(61 days)
The Sensititre ESBL confirmatory test plate is an in vitro diagnostic product for detection of ESBL's in clinical isolates of Klebsiella pneumoniae, Klebsiella oxytoca and Escherichia coli. Test results can be read either manually or automatically on a Sensititre® ARIS or Autoreader.
This 510(K) is for ESBL Confirmatory Test Plate for Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli containing the following antimicrobials as per the NCCLS reference standard (M7):
Ceftazimdime: 0.06-128
Ceftazidime/clavulanic acid: 0.06/4-128/4
Cefotaxime: 0.06-64
Cefotaxime/clavulanic acid: 0.06/4-64/4
Not Found
Here's an analysis of the provided text regarding the ESBL Confirmatory Test Plate, focusing on the acceptance criteria and study information:
The provided document is a 510(k) clearance letter from the FDA for the TREK Diagnostic System's ESBL Confirmatory Test Plate. It primarily focuses on regulatory approval and equivalence to a predicate device. While it mentions the "Indications For Use" and the antimicrobials included, it does not contain the detailed acceptance criteria or the specific study results used to demonstrate device performance beyond stating it's an "in vitro diagnostic product for detection of ESBL's in clinical isolates."
Therefore, based solely on the provided text, many of the requested details about the study design and performance metrics cannot be extracted. The document points to the NCCLS reference standard (M7) for the antimicrobials, which would likely contain the methodology, but the actual performance data or acceptance criteria for this specific device are not present in this letter.
Based on the provided text, here's what can be answered:
Acceptance Criteria and Device Performance Study Details
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not contain a specific table of acceptance criteria or detailed reported device performance metrics (e.g., sensitivity, specificity, accuracy percentages) for the ESBL Confirmatory Test Plate. It states the device is "for detection of ESBL's in clinical isolates of Klebsiella pneumoniae, Klebsiella oxytoca and Escherichia coli." The performance criteria would typically involve comparing the device's results against a gold standard for ESBL detection.
2. Sample Size for the Test Set and Data Provenance:
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The provided document does not specify the number of experts or their qualifications used to establish ground truth for the test set.
4. Adjudication Method for the Test Set:
The provided document does not describe any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size:
The provided document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study is more common for imaging devices where human interpretation is a key factor. This device is an in-vitro diagnostic test.
6. If a Standalone Performance Study (Algorithm Only Without Human-in-the-Loop) was Done:
The device is an "in vitro diagnostic product" whose results "can be read either manually or automatically on a Sensititre® ARIS or Autoreader." This implies it has both automated and manual reading capabilities. A standalone performance study for the automated reading would be expected, but specific details of such a study are not provided in this document.
7. The Type of Ground Truth Used:
While not explicitly stated for this device, for an in-vitro diagnostic test like this, the ground truth would typically be established by a reference method for ESBL detection (e.g., molecular methods, or a universally accepted phenotypic confirmatory test performed by a reference laboratory, often following CLSI/NCCLS guidelines). The reference to NCCLS standard M7 for the antimicrobials suggests that the ground truth methodology would align with established microbiology protocols.
8. The Sample Size for the Training Set:
The provided document does not specify the sample size for the training set. (It's unclear if a separate "training set" in the machine learning sense was explicitly used or if the product validation was based on a single test set).
9. How the Ground Truth for the Training Set Was Established:
The provided document does not describe how the ground truth for any potential training set was established. As mentioned in point 7, it would typically be via a reference method.
Summary of Missing Information:
The critical information regarding the specific performance metrics (sensitivity, specificity, accuracy), the size and characteristics of the study populations (test set, training set), details of ground truth establishment, and expert involvement are not present in this FDA 510(k) clearance letter. This document confirms the regulatory approval and indications for use but does not delve into the detailed technical performance data from the validation studies. This information would typically be found in the full 510(k) submission or associated scientific publications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
JUL 16 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Cynthia C. Knapp Director Lab Services TREK Diagnostic System 982 Keynote Circle, Suite 6 Cleveland, Ohio 44131
K031545 Re:
Trade/Device Name: ESBL Confirmatory Test Plate Ceftazimdime, Ceftazidime/clavulanic acid, Cefotaxime,
Cefotaxime/ clavulanic acid
Regulation Number: 21 CFR 866.1640
Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: May 16, 2003 Received: May 20, 2003
Dear Ms. Knapp:
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. Iisting 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 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); 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510 (k) Number (If known):
O31545
Device Name: ESBL Confirmatory Test Plate
Indications For Use:
The Sensititre ESBL confirmatory test plate is an in vitro diagnostic product for detection of ESBL's in clinical isolates of Klebsiella pneumoniae, Klebsiella oxytoca and Escherichia coli. Test results can be read either manually or automatically on a Sensititre® ARIS or Autoreader.
This 510(K) is for ESBL Confirmatory Test Plate for Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli containing the following antimicrobials as per the NCCLS reference standard (M7):
Ceftazimdime: 0.06-128 Ceftazidime/clavulanic acid: 0.06/4-128/4 Cefotaxime: 0.06-64 Cefotaxime/clavulanic acid: 0.06/4-64/4
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Division Sign-Off | 7/10/03 | |
| Office of In Vitro Diagnostic DeviceEvaluation and Safety | ||
| 510(k) | K031545 | |
| Prescription Use(Per 21 CFR 801.109 | OR | Over-The-Counter Use |
§ 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).