(309 days)
EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli /Klebsiella pneumoniae and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. The test does not distinguish between E. coli and K. pneumoniae. Further testing is needed to differentiate E. coli and K. pneumoniae. The EK/P. aeruginosa PNA FISH assay is indicated for use in conjunction with positive blood subcultures as an aid in the identification of E. coli/K. pneumoniae, and/or P. aeruginosa.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called EK/P. aeruginosa PNA FISH. It does not contain the detailed study information required to answer the prompt thoroughly.
Here's why and what's missing:
The provided text informs AdvanDx, Inc. that their device EK/P. aeruginosa PNA FISH has received 510(k) clearance. It specifies the regulation number, name, class, and product code. It also includes the indications for use.
Crucially, it does not include the results of any clinical studies, performance data, or detailed acceptance criteria. A 510(k) clearance letter acknowledges substantial equivalence to a predicate device, but the supporting data for that claim is typically found in the 510(k) submission itself, not the clearance letter.
Therefore,Based on the provided FDA 510(k) clearance letter for the EK/P. aeruginosa PNA FISH device, the following information regarding acceptance criteria and supporting studies cannot be extracted:
- Table of acceptance criteria and reported device performance: This document only states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not present the specific acceptance criteria or the performance metrics of the new device.
- Sample size used for the test set and data provenance: No details are provided about the test set size, nor where the data originated (country, retrospective/prospective).
- Number of experts used to establish ground truth and their qualifications: The document does not discuss the methodology of ground truth establishment for any studies.
- Adjudication method for the test set: There is no mention of adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: The document does not describe any MRMC studies or human-in-the-loop performance.
- Standalone (algorithm only) performance study: This document does not describe standalone performance. The device is a "qualitative nucleic acid hybridization assay," implying it's a lab-based test, not a standalone algorithm in the typical sense of AI imaging.
- Type of ground truth used: No information is given about how ground truth was established for any study (e.g., pathology, outcomes data, expert consensus).
- Sample size for the training set: There is no mention of a training set, as this is a diagnostic assay, not an AI/ML device in the context of the prompt's typical questions.
- How the ground truth for the training set was established: No information is available for a training set.
Summary of available information from the document:
- Device Name: EK/P. aeruginosa PNA FISH
- Intended Use: Qualitative nucleic acid hybridization assay for identification of Escherichia coli / Klebsiella pneumoniae and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods.
- Regulatory Status: 510(k) clearance, found substantially equivalent to predicate devices.
- Key Indication Note: The test does not distinguish between E. coli and K. pneumoniae; further testing is needed. It is indicated for use in conjunction with positive blood subcultures.
To answer your prompt comprehensively, one would need to access the full 510(k) submission documentation, which would contain the detailed study reports and performance data.
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.