(85 days)
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms. This 510(k) is for the addition of: "Cefoxitin Screen". The "Cefoxitin Screen ( 6ug/ml) " can be used to predict the presence of mecAmediated resistance in Staphylococcus aureus. Isolates for which cefoxitin MIC tests > 6 (positive growth) should be reported as oxacillin resistant. Those which have cefoxitin MIC's of <= 6 (no growth) should be reported as oxacillin susceptible.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "Sensititre® 18-24 hour MIC or BP Susceptibility Test System" with a Cefoxitin Screen (6μg/ml) for Staphylococcus aureus. This document grants market clearance for the device but does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in the manufacturer's 510(k) submission or a separate clinical study report.
Therefore, I cannot provide the requested information. The clearance letter only states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
To obtain the requested information, you would need to consult the actual 510(k) submission (K073558) itself, which would contain:
- Details of the performance studies conducted.
- The specific acceptance criteria used for the Cefoxitin Screen's ability to predict mecA-mediated resistance in Staphylococcus aureus.
- The reported device performance against those criteria.
- Information on sample size, ground truth establishment, expert qualifications, etc.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 3 2008
Ms. Cynthia C. Knapp Director Lab Services Trek Diagnostic System Inc 982 Keynote Circle, Suite 6 Cleveland, OH 44131
K073558 Re:
Ko 15550 with Cefoxitin Screen (6μg/ml) for Staphylococcus aureus Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY, LRG Dated: February 27, 2008 Received: February 26, 2008
Dear Ms. Knapp:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attyms
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K073S58
Device Name:
The "Sensititre® 18-24 hour MIC or BP Susceptibility Test System" with a Cefoxitin Screen (6ug/ml) for Staphylococcus aureus
Indications For Use:
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms.
This 510(k) is for the addition of: "Cefoxitin Screen"
The "Cefoxitin Screen ( 6ug/ml) " can be used to predict the presence of mecAmediated resistance in Staphylococcus aureus. Isolates for which cefoxitin MIC tests > 6 (positive growth) should be reported as oxacillin resistant. Those which have cefoxitin MIC's of <= 6 (no growth) should be reported as oxacillin susceptible.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
K 073558
§ 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).