FDA product code OUF: Everolimus Immunoassay
OUF is the FDA product code for everolimus immunoassay. It is a Class II device, regulated under 21 CFR 862.3840 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under OUF. The average 510(k) review took 366 days (median 366). FDA has posted 1 recall for OUF devices.
Definition
To quantify everolimus in whole blood.
Classification
| Field | Value |
|---|---|
| Device name | Everolimus Immunoassay |
| Device class | Class II |
| Regulation | 21 CFR 862.3840 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OUF clearance
Top OUF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Microgenics Corp. | 2 | 2013-08-20 |
Most recent OUF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K122766 | Microgenics Corp. | THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY | 2013-08-20 | 344 |
| K100144 | Microgenics Corp. | THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS | 2011-02-11 | 388 |
Recalls for OUF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-08-15.
Frequently asked questions
What is FDA product code OUF?
OUF is the FDA product code for everolimus immunoassay. It is a Class II device, regulated under 21 CFR 862.3840 and reviewed by the Clinical Toxicology panel.
What device class is OUF?
Class II, regulation 21 CFR 862.3840. Typical premarket route: 510(k).
How long does a 510(k) take for product code OUF?
Across 2 cleared submissions the average was 366 days from receipt to decision (median 366).
Which companies have the most OUF clearances?
Microgenics Corp. (2).
Have OUF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-08-15.
Next steps
- Run an FDA pathway report with predicate devices for product code OUF
- Run a recall and safety report across every OUF manufacturer
- Watch product code OUF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times