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EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears made 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.

Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.

The EK/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the AdvanDx EK/P. aeruginosa PNA FISH device. It confirms the device's substantial equivalence to a legally marketed predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about sample sizes, ground truth establishment, or expert qualifications.

The letter primarily focuses on:

• Device Name: AdvanDx EK/P. aeruginosa PNA FISH
• Regulation Number/Name: 21 CFR 866.2660, Microorganism differentiation and identification device
• Regulatory Class: Class I
• Product Code: JSS, JSZ
• Indications for Use: Multicolor, qualitative nucleic acid hybridization assay for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. It also states that the test does not distinguish between E. coli and K. pneumoniae and serves as an aid in diagnosis.

To answer your specific questions, one would need access to the actual 510(k) submission or the study report that was cited in the submission. The information requested falls under the detailed performance data and clinical evidence typically presented in such submissions, which are not part of this clearance letter.

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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:

1. 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.
2. 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).
3. 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.
4. Adjudication method for the test set: There is no mention of adjudication methods.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: The document does not describe any MRMC studies or human-in-the-loop performance.
6. 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.
7. 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).
8. 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.
9. 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.

Ask a specific question about this device