(33 days)
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No
The summary describes a traditional antimicrobial sensitivity disk used for manual agar diffusion testing, with no mention of AI or ML technologies.
No
The device is described as an "Antimicrobial Sensitivity Disk" used for in vitro susceptibility testing of bacterial pathogens. This indicates it is for diagnostic purposes, not for treating diseases or conditions.
Yes
HardyDisk™ Antimicrobial Sensitivity Disks are used for in vitro susceptibility testing to determine how rapidly growing and certain fastidious bacterial pathogens respond to antimicrobial agents, which is a diagnostic purpose.
No
The device description clearly states it is an "Antimicrobial Sensitivity Disk," which is a physical, hardware component used in laboratory testing. The summary does not mention any software component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the disks are used for "semi-quantitative in vitro susceptibility testing". The term "in vitro" means "in glass" or "in the laboratory," referring to tests performed outside of a living organism.
- Purpose: The purpose of the device is to test the susceptibility of bacterial pathogens to antimicrobial agents, which is a diagnostic process to determine the best treatment for an infection.
- Device Description: The description confirms it's an "Antimicrobial Sensitivity Disk," a common type of IVD used in microbiology laboratories.
- Intended User / Care Setting: The intended user is a "Clinical Laboratory," which is where IVD testing is performed.
All of these points strongly indicate that the HardyDisk™ Antimicrobial Sensitivity Disks are intended for use in a laboratory setting to diagnose or aid in the diagnosis of a condition (bacterial infection) by testing a sample (bacterial culture) outside of the body.
N/A
Intended Use / Indications for 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 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.
Product codes
JTN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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 (770)488-7655.
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 (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" (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 (800) 638-2041 or at (301) 443-6597 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
2
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:(005) 340-2100
Fax. (80.5/316-27e
att Lake City Litar
- 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.
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)