(426 days)
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No
The description focuses on a traditional agar-based gradient technique for susceptibility testing and does not mention any AI/ML components or image processing.
No
The device is described as a diagnostic tool for determining the Minimum Inhibitory Concentration (MIC) of antifungal agents against Candida species, which is used for susceptibility testing, not for treatment.
Yes
The device is used for determining the Minimum Inhibitory Concentration (MIC) of an antifungal agent against Candida species, which is a key step in diagnosing and guiding treatment for fungal infections.
No
The device description clearly states it is an "agar-based gradient technique" and uses a "predefined concentration gradient of the specific antifungal agent," indicating a physical, hardware-based method for testing.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "MIC determinations across 0.002-32 µg/mL with C. albicans, C. glabrata, C. parapsilosis and C. tropicalis." This involves testing biological samples (Candida species) outside of the body to provide information about a patient's potential response to an antifungal agent.
- Device Description: The description further clarifies that it's an "agar-based gradient technique for quantitative antifungal susceptibility testing of Candida species." This is a classic description of an in vitro diagnostic method used in a laboratory setting.
- Function: The device determines the Minimum Inhibitory Concentration (MIC), which is a crucial piece of information for guiding treatment decisions for fungal infections. This information is derived from testing the organism in a laboratory setting, not directly on the patient.
Therefore, based on the provided information, the Etest Voriconazole device fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This submission is for Etest Voriconazole for MIC determinations across 0.002-32 µg/mL with C. albicans, C. glabrata, C. parapsilosis and C. tropicalis.
Etest is an agar-based gradient technique for quantitative antifungal susceptibility testing of Candida species. It uses a predefined concentration gradient of the specific antifungal agent to determine the Minimum Inhibitory Concentration (MIC) in ug/mL inhibiting the growth of the test organism under defined conditions.
Product codes
NGZ
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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§ 866.1640 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three wavy lines, and the text is in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AB BioMerieux c/o Anette Engelhardt CEO Dalvagen 10 16956 Solna Sweden
NOV - 2 2009
Re: K082534
Trade/Device Name: E test Voriconazole (0.002-32 mg/ml) Regulation Number: 21CFR 866.1640 Regulation Name: Etest® for Antimicrobial Suspectibility Testing Regulatory Class: Class II Product Code: NGZ Dated: October 2, 2009 Received: October 8, 2009
Dear Ms. Engelhardt
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 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.
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its wing and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.
Page 2 - Anette Engelhardt
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
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/ucm115809.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/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Jalquitingo
Sally A. Hojvat, 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): K082534
Device Name: Etest Voriconazole - Antifungal Susceptibility Test - MIC at 0.002-32 ug/mL
Indications For Use: This submission is for Etest Voriconazole for MIC determinations across 0.002-32 µg/mL with C. albicans, C. glabrata, C. parapsilosis and C. tropicalis.
Etest is an agar-based gradient technique for quantitative antifungal susceptibility testing of Candida species. It uses a predefined concentration gradient of the specific antifungal agent to determine the Minimum Inhibitory Concentration (MIC) in ug/mL inhibiting the growth of the test organism under defined conditions.
Prescription Use __ ਮ (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)
Leedalie k. Poolr
Division Sign-Off
Page1 of 1
ision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082534