(193 days)
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No
The description focuses on a traditional antimicrobial susceptibility testing method using a predefined antibiotic gradient on agar media and comparison to a reference method. There is no mention of AI/ML algorithms for interpretation or analysis.
No.
The device determines antimicrobial susceptibility of bacteria for diagnostic purposes, rather than providing direct therapy or treatment.
Yes
The Etest® system determines the Minimum Inhibitory Concentration (MIC) of antimicrobial agents against microorganisms, which is a diagnostic function used to assess antimicrobial susceptibility.
No
The device description explicitly states that 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." This indicates the use of physical components (agar media, antibiotic gradient strips) and a biological process (microorganism growth and incubation), which are not software-only elements. The submission is for the addition of a specific antimicrobial to this existing system, not for a standalone software product.
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 both nonfastidious Gram negative and Gram positive aerobic bacteria... and fastidious bacteria...". This involves testing biological samples (bacteria) outside of the body to provide information for diagnosis and treatment decisions.
- Device Description: The description reinforces the intended use by explaining how the device works to determine the Minimum Inhibitory Concentration (MIC) of antimicrobial agents against microorganisms tested on agar media. This is a standard in vitro diagnostic procedure.
- Performance Studies: The performance studies describe comparing the Etest® Ceftaroline to a "CLSI broth microdilution reference method". CLSI (Clinical and Laboratory Standards Institute) methods are widely recognized standards for in vitro diagnostic testing in microbiology. The metrics used (Essential Agreement and Category Agreement) are also standard metrics for evaluating the performance of antimicrobial susceptibility testing devices.
- Predicate Device: The mention of a predicate device (K102668; Etest® Tobramycin) which is also an Etest product, further indicates that this device falls within the category of IVDs.
The core function of the device is to test a biological sample (bacteria) in a laboratory setting to provide information about its susceptibility to an antimicrobial agent, which is a classic 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 both 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. This submission is for the addition of the antimicrobial ceftaroline at concentrations of 0.002 – 32 µg/mL to the Etest® products. Ceftaroline has been shown to be active in vitro against most strains of the microorganism listed below, as described in the FDA-approved label for this antimicrobial agent. Active in vitro and in clinical infections Skin Infections · Staphylococcus aureus (including methicillin-susceptible and -resistant isolates)
Product codes
JWY
Device Description
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. This submission is for the addition of the antimicrobial ceftaroline at concentrations of 0.002 – 32 ug/mL to the Etest® products. Ceftaroline has been shown to be active in vitro against most strains of the microorganism listed below, as described in the FDA-approved label for this antimicrobial agent.
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
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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
An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of Etest® Ceftaroline by comparing its performance with the CLSI broth microdilution reference method incubated at 16 by officialing to performance information performance of 99.8% overall Essential Agreement (EA) and 99.8% overall Category Agreement (CA) with the reference method for Staphylococcus aureus during the trial.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Etest Ceftaroline demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA. Issued August 28, 2009. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of Etest® Ceftaroline by comparing its performance with the CLSI broth microdilution reference method incubated at 16 by officialing to performance information performance of 99.8% overall Essential Agreement (EA) and 99.8% overall Category Agreement (CA) with the reference method for Staphylococcus aureus during the trial. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
99.8% overall Essential Agreement (EA) and 99.8% overall Category Agreement (CA)
Predicate Device(s)
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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OCT 1 2 2012
Image /page/0/Picture/2 description: The image shows the logo for bioMerieux. The logo consists of the word "BIOMERIEUX" in a sans-serif font, with a stylized graphic above it. The graphic is a circle that is bisected by a curved line, with one half of the circle filled with vertical lines.
510(k) SUMMARY
Etest® Ceftaroline
A. 510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jennifer Chia-Hsuan Lin |
| Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8639 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | March 30, 2012 |
| B. Device Name: | |
| Formal/Trade Name: | Etest® Ceftaroline |
Classification Name:
21 CFR 866.1640 Antimicrobial Susceptibility Test (AST) Powder Product Code - JWY
Common Name: Antimicrobial susceptibility test
C. Predicate Device:
D. 510(k) Summary:
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.
Etest® Tobramycin (K102668)
This submission is for the addition of the antimicrobial ceftaroline at concentrations of 0.002 – 32 ug/mL to the Etest® products. Ceftaroline has been shown to be active in vitro against most strains of the microorganism listed below, as described in the FDA-approved label for this antimicrobial agent.
Active in vitro and in clinical infections
Skin Infections
Staphylococcus aureus (including methicillin-susceptible and-resistant isolates)
Etest Ceftaroline demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls
bioMérieux, Inc. 595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 Fax: 314/731-8700 · http://www.biomerieux-usa.com Page 85 of 134
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Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA. Issued August 28, 2009.
The Premarket Notification (510[k]) presents data in support of Etest® Ceftaroline. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of Etest® Ceftaroline by comparing its performance with the CLSI broth microdilution reference method incubated at 16 by officialing to performance information performance of 99.8% overall Essential Agreement (EA) and 99.8% overall Category Agreement (CA) with the reference method for Staphylococcus aureus during the trial. Reproducibility and Quality Control demonstrated acceptable results. Details can be found in the submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. In the center of the logo is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-002
bioMérieux, Inc. c/o Jennifer CH Lin Specialist, Regulatory Affairs 595 Anglum Road Hazelwood, MO 63042
T 12 202
Re: K121002
Trade Name: Etest Ceftaroline (0.002 - 32ug/mL) Regulation Number: 21 CFR §866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: October 4, 2012 Received: October 5. 2012
Dear Lin:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Jennifer CH Lin
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.
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 Diagnostics and Radiological Health 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 yours,
Sally A. Hojvat
Sally A. Hojvat, 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): K121002
Device Name: Etest® Ceftaroline (0.002 - 32 µg/mL)
Indications For Use:
Etest® is a quantitative technique for determination of antimicrobial susceptibility of both 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.
This submission is for the addition of the antimicrobial ceftaroline at concentrations of 0.002 – 32 µg/mL to the Etest® products. Ceftaroline has been shown to be active in vitro against most strains of the microorganism listed below, as described in the FDA-approved label for this antimicrobial agent.
Active in vitro and in clinical infections
Skin Infections ·
Staphylococcus aureus (including methicillin-susceptible and -resistant isolates)
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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)
Sagalh
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
(x) k12/002
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