HARDYDISK CEFIXIME, 5MCG

K994129 · Hardy Diagnostics · JTN · Feb 11, 2000 · Microbiology

Device Facts

• Record ID: K994129
• Device Name: HARDYDISK CEFIXIME, 5MCG
• Applicant: Hardy Diagnostics
• Product Code: JTN · Microbiology
• Decision Date: Feb 11, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Intended Use

HardyDisk™ Antimicrobial Sensitivity Disks are used for semi-quantiative in vitro susceptibility testing by the agar diffusion test procedure (Kirhy-Kauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion lesting; luxe been described for Enterobacteriaccae, Staphylococcus spp., Pseudomonus spp., Acinctobacter spr., Listeria monocytogenes. Enterococcus spp., other streplocucci and, by modified proccdures, Haemophilus influenzae, Nelsseria gonorrhoeae and Streptvcoccus pneumoniae. Hardy) Jisk™ Cefixince is indicated for in vitro activity against the Enterobactoriaciae, Streptococcus spp., Haemophilus spp., Neisseriu yonorrhoeae and Moraxella catarrhalis.

Device Story

HardyDisk™ Cefixime 5mcg is an antimicrobial susceptibility test disk used in clinical microbiology laboratories. It utilizes the Kirby-Bauer agar diffusion method to determine bacterial sensitivity to the antibiotic Cefixime. The device consists of paper disks impregnated with a specific concentration of the antibiotic. When placed on inoculated agar plates, the antibiotic diffuses into the medium, creating a concentration gradient. After incubation, the zone of inhibition around the disk is measured by laboratory personnel. The size of this zone correlates with the susceptibility of the bacterial pathogen to the antibiotic. This information assists clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections, potentially improving treatment outcomes.

Clinical Evidence

No clinical data provided; device relies on standardized in vitro agar diffusion methodology.

Technological Characteristics

Antimicrobial susceptibility test disk; paper disk impregnated with 5mcg Cefixime; utilizes Kirby-Bauer agar diffusion principle; in vitro diagnostic use.

Indications for Use

Indicated for in vitro susceptibility testing of rapidly growing and fastidious bacterial pathogens, including Enterobacteriaceae, Streptococcus spp., Haemophilus spp., Neisseria gonorrhoeae, and Moraxella catarrhalis.

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 Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle with three stripes forming its wing, positioned to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

FEB 1 1 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Melissa M. Traylor. RAC Director of Technical Services Regulatory Affairs Hardy Diagnostics 1430 West McCoy Lane Santa Maria, California 93455

K994129 Re: Trade Name: HardyDisk™ Cefixime 5mcg Regulatory Class: II Product Code: JTN Dated: December 2, 1999 Received: December 7, 1999

Dear Ms. Traylor:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807,97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

Steven I. Gutman. M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological 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 to the left of the company name. The circle is filled with a series of parallel lines. The text "HARDY" is stacked on top of the text "DIAGNOSTICS" to the right of the circle.

Email: [e-mail]
Website: Hardydynamics.com

anta Matis Californ 1430 Wass McCov Lan: Td: 12.751 346-1764 4 68191 3452769

> Salt Lake City, Utar 15+ W. Concess And 0088811 Mir Tel: [phone] 10211552 2214 Prostive Articon 535W. Hon Ave., #165

Missa. AZ 85210 Tot: 18001 005 RALL For 15.921 964 92:0

510K Number K994129

## Indications for Use Statement-HardyDisk™ Cefixime Smcg

HardyDisk™ Antimicrobial Sensitivity Disks are used for semi-quantiative in vitro susceptibility testing by the agar diffusion test procedure (Kirhy-Kauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion lesting; luxe been described for Enterobacteriaccae, Staphylococcus spp., Pseudomonus spp., Acinctobacter spr., Listeria monocytogenes. Enterococcus spp., other streplocucci and, by modified proccdures, Haemophilus influenzae, Nelsseria gonorrhoeae and Streptvcoccus pneumoniae.

Hardy) Jisk™ Cefixince is indicated for in vitro activity against the Enterobactoriaciae, Streptococcus spp., Haemophilus spp., Neisseriu yonorrhoeae and Moraxella catarrhalis.

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Concurrence of CDRH-ODE

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Prescription Use (per 21 CFR 801 109)

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Over-the Counter-Use (Optioual format 1-2-96)

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