(51 days)
Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Meropenem these include Enterobacteriaceae, and Staphylococcus spp. Pseudomonas spp. and by modified procedures Haemophilus influenzae and Streptococcus pneumoniae.
Oxoid Meropenem Susceptibility Test Disc
This is an FDA Premarket Notification (510(k)) summary for an in vitro diagnostic device, not a study report for an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, and comparative effectiveness studies is not available in the provided text.
The document states that the "Oxoid Meropenem Susceptibility Test Disc" is for semi-quantitative susceptibility testing of rapidly growing micro-organisms, including Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Haemophilus influenzae, and Streptococcus pneumoniae. It is regulated as a Class II device with product code JTN.
The FDA has determined that this device is substantially equivalent to legally marketed predicate devices, meaning it performs as safely and effectively as a previously cleared device. This determination is not based on a new clinical study with acceptance criteria as would be required for novel AI/ML devices, but rather on demonstrating equivalence to existing technology.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 1 1998
Andy Hollingsworth Regulatory Affairs Manager . Oxoid Limited Wade Road Basingstoke Hants RG24 8PW England
Re: K983718
Trade Name: Oxoid Meropenem Susceptibility Test Disc Regulatory Class: II Product Code: JTN Dated: October 19, 1998 Received: October 21, 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 Sutman
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
MEROPENEM
OXOID LTD
TM
TH
Device Name : Oxoid Meropenem Susceptibility Test Disc
Indication for Use :
Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Meropenem these include Enterobacteriaceae, and Staphylococcus spp. Pseudomonas spp. and by modified procedures Haemophilus influenzae and Streptococcus pneumoniae.
Woody Dubala
(Division Sign Off)
510(k) Number .
PRESCRIPTION USE X
§ 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).