(42 days)
Tigecycline is indicated for Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and by modified procedures Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pnemoniae.
Not Found
The provided text is related to a 510(k) premarket notification for a medical device: "Tigecycline Antimicrobial Susceptibility Test Disc." This document is a clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies. It is a regulatory clearance document, not a scientific study report.
Therefore, I cannot provide the requested information from the given text.
To be clear:
- A table of acceptance criteria and the reported device performance: Not available in the provided text.
- Sample sized used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not available.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available (this device is a physical test disc, not an algorithm).
- The type of ground truth used: Not available.
- The sample size for the training set: Not available (training set would not be applicable in the typical sense for this device).
- How the ground truth for the training set was established: Not available.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 7 2006
Mr. Andy Hollingsworth Regulatory Affairs Manager Oxoid Limited Wade Road, Basingstoke, Hants RG24 8PW England
Re: K060286
Trade/Device Name: Tigecycline Antimicrobial Susceptibility Test Disc Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disc Regulatory Class: Class II Product Code: JTN Dated: November 2, 2005 Received: February 8, 2006
Dear Mr. Hollingsworth:
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sale, a For
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): K060286
Device Name: Tigecycline Antimicrobial Susceptibility Test Disc
Indications For Use :
Tigecycline is indicated for Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and by modified procedures Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pnemoniae.
Prescription Use X_ AND/OR (Part 211 CFR 801 Subpart D)
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)
Ludden L. Cook
ision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and brain
51664 K060286
§ 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).