(63 days)
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™ Mezlocillin is indicated for in vitro activity against the Enterobacteriaciae, Pseudomonas aeruginosa and Acinetobacter spp.,
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device, specifically the HardyDisk™ Mezlocillin, 75mcg. This type of document is a regulatory approval and does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes for test/training, expert qualifications, etc.) that you are asking for.
The letter confirms that the FDA has reviewed the manufacturer's submission and determined that the device is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided in the original 510(k) submission by Hardy Diagnostics, which would have included details of their testing and validation.
Therefore, it is not possible to extract the requested information from the provided text. The text only states the device's indications for use:
- Device Name: HardyDisk™ Mezlocillin, 75mcg
- Intended Use: Semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens.
- Specific Organisms (for Mezlocillin): Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter spp.
To obtain the information you requested, you would need to access the original 510(k) submission document (K994212) filed by Hardy Diagnostics with the FDA, which would detail the studies conducted to demonstrate substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows a stylized graphic, possibly a logo or emblem. It features three parallel, curved lines that resemble abstract wings or waves. The lines are thick and black, creating a bold visual impact. The word "DEPARTMENT" is partially visible along the left edge of the image, oriented vertically.
FEB 1 5 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Melissa Traylor, RAC Technical Services Director/Regulatory Affairs Hardy Diagnostics, Inc. 1430 West McCoy Lane Santa Maria, California 93455
K994212 Re: Trade Name: HardyDisk™ Mezlocillin, 75mcg Regulatory Class: II Product Code: JTN Dated: December 8, 1999 Received: December 14, 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Image /page/2/Picture/0 description: The image shows the logo for Hardy Diagnostics. The logo consists of a circular graphic on the left, followed by the text "HARDY" in large, bold letters. Below "HARDY" is the word "DIAGNOSTICS" in smaller letters. The circular graphic appears to be a stylized representation of a petri dish or a cell, with several curved lines inside.
Frail: Sales@Hardydiannostics Com
Santa Maria, California
1430 West McCoy Lane
Santa Maria, CA 93455
Tel: (805) 346-2766
Fax. (805) 346-2760
Salt Lake City Ustat 254 W. Cottage Ave Sandy, UT 84070 Tel: 18001 995-4773 Fax: 18011562-3214
Phoenix Arizona Iron Ave #105 Mesa, AZ 85210 Tel: 18001 995-845
Indications for Use Statement-HardyDisk tm Mezlocillin, 75mcg f2.100/144482
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™ Mezlocillin is indicated for in vitro activity against the Enterobacteriaciae, Pseudomonas aeruginosa and Acinetobacter spp.,
Concurrence of CDRH-ODE
Woody Duboes
510(k) Number.
Prescription Use (per 21 CFR 801.109) OR
Over-the Counter-Use (Optional format 1-2-96)
§ 866.1620 Antimicrobial susceptibility test disc.
(a)
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.(b)
Classification. Class II (performance standards).