(35 days)
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No
The summary describes a traditional antimicrobial susceptibility test using agar diffusion discs, with no mention of AI or ML.
No.
The Antimicrobial Susceptibility Test Discs are used for in vitro testing of micro-organisms to determine their susceptibility to antimicrobial agents, not for direct treatment or diagnosis within the body.
Yes
The device is used for "semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms," which determines the susceptibility of microorganisms to antimicrobial agents. This process provides information about the state of the microorganism, which is a diagnostic function.
No
The 510(k) summary describes "Antimicrobial Susceptibility Test Discs," which are physical discs used in laboratory testing. There is no mention of software as the primary or sole component of the device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms." This describes a test performed in vitro (outside the body) on biological samples (micro-organisms) to determine their susceptibility to antimicrobial agents. This is a classic definition of an in vitro diagnostic test.
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. For Daptomycin these include Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysagalactiae subsp. equisimilis, Staphylococcus aureus including MRSA () & Enterococcus faecalis (vancomycin-susceptible strains only).
Prescription Use (21CFR801 subpart D)
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread, with three lines representing the feathers.
SEP 1 4 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Andy Hollingsworth Regulatory Affairs Manager Oxoid Limited Wade Road Basingstoke, Hants RG24 8PW United Kingdom
K042157 Re:
Trade/Device Name: Oxoid Daptomycin Susceptibility Test Disc Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disc Regulatory Class: Class II Product Code: JTN Dated: August 5, 2004 Received: August 10, 2004
Dear Mr. Hollingsworth:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalent as and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10. use stated in the encreative to togally in togens )
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered phor to they 20, 2017 11:51 in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mererore, mains of the Act include requirements for annual registration, listing of general controls provision practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device It inay be subject to satin additions (CFR), Parts 800 to 895. In addition, FDA can oe found in There announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised that I Dri brissantes cour device complies with other requirements of the Act mail 1 Drias made a acterimentations administered by other Federal agencies. You must of any I cach statutes and regaranents, including, but not limited to: registration and listing (21 Comply with and the Frequirements 801 and 809); and good manufacturing practice CI K Fart 807), labeling in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will and w you w ough finding of substantial equivalence of your device to a legally promatics notification: "The Profit and classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you destions on the promotion and advertising of your device, please contact the Office of or questions on the promotion and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Four may of Small Manufacturers, International and Consumer 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,
Salgado
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(K) Submission for Oxoid Antimicrobial Susceptibility Test Disc Daptomycin
Indications for Use
510(K) Number : K042157
Oxoid Daptomycin Susceptibility Test Disc Device Name :
Indication for Use :
Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar Alfinincrootal Gaseeparemly Troly growing micro-organisms. For Daptomycin these include unnusion icsi procedure of inprary gromang resus agalactiae, Streptococcus disagalactiae subsp. Stapily to Coccus antous metading Mires () & Prococus faccalis (vancomycin-susceptible strains only).
Prescription Use (21CFR801 subpart D) Over-The-Counter Use (21CFR807 subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics Division Sign-Off
AND/OR
Office of In Vitro Diagnostic Device Evaluation and Safety
cinni KO42157