(87 days)
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of nonfastidious isolates.
This 510(k) is for the addition of Ceftaroline in the dilution range of 0.004-8ug/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 0.06-64ug/ml for testing gram positive isolates. The organisms which may be used for Ceftaroline susceptibility testing in this panel are:
Facultative Gram-Positive Microorganisms: Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pyogenes Streptococcus agalactiae Streptococcus pneumoniae
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding an antimicrobial susceptibility test (AST) device. It does not contain information about acceptance criteria, device performance tables, study designs (sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance), or ground truth establishment methods in the depth requested.
The document primarily focuses on:
- Device Identification: Sensititre HP MIC Susceptibility Plate with Ceftaroline (0.004-8ug/ml) and The Sensititre® 18-24 Hour MIC Susceptibility System Test Panel with Ceftaroline (0.06-64ug/ml).
- Regulatory Classification: Class II, Product Code JWY, LRG.
- Indications for Use: Clinical susceptibility testing of fastidious (Sensititre HP) and nonfastidious (Sensititre 18-24 hour MIC) isolates. Specifically for Ceftaroline susceptibility testing of Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus pneumoniae.
- FDA Clearance: A determination of substantial equivalence to predicate devices, allowing the device to be marketed.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, or study details, as it is not present in the provided text.
To answer your questions, I would need a detailed study report, a summary of safety and effectiveness, or a more comprehensive technical document from the manufacturer or FDA submission.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle.
Food and Druq Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
TREK Diagnostic Systems, Inc. c/o Ms. Cynthia C. Knapp Director of US Regulatory and Global Clinical Affairs 982 Keynote Circle, Suite 6 Cleveland. OH 44131
AUG 1 8 2011
Re: K111429
Trade/Device Name: Sensititre HP MIC Susceptibility Plate Ceftaroline (0.004-8ug/ml) and The Sensititre® 18-24 Hour MIC Susceptibility System Test Panel with Ceftaroline (0.06-64ug/ml) Regulation Number: 21 CFR§ 866.1640 Regulation Name: Antimicrobial Susceptibility Test (AST) Powder Regulatory Class: Class II Product Code: JWY, LRG Dated: August 8, 2011 Received: August 9, 2011
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.
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
{1}------------------------------------------------
Page 2 - Cynthia C. Knapp
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 renaketed 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 (01) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to paremarket 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/ReportaProblem/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 fire number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Vayaitmes
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: Sensititre® HP MIC Susceptibility Plate with Ceftaroline (0.004-8ug/ml) and The Sensititre® 18 - 24 hour MIC Susceptibility System Test Panel with Ceftaroline (0.06-64ug/ml)
Indications for Use: The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of nonfastidious isolates.
This 510(k) is for the addition of Ceftaroline in the dilution range of 0.004-8ug/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 0.06-64ug/ml for testing gram positive isolates. The organisms which may be used for Ceftaroline susceptibility testing in this panel are:
Facultative Gram-Positive Microorganisms: Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pyogenes Streptococcus agalactiae Streptococcus pneumoniae
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Ludale le. Poole
Elsie Sig. 98
sion Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
510(k) K111429
§ 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).