Sirolimus Test System
The Sirolimus Test System is an in vitro diagnostic device intended for the quantitative measurement of sirolimus (rapamycin) concentrations in whole blood, used as an aid in the management of transplant patients taking this immunosuppressant drug. Therapeutic drug monitoring of sirolimus helps clinicians ensure appropriate dosing to prevent organ rejection while minimizing toxicity. This is an FDA Class 2 device regulated under 21 CFR 862.3840 in the Clinical Toxicology specialty, with product code NRP, requiring 510(k) clearance. The device is eligible for third-party review. It is not an implant and does not provide life-sustaining support.
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Basic Information
- Product Code
- NRP
- Device Class
- FDA class 2
- Regulation Number
- 862.3840
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
Definition
Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K083487 | EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR | Mar 30, 2009 | Substantially Equivalent | Siemens Healthcare Diagnostics |
| K081857 | DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 | Oct 30, 2008 | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. |
| K070822 | ARCHITECT SIROLIMUS ASSAY | Sep 28, 2007 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K042411 | ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY | Apr 07, 2005 | Substantially Equivalent | Axis-Shield , Ltd. |
| DEN040008 | CEDIA SIROLIMUS ASSAY | Jul 28, 2004 | Unknown | Microgenics Corp. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.