K082118 is an FDA 510(k) clearance for the XPERT HEMOSIL FACTOR II & FACTOR V ASSAY. This device is classified as a Test, Factor V Leiden Mutations, Genomic Dna Pcr (Class II - Special Controls, product code NPQ).
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on September 18, 2009, 417 days after receiving the submission on July 28, 2008.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.7280. In Vitro Diagnostic Test To Detect The Factor V Leiden Mutation In Genomic Dna, As An Aid To Diagnosis In The Evaluation Of Patients With Suspected Thrombophilia..
| 510(k) Number | K082118 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2008 |
| Decision Date | September 18, 2009 |
| Days to Decision | 417 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | NPQ — Test, Factor V Leiden 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 V Leiden Mutation In Genomic Dna, As An Aid To Diagnosis In The Evaluation Of Patients With Suspected Thrombophilia. |