FACTOR V LEIDEN KIT
Device Facts
| Record ID | DEN030005 |
|---|---|
| Device Name | FACTOR V LEIDEN KIT |
| Applicant | Roche Diagnostics Corp. |
| Product Code | NPQ · Hematology |
| Decision Date | Dec 17, 2003 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 864.7280 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Factor V Leiden mutation detection system is a device that allows the detection and genotyping of a single point mutation of the human Factor V gene, referred to as Factor V Leiden mutation, from DNA isolated from human whole peripheral blood. The system consists of different reagents and instruments which includes polymerase chain reaction (PCR) primers, hybridization matrices, thermal cyclers, imagers, and software packages. The detection system is an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems.” (See § 864.1(d) for the availability of this guidance document.)
