(70 days)
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No
The document describes a standard antimicrobial susceptibility testing disk and does not mention any AI/ML components or related technologies.
No
This device is an in vitro diagnostic device used for susceptibility testing of bacterial pathogens, not for direct therapeutic use on a patient.
Yes
The device is described as "Chloramphenicol Antinuicobial Seusitivity Disks [sic] are used for semi-quantiarive in vitro susceptibility testing," which is a diagnostic purpose to determine the susceptibility of bacteria to antimicrobial agents.
No
The device is described as "HardyDisk™ Chloramphenicol Antinuicobial Seusitivity Disks," which are physical disks used in an in vitro diagnostic procedure (agar diffusion test). This description clearly indicates a hardware component, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the HardyDisk™ Chloramphenicol Antimicrobial Sensitivity Disks are used for "semi-quantitative in vitro susceptibility testing". The term "in vitro" is a key indicator of an IVD.
N/A
Intended Use / Indications for Use
HardyDiskTM Chloramphenicol 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 described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas aeruginosa, Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures; Haemophilus influenzae, and streptococci, including Streptococcus pneumoniae. HardyDiskTM Chloramphenicol is indicated for in vitro activity against the Enterobacteriaceae, Staphylococcus spp., Haemophilus spp., and Streptococcus spp., including Streptococcus pneumoniae.
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
Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines representing movement or connection.
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: K994089
Trade Name: HardyDiskTM Chloramphenicol 30mcg Regulatory Class: II Product Code: JTN Dated: December 2, 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 and the company name on the right. The company name is written in a bold, sans-serif font, with the word "HARDY" on top and "DIAGNOSTICS" below it.
שמסתמביר וסורר וסורר אופנילורג ווער Website: Hardvelizations in
ato Maria, Califo 430 WESC MCCory 4 S:10127 A.1787 1 11 934 5 Tel 19051 316-2:63 218 1:3051 346-2:617
to Lake City, Ura JUS 841 10 Fax: 18011562 3:11
Hispair Asiana At 30 A 85 : 11 4. 18001 44.349 Frix, 16021 464-91 21
510K Number K994089
Indications for Use Statement-HardyDisk ™ Chloramphenicol 30mcg
HardyDisk™ Chloramphenicol Antinuicobial Seusitivity Disks are used for semi-quantiarive in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and ccrtain fastidious bactcrial pathogens. Standardized methods for agar diffusion icsting have been described for Entcrobactcriaccas, Staphylococcus spp., I seudomonas aeruginusu, Acinctobacter spp., Eisteria monocytogenes, Enterococcus spp., other streptococi and, by modified procedures; Huemophilus influcitzae, and streptococci, including Streptococcus рпеитопіав.
HardyDisk™ Chloranophenicol is indicated for in vitro activity against the Enterobacteriaciae, Staphylococcus spp., Haemophilus spp., and Streptococous spp., including Streptococcus pneumoniae.
Concurrence of CDRH-ODE
Woodley Dubois
Division of Cit al Laboratory Devices પપ્પ ધા 510(k) Number_
Prescription Use
(per 21 CFR 801.109)
OR
Over-the Counter-Use (Optional format 1-2-96)