(41 days)
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No
The document describes a traditional antimicrobial susceptibility testing method (Kirby-Bauer) using physical disks and does not mention any computational analysis or AI/ML techniques.
No
The device is used for in vitro susceptibility testing of bacterial pathogens to determine their sensitivity to antimicrobial agents, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is used for in vitro susceptibility testing of bacterial pathogens to determine their sensitivity to antimicrobials, which is a diagnostic purpose.
No
The device is described as "Antimicrobial Sensitivity Disks," which are physical disks used in laboratory testing. The description focuses on the intended use of these physical disks for susceptibility testing. There is no mention of software as the primary component or function of the device.
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 HardyDisk™ Antimicrobial Sensitivity Disks are used for "semi-quantitative in vitro susceptibility testing". The term "in vitro" is a key indicator of an IVD.
- Purpose: The purpose of the device is to test the susceptibility of bacterial pathogens to antimicrobial agents, which is a diagnostic process performed outside of the living organism.
- Method: The method described, the agar diffusion test procedure (Kirby-Bauer), is a standard laboratory technique for in vitro diagnostic testing.
- Indicated Organisms: The list of indicated organisms (Enterobacteriacae, Staphylococcus spp., etc.) are pathogens that are typically identified and tested in a clinical laboratory setting for diagnostic purposes.
- Intended User/Care Setting: The "Intended User / Care Setting" is listed as "Clinical Laboratory," which is where IVD testing is performed.
All of these factors strongly indicate that the HardyDisk™ Antimicrobial Sensitivity Disks are intended for use in a laboratory setting to perform diagnostic tests on biological samples (bacterial pathogens), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HardyDisk™ Antimichobial 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. Sundardized methods for agar diffusion testing have been described for Enterotaciacae, Stuphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterocccus spp., other streptococci and, by modified procedures, Huemophilus influenque, Neisseria gonorrhoeae and Streptococcus pneumoniae.
HardyDisk™ Doxycycline are indicated for in vitro activity against the Enterobacteriaciae, Acinetobacter spp., Staphylococcus spp., and Enterococcus 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three curved lines suggesting a profile, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged in a semi-circular fashion around the figure. The text is in all caps and is oriented to follow the curve of the circle.
JAN 1 0 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
K994051 Re: Trade Name: HardyDisk™ Doxycycline 30mcg Regulatory Class: II Product Code: JTN Dated: November 30, 1999 Received: November 30, 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 (OS) 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 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" (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 Sutman
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/3 description: The image shows the logo for Hardy Diagnostics. The logo consists of a circular graphic on the left and the text "HARDY DIAGNOSTICS" on the right. The circular graphic is black and white and appears to be a stylized representation of a petri dish or similar laboratory item. The text is in a bold, sans-serif font, with "HARDY" on top and "DIAGNOSTICS" below.
Email: Sales (2)Hardyn = annostics ( anta Maria, Callur 1430 Wen McCov Lans Sanca Maria, CA 93455 Try 19951 346 7765
Lake Cliv. Ul 4 W. Cellace An Sandy, UT 84070 2011 547.27
Artist Artras. on ive sit Acca A7 A5710 19001 995,84
510K. Number K994051
Indications for Use Statement-HardyDisk ™ Doxycycline 30mcg
HardyDisk™ Antimichobial 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. Sundardized methods for agar diffusion testing have been described for Enterotaciacae, Stuphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterocccus spp., other streptococci and, by modified procedures, Huemophilus influenque, Neisseria gonorrhoeae and Streptococcus pneumoniae.
HardyDisk™ Doxycycline are indicated for in vitro activity against the Enterobacteriaciae, Acinetobacter spp., Staphylococcus spp., and Enterococcus spp.
Concurrence of CDRII-ODE
Woodes Dubose
(Division Signer)
vision Sigr Division of Clinical Laboratory Devices K99405 510(k) Number
Prescription Use
(per 21 CFR 801.109)
OR
Over-the Counter-Use (Optional format 1-2-96)
Serving the laboratories since 1980