K250218 is an FDA 510(k) clearance for the Xpert® FII & FV. This device is classified as a Test, Factor Ii G20210a Mutations, Genomic Dna Pcr (Class II - Special Controls, product code NPR).
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on February 21, 2025, 28 days after receiving the submission on January 24, 2025.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7280. 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..
| 510(k) Number | K250218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2025 |
| Decision Date | February 21, 2025 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | NPR — Test, Factor Ii G20210a Mutations, Genomic Dna Pcr |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7280 |
| Definition | 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. |