(44 days)
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., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae. HardyDisk™ Aztreonam is indicated for in vitro activity against gram negative aerobic pathogens including Escherichia coli, Enterobacter spp., Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens, and Citrobacter spp. HardyDisk™ Aztreonam is also indicated for in vitro activity against Haemophilus influenzae.
HardyDisk™ Antimicrobial Sensitivity Disks
I am sorry, but the provided text from the FDA 510(k) K994063 letter and accompanying "Indications for Use Statement" does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving a device meets those criteria.
The document is a regulatory approval letter for a device named "HardyDiskTM Aztreonam 30mcg" and its "Indications for Use Statement." It confirms that the device is substantially equivalent to a legally marketed predicate device and outlines its intended use for antimicrobial susceptibility testing.
The document does NOT include:
- A table of acceptance criteria or reported device performance.
- Information on sample sizes, data provenance, or details about test sets.
- The number or qualifications of experts used for ground truth, or adjudication methods.
- Details about a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes.
- Results from a standalone algorithm performance study.
- The type of ground truth used for performance evaluation (e.g., pathology, outcomes data).
- Any information regarding a training set's sample size or how its ground truth was established.
This document is a formal communication of regulatory clearance, not a technical report detailing the performance study of the device. Such details would typically be found in the manufacturer's 510(k) submission, which is not provided here.
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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" around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 4 2000
Ms. Melissa M. Traylor, RAC Director of Technical Services Regulatory Affairs Hardy Diagnostics 1430 West McCoy Lane Santa Maria, California 93455
Re: K994063
Trade Name: HardyDiskTM Aztreonam 30mcg 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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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 vours.
Steven Autman
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/3 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 black and white and appears to have several lines running through it. The text is in a bold, sans-serif font, with "HARDY" on top and "DIAGNOSTICS" below.
Forail: Sales Bitaria Lannstics com
und Merid. na Maria, CA 9345 Tel. 1.3051 346-27
Is Laste City, Uce 54 Kr. Concercial C SADOY. UI 144010 Tct: 18001 995-4273 19011567 7714
1999 Ave
510K Number K994063
Indications for Usc Statement-HardyDisk™ Aztreonam 30mcg
I lardyDisk™ Antimicrobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test proccdure (Kirby-Baucr) of rapidly growing and corain fastidious bactcrial pathogens. Standardized mothods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococous spp., Pscudomonas spp., Acinesobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Ilacmophilus influenzas. Neisseria gonorrhocas and Streptococcus pneumoniae.
HardyDisk™ Aztroottam is indicated for in vitro activity against gram negative aerobic pathogens including Escherichia coli, Enterobacter spp., Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens, and C.itrobacter spp. HardyDisk™ Aztreonam is also indicated for in vitro activity against Haemaphilus influenzae.
Concurrence of CDRH-ODE
Woody Dubois
Laboratory Devices Division of Clini 510(k) Number
Prescription Use (per 21 CFR 801.109) OR
Over-the Counter-lise. (( Intional format 1-2-96)
Scring the laboratorian since: 1990
§ 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).