510(k) · Cleared
Recalled · Class II · 2018Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models DR 306, DC 306
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · NRP Sirolimus Test System
Cleared on Oct 30, 2008 as substantially equivalent to K042411 (Axis-Shield, Ltd., 2005) after a 121-day review. Its family tree reaches back 2 generations to 2004. It has been recalled 2 times.
- Decided
- Oct 30, 2008
- Review
- 121 days
- Class
- Class II
- Product code
- NRP
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN040008 (2004). No later device cites it as a predicate yet.
- Root · 2 generations backDEN040008 Cedia Sirolimus AssayMicrogenics Corp. · 2004
- 1 generation backK042411 Abbott Imx Sirolimus Microparticle Enzyme ImmunoassayAxis-Shield, Ltd. · 2005 · Recalled
- This deviceK081857 Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus…Siemens Healthcare Diagnostics, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN040008 | Cedia Sirolimus Assay | Microgenics Corp. | 2004 | — |
| −1 | K042411 | Abbott Imx Sirolimus Microparticle Enzyme Immunoassay | Axis-Shield, Ltd. | 2005 | 2 |
| 0 (this device) | K081857 | Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator… | Siemens Healthcare Diagnostics, Inc. | 2008 | — |
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
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 | Decided |
|---|---|---|---|
| * | K042411 | Abbott Imx Sirolimus Microparticle Enzyme ImmunoassaySummary page 1…Systems Predicate Device(s): Abbott IMx Sirolimus Microparticle Enzyme Immunoassay and IMx Sirolimus Calibrator (k04241 1) Device Description(s): The automated Dimension® SIRO method uses an immunoassay technique in which free and sirolimus-… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 2, 2018 | Class II | Z-1670-2018 | Error in labeling | 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 FOL, ADVIA Centaur aHBcM and the… |
| Feb 9, 2016 | Class II | Z-1633-2016 | Under Investigation by firm | 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 meet the open well stability claim of… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K042411.
How does its category compare?
All NRP devicesNRP Sirolimus Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NRP
1in 2009
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NRP
1in 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081857: Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models DR 306, DC 306.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081857
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