HARDYDISK AZITHROMYCIN 15MCG

K993994 · Hardy Diagnostics · JTN · Dec 21, 1999 · Microbiology

Device Facts

• Record ID: K993994
• Device Name: HARDYDISK AZITHROMYCIN 15MCG
• Applicant: Hardy Diagnostics
• Product Code: JTN · Microbiology
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Intended Use

HardyDisk™ Antimicrobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae. HardyDisk™ Azithromycin is indicated for Staphylococcus spp., Streptococcus spp., including S. pneumoniae, and Haemophilus spp.

Device Story

HardyDisk™ Azithromycin 15mcg is an antimicrobial susceptibility test disk used in clinical microbiology laboratories. The device consists of paper disks impregnated with a specific concentration of the antibiotic azithromycin. In the Kirby-Bauer agar diffusion procedure, the disk is placed on an agar plate inoculated with a bacterial culture. As the antibiotic diffuses into the agar, it creates a concentration gradient. After incubation, the zone of inhibition around the disk is measured. The size of this zone is inversely proportional to the minimum inhibitory concentration (MIC) of the bacteria. Healthcare providers use these results to determine the susceptibility of bacterial pathogens to azithromycin, aiding in the selection of appropriate antibiotic therapy for patients.

Clinical Evidence

No clinical data provided; device performance is established through standardized in vitro susceptibility testing methods (Kirby-Bauer).

Technological Characteristics

The device consists of paper disks impregnated with 15mcg of azithromycin. It functions via the Kirby-Bauer agar diffusion principle, where the antibiotic diffuses into agar media to inhibit bacterial growth. It is a standalone, non-electronic, in vitro diagnostic device.

Indications for Use

Indicated for in vitro susceptibility testing of Staphylococcus spp., Streptococcus spp. (including S. pneumoniae), and Haemophilus 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 1 1999

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

Re: K993994 Trade Name: HardyDisk™ Azithromycin 15mcg Regulatory Class: II Product Code: JTN Dated: November 17, 1999 Received: November 24, 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/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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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 words "HARDY" and "DIAGNOSTICS" on the right. The circular graphic is made up of several diagonal lines. The words "HARDY" and "DIAGNOSTICS" are stacked on top of each other.

1911 Calorest Carrierli vonno

1430 West McCo DR Marce CA 9345 W. Lettere A Saray, UT 840711 18001995477 18011567371

> ext alle 1253 12 852117

510K Number K993994

## Indications for Use Statement-HardyDisk ™ Azithromycin 15mcg

HardyDisk" Autuniciplial Seusitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and ccrtain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., I seudomonas spp., Acinetobacter spp., Listeria monocylogenes, Enterococcus spp., other streptococci and, by modified procedures, Ilaemophilus influenzae, Neisseria gonorrhoeae and Streptococcus preumoniae.

Hardy Disker Azithromycin is indicated for Staphylococcus spp., Streptococcus spp., including S. pncumoniae, and Haemophilus spp.

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Concurrence of CIDKH-()I)F.

Woody Dubose

(Division Sign-Off)
Division of Clmical Laboratory Devices
510(k) Number K993994

Prescription Use X:
(per 21 CFR 801.109)

OR

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