OUF · Everolimus Immunoassay
Clinical Toxicology · 21 CFR 862.3840 · Class 2
Overview
| Product Code | OUF |
|---|---|
| Device Name | Everolimus Immunoassay |
| Regulation | 21 CFR 862.3840 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
Identification
A sirolimus test system is a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus.
Classification Rationale
Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Sirolimus Test Systems.” See § 862.1(d) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Sirolimus Test Systems.” See § 862.1(d) for the availability of this guidance document.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K122766 | THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY | Microgenics Corp. | Aug 20, 2013 | SESE |
| K100144 | THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS | Microgenics Corp. | Feb 11, 2011 | SESE |
Top Applicants
- Microgenics Corp. — 2 clearances
