HARDYDISK AST TELAVANCIN,30UG

K093807 · Hardy Diagnostics · JTN · Jan 8, 2010 · Microbiology

Device Facts

• Record ID: K093807
• Device Name: HARDYDISK AST TELAVANCIN,30UG
• Applicant: Hardy Diagnostics
• Product Code: JTN · Microbiology
• Decision Date: Jan 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Intended Use

Use of HardyDisk™ Telavancin 30 µg for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to telavancin. The concentration of Telavancin 30 ug has been shown to be active against most isolates of the following microorganisms both in vitro and in clinical infections: Methicillin-resistant staphylococci, streptococci, and vancomycinsusceptible enterococci.

Device Story

HardyDisk Telavancin 30 µg is an antimicrobial susceptibility test disc used in clinical microbiology laboratories. The device consists of a paper disc impregnated with 30 µg of the antibiotic telavancin. It is used in agar diffusion testing (Kirby-Bauer method) to determine the susceptibility of bacterial isolates to telavancin. The laboratory technician places the disc onto an agar plate inoculated with the patient's bacterial isolate. Following incubation, the zone of inhibition around the disc is measured. The size of the zone correlates with the susceptibility of the organism to the antibiotic, assisting clinicians in selecting appropriate antimicrobial therapy for patients with bacterial infections.

Clinical Evidence

No clinical data required. Performance characteristics established via interpretive criteria and quality control ranges derived from CDER-approved pharmaceutical package inserts and clinical trial data evaluated during original drug approval (1794 patients with skin and skin structure infections).

Technological Characteristics

Paper disc impregnated with 30 µg of telavancin. Operates via agar diffusion principle. Class II medical device under 21 CFR 866.1620.

Indications for Use

Indicated for in vitro agar diffusion susceptibility testing to determine bacterial susceptibility to telavancin. Active against Methicillin-resistant Staphylococci, Streptococci, and Vancomycin-susceptible Enterococci.

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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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized graphic of three wavy lines, which are meant to represent the human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002

JAN - 8 2010

Ms. Wendy Phillips Hardy Diagnostics 1430 McCoy Lane Santa Maria, CA 93455

Re: K093807

Trade/Device Name: Hardy Disk μg Telavancin, 30μg Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disc Regulatory Class: Class: II Product Code: JTN Dated: December 10, 2009 Received: December 11, 2009

Dear Ms. Phillips:

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

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CFR Part 807): labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of 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 marketed 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 [phone]. 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/ReportalProblem/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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for Hardy Diagnostics. The logo consists of a circular graphic on the left and the text "HARDY DIAGNOSTICS" on the right. The word "HARDY" is in a larger font size than the word "DIAGNOSTICS", and it is placed above the word "DIAGNOSTICS".

## Headquarters & Customer Se

1430 West McCoy Lane Santa Maria, CA 93455

phone: [phone] fax: [phone] email: [e-mail] web: www.hardydiagnostics.com

## Distribution Centers:

Phoenix, Arizona Salt Lake City, Utah Tacoma, Washington Lima, Ohio

## Indications for Use

510(k) Number (if known):

Device Name: HardyDisk Telavancin, 30 ug

Indications for Use:

Use of HardyDisk™ Telavancin 30 µg for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to telavancin. The concentration of Telavancin 30 ug has been shown to be active against most isolates of the following microorganisms both in vitro and in clinical infections:

Methicillin-resistant staphylococci, streptococci, and vancomycinsusceptible enterococci.

Prescription Use Frescription Ose
(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Freddie L. Cole

Vision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KD93807

Image /page/2/Picture/20 description: The image shows a logo indicating ISO 13485 certification. The logo features the letters "QMI" inside a circle, with the word "REGISTERED" below it. Above the circle, the text "ISO 13485 CERTIFIED" is displayed, and below the circle, the certification number "CERT 1035006" is printed.