510(k) K223046
K223046 is an FDA 510(k) premarket notification submitted by Cepheid® for the device "Xpert® FII & FV". The FDA issued a decision of Substantially Equivalent on February 15, 2023. The device falls under product code NPR (Test, Factor Ii G20210a Mutations, Genomic Dna Pcr), a Class II device regulated under 21 CFR 864.7280. Cepheid® has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 15, 2023
- Date Received
- September 29, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
- Device Class
- Class II
- Regulation Number
- 864.7280
- Review Panel
- PA
- Submission Type
In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.