(71 days)
To detect Escherichia coli, Klebsiella oxytoca, and K. pneumoniae strains suspected of harboring suspected extended spectrum betalactamase enzymcs.
MicroScan® Dried Gram Negative MIC/Combo Panels Cefpodoxime (0.015-64 ug/ml)
The provided text is a 510(k) premarket notification approval letter for the MicroScan® Dried Gram Negative MIC/Combo Panels Cefpodoxime. This document is a regulatory approval and does not contain the detailed study results, acceptance criteria, or ground truth establishment methods that would typically be found in a study report or the 510(k) submission itself.
Therefore, I cannot provide the requested information from the text given. The document explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This indicates that the FDA reviewed the manufacturer's submission which would have contained the study information, but this specific letter is only the approval notification.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wavy lines representing the body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Cynthia Van Duker Manager, Regulatory Affairs Dade Behring 1584 Enterprise Boulevard West Sacramento, CA 95691
DEC 1 2 2001
Re: K013423
Trade/Device Name: MicroScan® Dried Gram Negative MIC/Combo Panels Cefpodoxime (0.015-64 ug/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LRG Dated: September 28, 2001 Received: October 2, 2001
Dear Ms. Van Duker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket I his lower will and in your your dine of substantial equivalence of your device to a legally marketed noutheation. The I Dr I intellig sification 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 1 II you desire specific an vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (201) 594-1566. Fraunce at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionitation on your respond and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/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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Intended Use Statcment
510(k) No.:
K013423
IDevice Name:
MicroScan® Dried Gram Negative MIC/Combo Panels Cefpodoxime (0.015-64 µg/ml)
Indications for Use:
To detect Escherichia coli, Klebsiella oxytoca, and K. pneumoniae strains suspected of harboring suspected extended spectrum betalactamase enzymcs.
Freddie Poole
(Division Sign-Off) Division of Clinical Laboratory Devices
101 3423 510(k) Number_
Prescription Use Device -
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).