(255 days)
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No
The document describes a standard antimicrobial susceptibility testing method (Etest) based on a predefined antibiotic gradient on agar, with no mention of AI or ML technologies.
No
The device determines antimicrobial susceptibility (Minimum Inhibitory Concentration or MIC) of microorganisms via a predefined antibiotic gradient on agar. It assists in diagnosis and monitoring, but does not directly treat or prevent a disease or condition in a patient, which would characterize a therapeutic device.
Yes
The device determines the Minimum Inhibitory Concentration (MIC) of antimicrobial agents against microorganisms, which is used for antimicrobial susceptibility testing. This testing provides information crucial for diagnosing and guiding treatment for bacterial infections.
No
The device description explicitly states the system comprises a "predefined antibiotic gradient" and is "tested on agar using overnight incubation," indicating physical components and laboratory procedures are integral to its function, not just software.
Based on the provided text, 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 involves testing biological samples (microorganisms) outside of the body to provide information for diagnosis and treatment decisions.
- Device Description: The description mentions testing "against microorganisms as tested on agar using overnight incubation." This is a classic in vitro diagnostic method.
- Nature of the Test: Determining the Minimum Inhibitory Concentration (MIC) of an antibiotic against a microorganism is a crucial step in guiding antibiotic therapy, which is a diagnostic process to determine the most effective treatment.
The core function of the device is to analyze a biological sample (microorganisms) in a laboratory setting to provide information relevant to a patient's condition (susceptibility to antibiotics). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This submission is for Etest® Telavancin for MIC determinations across 0.002-32 µg/mL and 0.016-256 µg/mL with Staphylooous aureus (including methicillin-resistant isolates), Entervoous faecalis (vancomycin-susceptible isolates only), Streptocous agalactive and Streptorous anginous group.
Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterbaturias, Staphylovaus and Entervoors species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptorouxu 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
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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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, featuring a staff with a single snake winding around it, topped with a three-pronged design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
bioMérieux c/o Asa Karlsson Regulatory Affairs Manager 5 rue des Aqueducs Craponne, France 69290
16 2011 MAY
Re: K102535
Trade/Device Name: Etest® Telavancin for Antimicrobial Susceptibility Testing Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test (AST) Powder Regulatory Class: Class II Product Code: JWY Dated: April 13, 2011 Received: April 19, 2011
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 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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket
1
Page 2 - Asa Karlsson
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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely vours.
fayazadym
Sally A. Hojvat, M.Sc., 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
K 102538 510(k) Number (if known):
Device Name: Etest® Telavancin - Antimicrobial Susceptibility: Test - MC at 0.002-32 µg/mL and 0.016-256 ug/mL.
Indications For Use: This submission is for Etest® Telavancin for MIC determinations across 0.002-32 µg/mL and 0.016-256 µg/mL with Staphylooous aureus (including methicillin-resistant isolates), Entervoous faecalis (vancomycin-susceptible isolates only), Streptocous agalactive and Streptorous anginous group.
Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterbaturias, Staphylovaus and Entervoors species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptorouxu 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)
Sae atter
Division Sign-Off
Office of In Vitro Diag
Device Evaluation and S
510(k) K 102535