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mecA XpressFISH® is a qualitative nucleic acid fluorescence in situ hybridization assay intended for the detection of mecA mRNA on smears from blood cultures that are positive for Staphylococcus aureus by the Staphylococcus QuickFISH™ BC assay.

The mecA XpressFISH® assay is indicated for use in conjunction with other laboratory tests and clinical data available to the clinician as an aid in the detection of mecA mRNA from methicillin-resistant S. aureus (MRSA) from patient positive blood cultures. The mecA XpressFISH® assay is not intended to monitor treatment for MRSA infections or for use with mixed cultures including those containing both S. aureus and coagulase negative staphylococci.

Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, epidemiological typing, and/or differentiation of mixed growth.

The mecA XpressFISH assay is a qualitative fluorescence in situ hybridization (FISH) assay which utilizes peptide nucleic acid (PNA) probes hybridizing to mecA messenger RNA (mRNA) on smears from blood cultures containing Staphylococcus aureus (SA). After the positive blood culture bottle is confirmed to have SA by Staphylococcus QuickFISH BC, an aliquot of the blood culture is incubated with media containing cefoxitin to induce mecA mRNA expression prior to mecA XpressFISH testing.

The assay consists of mecA mRNA inducing cefoxitin reagents, a fixation reagent, a hybridization reagent, a wash solution concentrate, coverslip mounting media and a microscope slide which has a sample well, and positive and negative control wells. Results are visualized and interpreted using fluorescence microscopy.

Here's an analysis of the provided text, extracting the acceptance criteria and study details for the mecA XpressFISH device:

The document describes the mecA XpressFISH assay, a qualitative nucleic acid fluorescence in situ hybridization assay for the detection of mecA mRNA in Staphylococcus aureus (SA) positive blood cultures. The goal is to identify methicillin-resistant S. aureus (MRSA).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied through the comparability with the predicate device (BinaxNOW PBP2a) and the detailed validation studies demonstrating high agreement, sensitivity, and specificity. Explicit, numerical acceptance criteria for each bench test are not always stated, but the results consistently show 100% agreement or very high percentages, indicating successful performance against internal or industry-standard benchmarks.

2. Sample Sizes Used for the Test Set and Data Provenance

• Clinical Study Test Set Sample Size: 339 routine blood culture bottles that were positive for Staphylococcus aureus by Staphylococcus QuickFISH BC.
• Data Provenance: The clinical study was conducted at seven clinical sites (6 in the US and 1 ex-US). This indicates a multi-center, prospective clinical study collecting real-world samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the clinical study was established using cefoxitin disk diffusion, which is a widely accepted laboratory method for determining methicillin resistance in clinical microbiology. The document does not specify the number or qualifications of experts who performed or interpreted the cefoxitin disk diffusion tests. It is assumed these were performed by trained laboratory personnel following standard clinical microbiology guidelines.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set in the clinical study beyond stating the comparison was made against cefoxitin disk diffusion. Discrepant results are noted and briefly analyzed (e.g., "False Positive mecA (weak Green Positive); Negative upon repeat testing. Cefoxitin disk=28 mm."), suggesting individual review of such cases, but a formal adjudication process (e.g., 2+1, 3+1 consensus) is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus human readers without AI assistance was not performed or described in this document.
• The device is a diagnostic assay interpreted visually by a single operator, not an AI-assisted diagnostic.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• The mecA XpressFISH assay is a standalone diagnostic assay in the context that its results are interpreted by an operator viewing fluorescence microscopy images. It is not an "algorithm only" device in the AI sense.
• The "standalone" performance here refers to the direct output of the assay itself, interpreted by a human, without further AI algorithms altering or assisting that interpretation. The clinical study precisely evaluates this standalone performance.

