(63 days)
The Sensitite HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.
The Sensititire 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates.
This 510(k) is for the addition of Telavancin in the dilution range of 0.001-2μg/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. and the Sensititre 18 -24 hour MIC panel in the dilution range of 0.03-16μg/ml for testing Gram positive isolates, The approved primary "Indications for Use" and clinical significance of Telavancin is for:
Facultative Gram-Positive Microorganisms: Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pyogenes Enterococcus faecalis Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. intermidius, and S. constellatus)
In vitro data, without clinical correlation is provided for: Facultative Gram-Positive Microorganisms: Enterococcus faecium (vancomycin-susceptible Isolates only) Staphylococcus haemolyticus Streptococcus dysgalactiae subsp, equisimilis Staphylococcus epidermidis
Not Found
The provided text is a cover letter from the FDA to Trek Diagnostic Systems Inc. regarding the clearance of their Sensititre HP susceptibility plate and Sensititre 18-24 hour susceptibility plate. It confirms that the devices are substantially equivalent to legally marketed predicate devices. The letter also includes the Indications for Use for the devices, specifically for the addition of Telavancin.
Unfortunately, the provided document does not contain the specific acceptance criteria, study details, or performance data that directly answer your questions. This document is a regulatory approval letter, not a scientific study report.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established from this document.
To obtain the information you're looking for, you would typically need to consult a different type of document, such as:
- The 510(k) premarket notification summary submitted by Trek Diagnostic Systems Inc. to the FDA (which often includes a summary of the studies and performance data).
- A scientific publication describing the validation studies for these devices.
- The actual study report submitted to the FDA during the clearance process.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
FEB 1 7 2010
Trek Diagnostic Systems Inc. c/o Cynthia C. Knapp Director, Lab Services 982 Keynote Circle Suite 6 Cleveland, OH 44131
Re: K093865
Trade/Device Name: Sensititre HP susceptibility plate and Sensititre 18-24 hour susceptibility plate. Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Test Powder Regulatory Class: Class II Product Code: JWY, LRG Dated: December 15, 2009 Received: December 17, 2009
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 class II (Special Controls), 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.
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Page 2 - Cynthia C. Knapp
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Salar
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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Number (if known): K 093865
Device Name: Sensititre® HP MIC Susceptibility Plate Telayancin 0.001-2μg/ml and The "Sensititre® 18 - 24 hour MiC Susceptibility System Susceptibility Test Panel for: Telavancin 0.03-10ug/ml
Indications for Use: The Sensitite HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.
The Sensititire 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates.
This 510(k) is for the addition of Telavancin in the dilution range of 0.001-2μg/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. and the Sensititre 18 -24 hour MIC panel in the dilution range of 0.03-16μg/ml for testing Gram positive isolates, The approved primary "Indications for Use" and clinical significance of Telavancin is for:
Facultative Gram-Positive Microorganisms: Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pyogenes Enterococcus faecalis Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. intermidius, and S. constellatus)
In vitro data, without clinical correlation is provided for: Facultative Gram-Positive Microorganisms: Enterococcus faecium (vancomycin-susceptible Isolates only) Staphylococcus haemolyticus Streptococcus dysgalactiae subsp, equisimilis Staphylococcus epidermidis
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Division Sign Off
Vision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
:.0(k) K093865
§ 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).