Susceptibility Test Disc" reinforces that this type of device is regulated as an IVD.
Therefore, based on the provided information, the Oxoid Compound Sulphonamide Antimicrobial Susceptibility Test Disc is an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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 : Enterobacteriacae, Pseud. aeruginosa, Acinetobacter spp., and Staphylococcus spp.
The technical product insert details the Quality Control organisms to be use with this disc.
Product codes
JTN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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/mL
Sensi -Disc - Antimicrobial Susceptibility Test Disc | | |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Manufacturer : | Becton Dickinson Microbiology Systems
Becton Dickinson and Company
250 Schilling Circle
Cockeysville, MD | | |
| Performance Data : | Oxoid Compound Sulphonamide Antimicrobial Susceptibility Test Disc
perform 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/mL
Sensi -Disc - Antimicrobial Susceptibility Test Disc | | |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------|--|
| Manufacturer : | Becton Dickinson Microbiology Systems
Becton Dickinson and Company
250 Schilling Circle
Cockeysville, MD | | |
| Performance Data : | Oxoid Compound Sulphonamide Antimicrobial Susceptibility Test Discs
perform 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.
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:
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.
5
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
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 : : : : :
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.
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)
OR
Over-The Counter Use
(Optional Format 1-2-96)