510(k) DEN080007
DEN080007 is an FDA 510(k) premarket notification submitted by Xdx for the device "ALLOMAP MOLECULAR EXPRESSION TESTING". The FDA issued a decision of De Novo Granted on August 26, 2008. The device falls under product code OJQ (Cardiac Allograft Gene Expression Profiling Test System), a Class II device regulated under 21 CFR 862.1163.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 26, 2008
- Date Received
- August 15, 2008
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cardiac Allograft Gene Expression Profiling Test System
- Device Class
- Class II
- Regulation Number
- 862.1163
- Review Panel
- CH
- Submission Type
In vitro diagnostic multivariate index assay (ivdmia) test service, performed in a single laboratory, for assessing the gene expression profile of rna isolated from peripheral blood mononuclear cells (pbmc) and indicated for use to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (acr) at the time of testing in conjunction with standard clinical assessment.