(278 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, with no mention of AI or ML.
No
The device is used for determining the minimum inhibitory concentration of antimicrobial agents against microorganisms, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device, Etest® Moxifloxacin, determines antimicrobial susceptibility and Minimum Inhibitory Concentration (MIC) of microorganisms, which are crucial for diagnosing the effectiveness of antibiotics against specific pathogens. This information is directly used to guide treatment decisions for infections, thus serving a diagnostic purpose.
No
The device description is not found, but the intended use describes a quantitative technique using a predefined antibiotic gradient on agar with overnight incubation. This strongly suggests a physical test strip or similar hardware component is involved, not a software-only device.
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 specific microorganisms. This is a classic example of an in vitro test performed on biological samples (microorganisms) to provide information about a patient's condition (susceptibility to antibiotics).
- Device Description (implied): While the "Device Description" section is marked as "Not Found," the "Intended Use" and the name "Etest®" describe a system used to determine antimicrobial susceptibility by testing microorganisms on agar. This process is performed outside of the human body, which is the definition of "in vitro."
- Function: The device determines the Minimum Inhibitory Concentration (MIC), which is a crucial piece of information for guiding antibiotic treatment. This information is derived from testing the microorganisms in a laboratory setting.
Therefore, based on the provided information, the Etest® Moxifloxacin is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This submission is for Etest® Moxifloxacin for MIC determinations across 0.002-32 µg/mL with B. fragilis, B. thetaiotaomirron, C. perfringens and Peptostreptoroccus spp.
Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobaterianas, Staphylocourus and Entervacus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, Streptowers 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
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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
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.
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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
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
Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's logo in the center. The logo is a stylized representation of an eagle or bird with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
AUG 2 5 2010
BIOMÉRIEUX c/o Asa Karlsson Quality and Regulatory Manager Dalvagen 10 Solna Sweden 169 56
Re: K093604
Trade/Device Name: Etest® Moxifloxacin for Antimicrobial Susceptibility Testing Regulation Number: 21 CFR §866.1640 Regulation Name: Antimicrobial susceptibility test powder. - Regulatory Class: Class II Product Code: JWY Dated: July 16, 2010 Received: July 20, 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 market in interestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or 10 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 misbrandiyneand adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Luddie McCool, M.S.
for
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
2
Indications For Use
510(k) Number (if known):
Device Name: Etest® Moxifloxacin - Antimicrobial Sysceptibility Test - MIC at 0.002-32 ug/mL.
Indications For Use: This submission is for Etest® Moxifloxacin for MIC determinations across 0.002-32 µg/mL with B. fragilis, B. thetaiotaomirron, C. perfringens and Peptostreptoroccus spp.
Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobaterianas, Staphylocourus and Entervacus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, Streptowers 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 (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Luddie L. Pool+
Division Sign-Off
sion Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KU9 3604