(60 days)
Not Found
No
The device description and performance studies focus on a physical strip with a predefined antibiotic gradient and manual reading of the inhibition ellipse. There is no mention of automated analysis, image processing, or any computational methods that would suggest the use of AI/ML.
No.
The device is used for determining antimicrobial susceptibility, which is a diagnostic purpose, not a therapeutic one.
Yes
This device is used to determine the Minimum Inhibitory Concentration (MIC) of antimicrobial agents against microorganisms, which provides information for determining antimicrobial susceptibility. This process is diagnostic in nature as it helps identify the susceptibility of bacteria to specific antibiotics, guiding treatment decisions.
No
The device description explicitly states that the device is a "thin, inert and non-porous plastic strip" which is a physical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the "determination of antimicrobial susceptibility of both non-fastive and Gram-positive aerobic bacteria... and fastidious bacteria...". This involves testing biological samples (bacteria) in vitro (outside the body) to provide information about a patient's potential response to antimicrobial treatment.
- Device Description: The description details a strip with an antibiotic gradient that interacts with bacteria on an agar surface to determine the Minimum Inhibitory Concentration (MIC). This is a classic method used in clinical microbiology laboratories for diagnostic purposes.
- Performance Studies: The performance studies describe testing the device with clinical isolates and comparing its results to a reference method (CLSI broth microdilution), which is standard practice for validating IVD devices. The metrics reported (Essential Agreement, Category Agreement, Error Rates) are also typical for IVD performance evaluation.
- Predicate Device: The mention of a predicate device (K170670 Etest® Ceftolozane/Tazobactam) further indicates that this device falls within the regulatory framework for IVDs, as predicate devices are used for demonstrating substantial equivalence for new IVDs.
All these elements strongly point to the Etest® being an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Etest is a quantitative technique for 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, 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.
Ceftazidime/Avibactam has been shown to be active against the Gram negative aerobic microorganisms listed below, according to the FDA label for this antimicrobial agent.
Etest CZA can be used to determine the MIC of Ceftazidime/Avibactam against the microorganisms listed below:
Active both in vitro and in clinical infections:
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Proteus mirabilis
Pseudomonas aeruginosa
The following in vitro data are available, but clinical significance is unknown:
Citrobacter koseri
Enterobacter aerogenes
Morganella morganii
Providencia rettgeri
Providencia stuartii
Serratia marcescens
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 (Part 21 CFR 801 Subpart D)
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 Ceftazidime/Avibactam by comparing with the CLSI broth microdilution reference method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Pre-market Notification (510[k]) presents data in support of Etest Ceftazidime/Avibactam for Gram negative aerobic bacteria: Enterobacteriaceae and Pseudomonas aeruginosa.
Etest® Ceftazidime/Avibactam demonstrated acceptable performance as presented in Table 1 below:
| % Essential Agreement (EA) | % Category Agreement (CA) | |
|---|---|---|
| Enterobacteriaceae* | 99.1 | 99.6 |
| Pseudomonas aeruginosa | 99.3 | 99.3 |
*The overall very major error rate for Enterobacteriaceae was 4.4%. The two very major errors were one dilution apart from the reference method and as such fall within essential agreement. Based on the essential agreement, and the lack of an intermediate breakpoint for Ceftazidime/Avibactam, the adjusted very major rate is 0.0%.
Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA)
Category Agreement (CA)
Very Major Error Rate
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15. 2017
BIOMÉRIEUX, INC CHERECE JONES STAFF REGULATORY AFFAIRS SPECIALIST 595 ANGLUM RD. HAZELWOOD MO 63042
Re: K172150
Trade/Device Name: Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: JWY Dated: July 13, 2017 Received: July 17, 2017
Dear Ms. Jones:
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 Parts 801 and 809); medical device reporting (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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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) K172150
Device Name
Etest® Ceftazidime/Avibactam (CZA) (0.016-256 µg/mL)
Indications for Use (Describe)
Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastive and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorhoeae, 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.
Ceftazidime/Avibactam has been shown to be active against the Gram negative aerobic microorganisms listed below. according to the FDA label for this antimicrobial agent.
Etest® CZA can be used to determine the MIC of Ceftazidime/Avibactam against the microorganisms listed below:
Active both in vitro and in clinical infections: Citrobacter freundii Enterobacter cloacae
Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
The following in vitro data are available, but clinical significance is unknown: Citrobacter koseri Enterobacter aerogenes Morganella morganii Providencia rettgeri Providencia stuartii Serratia marcescens
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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510(k) SUMMARY
Etest® Ceftazidime/Avibactam (CZA) (0.016-256 µg/mL)
A. 510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Cherece L. Jones |
| Staff Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8684 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | July 13, 2017 |
B. Device Name:
| Formal/Trade Name: | Etest® Ceftazidime/Avibactam (CZA) (0.016-256
µg/mL) |
|----------------------|------------------------------------------------------------------------------------------|
| Classification Name: | 21 CFR 866.1640
Manual Antimicrobial Susceptibility Test Systems
Product Code: JWY |
| Common Name(s): | Etest® Ceftazidime/Avibactam; Etest® CZA |
| C. Predicate Device: | Etest® Ceftolozane/Tazobactam (0.016-256 µg/ml)
(K170670) |
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.
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E. Intended Use:
Etest is a quantitative technique for 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, 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.
Ceftazidime/Avibactam has been shown to be active against the Gram negative aerobic microorganisms listed below, according to the FDA label for this antimicrobial agent.
Etest CZA can be used to determine the MIC of Ceftazidime/Avibactam against the microorganisms listed below:
Active both in vitro and in clinical infections:
Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
The following in vitro data are available, but clinical significance is unknown:
Citrobacter koseri Enterobacter aerogenes Morganella morganii Providencia rettgeri Providencia stuartii Serratia marcescens
F. Performance Overview
Etest Ceftazidime/Avibactam 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-S26 January 2016.
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Notification (510[k]) presents data in support oof Etest This Premarket Ceftazidime/Avibactam for Gram negative aerobic bacteria: Enterobacteriaceae and Pseudomonas aeruginosa. 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 Ceftazidime/Avibactam by comparing with the CLSI broth microdilution reference method.
Etest® Ceftazidime/Avibactam demonstrated acceptable performance as presented in Table 1 below:
| % Essential Agreement | % Category Agreement | |
|---|---|---|
| (EA) | (CA) | |
| Enterobacteriaceae* | 99.1 | 99.6 |
| Pseudomonas aeruginosa | 99.3 | 99.3 |
Table 1: Performance Characteristics for Etest® Ceftazidime/Avibactam
*The overall very major error rate for Enterobacteriaceae was 4.4%. The two very major errors were one dilution apart from the reference method and as such fall within essential agreement. Based on the essential agreement, and the lack of an intermediate breakpoint for Ceftazidime/Avibactam, the adjusted very major rate is 0.0%.
Reproducibility and Quality Control demonstrated acceptable results.
G. Conclusion:
The performance data presented in this submission support a substantial equivalence decision. The Etest® Ceftazidime/Avibactam (CZA) (0.016-256 ug/ml) is substantially equivalent to the Etest Ceftolozane/Tazobactam (0.016-256 ug/ml) (K170670).