(110 days)
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None
No
The summary describes a standard antimicrobial susceptibility test disc and does not mention any AI or ML components or capabilities.
No
This device is an in vitro diagnostic product designed for antimicrobial susceptibility testing, not for direct therapeutic intervention on a patient.
Yes
The device is described as an "Antimicrobial Susceptibility Test Disc" indicated for "semi-quantitative susceptibility testing," which directly relates to diagnosing the susceptibility of microorganisms to antimicrobials.
No
The device description clearly states "Antimicrobial Susceptibility Test Discs" and "Oxoid Clarithromycin 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 that the device is for "semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms." This is a diagnostic test performed in vitro (outside the body) 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 type of reagent used in IVD procedures for determining antibiotic resistance.
The information provided directly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Antimicrobial Susceptibility Test Discs are indicated for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Staphylococcus spp., Maraxella catarrhalis, and some Streptococci, and by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae.
The technical product insert details the Quality Control organisms to be use with this disc.
Product codes
JTN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
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.)
Not Found
Predicate Device(s)
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Reference Device(s)
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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).
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Andy Hollingsworth Quality Systems Manager Oxoid Limited Wade Road Basingstoke Hants RG24.8PW ... . . . . . . . . . . . . . England
AUG 20 1997
Re: K971638 Trade Name: Oxoid Clarithromycin Susceptibility Test Disc Regulatory Class: II Product Code: JTN Dated: June 10, 1997 Received: June 12, 1997
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 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 roquirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 vour 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 Sutman
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
CLARITHROMYCIN
OXOID LTD
K971638 510(K) Number :
Oxoid Clarithromycin Susceptibility Test Disc Device Name :
Indication for Use :
Antimicrobial Susceptibility Test Discs are indicated for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Staphylococcus spp., Maraxella catarrhalis, and some Streptococci, and by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae.
The technical product insert details the Quality Control organisms to be use with this disc.
Elmer Henry, Lillian Parker
ision of Clin. : aboratory Devices 510(k) Number .
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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