COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K971637 · Oxoid , Ltd. · JTN · Dec 23, 1997 · Microbiology

Device Facts

• Record ID: K971637
• Device Name: COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
• Applicant: Oxoid , Ltd.
• Product Code: JTN · Microbiology
• Decision Date: Dec 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

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.

Device Story

Device consists of antimicrobial susceptibility test discs impregnated with 300µg of compound sulphonamides. Used in clinical microbiology laboratories by technicians to perform agar diffusion susceptibility testing. Discs are placed on agar plates inoculated with rapidly growing microorganisms; antimicrobial agent diffuses into the medium. Healthcare providers observe zones of inhibition around discs to determine susceptibility of the organism to the antimicrobial agent. Results assist in selecting appropriate antibiotic therapy for patients. Device provides standardized testing performance in accordance with NCCLS standards.

Clinical Evidence

Bench testing only. Performance demonstrated by adherence to NCCLS Approved Performance Standards (M2-A5 and M100-S6).

Technological Characteristics

Antimicrobial susceptibility test disc; 300µg compound sulphonamide content; agar diffusion principle; manual application; non-electronic; non-software.

Indications for Use

Indicated for semi-quantitative susceptibility testing of rapidly growing microorganisms (Enterobacteriacae, Pseud. aeruginosa, Acinetobacter spp., and Staphylococcus spp.) 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.

Predicate Devices

• BBL Sensi-Disc Sulphonamides 300µg/mL (K971637)

Submission Summary (Full Text)

{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<br>Sensi -Disc - Antimicrobial Susceptibility Test Disc | | |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Manufacturer : | Becton Dickinson Microbiology Systems<br>Becton Dickinson and Company<br>250 Schilling Circle<br>Cockeysville, MD | | |
| Performance Data : | Oxoid Compound Sulphonamide Antimicrobial Susceptibility Test Disc<br>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 [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 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<br>Sensi -Disc - Antimicrobial Susceptibility Test Disc | | |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------|--|
| Manufacturer : | Becton Dickinson Microbiology Systems<br>Becton Dickinson and Company<br>250 Schilling Circle<br>Cockeysville, MD | | |
| Performance Data : | Oxoid Compound Sulphonamide Antimicrobial Susceptibility Test Discs<br>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 [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 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)