# K042411: Abbott Imx Sirolimus Microparticle Enzyme Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield, Ltd.
- Decided: Apr 7, 2005 after 212 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: 1 generation back to DEN040008 (2004). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN040008: Cedia Sirolimus Assay, Microgenics Corp. (2004). Our reading of the summary gave K034069, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN040008, Cedia Sirolimus Assay (Microgenics Corp.), granted Jul 28, 2004; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K083487: Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment Reagent, and Emit 200 Sirolimus Calibrator (2009), 0 descendants of its own
- K081857: Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models DR 306, DC 306 (2008), 0 descendants of its own
- K070822: Architect Sirolimus Assay (2007), 0 descendants of its own

## Recalls of this device
- Apr 30, 2010 · Not classified · Z-2171-2010: IMx Sirolimus reagent lot 802873106 has exhibited an increased frequency of calibration errors.
- Aug 11, 2006 · Not classified · Z-0501-2007: The sirolimus values may shift higher after storage at 2-8C or after one freeze/thaw cycle of specimens.

## Indications for use
The IMX@Sirolimus assay is an in vitro reagent system for the quantitative determination of sirolimus in human whole blood as an aid in the management of renal transplant patients receiving sirolimus therapy. The IMX@Sirolimus Calibrators are for the calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood. The IMX@Sirolimus MODE 1 Calibrator is for the adjustment of the stored calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood. The IMX@Sirolimus Controls are for the verification of the calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood. The IMX@Sirolimus Whole Blood Precipitation Reagent is for the extraction of sirolimus from samples (whole blood patient specimens, IMX@Sirolimus Calibrators and Controls) to be tested on the IMX@Sirolimus assay.

Source page: https://510kreport.com/device/K042411
Methodology: https://510kreport.com/methodology