510(k) · Cleared

Cleared

Thermo Scientific QMS Everolimus Reagents, Calibrators and Controls

K100144510(k) TraditionalCleared Feb 11, 2011388-day reviewClass II21 CFR 862.3840

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Microgenics Corp. · OUF Everolimus Immunoassay

Cleared on Feb 11, 2011 as substantially equivalent to DEN040008 (Microgenics Corp., 2004) after a 388-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.

Decided: Feb 11, 2011
Review: 388 days
Class: Class II
Product code: OUF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN040008 (2004). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backDEN040008 Cedia Sirolimus AssayMicrogenics Corp. · 2004
This deviceK100144 Thermo Scientific QMS Everolimus Reagents, Calibrators and ControlsMicrogenics Corp. · 2011
Descendant · cites it directly · 0 of its ownK122766 Thermo Scientific QMS Everolimus AssayMicrogenics Corp. · 2013 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K122766Thermo Scientific QMS Everolimus AssayMicrogenics Corp. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN040008	Cedia Sirolimus Assay	Microgenics Corp.	2004	—
0 (this device)	K100144	Thermo Scientific QMS Everolimus Reagents, Calibrators and Controls	Microgenics Corp.	2011	—
+1	K122766	Thermo Scientific QMS Everolimus Assay	Microgenics Corp.	2013	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K100144, 2004–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OUF? 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

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	DEN040008	Cedia Sirolimus Assay Our reading of the summary gave K034069, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN040008, Cedia Sirolimus Assay (Microgenics Corp.), granted Jul 28, 2004; older De Novo requests were first filed under a 510(k) number, so this links to the grant.	Microgenics Corp.	2004	—

Also cleared against DEN040008: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K122766	Thermo Scientific QMS Everolimus Assay	Microgenics Corp.	2013	0

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?

Its one ancestor has no recall.
Of its descendants, K122766 (Microgenics Corp., 2013) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate DEN040008.

How does its category compare?

All OUF devices

OUF Everolimus Immunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · OUF

1in 2013

2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OUF

Too few OUF 510(k)s in any year since 2007 to give a median.

Recalls per year · OUF

1in 2016

2007high 1 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OUF

1in 2017

2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code OUF, 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	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	1	—	0	0
2012	0	—	0	0
2013	1	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	1	0
2017	0	—	0	1
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The OMS® Everolimus assay is intended for the quantitative determination of everolimus, the active ingredient of Zortresso in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only.

The OMS®9 Everolimus Calibrator set is intended for use in calibration of the QMS® Everolimus Assay.

The OMSO Everolimus Control set is intended for use in quality control of the QMS® Everolimus Assay.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100144 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100144: Thermo Scientific QMS Everolimus Reagents, Calibrators and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100144

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026