NRP · Sirolimus Test System
Clinical Toxicology · 21 CFR 862.3840 · Class 2
Overview
| Product Code | NRP |
|---|---|
| Device Name | Sirolimus Test System |
| Regulation | 21 CFR 862.3840 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 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 | EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR | Siemens Healthcare Diagnostics | Mar 30, 2009 | SESE |
| K081857 | DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 | Siemens Healthcare Diagnostics, Inc. | Oct 30, 2008 | SESE |
| K070822 | ARCHITECT SIROLIMUS ASSAY | Fujirebio Diagnostics,Inc. | Sep 28, 2007 | SESE |
| K042411 | ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY | Axis-Shield , Ltd. | Apr 7, 2005 | SESE |
| DEN040008 | 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
