HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939

K103538 · Hardy Diagnostics · JTN · Dec 17, 2010 · Microbiology

Device Facts

• Record ID: K103538
• Device Name: HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939
• Applicant: Hardy Diagnostics
• Product Code: JTN · Microbiology
• Decision Date: Dec 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Intended Use

Use of HardyDisk™ Ceftaroline 30 µg for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ceftaroline. The concentration of Ceftaroline 30 µg has been shown to be active against most isolates of the following microorganisms both in vitro and in clinical infections: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoc, and Haemophilus influenza.

Device Story

HardyDisk Ceftaroline 30 µg is an antimicrobial susceptibility test disc used in clinical microbiology laboratories. Device consists of paper discs impregnated with 30 µg of the antibiotic Ceftaroline. Used in agar diffusion (Kirby-Bauer) testing to determine bacterial susceptibility. Laboratory technicians place discs onto inoculated agar plates; antibiotic diffuses into medium; zone of inhibition measured after incubation. Output is zone diameter, interpreted by clinicians to guide antibiotic therapy selection for bacterial infections. Benefits include standardized, rapid assessment of bacterial resistance profiles to inform patient treatment decisions.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing demonstrating performance of the antimicrobial susceptibility test disc.

Technological Characteristics

Antimicrobial susceptibility test disc; 30 µg Ceftaroline concentration; paper disc format; agar diffusion principle; in vitro diagnostic use.

Indications for Use

Indicated for in vitro agar diffusion susceptibility testing of bacteria to Ceftaroline. Target organisms include Staphylococcus aureus (MSSA/MRSA), Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, and Haemophilus influenzae.

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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with stylized wings and body.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Hardy Diagnostics c/o Ms. Wendy Hadley Quality Control Manager 1430 McCoy Lane Santa Maria, CA 93455

DEC 1 7 7010

Re: K103538

Trade/Device Name: Hardy Disk Ceftaroline, 30μg Regulation Number: 21 CFR§866.1620 Regulation Name: Antimicrobial susceptibility test disc. Regulatory Class: Class II Product Code: JTN Dated: November 24, 2010 Received: December 2, 2010

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

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Page- 2 - Ms. Wendy Hadlev

and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely vours.

Vall, abtup

Sally A. Hoivat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices Radiological Health

Enclosure

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## FDA CDRH DMC Indications for Use

510(k) Number (if known):

DEC - 2 2010

Received

Device Name: HardyDisk Ceftaroline, 30 µg

Indications for Use:

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

Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoc, and Haemophilus influenza.,

Prescription Use X (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 Mc. Code

dsion Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K/03538

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