7. Type of Ground Truth Used

• Clinical Study Ground Truth: Cefoxitin Disk Diffusion for identification of methicillin-resistant S. aureus (MRSA). This is a well-established phenotypic method used in clinical microbiology as a standard of care for resistance testing.
• Bench Testing Ground Truth: Laboratory-characterized strains (e.g., ATCC strains, well-characterized clinical isolates) with known mecA gene status or methicillin resistance phenotypes were used for inclusivity, exclusivity, LOD, and reproducibility studies.

8. Sample Size for the Training Set

• The document does not specify a distinct "training set" in the context of machine learning.
• This device is a traditional in vitro diagnostic (IVD) assay, not an AI/ML-based device that would typically have a separate training set. Development and internal bench testing used various characterized strains, but these do not constitute a "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

• As there isn't a "training set" in the AI sense, this question isn't directly applicable.
• For the development and bench marking activities, ground truth was established through:
  • Using reference strains (e.g., ATCC strains with known characteristics).
  • Characterization of clinical isolates using standard microbiological methods to determine their mecA status or methicillin resistance profile.

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The provided document is a 510(k) clearance letter from the FDA for the "Gram-Negative QuickFISH™ BC Blood Culture Identification Kit." This letter grants market clearance based on substantial equivalence to a predicate device, but it does not contain the detailed study information, acceptance criteria, or performance data typically found in the 510(k) submission itself.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, ground truth methods), or the specifics of standalone or MRMC studies from this document.

To answer your questions, I would need access to the actual 510(k) submission for K123418, which would include the clinical and analytical study reports.

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Enterococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Enterococcus faecalis and/or the detection of selected other enterococci on smears prepared from positive blood cultures containing grampositive cocci in pairs and chains observed on Gram stain.

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

Enterococcus QuickFISH BC is indicated in an aid in the diagnosis of bacteremia caused by enterococci.

Enterococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay

This document is a 510(k) clearance letter for the Enterococcus QuickFISH BC device. It does not contain the acceptance criteria or a study that proves the device meets specific performance acceptance criteria.

The letter primarily covers:

• The FDA's determination of substantial equivalence for the device.
• Regulatory information regarding the device's classification and applicable regulations.
• The intended use statement for the device.

Therefore, I cannot provide the requested information based on the provided text. The document acts as an approval notice, not a detailed performance study report.

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The Staphylococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or coagulasenegative staphylococci commonly isolated from human blood cultures, on smears prepared from positive blood cultures containing gram-positive cocci in clusters observed on Gram stain.

Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, and/or differentiation of mixed growth.

Staphylococcus QuickFISH BC is indicated as an aid in the diagnosis of S. aureus bacteremia and/or coagulase-negative staphylococci commonly isolated from human blood cultures.

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The provided text is a 510(k) clearance letter from the FDA for a device called "Staphylococcus QuickFISH BC." This document primarily focuses on the regulatory clearance for the device and its intended use, rather than a detailed study report with specific acceptance criteria and performance data.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its 510(k) clearance.

However, I can extract the following information:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The FDA letter is a clearance notification and does not detail the specific performance metrics or acceptance criteria used in the underlying studies that led to the clearance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The letter does not describe the specific studies or their methodologies.

3. 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):

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the document.

5. 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:

This information is not provided and is likely not applicable. The device, "Staphylococcus QuickFISH BC," is described as a "qualitative nucleic acid hybridization assay" for identifying bacteria directly from blood cultures. This is an in-vitro diagnostic (IVD) test, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

While the document doesn't explicitly state "standalone performance study," the nature of an in-vitro diagnostic test like the QuickFISH BC implies that its performance is evaluated in a standalone manner, separate from human interpretation of complex images or data that AI might assist with. The test itself provides a qualitative result. However, the details of such evaluation are not provided here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided in the document. For an in-vitro diagnostic test, ground truth would typically be established by established microbiological culture methods and advanced molecular techniques for bacterial identification.

8. The sample size for the training set:

This information is not provided in the document.

9. How the ground truth for the training set was established:

This information is not provided in the document.

