# K122766: Thermo Scientific QMS Everolimus Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Aug 20, 2013 after 344 days
- Product code: OUF (Everolimus Immunoassay)
- Device class: 2
- Regulation: 21 CFR 862.3840
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN040008 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100144: Thermo Scientific QMS Everolimus Reagents, Calibrators and Controls, Microgenics Corp. (2011) Summary page 3.

## Recalls of this device
- Aug 15, 2016 · Class II · Z-0008-2017: A reagent stability issue (still under investigation) causes less separation in the calibration curve, which affects results across the entire range. For controls, maximum bias of +/- 35% for low leve

## Indications for use
The QMS® Everolimus Assay is intended for the quantitative determination of Everolimus in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only.

Source page: https://510kreport.com/device/K122766
Methodology: https://510kreport.com/methodology