| K-number | K250218 |
| Device name | Xpert® FII & FV |
| Applicant | Cepheid |
| Product code | NPR |
| Device class | Class II |
| Decision date | Feb 21, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 864.7280 |
The Xpert FII & FV is an automated genotyping test that detects Factor II (G20210A) and Factor V Leiden (G1691A) mutations from whole blood samples using real-time PCR on GeneXpert Instrument Systems. It is intended as an aid in diagnosing thrombophilia in individuals with suspected clotting disorders, providing results in approximately 30 minutes.
The device uses fully automated nucleic acid amplification via real-time PCR with Scorpion probes for target-specific detection. It employs a disposable, self-contained, multi-chambered cartridge with internal controls (Sample Processing Control and Probe Check Control) and accepts sodium citrate or EDTA anticoagulated whole blood specimens. The technological characteristics are identical to the predicate device.
Not stated in this summary.
The device is substantially equivalent because it has identical intended use, technological platform, assay format, specimen types, and performance to the predicate device (K223046). The three modifications—removal of the erroneous pediatric limitation statement (supported by existing clinical validation data from K082118), simplification of branding from 'Cepheid GeneXpert' to 'GeneXpert', and a new catalog number—do not raise different safety or effectiveness questions and have no impact on device performance.
View the full FDA submission: accessdata.fda.gov