# K100144: Thermo Scientific QMS Everolimus Reagents, Calibrators and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Feb 11, 2011 after 388 days
- Product code: OUF (Everolimus Immunoassay)
- 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
Longest line of descent: 1 generation back to DEN040008 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN040008: Cedia Sirolimus Assay, Microgenics Corp. (2004). 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.

## Most influential descendants
- K122766: Thermo Scientific QMS Everolimus Assay (2013), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K100144
Methodology: https://510kreport.com/methodology