Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3840](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3840) → OUF — Everolimus Immunoassay

# OUF · Everolimus Immunoassay

_Clinical Toxicology · 21 CFR 862.3840 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/OUF

## Overview

- **Product Code:** OUF
- **Device Name:** Everolimus Immunoassay
- **Regulation:** [21 CFR 862.3840](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3840)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)

## 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](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/OUF/K122766.md) | THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY | Microgenics Corp. | Aug 20, 2013 | SESE |
| [K100144](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/OUF/K100144.md) | THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS | Microgenics Corp. | Feb 11, 2011 | SESE |

## Top Applicants

- Microgenics Corp. — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/OUF](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/OUF)

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