Centers for Disease Control and Prevention · Class II · Cleared Mar 14, 2025
| K-number | K243931 |
| Device name | 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 Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) |
| Applicant | Centers for Disease Control and Prevention |
| Product code | OZE |
| Device class | Class II |
| Decision date | Mar 14, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.3980 |
The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel is a collection of four real-time reverse-transcription PCR (rRT-PCR) assays used to detect and characterize influenza A and B viruses from respiratory and conjunctival specimens. The panel includes kits for A/B typing, A subtyping, B lineage genotyping, and A/H5 subtyping, intended for qualitative detection, surveillance, and epidemiological characterization of circulating influenza viruses in patients with respiratory symptoms or from viral culture.
The device uses real-time RT-PCR technology with oligonucleotide primers and fluorescently labeled hydrolysis probes targeting highly conserved regions of influenza viral genes (matrix, non-structural, nucleoprotein, and hemagglutinin genes). It employs standard nucleic acid extraction kits (QIAGEN, Roche, bioMérieux) and validated RT-PCR enzyme master mixes (Invitrogen, Quanta BioSciences) on FDA-cleared real-time PCR instruments (Applied Biosystems 7500 Fast Dx, QuantStudio Dx, QIAGEN Rotor-Gene Q MDx). The technological characteristics remain identical to the predicate device.
Not stated in this summary.
The device is substantially equivalent because it maintains identical technological principles, specimen types, organisms detected, analytes, instrumentation, and enzyme master mixes as the predicate (K190302). The primary modification is the expansion of specimen types for the A/H5 kit to include conjunctival swabs in addition to respiratory specimens. Analytical and clinical validation data demonstrate that the A/H5 assay achieves a limit of detection of 10^5.5 EID₅₀/ml for conjunctival swabs, with no interference from common ocular substances. Clinical performance across 35-37 confirmed/probable A/H5N1 cases shows 78.8% sensitivity on conjunctival specimens among symptomatic cases, supporting the addition of this specimen type without changing the underlying assay methodology or introducing new risks.
View the full FDA submission: accessdata.fda.gov