De Novo · Granted
GrantedCedia Sirolimus Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · NRP Sirolimus Test System
Granted on Jul 28, 2004 as a new device type through De Novo after a 41-day review. 6 later devices descend from it.
- Decided
- Jul 28, 2004
- Review
- 41 days
- Class
- Class II
- Product code
- NRP
- Recalls
- None
6 later devices descend from it, 2 citing it directly.
- This deviceDEN040008 Cedia Sirolimus AssayMicrogenics Corp. · 2004
- Descendant · cites it directly · 3 of its ownK042411 Abbott Imx Sirolimus Microparticle Enzyme ImmunoassayAxis-Shield, Ltd. · 2005 · Recalled
- Descendant · cites it directly · 1 of its ownK100144 Thermo Scientific QMS Everolimus Reagents, Calibrators and ControlsMicrogenics Corp. · 2011
- Descendant · 2 generations on · 0 of its ownK122766 Thermo Scientific QMS Everolimus AssayMicrogenics Corp. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK083487 Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment…Siemens Healthcare Diagnostics · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK081857 Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus…Siemens Healthcare Diagnostics, Inc. · 2008 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K042411Abbott Imx Sirolimus Microparticle Enzyme ImmunoassayAxis-Shield, Ltd. · 2005 · cites it directly3descendants
- K100144Thermo Scientific QMS Everolimus Reagents, Calibrators and ControlsMicrogenics Corp. · 2011 · cites it directly1descendant
- K122766Thermo Scientific QMS Everolimus AssayMicrogenics Corp. · 2013 · 2 generations on0descendants
- K083487Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment Reagent, and Emit…Siemens Healthcare Diagnostics · 2009 · 2 generations on0descendants
- K081857Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models DR 306…Siemens Healthcare Diagnostics, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN040008 | Cedia Sirolimus Assay | Microgenics Corp. | 2004 | — |
| +1 | K042411 | Abbott Imx Sirolimus Microparticle Enzyme Immunoassay | Axis-Shield, Ltd. | 2005 | 2 |
| +1 | K100144 | Thermo Scientific QMS Everolimus Reagents, Calibrators and Controls | Microgenics Corp. | 2011 | — |
| +2 | K122766 | Thermo Scientific QMS Everolimus Assay | Microgenics Corp. | 2013 | 1 |
| +2 | K083487 | Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment Reagent… | Siemens Healthcare Diagnostics | 2009 | 1 |
| +2 | K081857 | Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator… | Siemens Healthcare Diagnostics, Inc. | 2008 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NRP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042411 (Axis-Shield, Ltd., 2005) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NRP devicesNRP Sirolimus Test System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NRP
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · NRP
Too few NRP 510(k)s in any year since 2007 to give a median.
Recalls per year · NRP
2in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NRP
1in 2025
MAUDE reports naming product code NRP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 2 | 12 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN040008 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN040008: Cedia Sirolimus Assay.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN040008
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026