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The Influenza A/B Typing Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with this kit in conjunction with clinical and epidemiological information:

• For qualitative detection of influenza virus type A or B viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NPS], nasal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]) and lower respiratory tract specimens (including bronchoalveolar lavage [BAL], bronchial wash [BW], tracheal aspirate [TA], sputum, and lung tissue) from human patients with signs and symptoms of respiratory infection and/or from viral culture.

• To provide epidemiological information for surveillance of circulating influenza viruses.

Performance characteristics for influenza were established during a season when seasonal influenza viruses A(H1N1) and A(H3N2) were the predominant influenza A viruses in circulation and during a season when the A(H1N1)pdm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted unless a BSL 3E facility is available to receive and culture specimens.

CDC Human Influenza Real-Time RT-PCR Diagnostic Panel: Influenza A Subtyping Kit (VER 4)

The Influenza A Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with this kit in conjunction with clinical and epidemiological information:

• For determination of the subtype of seasonal human influenza A viruses as seasonal A(H3) and/or A(H1)pdm09 from viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NPS], nasal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]) and lower respiratory tract specimens (including bronchoalveolar lavage [BAL], bronchial wash [BW], tracheal aspirate [TA], sputum, and lung tissue) from human patients with signs and symptoms of respiratory infection and/or from viral culture;

• To provide epidemiological information for surveillance of circulating influenza viruses.

Performance characteristics for influenza were established during a season when seasonal influenza viruses A(H1N1) and A(H3N2) were the predominant influenza A viruses in circulation and during a season when the A(H1N1)pdm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted unless a BSL 3E facility is available to receive and culture specimens.

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit (VER 1.1 and 2)

The Influenza B Lineage Genotyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with this kit in conjunction with clinical and epidemiological information:

• For the determination of the genetic lineage of human influenza B viruses as B/Victoria or B/Yamagata lineage from viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NPS], nasal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]) from human patients with signs and symptoms of respiratory infection and/or from viral culture;

• To provide epidemiologic information for surveillance of circulating influenza viruses.

Performance characteristics for influenza B lineage genotyping were established during a season when influenza B/Victoria and B/Yamagata lineages were in circulation.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/H5 Subtyping Kit (VER 4)

The Influenza A/H5 Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with this kit in conjunction with clinical and epidemiological information:

• For the presumptive identification of virus in patients who may be infected with influenza A subtype A(H5) (Asian lineage) from viral RNA in human respiratory specimens, conjunctival swabs, and viral culture in conjunction with clinical and epidemiological risk factors;

• To provide epidemiologic information for surveillance of circulating influenza viruses.

Performance characteristics for influenza were established during a season when seasonal influenza viruses A(H1N1) and A(H3N2) were the predominant influenza A viruses in circulation and during a season when the A(H1N1)pdm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses.

Testing with the influenza H5a and H5b primer and probe sets should not be performed unless the patient meets the most current U.S.Department of Health and Human Services (DHHS) clinical and epidemiologic criteria for testing suspect A(H5) specimens. The definitive identification of influenza A(H5) (Asian lineage) either directly from patient specimens or from virus cultures requires additional laboratory testing, along with clinical and epidemiological assessment in consultation with national influenza surveillance experts.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted unless a BSL 3E facility is available to receive and culture specimens.

The CDC Human Influenza Real-Time RT-PCR Diagnostic Panel is used in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with the CDC device. The panel is configured in four separate kits. Each kit consists of oligonucleotide primers, fluorescently labeled hydrolysis probes, and controls which are used in rRT-PCR assays for the in vitro qualitative detection and characterization of influenza virus RNA in respiratory specimens from patients presenting with influenza-like illness (ILI) or from viral culture.

Oligonucleotide primers and probes for detection of influenza A, influenza B, and influenza A of swine origin were selected from highly conserved regions of the matrix (M), non-structural (NS), and nucleoprotein (NP) genes, respectively. Oligonucleotide primers and probes for characterization and differentiation of influenza A(H3) and A(H1)pdm09 viruses, avian influenza A(H5) viruses, and genetic lineages of influenza B were selected from highly conserved regions of their hemagglutinin (HA) genes. Oligonucleotide primers and probes to detect the human RNase P gene (RP) in control samples and clinical specimens is also included in the panel.

