(62 days)
Not Found
Not Found
No
The summary describes a traditional antimicrobial susceptibility testing method (Etest) based on a predefined antibiotic gradient and overnight incubation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as a quantitative technique for determining antimicrobial susceptibility and Minimum Inhibitory Concentration (MIC) of antimicrobial agents against microorganisms, which are diagnostic purposes, not therapeutic.
Yes
Explanation: The device is used for "determination of antimicrobial susceptibility," specifically to "determine the Minimum Inhibitory Concentration (MIC)" of different antimicrobial agents against microorganisms. This process of identifying the susceptibility of bacteria to antibiotics and quantifying that susceptibility is a form of diagnosis, as it helps determine the appropriate treatment for an infection.
No
The provided text describes a physical device (Etest®) used for determining antimicrobial susceptibility, which involves a predefined antibiotic gradient on agar and overnight incubation. This clearly indicates a hardware component and a laboratory-based testing method, not a software-only device.
Based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "MIC determinations" of antimicrobial susceptibility against microorganisms. This involves testing biological samples (bacteria) in vitro (outside the body) to diagnose or monitor a condition (bacterial infection) and guide treatment (antibiotic selection).
- Device Description (implied): While the "Device Description" section is marked "Not Found," the "Intended Use" describes the Etest® as a "quantitative technique" and a "system comprising a predefined antibiotic gradient." This strongly suggests a test kit or system used to perform the in vitro diagnostic procedure.
The core function of determining the Minimum Inhibitory Concentration (MIC) of an antibiotic against a microorganism is a classic example of an in vitro diagnostic test used in clinical microbiology laboratories.
N/A
Intended Use / Indications for Use
This submission is for Etest® Tobramycin for MIC determinations across 0.016-256 ug/ml. and 0.064-1024 ug/mL vith Staphylowouns aureus, Enterbacteriareae and P. aerweinosa. Etest® is a quantitative technique for determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram posstive aerobic bacteria such as Enterbacteriateae. Pseudomonas, Staphylococus and Entervocus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptorocus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/mL of different antimicrobial agents against microorganisms as tested on agar using overnight incubation.
Product codes
JWY
Device Description
Etest® is a quantitative technique for determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram posstive aerobic bacteria such as Enterbacteriateae. Pseudomonas, Staphylococus and Entervocus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptorocus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/mL of different antimicrobial agents against microorganisms as tested on agar using overnight incubation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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): 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.
Not Found
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.
Not Found
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).
Not Found
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
BIOMÉRIEUX c/o Ms. Asa Karlsson Regulatory Affairs Manager 5, rue des Aqueducs 69290 Craponne, France
NOV 1 7 2010
Re: K102668
Trade/Device Name: Etest Tobramycin for Antimicrobial Susceptibility Test Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test (AST) Powder Regulatory Class: Class II Product Code: JWY Dated: September 17, 2010 Received: September 16, 2010
Dear Ms. Karlsson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
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Page 2 - Asa Karlsson
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jayanand
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number: K102668
Device Name: Etest® Tobramycin - Antimicrobial Susceptibility Test - MIC at 0.016-256 ug/mL and 0.064-1024 ug/mL.
Indications For Use: This submission is for Etest® Tobramycin for MIC determinations across 0.016-256 ug/ml. and 0.064-1024 ug/mL vith Staphylowouns aureus, Enterbacteriareae and P. aerweinosa.
Etest® is a quantitative technique for determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram posstive aerobic bacteria such as Enterbacteriateae. Pseudomonas, Staphylococus and Entervocus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptorocus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/mL of different antimicrobial agents against microorganisms as tested on agar using overnight incubation.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
NOV 1 7 2010
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Freddie McCoole
Division Sign Off
Vision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)