(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.
§ 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).