(73 days)
This submission is for Etest Doripenem for MIC determinations across 0.002-32 µg/mL with Gram negative aerobic bacteria such as Enterchacteriaceae, Accretobacer baumanii, Pseudomonas aeraginesa and Gram negative anaerobic bacteria such as Bacteroides aacae, B. fragilis, B.thetaiotaorracron, B. uniformis and B. ulgatus.
Etest is a quantitative technique for determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram positive aerobic bacteria such as Enterchaceriane, Pseudomnas, Staphylococus and Enteroxous species and fastidious bacteria, such as anaerobes, N. gonombeae, S. preumoniae, Streptoxous and Haemophilus species. The system comprises a predelined 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.
Not Found
This FDA 510(k) clearance letter pertains to the administrative process of marketing the Etest® Antimicrobial Susceptibility Test for Doripenem, rather than a detailed scientific study report. Therefore, much of the requested information about acceptance criteria and study particulars is not present in this document.
However, based on the context of an antimicrobial susceptibility test and the information provided, we can infer some aspects and acknowledge the limitations:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria or specific performance values for the Etest® Doripenem test. Such information would typically be found in the manufacturer's 510(k) submission itself (which this document is a response to), or in scientific publications. However, for a device like this, the acceptance criteria would generally revolve around:
- Essential Agreement (EA) with a reference method: The percentage of MIC values that are within ±1 dilution of the reference method.
- Categorical Agreement (CA) with a reference method: The percentage of isolates where the Etest interpretation (Susceptible, Intermediate, Resistant) matches the reference method's interpretation.
- Minor Errors (mE), Major Errors (ME), and Very Major Errors (VME): These refer to specific types of discordance between the test and reference method, particularly concerning clinical interpretation. The acceptable rates for these errors are usually defined by regulatory bodies (e.g., FDA, CLSI).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document. A typical premarket submission for an antimicrobial susceptibility test would involve testing a substantial number of bacterial isolates (e.g., hundreds or even thousands) for each drug-bug combination, often collected from diverse geographical locations. The studies would predominantly be prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided document. For antimicrobial susceptibility testing, the "ground truth" (or reference method) is typically established by laboratory-based, standardized methods using trained microbiologists (e.g., broth microdilution or agar dilution). It's not usually based on expert consensus in the same way as, for example, reading medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document. Adjudication methods are not typically relevant for establishing the "ground truth" for a microbial susceptibility test; the reference method itself serves as the standard.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not applicable to this type of device. The Etest is a diagnostic test for determining drug susceptibility, not an AI-assisted diagnostic imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Etest is a manual, phenotypic test strip. It is not an algorithm, nor does it operate "standalone" in the sense of a software algorithm. Its performance is evaluated based on its interpretability by trained laboratory personnel against a recognized reference method.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for antimicrobial susceptibility testing is typically established using a standardized reference method, such as:
- Broth Microdilution (BMD): Considered the gold standard for MIC determination.
- Agar Dilution: Another standardized method for MIC determination.
These methods involve precise dilutions of the antimicrobial agent and inoculation with a standardized bacterial suspension.
8. The sample size for the training set
This information is not available in the provided document. The Etest method relies on a pre-defined antibiotic gradient within the strip, not a "training set" in the machine learning sense. However, the manufacturer would have conducted extensive internal development and validation studies to determine the appropriate gradient and how to interpret the ellipse.
9. How the ground truth for the training set was established
As noted above, there isn't a "training set" in the machine learning context for this device. The development of Etest strips generally involves:
- Careful preparation of the antibiotic gradient: Ensuring precise and stable concentrations along the strip.
- Extensive testing against known bacterial strains: Using reference methods (like BMD) to correlate the ellipse formed by the Etest strip with the actual MIC of the drug for those strains. This helps in establishing the interpretive breakpoints for susceptibility, intermediate, and resistance categories.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Asa Karlsson Quality Assurance and Regulatory Manager AB BIODISK Dalvägen 10 169 56 Solna, Sweden
JUL 2 4 2008
Re: K081325
Trade/Device Name: Etest® Antimicrobial Susceptibility Test – Doripenem MIC at 0.002-32 µg/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: May 6, 2008 Received: May 12, 2008
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 Federall 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, isting 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 Degister.
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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attaym
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): K081325
Device Name: Etest Antimicrobial Susceptibility Test - Doripenem MIC at 0.002-32 ug/mL.
Indications For Use: This submission is for Etest Doripenem for MIC determinations across 0.002-32 µg/mL with Gram negative aerobic bacteria such as Enterchacteriaceae, Accretobacer baumanii, Pseudomonas aeraginesa and Gram negative anaerobic bacteria such as Bacteroides aacae, B. fragilis, B.thetaiotaorracron, B. uniformis and B. ulgatus.
Etest is a quantitative technique for determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram positive aerobic bacteria such as Enterchaceriane, Pseudomnas, Staphylococus and Enteroxous species and fastidious bacteria, such as anaerobes, N. gonombeae, S. preumoniae, Streptoxous and Haemophilus species. The system comprises a predelined 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)
Freddie Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081325
§ 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).