(70 days)
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No
The document describes a standard antimicrobial susceptibility testing disk and does not mention any AI or ML components.
No.
The device is used for in-vitro susceptibility testing of bacterial pathogens, which is a diagnostic purpose, not a therapeutic one for treating diseases in patients.
Yes
Explanation: The device is used for in vitro susceptibility testing of bacterial pathogens, which is a diagnostic process to determine the effectiveness of antimicrobials against specific bacteria.
No
The device description is not found, but the intended use clearly describes a physical product (antimicrobial susceptibility disks) used in a laboratory procedure (agar diffusion test). This indicates a hardware component is central to the device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the HardyDisk® Antimicrobial Susceptibility Disks are used for "semi-quantitative in vitro susceptibility testing". The term "in vitro" is a key indicator of an IVD, as it means "in glass" or "in the lab," referring to tests performed outside of a living organism.
Furthermore, the description of the testing procedure ("agar diffusion test procedure (Kirby-Bauer)") and the types of samples being tested (bacterial pathogens) are consistent with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
N/A
Intended Use / Indications for Use
HardyDisk® Antimierobial Seusilivity Disks are used for scini-quantitative in vitro susceptibility testing by the agat diffusion test procedure (Kirby-Bauer) of rapidly growing and ccrtain fastidious bactcrial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaces, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Haemophilus influerizae, Neisseria gonorrhoeae and Streptococcus pneumoniae.
HardyDisk™ Gentomicin is indicated for in vitro activity against the Enterobacteriaciae, Pscudomonas acruginosa, and 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 (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)
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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).
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle is blank. Inside the circle is a stylized image of a bird or other winged creature.
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
Re: K994091
Trade Name: HardyDisk™ Gentamicin 10mcg Regulatory Class: II Product Code: JTN Dated: December 3, 1999 Received: December 3, 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, which is filled with a series of parallel lines. To the right of the graphic, the word "HARDY" is written in large, bold letters. Below "HARDY", the word "DIAGNOSTICS" is written in smaller letters.
mail: Sales Billardy 1:30 nostics (18) Acres Hardioiao Santa Maria, Callifornia 1430 West McCoy 1300 Santa Nisma, CA 93455 Tri-19051 744-7761. Fir. 1905) 346-11411 San Lake Clev. Uldl 154 W. Cortage Ave. Survey. UT 846 711 Tet: 1900] 995-4 - 73 Fac. 18011562-7: 1.
PIKKING Asiculus 1453 AZ 852 10 Tcd: 19001 995-84 56 Fire 1602) 444 of 712
510K Number K994091
Indications for Use Statement-HardyDisk ™ Ccntamicin 10mcg
HardyDisk® Antimierobial Seusilivity Disks are used for scini-quantitative in vitro susceptibility testing by the agat diffusion test procedure (Kirby-Bauer) of rapidly growing and ccrtain fastidious bactcrial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaces, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Haemophilus influerizae, Neisseria gonorrhoeae and Streptococcus pneumoniae.
HardyDisk™ Gentomicin is indicated for in vitro activity against the Enterobacteriaciae, Pscudomonas acruginosa, and Staphylococcus spp.
OR
Concurrence of CDRH-ODDF
Woody Dubois
Division of Clit 510(k) Number
Prescription Use (pcr 21 CFR 801.109)
Over the Counter Use (Optional format 1-2-96)
Soving the laboratorian since: 1 '80's