Sirolimus Test System
FDA product code NRP · Class II (moderate risk) · 21 CFR 862.3840 · Clinical Toxicology
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.
4510(k) clearances
0PMA approvals
6recalls
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K083487 | Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment Reagent, and Emit…NRP · Traditional | Siemens Healthcare Diagnostics | 03/30/2009SE |
| K081857 | Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models DR 306…NRP · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/30/2008SE |
| K070822 | Architect Sirolimus AssayNRP · Traditional | Fujirebio Diagnostics,Inc. | 09/28/2007SE |
| K042411 | Abbott Imx Sirolimus Microparticle Enzyme ImmunoassayNRP · Traditional | Axis-Shield , Ltd. | 04/07/2005SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1670-2018 Class II | Dimension Sirolimus (SIRO) Flex reagent cartridgeConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | Siemens Healthcare Diagnostics, Inc. | 01/02/2018Terminated |
| Z-1662-2018 Class II | Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | Siemens Healthcare Diagnostics, Inc. | 06/29/2017Terminated |
| Z-1633-2016 Class II | Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN…Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after… | Siemens Healthcare Diagnostics, Inc. | 02/09/2016Terminated |
| Z-2172-2010 | Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL)…The Architect Sirolimus assay lot 80162M100 is exhibiting higher than normal reports of barcode read errors. | Abbott Laboratories | 05/27/2010Terminated |
| Z-2171-2010 | IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus…IMx Sirolimus reagent lot 802873106 has exhibited an increased frequency of calibration errors. | Abbott Laboratories | 04/30/2010Terminated |
| Z-0501-2007 | IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL)…The sirolimus values may shift higher after storage at 2-8C or after one freeze/thaw cycle of specimens. | Abbott Laboratories MPG | 08/11/2006Terminated |