510(k) · Cleared
Recalled · Class II · 2016Thermo Scientific QMS Everolimus Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · OUF Everolimus Immunoassay
Cleared on Aug 20, 2013 as substantially equivalent to K100144 (Microgenics Corp., 2011) after a 344-day review. Its family tree reaches back 2 generations to 2004. It has been recalled once.
- Decided
- Aug 20, 2013
- Review
- 344 days
- Class
- Class II
- Product code
- OUF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN040008 (2004). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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
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 | Decided |
|---|---|---|---|
| * | K100144 | Thermo Scientific QMS Everolimus Reagents, Calibrators and ControlsSummary page 3…mparison Proposed Device Predicate Proprietary Name Thermo Scientific OMS8 Everolimus Assay OMS a Everolimus Assay (k<100144) Intended Use The OMS® Everolimus Assay is intended for The OMS® Everolimus Assay is intended for… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 15, 2016 | Class II | Z-0008-2017 | Under Investigation by firm | 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 levels, +/- 33% for mid-range levels, and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 6.5 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All OUF devicesOUF Everolimus Immunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OUF
1in 2013
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OUF
1in 2017
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122766: Thermo Scientific QMS Everolimus Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122766
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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