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E. colilP. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods.

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

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

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This document is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain the detailed study results, acceptance criteria, or performance metrics typically found in a clinical study report or a summary of safety and effectiveness.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be gathered and what cannot:

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: This document is the clearance letter, not the study report.
• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not present.
• 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): Not present.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present.
• 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: Not applicable as this is not an AI-assisted device for human readers; it's a diagnostic test for identifying bacteria.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a laboratory assay, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
• The sample size for the training set: Not present.
• How the ground truth for the training set was established: Not present.

Information that can be extracted or inferred:

1. Device Name: E. coli/P. aeruginosa PNA Fish™
2. Indications for Use (from the document):
   • E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods.
   • The E. coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.
   • Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth.
3. Regulatory Class: Class I
4. Product Codes: JSS
5. Regulatory Regulation Number: 21 CFR §866.2660
6. Regulatory Regulation Name: Microorganism differentiation and identification device.

To obtain the detailed study information, one would typically need to consult the complete 510(k) submission summary, which is often publicly available on the FDA's website, or directly request it from the manufacturer. The provided document is merely the FDA's clearance letter stating that the device is substantially equivalent to a predicate device.

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E. colilP. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. The E. colifP. aeruginosa PNA FISH assay is indicated for use in conjunction with positive blood subcultures as an aid in the identification of E.coli and/or P. aeruginosa.

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Here's an analysis of the provided text regarding the E. coli/P. aeruginosa PNA FISH Culture Identification Kit, focusing on the acceptance criteria and study details:

Unfortunately, the provided text is a 510(k) clearance letter from the FDA and does not contain the specific details of the acceptance criteria nor the study results that proved the device met those criteria. The letter acknowledges that a 510(k) premarket notification was submitted and reviewed, determining the device is "substantially equivalent" to legally marketed predicate devices. This means that AdvanDx Inc. provided data demonstrating safety and effectiveness, likely including performance studies, but those study details are not present in this document.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer many of your specific questions about the study design.

However, based on the context of FDA device clearance and the nature of an "Identification Kit," I can infer some general aspects and what kind of information would typically be found in the actual study reports.

Based on the provided document, I cannot answer the following questions as the information is not present:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set
• Data provenance (country of origin, retrospective/prospective)
• Number of experts used to establish ground truth for the test set
• Qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• If a standalone (algorithm only) performance was done (as this is a lab kit, not an AI algorithm)
• The type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

What can be inferred or stated from the provided document:

• Device Name: E. coli/P. aeruginosa PNA FISH Culture Identification Kit
• Intended Use: "identification of Escherichia coli and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. The E. coli/P. aeruginosa PNA FISH assay is indicated for use in conjunction with positive blood subcultures as an aid in the identification of E.coli and/or P. aeruginosa."
• Regulatory Class: Class I (indicated by the 510(k) process and the lack of mention of Special Controls or PMA). This generally means a lower regulatory burden and often substantial equivalence is based on comparisons to well-established predicate devices.
• Nature of the Device: It's a "qualitative nucleic acid hybridization assay." This means it likely uses probes (PNA FISH - Peptide Nucleic Acid Fluorescent In Situ Hybridization) to bind to specific RNA sequences of the target bacteria (E. coli and P. aeruginosa) within a sample, and the binding is detected qualitatively (e.g., presence/absence of fluorescence under a microscope).

Hypothetical Information (what would typically be found in the supporting 510(k) submission but is not in this letter):

For a device like this, the acceptance criteria would most likely revolve around:

• Sensitivity: The ability of the test to correctly identify E. coli or P. aeruginosa when they are present in the sample.
• Specificity: The ability of the test to correctly identify when E. coli or P. aeruginosa are not present (i.e., not cross-reacting with other common blood culture pathogens).
• Accuracy: Overall agreement with a gold standard method.
• Reproducibility/Repeatability: Consistency of results when tested multiple times under the same or varying conditions.

The study would typically involve:

• Test Set: A collection of positive blood culture samples (either contrived or clinical) known to contain E. coli, P. aeruginosa, other Gram-negative rods, or other bacteria/no bacteria.
• Ground Truth: For a microbiology identification kit, the ground truth would almost certainly be established by culture and biochemical identification methods (e.g., Vitek, API, or 16S rRNA gene sequencing) performed by trained microbiologists. This is the "gold standard" for bacterial identification. Pathology or outcomes data would not be relevant here.
• Standalone Performance: For a diagnostic kit, the performance is almost always "standalone" – the kit itself processes the sample and gives a result. There isn't typically an "algorithm only" or a "human-in-the-loop" aspect in the same way there would be for an AI imaging device. Human interpretation might be involved in reading a fluorescent signal under a microscope, but the "performance" is tied to the chemical reaction of the kit.
• Training Set: While not explicitly mentioned, during the development of such an assay, "training" might involve optimizing probe design, hybridization conditions, and interpretation criteria using a smaller set of known positive and negative samples before large-scale validation. The ground truth for this would also be established by culture.

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