# K081857: Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models DR 306, DC 306

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Oct 30, 2008 after 121 days
- Product code: NRP (Sirolimus Test System)
- Device class: 2
- Regulation: 21 CFR 862.3840
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN040008 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042411: Abbott Imx Sirolimus Microparticle Enzyme Immunoassay, Axis-Shield, Ltd. (2005) Summary page 1.

## Recalls of this device
- Jan 2, 2018 · Class II · Z-1670-2018: Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur 
- Feb 9, 2016 · Class II · Z-1633-2016: Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension¿ SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not 

## Indications for use
The SIRO method is an in vitro diagnostic test for the quantitative measurement of Sirolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of Sirolimus are used as an aid in the management of sirolimus therapy in renal transplant patients. The Sirolimus Calibrator is an in vitro diagnostic product for the calibration of Sirolimus (SIRO) on the Dimension® clinical chemistry system.

Source page: https://510kreport.com/device/K081857
Methodology: https://510kreport.com/methodology