# K221640: AlloMap Heart Molecular Expression Testing

- Pathway: 510(k) (Traditional)
- Applicant: Caredx, Inc.
- Decided: Sep 13, 2023 after 464 days
- Product code: OJQ (Cardiac Allograft Gene Expression Profiling Test System)
- Device class: 2
- Regulation: 21 CFR 862.1163
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN080007 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN080007: Allomap Molecular Expression Testing, Xdx (2008). Our reading of the summary gave K073482, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN080007, Allomap Molecular Expression Testing (Xdx), granted Aug 26, 2008; older De Novo requests were first filed under a 510(k) number, so this links to the grant. Summary page 4.

## Indications for use
AlloMap Heart Molecular Expression Testing is an In Vitro Diagnostic Multivariate Index assay (IVDMIA) test service, performed in a single laboratory, assessing the gene expression profile of RNA isolated from peripheral blood mononuclear cells (PBMC). AlloMap Heart Testing is intended 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. Indicated for use in heart transplant recipients: • 15 years of age or older • At least 2 months (≥55 days) post-transplant

Source page: https://510kreport.com/device/K221640
Methodology: https://510kreport.com/methodology