TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K060286 · Oxoid , Ltd. · JTN · Mar 17, 2006 · Microbiology

Device Facts

• Record ID: K060286
• Device Name: TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
• Applicant: Oxoid , Ltd.
• Product Code: JTN · Microbiology
• Decision Date: Mar 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Intended Use

Tigecycline is indicated for Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and by modified procedures Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pnemoniae.

Device Story

Tigecycline Antimicrobial Susceptibility Test Disc used in clinical microbiology laboratories to determine susceptibility of specific bacteria to the antibiotic tigecycline. Device consists of paper discs impregnated with specific concentration of tigecycline. Laboratory technicians place discs on agar plates inoculated with patient bacterial isolates. Antibiotic diffuses into agar, creating zone of inhibition around disc. Technician measures diameter of zone; compares result to established interpretive criteria to classify organism as susceptible, intermediate, or resistant. Results assist clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections.

Clinical Evidence

Bench testing only. Performance established through in vitro susceptibility testing of specified bacterial strains.

Technological Characteristics

Paper disc impregnated with tigecycline; used for disk diffusion susceptibility testing; manual measurement of inhibition zones.

Indications for Use

Indicated for in vitro antimicrobial susceptibility testing of Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Haemophilus influenzae, Neisseria gonorrhoeae, and Streptococcus pneumoniae.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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