510(k) K221640
K221640 is an FDA 510(k) premarket notification submitted by Caredx, Inc. for the device "AlloMap Heart Molecular Expression Testing". The FDA issued a decision of Substantially Equivalent on September 13, 2023. 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
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 2023
- Date Received
- June 6, 2022
- Clearance Type
- Traditional
- 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.