(45 days)
Not Found
No
The summary describes a traditional in vitro diagnostic test (Etest®) for determining antimicrobial susceptibility based on a predefined antibiotic gradient and overnight incubation. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of these technologies.
No
The Etest® system is designed for in vitro susceptibility testing of microorganisms to determine antimicrobial susceptibility and Minimum Inhibitory Concentration (MIC), which is a diagnostic tool, not a therapeutic one.
Yes
Explanation: The device is used for "determination of antimicrobial susceptibility of microorganisms," which is a diagnostic purpose to identify appropriate treatment.
No
The device description is not found, but the intended use clearly describes a physical product (Etest®) which is a quantitative technique using a predefined antibiotic gradient on agar for determining antimicrobial susceptibility. This involves physical components and processes, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "In vitro susceptibility testing of Tigecycline is indicated for Gram positive and Gram negative aerobic bacteria... and anaerobic bacteria." This describes testing biological samples (microorganisms) outside of the body to determine their susceptibility to an antimicrobial agent.
- Device Description (implied): While the "Device Description" section is marked as "Not Found," the "Intended Use" and "Predicate Device" sections clearly describe a product used for in vitro testing. The Etest® system is a well-known method for determining antimicrobial susceptibility in a laboratory setting.
- Predicate Device: The predicate device listed, K052300, is described as "Etest® Antimicrobial Susceptibility Test – Tigecycline MIC at 0.016-256". This further confirms that the device falls under the category of in vitro diagnostic tests.
- Care Setting: The intended user is listed as "Prescription Use," which is common for IVD devices used in clinical laboratories.
All of these points strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This submission is for the addition of Tigeycline to the Etest® product range for MIC determination across a concentration range of 0.016-256 ug/mL against susceptible strains of Gram positive and Gram negative aerobic bacteria, specifically including Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and in S. pneumoniae and anaerobic bacteria.
Etest® is a quantitative technique for the determination of antimicrobial susceptibility of aerobic bacteria such as both non-fastidious Gram negative and Gram positive coccus and Enterococcus species and fastidious bacteria, such as anaerobes, S. pneumoniae, N. gonorrhoeae, Streptococcus, Haemophilus Species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in microorganisms as tested on agar using overnight incubation.
Product codes
JWY
Device Description
Not Found
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
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s):
Reference Device(s):
Not Found
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/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States of America. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 3 2005
Ms. Anne Bolmström President and CEO AB Biodisk Dalvägen 10 S-169 56 Solna Sweden
K052366 Re:
K052300
Trade/Device Name: Etest® Antimicrobial Susceptibility Test – Tigecycline MIC at 0.016-256 Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: August 24, 2005 Received: August 29, 2005
Dear Ms. Bolmström:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications ferenced above und have actes negally marketed predicate devices marketed in interstate 10 use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commence provision to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices mat have been receasined in quire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r out may, therefore, mainer of the Act include requirements for annual registration, listing of general condors provisions of wactice, 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 your device is elaborized (ove a controls. Existing major regulations affecting your device it may be subject to such additions (CFR), Parts 800 to 895. In addition, FDA can be found in fire announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of advised that I Drivers and evice complies with other requirements of the Act mall i DA has made a determinations administered by other Federal agencies. You must of any I edital statutes and regainents ancluding, but not limited to: registration and listing (21 Comply with an the Free Feep Parts 801 and 809); and good manufacturing practice CI It I art 807), labeling in the quality systems (QS) regulation (21 CFR Part 820).
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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. 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 Division 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/industry/support/index.html
Sincerely yours,
Sale, a 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: K052366
Device Name: Etest® Antimicrobial Susceptibility Test – Tigecycline MIC at 0.016-256 ug/mL.
Indications For Use: This submission is for the addition of Tigeycline to the Etest® Indications For Use. This Submission is for the addition with Gram positive and product range for MIC delemination across of For 200 pg.m. In S. pneumoniae and anaerobic bacteria.
Etest® is a quantitative technique for the determination of antimicrobial susceptibility of Efest® is a quantitative technique for the acterials aerobic bacteria such as both non-fastidious Gran negative and Olain poccus and Entercococus species and
Enterobacteriaceae, Pseudomonas, Staphylococcus and Entercococus species and Enterobacteriatede, I Scadomondo, S. J. gonorrhoeae, S. pneumoniae, fastidious bacteria, such as anaerooss, The system comprises a predefined antibiotic Streptococcus, Haemophilus Species: The Uyeton Institution (MIC) in
gradient which is used to determine the Minimum Instagramiams on tested on agar gradient which is used to determine the Miniman 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)
Salazar
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Kos 2366
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