(21 days)
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No
The summary describes a standard antimicrobial sensitivity disk used for a well-established, non-AI/ML based testing procedure (Kirby-Bauer). There are no mentions of AI, ML, image processing, or any data-driven algorithms.
No
This device is used for in vitro susceptibility testing to determine the effectiveness of an antimicrobial agent against microorganisms, not for directly treating a patient.
Yes
Explanation: The device is used for "semi-quantitative in vitro susceptibility testing," which is a diagnostic procedure to determine the effectiveness of antimicrobials against microorganisms.
No
The device is described as "Antimicrobial Sensitivity Disks," which are physical components used in laboratory testing. The description does not mention any software component.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the HardyDisk®1 Tigecycline Antimicrobial Sensitivity Disks are used for "semi-quantitative in vitro susceptibility testing". The term "in vitro" is a key indicator of an IVD.
Furthermore, the description mentions that the testing is done by the "agar diffusion test procedure (Kirby-Bauer)", which is a standard laboratory method for determining the susceptibility of microorganisms to antimicrobial agents outside of a living organism. This is consistent with the definition of an IVD.
N/A
Intended Use / Indications for Use
HardyDisk®1 Tigecycline Antimicrobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer). Zone sizes used for interpretation of tests and control organism limits were determined by the drug manufacturer and received FDA approval under NDA Number 21-821.
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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 3 2006
Mr. Andre Hsiung Director of Technical Services/R&D Hardy Diagnostics 1430 W. McCoy Lane Santa Maria, California 93455
K062245 Re:
Trade/Device Name: HardyDisk Tigecycline, 15 µg Regulation Number: 21 CFR § 866.1620 Regulation Name: Antimicrobial susceptibility test disc Regulatory Class: II Product Code: JTN Dated: July 28, 2006 Received: August 7, 2006
Dear Mr. Hsiung:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
1
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Sally, attorn
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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YOUR MICROBIOLOGY SPECIALIST FOR 25 YEARS AND COUNTING
Indications for Use
K062245 510(k) Number (if known):
Device Name: HardyDisk Tigecycline, 15 µg
Indications for Use:
HardyDisk®1 Tigecycline Antimicrobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer). Zone sizes used for interpretation of tests and control organism limits were determined by the drug manufacturer and received FDA approval under NDA Number 21-821.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Salazar
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K062245
Image /page/2/Picture/15 description: The image shows a logo with the word "HARD" in bold, uppercase letters. Below "HARD" is the word "DIAGNOSTICS" in a smaller font size. To the left of the text is a graphic of a globe with curved lines representing the continents or longitudinal lines.
Headquarters & Customer Service
1430 West McCoy Lane
Santa Maria, CA 93455
phone: (800) 266-2222
fax: (805) 346-2760
email: sales@hardydiagno
web: www.hardydiagnostic
Distribution Centers:
Phoenix, Arizona
(800) 995-8456
Salt Lake City, Utah
(800) 266-2222
Tacoma, Washington
(800) 266-2222
Lima, Ohio
(800) 266-2222