(51 days)
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No
The summary describes a traditional antimicrobial susceptibility test disc and does not mention any AI or ML components.
No
Explanation: The device is an antimicrobial susceptibility test disc, used for testing microbial susceptibility to antibiotics, not for treating a disease or condition.
Yes
Explanation: The device is an "Antimicrobial Susceptibility Test Disc" used for "semi-quantitative susceptibility testing" of microorganisms. This testing helps determine which antimicrobial agents will be effective against a specific infection, which is a diagnostic function, guiding treatment decisions.
No
The device is described as "Antimicrobial Susceptibility Test Discs" and "Oxoid Sparfloxacin Susceptibility Test Disc," which are physical components used in laboratory testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms." This is a laboratory test performed on biological samples (micro-organisms) to determine their susceptibility to antimicrobial agents.
- Device Description: The device is an "Antimicrobial Susceptibility Test Disc," which is a common component used in in vitro diagnostic procedures for determining microbial susceptibility.
- Intended User / Care Setting: The intended user is a "Clinical Laboratory," which is the typical setting for performing in vitro diagnostic tests.
These factors strongly indicate that the device is intended for use in a laboratory setting to perform tests on biological samples outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriaceae, Staphylococcus spp., Pseudomonas aeruginosa ,and by modified procedures, and Streptococcus spp.
This submission is for the use of Sparfloxacin with Staphylococcus spp. and 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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g 1998 SEP
Andy Hollingsworth Ouality Systems Manager Oxoid. Ltd. Wade Road Basingstoke Hants RG24 8PW England
Re: K982526
Trade Name: Sparfloxacin Antimicrobial Susceptibility Test Disc Regulatory Class: II Product Code: JTN Dated: July 14, 1998 Received: July 20, 1998
Dear Mr. Hollingsworth:
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 premarkee 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 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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510(K) Submission for Oxoid Antimicrobial Susceptibility Test Disc
SPARFLOXACIN
OXOID LTD
510(K) Number : Unknown
Oxoid Sparfloxacin Susceptibility Test Disc Device Name :
Indication for Use :
... . .
Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriaceae, Staphylococcus spp., Pseudomonas aeruginosa ,and by modified procedures, and Streptococcus spp.
This submission is for the use of Sparfloxacin with Staphylococcus spp. and Streptococcus pneumoniae.
Woody Dubose
nical Laboratory Devices Division of C 510(k) Number.
PRESCRIPTION USE X