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

• For determination of the subtype of seasonal human influenza A viruses as seasonal A/H1, A/H3, and/or A/H1pdm09 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 Subtyping 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 Subtyping Kit consists of oligonucleotide primers and dual-labeled hydrolysis (TaqMan®) 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 Subtyping 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 5' nuclease activity of Tag polymerase degrades any probe molecules hybridized to amplified target sequence, causing the reporter dve 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.

This 510(k) submission, K140851, is a "Special 510(k)" for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit. The documentation states that the changes proposed are "for labeling purposes only and will not alter the technological attributes of the device." Therefore, this submission provides a comparison to the predicate device (K132508) based on intended use, specimen types, technology, required instrumentation, organism detected, and nucleic acid extraction, rather than new performance data. No new studies were conducted to re-establish acceptance criteria or device performance, as the device itself is considered unchanged from the predicate.

Here's a breakdown of the requested information based on what's available in the provided text:

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

Since this is a Special 510(k) for a labeling change and explicitly states "will not alter the technological attributes of the device," no new performance studies were conducted to establish new acceptance criteria or reported device performance for K140851. The performance characteristics are assumed to be identical to the predicate device (K132508).

The table provided in the submission (Table 1: Device Comparison) outlines the differences in the intended use language and organism detection specificity between the predicate device (K132508) and the new Influenza A Subtyping Kit, which represents a subset of the predicate's capabilities.

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

No new test set data is presented for this Special 510(k) as it is a labeling modification. The original performance characteristics were established during a season when seasonal influenza viruses A/H1 and A/H3 were predominant, and during a season when A/H1pdm09 was predominant.

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)

Not applicable, as no new performance studies were conducted. The ground truth for the predicate device's performance would have been established through a combination of methods, likely including viral culture, sequencing, and/or other validated molecular methods, but this information is not provided in the current document.

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

Not applicable, as no new performance studies were conducted.

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

Not applicable. This is a molecular diagnostic assay, not an imaging device requiring human reader interpretation in an MRMC study and does not involve AI.

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

This is a standalone diagnostic kit that produces qualitative results (presence/absence and subtyping of specific influenza viruses). The performance information presented for the predicate device would have been standalone performance. The current submission, being a labeling change, does not include new standalone performance data.

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

Not explicitly stated in this document. For the predicate device, ground truth for influenza detection and subtyping would typically be established by viral culture isolation and identification, and/or by sequencing, or other highly validated molecular diagnostic methods.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, and no new training set data is discussed.

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

Not applicable. This is not a machine learning/AI device.

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