HARDYDISK AMIKACIN 30MCG

K993993 · Hardy Diagnostics · JTN · Dec 27, 1999 · Microbiology

Device Facts

• Record ID: K993993
• Device Name: HARDYDISK AMIKACIN 30MCG
• Applicant: Hardy Diagnostics
• Product Code: JTN · Microbiology
• Decision Date: Dec 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Intended Use

HardyDisk™ Antimicrohial 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 Jeseribed for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Huemophilus influentae, Neisseria gonorrhoeae and Streptococcus pneumoniae. IlardyDisk™ Anuikach is indicated for gram nogative Enterobacteriaciae including Escherichla coli, Proteus spp., Providencia spp., Klebsiella-Enternhacler-Serratia spp., Citrobacter spp. Acinetobacter spp, and Pseudomonas aeruginosa. HardyDisk™ Amikacin is also active in vitro against Staphylococcus spp.

Device Story

HardyDisk Amikacin 30mcg is an antimicrobial susceptibility test disk used in clinical microbiology laboratories. It functions via the Kirby-Bauer agar diffusion method; disks impregnated with a specific concentration of Amikacin are placed on agar plates inoculated with bacterial pathogens. As the antibiotic diffuses into the agar, it creates 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 bacteria to the antibiotic, aiding clinicians in selecting appropriate antimicrobial therapy for patients with bacterial infections.

Clinical Evidence

No clinical data provided; device relies on standardized in vitro agar diffusion (Kirby-Bauer) methodology.

Technological Characteristics

Antimicrobial sensitivity disk impregnated with 30mcg of Amikacin. Operates via passive diffusion in agar media. Form factor is a standardized disk for use in Kirby-Bauer susceptibility testing.

Indications for Use

Indicated for semi-quantitative in vitro susceptibility testing of rapidly growing and fastidious bacterial pathogens, including gram-negative Enterobacteriaceae (E. coli, Proteus, Providencia, Klebsiella-Enterobacter-Serratia, Citrobacter, Acinetobacter, 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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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of a bird or abstract human figure, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# DEC 27 1999

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

K993993 Re:

> Trade Name: HardyDisk™ Amikacin 30mcg 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 discussiones); 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/4 description: The image shows the logo for Hardy Diagnostics. The logo consists of a circular graphic on the left and the words "HARDY DIAGNOSTICS" on the right. The circular graphic is made up of several black lines. The words "HARDY DIAGNOSTICS" are stacked on top of each other.

ata Maria Californi 30 Wast McCrow

Carta Adaria, CA 93155-
10:[phone]
Fax. [phone]e

att Lake City Litar

1602) 464 84 %

#### 510K Number K993993

# Indications for, Use Statement-HardyDisk 40 Amikacin 30mcg

HardyDisk" Antimicrohial 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 Jeseribed for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Huemophilus influentae, Neisseria gonorrhoeae and Streptococcus pneumoniae.

IlardyDisk™ Anuikach is indicated for gram nogative Enterobacteriaciae including Escherichla coli, Proteus spp., Providencia spp., Klebsiella-Enternhacler-Serratia spp., Citrobacter spp. Acinetobacter spp, and Pseudomonas aeruginosa. HardyDisk™ Amikacin is also active in vitro against Staphylococcus spp.

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Concurrence of CDRH-ODE

Woody Dubose

inical Laboratory Devices gg 2492 510(k) Number

Prescription Use (per 21 CFR 801.109) OR

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

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