(84 days)
Not Found
No
The description details a manual method for determining antimicrobial susceptibility based on visual interpretation of an inhibition ellipse. There is no mention of automated analysis, image processing, or any AI/ML algorithms.
No
The device is used to determine the antimicrobial susceptibility of bacteria, which is a diagnostic purpose, not a therapeutic one.
Yes
The device determines the Minimum Inhibitory Concentration (MIC) of antimicrobial agents against microorganisms, which is used to assess antimicrobial susceptibility. This is a diagnostic technique to guide treatment decisions.
No
The device description explicitly states that the device is a "thin, inert and non-porous plastic strip" which is a physical hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "determination of antimicrobial susceptibility of non-fasticious Gram-negative and Gram-positive aerobic bacteria... and fastidious bacteria...". This is a diagnostic purpose, specifically determining how susceptible bacteria are to antimicrobial agents.
- Device Description: The device works by creating an antibiotic gradient on an agar surface and observing bacterial growth inhibition. This process is performed in vitro (outside of the living body) on a sample (bacterial culture).
- Performance Studies: The performance studies compare the ETEST® Telavancin to a "CLSI broth microdilution reference method," which is a standard method for in vitro antimicrobial susceptibility testing.
- Key Metrics: The key metrics presented (% Essential Agreement and % Category Agreement) are standard metrics used to evaluate the performance of in vitro diagnostic tests for antimicrobial susceptibility.
The entire description points to a device used to perform a test on a biological sample (bacterial culture) outside of the body to provide information about the sample's characteristics (antimicrobial susceptibility), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ETEST® is a quantitative technique for determination of antimicrobial susceptibility of non-fasticious Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus 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 media using overnight incubation.
Telavancin has been shown to be active against the Gram positive aerobic microorganisms listed below, according to the FDA label for this antimicrobial agent.
Active both in vitro and in clinical infections:
Staphylococcus aureus (including methicillin resistant isolates)
Enterococcus faecalis (vancomycin susceptible isolates only)
Product codes (comma separated list FDA assigned to the subject device)
JWY
Device Description
ETEST® is a thin, inert and non-porous plastic strip carrying on one side (A) the MIC reading scale in ug/mL, and on the other side (B) a predefined antibiotic gradient.
When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.
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
Prescription Use
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
External evaluations were conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to establish the performance of ETEST® Telavancin by comparing with the CLSI broth microdilution reference method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
ETEST® Telavancin demonstrated substantially equivalent performance when compared with the CLSI M07-A10 January 2015 broth microdilution reference method, following rules as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, issued on August 28, 2009 and following specifications as defined in CLSI M100-S27 January 2017.
This Premarket Notification (510[k]) presents data in support of ETEST® Telavancin for Gram positive aerobic bacteria: Staphylococcus aureus and Enterococcus faecalis. External evaluations were conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to establish the performance of ETEST® Telavancin by comparing with the CLSI broth microdilution reference method.
Results:
Staphylococcus aureus (including methicillin resistant isolates): Essential Agreement (EA) 98.4%, Category Agreement (CA) 97.9%
Enterococcus faecalis (vancomycin susceptible isolates only): Essential Agreement (EA) 91.6%, Category Agreement (CA) 97.6%
Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA) and Category Agreement (CA)
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.
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.
Not Found
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).
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 3, 2018
bioMérieux SA Asa Karlsson Sr. Regulatory Affairs Manager 376 Chemin de l'Orme Marcy L'Etoile, 69280 Fr
Re: K180936
Trade/Device Name: ETEST Telavancin (TLA) (0.002-32 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY Dated: April 9, 2018 Received: April 10, 2018
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 and Part 809); medical device 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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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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ribhi Shawar -S
For
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180936
Device Name ETEST® Telavancin (TLA) (0.002 - 32 ug/mL)
Indications for Use (Describe)
ETEST® is a quantitative technique for determination of antimicrobial susceptibility of non-fasticious Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus 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 media using overnight incubation.
Telavancin has been shown to be active against the Gram positive aerobic microorganisms listed below, according to the FDA label for this antimicrobial agent.
Active both in vitro and in clinical infections: Staphylococcus aureus (including methicillin resistant isolates) Enterococcus faecalis (vancomycin susceptible isolates only)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo features a stylized globe with horizontal lines on the left side and a solid dark circle on the right. A curved line extends from the top of the globe, arcing over it and down to the bottom right, creating a sense of movement. Below the globe is the company name, "BIOMÉRIEUX", in a simple sans-serif font.
510(k) SUMMARY
ETEST® Telavancin
A. 510(k) Submission Information:
| Submitter's Name: | bioMerieux SA |
|---|---|
| Address: | 376 Chemin de l'Orme |
| 69280 Marcy-l'Etoile, FRANCE | |
| Contact Person: | Asa Karlsson |
| Sr. Regulatory Affairs Manager | |
| Phone Number: | +33 (0)6 48 61 68 49 |
| Date of Preparation: | July 2, 2018 |
B. Device Name:
| Formal/Trade Name: | ETEST® Telavancin (TLA) (0.002 - 32 ug/mL) |
|---|---|
| Classification Name: | 21 CFR 866.1640 |
| Manual Antimicrobial Susceptibility Test Systems | |
| Product Code: JWY | |
| Common Name(s): | ETEST® Telavancin; ETEST® TLA |
| C. Predicate Device: | ETEST® Ceftaroline (CPT) (0.002-32 µg/mL) |
| (K151873) |
D. Device Description:
ETEST® is a thin, inert and non-porous plastic strip carrying on one side (A) the MIC reading scale in ug/mL, and on the other side (B) a predefined antibiotic gradient.
When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.
E. Intended Use:
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ETEST® is a quantitative technique for determination of antimicrobial susceptibility of nonfastidious Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus 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 media using overnight incubation.
Telavancin has been shown to be active against the Gram positive aerobic microorganisms listed below, according to the FDA label for this antimicrobial agent.
Active both in vitro and in clinical infections:
Staphylococcus aureus (including methicillin resistant isolates) Enterococcus faecalis (vancomycin susceptible isolates only)
F. Performance Overview
ETEST® Telavancin demonstrated substantially equivalent performance when compared with the CLSI M07-A10 January 2015 broth microdilution reference method, following rules as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, issued on August 28, 2009 and following specifications as defined in CLSI M100-S27 January 2017.
This Premarket Notification (510[k]) presents data in support of ETEST® Telavancin for Gram positive aerobic bacteria: Staphylococcus aureus and Enterococcus faecalis. External evaluations were conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to establish the performance of ETEST® Telavancin by comparing with the CLSI broth microdilution reference method.
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ETEST® Telavancin demonstrated acceptable performance as presented in Table 1 below: Table 1: Performance Characteristics for ETEST® Telavancin
| % Essential Agreement | % Category Agreement | |
|---|---|---|
| (EA) | (CA) | |
| Staphylococcus aureus | ||
| (including methicillin resistant | ||
| isolates) | 98.4 | 97.9 |
| Enterococcus faecalis | ||
| (vancomycin susceptible | ||
| isolates only) | 91.6 | 97.6 |
Reproducibility and Quality Control demonstrated acceptable results.
G. Conclusion:
The performance data presented in this submission support a substantial equivalence decision. ETEST® Telavancin (0.002-32 µg/mL) is substantially equivalent to ETEST® Ceftaroline (0.002-32 µg/mL) (K151873).