K100980 is an FDA 510(k) clearance for the INVADER FACTOR V. This device is classified as a Test, Factor V Leiden Mutations, Genomic Dna Pcr (Class II - Special Controls, product code NPQ).
Submitted by Hologic, Inc. (Malborough, US). The FDA issued a Cleared decision on June 1, 2011, 419 days after receiving the submission on April 8, 2010.
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 | K100980 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2010 |
| Decision Date | June 01, 2011 |
| Days to Decision | 419 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. |