(121 days)
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No
The provided text describes a standard antimicrobial susceptibility testing method (Etest) and does not mention any AI or ML components.
No.
The device is for in vitro diagnostic use to determine antimicrobial susceptibility, not for treating a condition or disease in a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "For in vitro diagnostic use" and describes its function in determining antimicrobial susceptibility and Minimum Inhibitory Concentration (MIC), which are diagnostic activities.
No
The provided text describes a method for determining antimicrobial susceptibility using a predefined antibiotic gradient on agar media. This process inherently involves physical components (agar plates, antibiotic strips, incubators, bacterial cultures) and is an in vitro diagnostic test, not a software-only device.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section begins with the clear statement: "For in vitro diagnostic use:".
- Description of Use: The description details a technique ("Etest") used to determine the antimicrobial susceptibility of bacteria by testing them on agar media. This process is performed in vitro (outside of a living organism) to diagnose or aid in the diagnosis of infections and guide treatment.
- Determination of MIC: The core function is to determine the Minimum Inhibitory Concentration (MIC), which is a key metric in clinical microbiology for assessing the effectiveness of antibiotics against specific bacteria. This information is used for diagnostic purposes and treatment decisions.
Therefore, the text clearly indicates that this device is intended for use in a laboratory setting to perform diagnostic tests on biological samples (bacteria).
N/A
Intended Use / Indications for Use
For in vitro diagnostic use: Etest is a quantitative technique for the determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneumococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in µg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.
This application is for MIC determination of Vancomycin in the range of 0.016 - 256 µg/ml with Streptococcus spp.
Previously cleared applications include non-fastidious Gram positive aerobic bacteria and S. pneumoniae.
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
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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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§ 866.1640 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its head and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
2 9 1998 MAY
Anne Bolmström President Ab Biodisk Dalvägen 10, S-169 56 Solna Sweden
K980348 Re: Trade Name: Etest® Vancomycin Regulatory Class: II Product Code: JWY Dated: May 6, 1998 Received: May 8, 1998
Dear Ms. Bolmström:
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 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). 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 requirements, as set forth in the Quality System Regulation (QS) 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 your 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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Page 1 of 1
510(k) Number (if known): K980348
Device Name: Etest® Vancomycin
Indications For Use:
For in vitro diagnostic use:
Etest is a quantitative technique for the determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneumococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in µg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.
This application is for MIC determination of Vancomycin in the range of 0.016 - 256 µg/ml with Streptococcus spp.
Previously cleared applications include non-fastidious Gram positive aerobic bacteria and S. pneumoniae.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Wordy Dubois
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K980348 |
|---|---|
| --------------- | --------- |
| Prescription Use | X | OR | Over-The Counter Use ______ |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |