Class Class II
Xpert® FII & FV (K223046)
Description
Xpert® FII & FV by Cepheid®, an FDA 510(k) cleared hematology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223046
Clearance Date2023-02-15
Clearance TypeSpecial
Product CodeNPR
Regulation Number864.7280
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223046
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® FII & FV (K223046) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K082118 | XPERT HEMOSIL FACTOR II & FACTOR V ASSAY | Cepheid | 2009 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250218 | Xpert® FII & FV | Cepheid | 2025 |
Trace the full predicate network for K223046
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.