(44 days)
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No
The description focuses on a traditional in vitro diagnostic method (agar diffusion) and does not mention any computational or algorithmic components indicative of AI/ML.
No.
The device is used for in vitro susceptibility testing of bacterial pathogens to determine their sensitivity to antimicrobial agents. It does not directly treat or prevent a disease or condition in a patient.
Yes
Explanation: The device is used for "in vitro susceptibility testing" to determine the effectiveness of antibiotics against bacterial pathogens, which is a diagnostic function in determining appropriate treatment.
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 in vitro 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).
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.
Furthermore, the description of the testing procedure ("agar diffusion test procedure (Kirby-Bauer)") and the types of organisms being tested (bacterial pathogens) are consistent with the use of an IVD in a laboratory setting to diagnose or aid in the diagnosis of infections by determining the susceptibility of bacteria to antibiotics.
N/A
Intended Use / Indications for Use
HardyDisk™ 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., Acinetobacter spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae.
HardyDisk™ Ampicillin/Sulbactam is indicated for in vitro activity against gram negative organisms including Escherichia coli, Klebsiella spp., Proteus spp., Providencia spp., Morganella morganii, Haemophilus spp. and Neisseria gonorrhoeae.
HardyDisk™ Ampicillin/Sulbactam is also indicated for in vitro activity against gram positive organisms including Staphylococcus spp., enterococci, and Streptococcus spp., including S. 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of three human figures.
JAN 1 4 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
K994067 Re:
Trade Name: HardyDisk™ Ampicillin/Sulbactam 10/10mcg Regulatory Class: II Product Code: JTN Dated: November 29, 1999 Received: December 1, 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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Page 2
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 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 text "HARDY DIAGNOSTICS" on the right. The word "HARDY" is on top of the word "DIAGNOSTICS".
mail: Sales@Hardydiannostics.com Website: Hardvdiaanostic
Santa Maria, California 430 West McCov Lane Santa Maria, CA 93455 Tel: 18051 346-7766 Fax: 18051 346-7760
Salt Lake City, Utah 254 W Cottane Ave Sandv. UT 84070 Tel: (800) 995-4273 Fax: 18011562-3214
Phoenix, Arizona 535 W. Iron Ave., #105 Mesa A7 85210 Tel: 18001 995-8456 Fax: 16021 464-9828
510K Number K994067
Indications for Use Statement-HardyDisk ™ Ampicillin/Sulbactam 10/10mcg
HardyDisk™ 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., Acinetobacter spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae.
HardyDisk™ Ampicillin/Sulbactam is indicated for in vitro activity against gram negative organisms including Escherichia coli, Klebsiella spp., Proteus spp., Providencia spp., Morganella morganii, Haemophilus spp. and Neisseria gonorrhoeae.
HardyDisk™ Ampicillin/Sulbactam is also indicated for in vitro activity against gram positive organisms including Staphylococcus spp., enterococci, and Streptococcus spp., including S. pneumoniae.
Concurrence of CDRH-ODE
Woody Dubois
(Division Sign-off)
Division of Cli aboratory Devices 510(k) Number
Prescription Use
X
(per 21 CFR 801.109)
OR
Over-the Counter-Use (Optional format 1-2-96)
Serving the laboratorian since 1 980 · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·