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) → NRP — Sirolimus Test System

# NRP · Sirolimus Test System

_Clinical Toxicology · 21 CFR 862.3840 · Class 2_

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

## Overview

- **Product Code:** NRP
- **Device Name:** Sirolimus Test System
- **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)
- **3rd-party reviewable:** yes

## 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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K083487](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NRP/K083487.md) | EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR | Siemens Healthcare Diagnostics | Mar 30, 2009 | SESE |
| [K081857](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NRP/K081857.md) | DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 | Siemens Healthcare Diagnostics, Inc. | Oct 30, 2008 | SESE |
| [K070822](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NRP/K070822.md) | ARCHITECT SIROLIMUS ASSAY | Fujirebio Diagnostics,Inc. | Sep 28, 2007 | SESE |
| [K042411](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NRP/K042411.md) | ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY | Axis-Shield , Ltd. | Apr 7, 2005 | SESE |
| [DEN040008](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NRP/DEN040008.md) | CEDIA SIROLIMUS ASSAY | Microgenics Corp. | Jul 28, 2004 | DENG |

## Top Applicants

- Axis-Shield , Ltd. — 1 clearance
- Fujirebio Diagnostics,Inc. — 1 clearance
- Microgenics Corp. — 1 clearance
- Siemens Healthcare Diagnostics — 1 clearance
- Siemens Healthcare Diagnostics, Inc. — 1 clearance

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

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