Class Class II
Xpert Xpress CoV-2/Flu/RSV plus (K250995)
Description
Xpert Xpress CoV-2/Flu/RSV plus by Cepheid®, an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250995
Clearance Date2025-05-01
Clearance TypeSpecial
Product CodeQOF
Regulation Number866.3981
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250995
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. Xpert Xpress CoV-2/Flu/RSV plus (K250995) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242071 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid | 2025 |
Trace the full predicate network for K250995
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.