510(k) · Cleared

Recalled · 2010

Abbott Imx Sirolimus Microparticle Enzyme Immunoassay

K042411510(k) TraditionalCleared Apr 7, 2005212-day reviewClass II21 CFR 862.3840Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Axis-Shield, Ltd. · NRP Sirolimus Test System

Cleared on Apr 7, 2005 as substantially equivalent to DEN040008 (Microgenics Corp., 2004) after a 212-day review. Its family tree reaches back 1 generation to 2004. 3 later devices descend from it. It has been recalled 2 times.

Decided: Apr 7, 2005
Review: 212 days
Class: Class II
Product code: NRP
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to DEN040008 (2004). 3 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backDEN040008 Cedia Sirolimus AssayMicrogenics Corp. · 2004
This deviceK042411 Abbott Imx Sirolimus Microparticle Enzyme ImmunoassayAxis-Shield, Ltd. · 2005
Descendant · cites it directly · 0 of its ownK083487 Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment…Siemens Healthcare Diagnostics · 2009 · Recalled
Descendant · cites it directly · 0 of its ownK081857 Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus…Siemens Healthcare Diagnostics, Inc. · 2008 · Recalled
Descendant · cites it directly · 0 of its ownK070822 Architect Sirolimus AssayFujirebio Diagnostics,Inc. · 2007 · Recalled

Most influential descendants

Showing 3 of 3 · See all

K083487Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment Reagent, and Emit…Siemens Healthcare Diagnostics · 2009 · cites it directly0descendants
K081857Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models DR 306…Siemens Healthcare Diagnostics, Inc. · 2008 · cites it directly0descendants
K070822Architect Sirolimus AssayFujirebio Diagnostics,Inc. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN040008	Cedia Sirolimus Assay	Microgenics Corp.	2004	—
0 (this device)	K042411	Abbott Imx Sirolimus Microparticle Enzyme Immunoassay	Axis-Shield, Ltd.	2005	—
+1	K083487	Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment Reagent…	Siemens Healthcare Diagnostics	2009	1
+1	K081857	Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator…	Siemens Healthcare Diagnostics, Inc.	2008	2
+1	K070822	Architect Sirolimus Assay	Fujirebio Diagnostics,Inc.	2007	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	1	0

FIG. 1 — Lineage of K042411, 2004–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NRP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	DEN040008	Cedia Sirolimus Assay 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.	Microgenics Corp.	2004	—

Also cleared against DEN040008: 1 other device →

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided
K083487	Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment Reagent, and Emit…	Siemens Healthcare Diagnostics	2009
K081857	Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models DR 306…	Siemens Healthcare Diagnostics, Inc.	2008
K070822	Architect Sirolimus Assay	Fujirebio Diagnostics,Inc.	2007

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 30, 2010	Not classified	Z-2171-2010	Other	IMx Sirolimus reagent lot 802873106 has exhibited an increased frequency of calibration errors.
Aug 11, 2006	Not classified	Z-0501-2007	Other	The sirolimus values may shift higher after storage at 2-8C or after one freeze/thaw cycle of specimens.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K083487 (Siemens Healthcare Diagnostics, 2009) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate DEN040008.

How does its category compare?

All NRP devices

NRP Sirolimus Test System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NRP

1in 2009

2007high 1 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NRP

Too few NRP 510(k)s in any year since 2007 to give a median.

Recalls per year · NRP

2in 2010

2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NRP

1in 2025

2007high 12 (2010) · low 0 (2007)2025

MAUDE reports naming product code NRP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	0
2008	1	—	0	0
2009	1	—	0	0
2010	0	—	2	12
2011	0	—	0	1
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	1
2015	0	—	0	2
2016	0	—	0	7
2017	0	—	0	1
2018	0	—	0	1
2019	0	—	0	1
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	1
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	1
2026	0	—	0	—

What is it indicated for?

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…

Read the full statement (139 words)

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042411 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042411: Abbott Imx Sirolimus Microparticle Enzyme Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042411

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026