(42 days)
Not Found
None
No
The provided text describes a drug (Tigecycline) and its indications, not a medical device, and contains no mention of AI or ML.
No.
The description indicates Tigecycline is an antibiotic used to treat bacterial infections, which classifies it as a drug, not a therapeutic device.
No
The provided text describes Tigecycline, which is an antibiotic used to treat specific bacterial infections. It indicates the conditions it's used for (e.g., infections by Escherichia coli, Staphylococcus aureus), but it does not describe a device that performs diagnosis.
Unknown
The provided text is a 510(k) summary, but it appears to be incomplete or incorrectly formatted. It only contains information related to the intended use of a drug (Tigecycline) and lacks any description of a medical device, software or otherwise. Therefore, it's impossible to determine if a software-only medical device is being described.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- The Intended Use describes a therapeutic drug: Tigecycline is an antibiotic indicated for treating infections caused by specific bacteria. This is a description of a drug's therapeutic use, not a diagnostic test performed in vitro (outside the body).
- There is no mention of diagnostic testing: The description focuses on the bacteria the drug is effective against, not on a method for detecting or measuring something in a biological sample to diagnose a condition.
- The other sections are "Not Found" or "Not Applicable": Sections typically found in IVD descriptions, such as device description, input imaging modality, anatomical site, and performance studies, are either missing or irrelevant to a drug.
Therefore, the provided information strongly suggests that this is a description of a drug, not an IVD.
N/A
Intended Use / 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)
Product codes
JTN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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).
1
Page 2 -
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
2
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