Class Class II
Xpert® Xpress CoV-2 plus (XPRS-COV2-10) (K242109)
Description
Xpert® Xpress CoV-2 plus (XPRS-COV2-10) by Cepheid®, an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242109
Clearance Date2025-01-15
Clearance TypeDual Track
Product CodeQQX
Regulation Number866.3981
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242109
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 plus (XPRS-COV2-10) (K242109) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230440 | Xpert® Xpress CoV-2 plus | Cepheid® | 2023 |
Trace the full predicate network for K242109
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.