(78 days)
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No
The summary describes a traditional in vitro diagnostic method (Etest) for determining antimicrobial susceptibility based on a predefined antibiotic gradient and overnight incubation. There are no mentions of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text.
No
The device is described as being "For in vitro diagnostic use" to determine antimicrobial susceptibility and minimum inhibitory concentrations (MICs) of antibiotics against bacteria. This indicates it is a diagnostic tool, not a device used for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use" and describes the device as determining antimicrobial susceptibility, which is a diagnostic purpose.
No
The provided text describes a physical device (Etest) used for in vitro diagnostic testing, which involves a predefined antibiotic gradient on agar media and overnight incubation. This clearly indicates a hardware component and a physical process, not a software-only device.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use:" This is the primary indicator that the device is intended for use outside of a living organism to diagnose or detect diseases, conditions, or states of health.
Furthermore, the description of its function – determining antimicrobial susceptibility and minimum inhibitory concentration (MIC) of bacteria – aligns perfectly with the definition of an in vitro diagnostic device used in clinical laboratories.
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 nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaxeae, Pseudomonas, Staphylooocus and Enteroous species and fastidious bacteria, such as anaerobes, Pneumooocus, Streptocous, Gonocous and Haemophilus species. The system comprises a predefined antibiotic gradient that 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 510(k) submission is for an additional drug for Etest for MIC determination of Gemifloxacin MIC 0.002 - 32 µg/ml with Enterobacteriaceae, S. pneumoniae and H. influenzae.
Product codes
JWY
Device Description
Etest is a quantitative technique for the determination of antimicrobial susceptibility. The system comprises a predefined antibiotic gradient that 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 submission specifically adds Gemifloxacin for MIC determination.
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
Prescription Use
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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 9 2004
Ms. Anne Bolmström President & CEO AB Biodisk Dalvägen 10 S-169 56 Solna Sweden
K042390 Re: Trade/Device Name: Etest® Gemifloxacin 0.002-32 µg/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: November 10, 2004 Received: November 12, 2004
Dear Ms. Bolmström:
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 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 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); and good manufacturing practice requirements as set forth 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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Salartys
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
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Indications for Use
510(k) Number (if known): K042390
Device Name: Etest® Gemifloxacin 0.002-32 µg/mL
Indications For Use:
For in vitro diagnostic use:
Etest is a quantitative technique for the determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaxeae, Pseudomonas, Staphylooocus and Enteroous species and fastidious bacteria, such as anaerobes, Pneumooocus, Streptocous, Gonocous and Haemophilus species. The system comprises a predefined antibiotic gradient that 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 510(k) submission is for an additional drug for Etest for MIC determination of Gemifloxacin MIC 0.002 - 32 µg/ml with Enterobacteriaceae, S. pneumoniae and H. influenzae.
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)
Ludolfo-Rocle
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K^{04}23^{D} Si
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C:\Documents and Settings\MBB\Desktop\O\VD\Review AST 510K\AB Biodisk[K042390](https://510k.innolitics.com/search/K042390) gemifloxacin\IFU 0410-1.00C