Summary based on the provided document:

The provided document is an FDA 510(k) clearance letter, which confirms that the Staphylococcus QuickFISH BC device is deemed substantially equivalent to existing devices and can be marketed. It defines the "Indications for Use" for the device, which involves the identification of Staphylococcus aureus and/or coagulase-negative staphylococci from positive blood cultures with gram-positive cocci in clusters. It also notes that sub-culturing is still necessary for susceptibility testing.

However, the letter does not contain the detailed study data, acceptance criteria, sample sizes, ground truth methodologies, or expert qualifications that would typically be found in a study report or a more extensive FDA review summary. These details would have been part of the 510(k) submission made by AdvanDx, Inc.

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GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli, and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gramnegative rods observed on Gram stain.

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

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

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This document is a 510(k) clearance letter for the AdvanDX GNR Traffic Light PNA FISH Identification Kit. It does not contain the detailed study information required to answer your request.

The letter acknowledges the substantial equivalence determination for the device based on a premarket notification. It outlines the regulatory classification, general controls, and responsibilities of the manufacturer. However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
• Details on multi-reader multi-case (MRMC) studies or standalone performance.
• The type of ground truth used, or sample sizes and ground truth establishment methods for a training set.

To obtain this information, you would typically need to refer to the original 510(k) submission document (K101558) itself, which would contain the validation study details.

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Yeast Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Candida albicans and/or Candida parapsilosis, identification of Candida tropicalis, and identification of Candida glabrata and/or Candida krusei on smears made from positive blood cultures containing yeasts observed on Gram stain or other microbiological stains. The test does not distinguish between C. albicans and C. parapsilosis. The test does not distinguish between C. qlabrata and C. krusei.

Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing, differentiation between C. albicans and C. parapsilosis, differentiation between C. glabrata and C. krusei, and/or differentiation of mixed growth.

Yeast Traffic Light PNA FISH is indicated for use as an aid in the diagnosis of C. albicans and/or C. parapsilosis, C. tropicalis, and C. glabrata and/or C. krusei fungemia.

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The provided document is a 510(k) summary for the Yeast Traffic Light PNA FISH device. It describes the device's intended use and includes some information about the studies conducted to support its substantial equivalence. However, it does not contain the detailed information requested in the prompt regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I can only provide information based on what is available in the document. Many of your questions cannot be answered from this text.

Here is what can be inferred or explicitly stated:

Acceptance Criteria and Study for Yeast Traffic Light PNA FISH

The document provides an "Indications for Use" statement, which outlines the device's intended diagnostic performance. While explicit "acceptance criteria" in a quantitative table are not provided in this document, the statement implies the device must accurately identify specific Candida species (or groups of species) from positive blood cultures. The provided text indicates that performance was evaluated against a predicate device for substantial equivalence, implying that the device's diagnostic accuracy for these identifications was deemed acceptable.

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantitative metrics (e.g., sensitivity, specificity thresholds) in this document. The implicit criterion is that the device must be able to qualitatively identify the specified Candida species or groups of species (C. albicans/C. parapsilosis, C. tropicalis, and C. glabrata/C. krusei) from positive blood cultures within an acceptable range, demonstrating substantial equivalence to a legally marketed predicate device.
• Reported Device Performance: Not provided in quantitative form (e.g., specific sensitivity or specificity values) within this 510(k) summary letter. The letter only states that the FDA has "determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the performance was found to be sufficient to meet the substantial equivalence standard, but the specific performance metrics are not detailed here.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: This information is not provided in the document.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not provided in the document.

4. Adjudication Method

• This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• This document does not describe an MRMC comparative effectiveness study, nor does it mention human readers or AI assistance. The device is a "qualitative nucleic acid hybridization assay," suggesting it is a lab-based test, not a diagnostic imaging AI system.

6. Standalone Performance Study

• The 510(k) process typically involves studies to demonstrate the device's performance, which in the context of a qualitative assay, would be a form of standalone performance evaluation. However, the specific details of such a study (e.g., sensitivity, specificity, PPV, NPV values against a gold standard) are not included in this document. The letter only confirms substantial equivalence.

