(66 days)
HardyDisk™ Antimicrobial Sensitivity Disks are used for semi-quantiative 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™ Cefixime is indicated for in vitro activity against the Enterobacteriaceae, Streptococcus spp., Haemophilus spp., Neisseria gonorrhoeae and Moraxella catarrhalis.
HardyDisk™ Cefixime 5mcg is an antimicrobial sensitivity disk.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device, specifically the HardyDisk™ Cefixime 5mcg. This document confirms the device's substantial equivalence to a legally marketed predicate but does not contain the acceptance criteria or a study proving that the device meets those criteria.
The 510(k) process is primarily a regulatory pathway to demonstrate that a new device is as safe and effective as a legally marketed predicate device. It does not typically include detailed performance study results or acceptance criteria in the approval letter itself. Such information would be part of the original 510(k) submission, which is not provided here.
Therefore, I cannot extract the requested information from the given text.
To answer your request, I would need access to the actual 510(k) submission document or a summary of its data, which would typically include:
- A table of acceptance criteria and the reported device performance: This would detail the specific metrics used (e.g., inhibition zone diameters, categorical agreement with a reference method) and the thresholds for acceptance (e.g., ±3mm for zone diameter, ≥90% essential agreement).
- Sample size used for the test set and the data provenance: This would describe the number of bacterial isolates tested and if the data was collected retrospectively or prospectively, and from what geographical regions.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For antimicrobial susceptibility testing, the ground truth is typically established by a reference method (e.g., broth microdilution or agar dilution) performed and interpreted by trained microbiologists. "Experts" in this context would refer to these individuals, though their specific qualifications (e.g., "clinical microbiologist with 10 years of experience") are rarely detailed in public summaries.
- Adjudication method for the test set: Not typically applicable for antimicrobial susceptibility testing, as the reference method provides a definitive result.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable for an antimicrobial susceptibility disk, as interpretation is standardized based on zone diameter.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself (an antibiotic disk) is not an algorithm. Its performance is evaluated by measuring inhibition zones.
- The type of ground truth used: For antimicrobial susceptibility testing, the ground truth is typically a reference broth microdilution (BMD) or agar dilution method as standardized by CLSI (Clinical and Laboratory Standards Institute).
- The sample size for the training set: Not applicable for this type of device, which is not an AI/ML algorithm that requires a "training set."
- How the ground truth for the training set was established: Not applicable.
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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 (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 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: Sales@Hardydynamics.com
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: 13201 995-4273 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.
Concurrence of CDRH-ODE
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on Sign-Off) Division of Clinical Laboratory Devices Kyy4 510(k) Number.
Prescription Use (per 21 CFR 801 109)
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Over-the Counter-Use (Optioual 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).