510(k) · Cleared
Recalled · Class II · 2017Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment Reagent, and Emit 200 Sirolimus Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · NRP Sirolimus Test System
Cleared on Mar 30, 2009 as substantially equivalent to K042411 (Axis-Shield, Ltd., 2005) after a 125-day review. Its family tree reaches back 2 generations to 2004. It has been recalled once.
- Decided
- Mar 30, 2009
- Review
- 125 days
- Class
- Class II
- Product code
- NRP
- Recalls
- 1
- 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 deviceK083487 Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment…Siemens Healthcare Diagnostics · 2009
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) | K083487 | Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment Reagent… | Siemens Healthcare Diagnostics | 2009 | — |
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…Emit® 2000 Sirolimus Calibrator / Clinical Toxicology Calibrator, 21 CFR 862.3200 3. Identification of the Predicate Device Abbott IMx® Sirolimus Assay, K04241 1 Abbott IMx® Sirolimus Calibrator, K04241 1… | 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 |
|---|---|---|---|---|
| Jun 29, 2017 | Class II | Z-1662-2018 | Device Design | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 4.0 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. 2009, 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 Emit® 2000 Sirolimus Assay is for the in vitro quantitative analysis of sirolimus in human whole blood as an aid in the management of sirolimus therapy in kidney transplant patients.
The Emit® 2000 Siro/Tacro Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Sirolimus Assay and/or the Emit® 2000 Tacrolimus Assay.
The Emit® 2000 Sirolimus Calibrators are intended for use in the calibration of the Emit® 2000 Sirolimus Assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083487 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083487: Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment Reagent, and Emit 200 Sirolimus Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083487
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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