Class Class II
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (K222736)
Description
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay by Hologic, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222736
Clearance Date2023-05-16
Clearance TypeTraditional
Product CodeQOF
Regulation Number866.3981
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222736
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (K222736) cites 0 predicate devices and is itself cited by 2 later devices.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241573 | Alinity m Resp-4-Plex | Abbott Molecular, Inc. | 2025 |
| K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. | 2024 |
Trace the full predicate network for K222736
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.