(42 days)
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No
The summary describes a traditional antimicrobial sensitivity disk used for in vitro testing, with no mention of AI or ML technologies.
No
The device is used for in vitro susceptibility testing of bacterial pathogens to determine antimicrobial sensitivity, which is a diagnostic procedure, not a therapeutic one.
Yes
The device is used for semi-quantitative in vitro susceptibility testing, which is a diagnostic procedure to determine the susceptibility of pathogens to antimicrobial agents.
No
The device description clearly indicates a physical product ("HardyDisk™ Imipenem 10mcg") which is a disk used in a laboratory procedure, not a software-only 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 disks are used for "semi-quantitative in vitro susceptibility testing". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Purpose: The purpose is to test the susceptibility of bacterial pathogens to an antimicrobial agent (Imipenem). This testing is performed on samples taken from a patient (though the patient themselves isn't directly interacting with the device).
- Setting: The "Intended User / Care Setting" is a "Clinical Laboratory," which is where IVD testing is typically performed.
Therefore, based on the provided information, the HardyDisk™ Imipenem Antimicrobial Sensitivity Disks fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HardyDisk™ Imipenem Antimicrobial Sensitivity Disks are used for scmi-quantitative in vitro susceptibility testing py the agar diffusion test procedure (Kirby-Baucr) of rapidly growing and certain tastidious bacterial pathogens. Standardized methods for agar diffusion testing have becn described list Enterobacteriaceae, Staphylococcus spp., Pscudomonus spp., Acinetobacter spp., Enterneonesus spp. other streptococci and, by modified procedures, Haemophilus influenzac, and Streptococcus pneumonine.
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three wavy lines, which are meant to represent the human form.
JAN 1 8 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: K994132 Trade Name: HardyDisk™ Imipenem 10mcg Regulatory Class: II Product Code: JTN Dated: December 7, 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 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 vour 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 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/4 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 a black circle with several white lines running through it. The text is in a bold, sans-serif font, with "HARDY" on top and "DIAGNOSTICS" below.
Email: Sales@Hardydiagnostics.com
Website: Hardydiagnostics.com
430 Wirer Ader
Salt Lake Chy, Uran
254 W. Commge Five
Surkly. UT 84173
Tel: (800) 995 4:173
Fax. 9011562.3.14
Pliveritx, Arizona
355 W. Iron Ave., 8:05
Mesa, AZ 852 10
Tel: 1800) 995 8:56
Fax: (602) 464-9128
510K Number: K994132
Indications for Use Use Statement-HardyDisk (4) Imipenem 10mcg
HardyDisk™ Imipenem Antimicrobial Sensitivity Disks are used for scmi-quantitative in vitro susceptibility testing py the agar diffusion test procedure (Kirby-Baucr) of rapidly growing and certain tastidious bacterial pathogens. Standardized methods for agar diffusion testing have becn described list Enterobacteriaceae, Staphylococcus spp., Pscudomonus spp., Acinetobacter spp., Enterneonesus spp. other streptococci and, by modified procedures, Haemophilus influenzac, and Streptococcus pneumonine.
Concurence of CDRH-ODE
Woody Dubois
Devices O(k) Number
Prescription Use (per 21 CFR 801. 109)
OR
Over-the Counter-Use (Optional formal 1-2-96)