# DEN080007: Allomap Molecular Expression Testing

- Pathway: De Novo (Post-NSE)
- Applicant: Xdx
- Decided: Aug 26, 2008 after 11 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K221640: AlloMap Heart Molecular Expression Testing (2023), 0 descendants of its own

Source page: https://510kreport.com/device/DEN080007
Methodology: https://510kreport.com/methodology