Diasorin Molecular, LLC · Class II · Cleared Dec 23, 2025
| K-number | K251978 |
| Device name | LIAISON NES FLU A/B, RSV & COVID-19 |
| Applicant | Diasorin Molecular, LLC |
| Product code | QOF |
| Device class | Class II |
| Decision date | Dec 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.3981 |
The LIAISON NES FLU A/B, RSV & COVID-19 is a real-time RT-PCR assay that simultaneously detects and differentiates nucleic acid from SARS-CoV-2, influenza A, influenza B, and RSV in anterior nasal swab specimens from individuals with respiratory tract infection signs and symptoms. It is intended for use as an aid in differential diagnosis when used with clinical and epidemiological information, and is designed for point-of-care environments in CLIA-waived facilities.
The device uses a real-time RT-PCR platform with fluorescence detection and analysis on the LIAISON NES Instrument, whereas the predicate (Biofire SPOTFIRE Respiratory Panel Mini) uses highly multiplexed PCR with DNA melting analysis. The candidate tests anterior nasal swabs (direct collection) while the predicate uses nasopharyngeal swabs. Time to result is approximately 18 minutes for the candidate versus approximately 15 minutes for the predicate. Both systems are automated with no user access to raw data.
Testing referenced CLSI standards (EP05-A3, EP07, EP12, EP17-A2, EP24-A2, EP25-A, MM13, MM17), IEC standards (61010-1, 60601-1-2, 61326-1, 61326-2, 62304, 80001-2-2, 80001-2-8), ISO 14971 and ISO 15223-1, AAMI documents (TIR57:2016, TIR97:2019), and FDA guidance on Class II Special Controls for Respiratory Viral Panel Multiplex Nucleic Acid Assays.
View the full FDA submission: accessdata.fda.gov