The provided document, K243274: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, is an FDA 510(k) clearance letter. This document primarily describes the device, its intended use, and confirms its substantial equivalence to a previously cleared predicate device (K243931). Critically, it states that no analytical or clinical testing was performed for this specific modification, as the submission was to add a Predetermined Change Control Plan (PCCP).

Therefore, the document does not contain the detailed study results, acceptance criteria, sample sizes, ground truth establishment, or expert involvement for the original validation of the device's performance. It explicitly states that "The performance characteristics of the CDC Flu rRT-PCR Dx Panel... were previously established and remain the same as the predicate device (K243931)."

As such, I cannot provide the specific information requested in the prompt based on the provided text alone. The prompt asks for details of "the device" meeting acceptance criteria, and this document pertains to a modification that did not involve re-evaluating performance.

However, I can interpret what would typically be sought for such an analysis in the context of an in vitro diagnostic (IVD) PCR panel like the one described. I will outline what the acceptance criteria and the study that proves the device meets them would likely entail for an IVD, but with the explicit understanding that the provided document does not contain these details.

Based on the provided document, the device's performance characteristics were "previously established" for the predicate device (K243931) and are simply carried over here as "remaining the same." The current submission (K243274) is for adding a Predetermined Change Control Plan (PCCP) and states that "No analytical testing was performed for this modification" and "No clinical testing was performed for this modification."

Therefore, the detailed information regarding acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment for the original validation of this device is NOT present in the provided text. The tables and descriptions below represent what would typically be expected for an FDA cleared RT-PCR diagnostic panel, assuming the original studies were conducted to industry standards, but are not extracted directly from the given document.

Acceptance Criteria and Device Performance (Hypothetical for an RT-PCR IVD)

For a real-time RT-PCR diagnostic panel like the CDC Human Influenza Virus Panel, acceptance criteria and performance would typically focus on analytical sensitivity (Limit of Detection - LoD), analytical specificity (cross-reactivity, inclusivity), and clinical performance (sensitivity, specificity).

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical)

Note: The actual quantitative values for LoD, PPA, and NPA would be specific to each kit and its validated performance.

Study Details (Hypothetical for an RT-PCR IVD)

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

• Test Set Sample Size (Hypothetical):
  • Analytical Validation: Typically involves a statistically significant number of replicates (e.g., 20-60 replicates per concentration level) for LoD, and a panel of 50-100 isolates/strains for inclusivity/exclusivity testing.
  • Clinical Validation (Prospective/Retrospective): For an IVD like this, hundreds to thousands of clinical specimens would be evaluated. For example:
    • Influenza A/B Typing Kit: ~500-1000 positive specimens (e.g., 200-400 A, 100-200 B, remaining co-infections/untouched negatives) and ~500-1000 negative specimens.
    • Influenza A Subtyping Kit: ~300-500 Influenza A positive specimens, including a balanced representation of H1 and H3.
    • Influenza B Lineage Genotyping Kit: ~100-200 Influenza B positive specimens, balanced for Victoria and Yamagata lineages.
    • Influenza A/H5 Subtyping Kit: Could involve a smaller number of true H5 positives (often spiked or well-characterized rare clinical samples) and a larger set of other influenza A types and negatives.
• Data Provenance (Hypothetical):
  • Country of Origin: Likely multi-center studies within the United States given CDC's role and FDA clearance. Could also include international sites for broader strain diversity.
  • Retrospective or Prospective: Clinical validation typically involves both.
    • Retrospective: Utilizing banked, well-characterized clinical specimens to ensure adequate representation of rare or specific targets/lineages.
    • Prospective: Collecting new clinical specimens as they arrive, processed independently to mimic real-world use conditions.

