# DEN040008: Cedia Sirolimus Assay

- Pathway: De Novo (Post-NSE)
- Applicant: Microgenics Corp.
- Decided: Jul 28, 2004 after 41 days
- Product code: NRP (Sirolimus Test System)
- Device class: 2
- Regulation: 21 CFR 862.3840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K042411: Abbott Imx Sirolimus Microparticle Enzyme Immunoassay (2005), 3 descendants of its own
- K100144: Thermo Scientific QMS Everolimus Reagents, Calibrators and Controls (2011), 1 descendant of its own
- K122766: Thermo Scientific QMS Everolimus Assay (2013), 0 descendants of its own
- K083487: Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment Reagent, and Emit 200 Sirolimus Calibrator (2009), 0 descendants of its own
- K081857: Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models DR 306, DC 306 (2008), 0 descendants of its own

Source page: https://510kreport.com/device/DEN040008
Methodology: https://510kreport.com/methodology