CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel is used to qualitatively detect and characterize influenza A and B viruses from respiratory specimens and viral cultures. It consists of four separate kits containing oligonucleotide primers, fluorescently labeled probes, and controls for use in real-time RT-PCR assays on FDA-cleared instruments. The kits enable typing of influenza A/B, subtyping of A(H3) and A(H1)pdm09, identification of B lineages (Victoria/Yamagata), and presumptive identification of A(H5) viruses for epidemiological surveillance.

The technological characteristics remain identical to the predicate device K243931. No changes were made to the oligonucleotide primers, probes, controls, or core assay methodology. The modification solely involved adding a Predetermined Change Control Plan (PCCP) that establishes protocols for future additions of IVD-labeled real-time PCR instruments, PCR master mixes, nucleic acid extraction methods, and modifications to probe quencher chemistry—each with defined validation and clinical evaluation requirements.

Not stated in this summary.

This submission involves no technical modification to the device itself; the intended use, instructions for use, and labeling are identical to the predicate. The sole change is the adoption of a Predetermined Change Control Plan that allows future component substitutions (instruments, extraction methods, master mixes, probe chemistry) without new 510(k) filings, provided they meet specified validation criteria within the PCCP. Because the current device maintains all prior performance characteristics and the PCCP establishes controlled pathways for acceptable future changes, the modification supports substantial equivalence while enabling operational flexibility.