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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 Applied Biosystems (ABI) 7500 Fast Dx Real Time PCR Instrument in conjunction with clinical and epidemiological information:

• For qualitative detection of influenza virus type A or B 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 epidemiologic information for surveillance of circulating influenza viruses.

The Influenza A/B Typing Kit contains components of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel that is used in real-time RT-PCR (rRT-PCR) assays on the ABI 7500 Fast Dx Real-Time PCR Instrument. The Influenza A/B Typing Kit consists of oligonucleotide primers and dual-labeled hydrolysis (TagMan®) probes to be used in rRT-PCR for the in vitro qualitative detection and characterization of human influenza viruses from viral RNA in respiratory specimens from patients presenting with influenza-like illness (ILI).

The Influenza A/B Typing Kit is based on technology which is used in many molecular diagnostic assays. rRT-PCR assays are one-tube assays that first reverse-transcribe specific regions of RNA into cDNA copies. The cDNA then serves as a template for a polymerase chain reaction that utilizes a thermocyclic heating and cooling of the reaction to logarithmically amplify a specific region of DNA. The probe anneals to a specific internal target sequence located between the target loci of the forward and reverse primers. During the extension phase of the PCR cycle, the 5' nuclease activity of Taq polymerase degrades any probe molecules hybridized to amplified target sequence, causing the reporter dye to separate from the quencher dye, and generating a fluorescent signal. With each cycle, additional reporter dye molecules are cleaved from their respective probes, increasing the fluorescence intensity. Fluorescence intensity is monitored at each PCR cycle. Amplification of targets is reflected by logarithmic increase in fluorescence over time in comparison to the background signal.

The provided text is a 510(k) summary for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit (K133869). This document describes a Special 510(k) submission, meaning it's for a modification to an already cleared predicate device (K132508). The submission explicitly states that the changes are "for labeling purposes only and will not alter the technological attributes of the device." Therefore, no new studies demonstrating device performance or acceptance criteria are present in this document.

The document highlights the substantial equivalence of the modified device to its predicate, largely based on the fact that the changes only involve labeling. It states: "The changes proposed to the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel do not alter the device's design or technological attributes. In addition, the indications for use and intended use of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel will remain the same."

As such, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria from this provided text because the submission is not for a new device requiring such de novo proof. Instead, it relies on the predicate device's established performance.

To answer your request, here's what can be inferred or stated based on the provided text, and what cannot be provided:

1. Table of acceptance criteria and reported device performance:

• Cannot be provided from this document. This special 510(k) relies on the predicate device's performance characteristics, which are alluded to but not detailed here. The submission states, "Performance characteristics for influenza were established during a season when seasonal influenza viruses A/H1 and A/H3 were the predominant influenza A viruses in circulation and during a season when the A/H1pdm09 influenza virus was the predominant influenza A virus in circulation." No specific performance metrics (e.g., sensitivity, specificity, accuracy) or acceptance criteria are listed for either the predicate or the modified device within this document.

2. Sample size used for the test set and data provenance:

• Cannot be provided from this document. No new test set data is presented for this Special 510(k). The document refers to performance characteristics "established during a season," implying previous studies for the predicate device, but does not provide details on sample size or data provenance.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• Cannot be provided from this document. This information would be part of a detailed performance study, which is not included here.

4. Adjudication method for the test set:

• Cannot be provided from this document. This information would be part of a detailed performance study, which is not included here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This device is a real-time RT-PCR diagnostic panel, not an imaging or AI-based device for which an MRMC study would typically be conducted. Therefore, there's no discussion of human reader improvement with or without AI assistance.

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

• Yes, implicitly. As a molecular diagnostic assay, the "performance" described for the predicate device would inherently be its standalone performance (the ability of the assay to detect and characterize viruses). However, no specific study details are provided in this document.

7. The type of ground truth used:

• Implicitly, viral culture or other established reference methods. For molecular diagnostic assays detecting influenza viruses, the "ground truth" for clinical samples is typically established by viral culture, sequencing, or a highly sensitive and specific reference PCR method. The document mentions "viral culture" in the intended use statement as a source for specimens.

8. The sample size for the training set:

• Cannot be provided from this document. No information on training sets for this molecular diagnostic is available here.

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

• Cannot be provided from this document. No information on training sets is available here.

In summary, this Special 510(k) is a regulatory submission for a minor change (labeling) to an already cleared diagnostic kit. It relies on the substantial equivalence principle, meaning it asserts that the modified device is as safe and effective as its predicate without requiring new performance studies. Therefore, the detailed information about acceptance criteria and performance studies that you requested is not present in this specific document.

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