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

• Number of Experts: For an RT-PCR assay, ground truth is usually established by highly reliable reference methods rather than human interpretation of images. However, if any interpretation or adjudication was needed (e.g., for discordant clinical results), it would involve a small panel.
  • For PCR-based diagnostics, ground truth is typically established by:
    • Confirmatory PCR methods (e.g., an FDA-cleared reference assay, sequencing of the target region, or a highly sensitive lab-developed test).
    • Viral culture (particularly for original isolation and characterization of strains).
    • Next-generation sequencing (NGS) for comprehensive genetic characterization.
• Qualifications of Experts (if applicable for discordant results/clinical adjudication):
  • Senior Clinical Microbiologists, PhD-level or MD, with extensive experience (e.g., 10-20+ years) in diagnostic virology and molecular diagnostics in CLIA-certified laboratories.
  • Researchers with expertise in influenza genomics and epidemiology (e.g., from CDC's influenza division).

4. Adjudication Method (Hypothetical)

• For discordant results between the investigational device and the initial reference method in clinical studies, an adjudication method would be employed.
  • Method: Often involves a third, more definitive method. For an RT-PCR assay, this would frequently be bi-directional Sanger sequencing of the viral target region detected, or a second, orthogonal PCR method run by an expert laboratory.
  • Process: Results would be reviewed by a qualified laboratory director or team, and the definitive result (ground truth) would be assigned based on the adjudicating test.
  • "None" is typically not an acceptable approach for discordant results in regulated clinical trials.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance (Hypothetical)

• No, an MRMC study would generally not be applicable nor performed for this type of device. This device is a diagnostic kit (RT-PCR) that generates quantitative cycle threshold (Cq) values and qualitative (positive/negative/subtype) results. It does not involve "human readers" interpreting images or complex data in the same way an AI-assisted diagnostic imaging device would.
• The "human-in-the-loop" aspect here is the laboratory technician performing the test and interpreting the Cq values based on predefined cut-offs. The device itself is not "AI-assisted."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done (Hypothetical)

• Yes, a "standalone" or "algorithm only" performance is inherently measured for this device. An RT-PCR assay's performance (sensitivity, specificity, LoD) is determined by its analytical component (primers, probes, reagents, thermal cycling) and the software's ability to interpret raw fluorescence data into Cq values and apply predefined cut-offs for positive/negative calls.
• This is the primary way the analytical performance is established and is the foundation for clinical performance. The "algorithm" here is the defined Cq cut-offs and interpretive logic built into the system.

7. The Type of Ground Truth Used (Hypothetical)

• Expert Consensus / Reference Methods:
  • Confirmatory Molecular Methodologies: Often a consensus derived from an FDA-cleared reference RT-PCR assay, or an independently validated, highly sensitive laboratory-developed PCR test.
  • Nucleotide Sequencing: Gold standard for definitive identification and subtyping (e.g., Sanger sequencing or Next-Generation Sequencing of key viral genes مثل Hemagglutinin (HA) or Neuraminidase (NA) for influenza).
  • Viral Culture: Historically a gold standard for detecting viable virus, though less sensitive than PCR for direct clinical specimens. Often important for initial characterization of novel strains.
  • Clinical Outcomes Data: While not the primary ground truth for the presence of the pathogen, clinical outcomes (e.g., patient recovery, severity of illness, epidemiological links) can provide supportive context for the clinical utility of the test.
• For an influenza diagnostic, the molecular sequencing data and confirmed viral culture (for positive samples) along with a robust negative control (absence confirmed by multiple methods) would be the primary components of ground truth.

8. The Sample Size for the Training Set (Hypothetical)

• Not applicable in the typical sense of machine learning/AI. This is a traditional RT-PCR assay kit. There isn't a "training set" for an AI model.
• The "training" analogue would be the extensive research and development process to design primers and probes that are specific and sensitive to the target viruses, and to optimize the reaction conditions. This involves screening numerous viral strains and non-target organisms, but it's not a "training set" in the machine learning context.

9. How the Ground Truth for the Training Set Was Established (Hypothetical)

• Not applicable due to the nature of the device. As mentioned, it's a traditional RT-PCR kit, not an AI/ML device that requires a training set and associated ground truth for model development. The design and optimization of such a kit rely on fundamental molecular biology principles, known genetic sequences of influenza viruses, and iterative laboratory testing.

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