# K083487: Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment Reagent, and Emit 200 Sirolimus Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Mar 30, 2009 after 125 days
- Product code: NRP (Sirolimus Test System)
- Device class: 2
- Regulation: 21 CFR 862.3840
- Recalls of this device: 1 (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
- Jun 29, 2017 · Class II · Z-1662-2018: 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 dep

## Indications for use
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.

Source page: https://510kreport.com/device/K083487
Methodology: https://510kreport.com/methodology