HARDYDISK GENTAMICIN, 10MCG

K994091 · Hardy Diagnostics · JTN · Feb 11, 2000 · Microbiology

Device Facts

• Record ID: K994091
• Device Name: HARDYDISK GENTAMICIN, 10MCG
• 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® Antimierobial Seusilivity Disks are used for scini-quantitative in vitro susceptibility testing by the agat diffusion test procedure (Kirby-Bauer) of rapidly growing and ccrtain fastidious bactcrial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaces, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Haemophilus influerizae, Neisseria gonorrhoeae and Streptococcus pneumoniae. HardyDisk™ Gentomicin is indicated for in vitro activity against the Enterobacteriaciae, Pscudomonas acruginosa, and Staphylococcus spp.

Device Story

HardyDisk™ Gentamicin 10mcg consists of paper disks impregnated with the antibiotic gentamicin; used in clinical microbiology laboratories for in vitro antimicrobial susceptibility testing. Operates via Kirby-Bauer agar diffusion method; disks placed on inoculated agar plates; antibiotic diffuses into medium; creates zone of inhibition around disk. Laboratory technicians measure zone diameters to determine bacterial susceptibility or resistance. Results assist clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections. Device provides semi-quantitative data to guide treatment decisions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on performance characteristics inherent to the standardized Kirby-Bauer agar diffusion test procedure.

Technological Characteristics

Antimicrobial susceptibility test disks; paper substrate impregnated with 10mcg gentamicin. Operates via passive diffusion in agar medium. Standardized for Kirby-Bauer method. In vitro diagnostic use only.

Indications for Use

Indicated for in vitro susceptibility testing of rapidly growing and certain fastidious bacterial pathogens, specifically Enterobacteriaceae, Pseudomonas aeruginosa, and Staphylococcus spp., using the Kirby-Bauer agar diffusion method.

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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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

Re: K994091

Trade Name: HardyDisk™ Gentamicin 10mcg Regulatory Class: II Product Code: JTN Dated: December 3, 1999 Received: December 3, 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 QS 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 Butman

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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## 510K Number K994091

## Indications for Use Statement-HardyDisk ™ Ccntamicin 10mcg

HardyDisk® Antimierobial Seusilivity Disks are used for scini-quantitative in vitro susceptibility testing by the agat diffusion test procedure (Kirby-Bauer) of rapidly growing and ccrtain fastidious bactcrial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaces, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Haemophilus influerizae, Neisseria gonorrhoeae and Streptococcus pneumoniae.

HardyDisk™ Gentomicin is indicated for in vitro activity against the Enterobacteriaciae, Pscudomonas acruginosa, and Staphylococcus spp.

OR

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Concurrence of CDRH-ODDF

Woody Dubois

Division of Clit 510(k) Number

Prescription Use (pcr 21 CFR 801.109)

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

Soving the laboratorian since: 1 '80's