(56 days)
Use of HardyDisk AST Ceftolozane Tazobactam, (30/10μg) - C/T40, for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Ceftolozane/Tazobactam. The concentration of Ceftolozane/Tazobactam, (30/10µg) - C/T40, has been shown to be active against most isolates of Pseudomonas aeruginosa both in vitro and in clinical infections.
HardyDisk AST Ceftolozane/Tazobactam. (30/10ug) - C/T40 is an Antimicrobial Susceptibility Test Disc.
This document does not contain information about acceptance criteria and study results in the typical format of a device performance report. It is an FDA 510(k) clearance letter for the HardyDisk AST Ceftolozane/Tazobactam. As such, it confirms the device's substantial equivalence to a predicate device for its indicated use but does not directly present the detailed acceptance criteria and study data.
Therefore, I cannot populate the table or answer most of the questions you asked based on the provided text.
However, I can extract the following relevant information:
1. Device Name and Indication for Use:
- Device Name: HardyDisk AST Ceftolozane/Tazobactam, (30/10μg) - C/T40
- Indications for Use: "Use of HardyDisk AST Ceftolozane Tazobactam, (30/10μg) - C/T40, for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Ceftolozane/Tazobactam. The concentration of Ceftolozane/Tazobactam, (30/10µg) - C/T40, has been shown to be active against most isolates of Pseudomonas aeruginosa both in vitro and in clinical infections."
The letter indicates that the FDA has reviewed a 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination implies that the company would have submitted data demonstrating this equivalence, likely including performance data against predefined criteria, but these specific criteria and the detailed study results are not included in this document.
Based on the available text, I cannot provide the specific details requested in your prompt regarding acceptance criteria, study design parameters, and results. These would typically be found in the 510(k) submission itself, not in the clearance letter.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 24, 2015
HARDY DIAGNOSTICS WENDY HADLEY QUALITY CONTROL MANAGER 1430 WEST MCCOY LANE SANTA MARIA CA 93455
Re: K152846
Trade/Device Name: HardyDisk AST Ceftolozane/Tazobactam. (30/10ug) - C/T40 Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disc Regulatory Class: II Product Code: JTN Dated: September 28, 2015 Received: September 29, 2015
Dear Ms. Hadley:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ribhi Shawar -S
For Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152846
Device Name
HardyDisk AST Ceftolozane/Tazobactam, (30/10μg) - C/T40
Indications for Use (Describe)
Use of HardyDisk AST Ceftolozane Tazobactam, (30/10μg) - C/T40, for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Ceftolozane/Tazobactam.
The concentration of Ceftolozane/Tazobactam, (30/10µg) - C/T40, has been shown to be active against most isolates of Pseudomonas aeruginosa both in vitro and in clinical infections.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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).