7. Type of Ground Truth Used

• While not explicitly stated for the studies supporting this device, for an infectious disease diagnostic like this, the ground truth would typically be established by conventional microbiological methods, such as culture followed by definitive species identification (e.g., biochemical tests, mass spectrometry, or another nucleic acid-based method often considered the "gold standard" at the time). The document indicates the device is used to identify yeast "on smears made from positive blood cultures," implying the "positive blood cultures" themselves are a starting point for evaluation against more definitive methods.

8. Sample Size for the Training Set

• This information is not provided in the document. (Note: For an assay like this, the concept of a "training set" in the AI/machine learning sense is not directly applicable. More likely, studies would involve verification and validation sets).

9. How Ground Truth for the Training Set Was Established

• This information is not provided in the document. (See note for point 8).

Summary Limitations:

The provided text is an FDA 510(k) substantial equivalence letter. This letter confirms that a submission was reviewed and found substantially equivalent to a predicate device, allowing it to be marketed. It typically summarizes findings but does not provide the full technical details of the underlying studies that were submitted to the FDA (which would be found in the 510(k) summary or full submission document, separate from this letter). Therefore, most of the detailed information requested is not present here.

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C. albicans/C. glabrata PNA FISH is a fluorescence qualitative nucleic acid hybridization assay intended for identification of C. albicans and/or C. glabrata on smears made from yeast positive blood cultures.

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

C. albicans/C. glabrata PNA FISH is indicated for use as an aid in the diagnosis of C. albicans and/or C. glabrata fungemia.

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The provided text is a 510(k) substantial equivalence letter for a medical device and therefore does not contain details about specific acceptance criteria, study data, or ground truth establishment for an AI/ML powered device. This type of document primarily confirms that a device is substantially equivalent to a previously marketed device and outlines regulatory responsibilities.

To provide the requested information, a clinical study report or a premarket submission summary for an AI/ML device would be necessary. The current document is for a traditional diagnostic assay, not an AI/ML system.

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C. albicans PNA FISH is a fluorescence qualitative nucleic acid hybridization assay intended for identification of Candida albicans on smears made from yeast positive blood cultures.

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

C. albicans PNA FISH is indicated for use as an aid in the diagnosis of C. albicans fungemia.

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This document is a marketing authorization from the FDA for a device called "C. albicans PNA FISH™". It is a letter confirming the device's substantial equivalence to previously marketed devices. However, the letter itself does not contain the detailed study information, acceptance criteria, or performance data requested in the prompt. This type of information is typically found in the 510(k) summary or the full submission.

Therefore, I cannot fulfill the request using only the provided text. The document primarily focuses on regulatory approval and classification, not the detailed scientific evidence supporting the device's performance.

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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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S. aureus/CNS PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or selected other Staphylococcus species on smears made from positive blood cultures containing Grampositive cocci in clusters observed on Gram stain.

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

S. aureus/CNS PNA FISH is intended as an aid in the diagnosis of S. aureus bacteremia.

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The provided document is a 510(k) clearance letter from the FDA for a diagnostic kit, not a study report. It does not contain the detailed information required to fulfill the request. The document clears the S. aureus and/or other Staphylococcus species PNA FISH® Culture Identification Kit based on its substantial equivalence to predicate devices, but it does not describe the specific acceptance criteria or the study that proves the device meets those criteria in the level of detail requested.

Therefore, I cannot provide the requested table, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case study details, standalone performance, ground truth types, or training set information.

The document only states the Indications for Use:

• Identification of Staphylococcus aureus and/or selected other Staphylococcus species on smears made from positive blood cultures containing Gram-positive cocci in clusters observed on Gram stain.
• Intended as an aid in the diagnosis of S. aureus bacteremia.

It also explicitly states: "Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth." This implies the device is an identification aid, not a complete diagnostic solution for resistance or mixed infections.

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