Xpert® FII & FV
FDA 510(k) K250218 · Cepheid
510(k) numberK250218
Submission
- Device name
- Xpert® FII & FV
- Applicant
- Cepheid
Sunnyvale, CA, US - Received
- January 24, 2025
- Decision date
- February 21, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NPR – Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7280
- Specialty
- Hematology
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.
Other 510(k)s with product code NPR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223046 | Xpert® FII & FVNPR · Special | Cepheid® | 02/15/2023SE |
| K172913 | cobas Factor II and Factor V TestNPR · Traditional | Roche Molecular Systems, Inc. | 01/12/2018SE |
| K100943 | Invader Factor IINPR · Traditional | Hologic, Inc. | 06/02/2011SE |
| K033612 | Factor II (Prothrombin) G20210A KitNPR · Traditional | Roche Diagnostics Corp. | 12/18/2003SE |
More from Roche Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K261362 | Xpert Hemorrhagic FeverQVR · Dual Track | 08/07/2026SE |
| K261867 | Xpert Carba-RPOC · Special | 07/02/2026SE |
| K253653 | Xpert Hemorrhagic Fever · Traditional | 02/20/2026SE |
| K251721 | Xpert GI PanelPCH · Traditional | 01/16/2026SE |
| K250996 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | 05/01/2025SE |
| K250995 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | 05/01/2025SE |
| K243730 | Xpert C. difficile/EpiOZN · Traditional | 02/28/2025SE |
| K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX · Dual Track | 01/15/2025SE |
| K242071 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Dual Track | 01/10/2025SE |
| K243625 | Xpert MRSA/SA SSTINQX · Special | 12/18/2024SE |
Questions and answers
When was Xpert® FII & FV cleared by the FDA?
Xpert® FII & FV (K250218) received a 510(k) decision of Substantially Equivalent on February 21, 2025, 28 days after the submission was received.
What is the product code of K250218?
The FDA product code is NPR – Test, Factor Ii G20210a Mutations, Genomic Dna Pcr, a Class II (moderate risk) device regulated under 21 CFR 864.7280.