# K070822: Architect Sirolimus Assay

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Sep 28, 2007 after 186 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: 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
- Apr 9, 2019 · Class III · Z-1355-2019: Devices were delivered without the required dry ice.
- May 27, 2010 · Not classified · Z-2172-2010: The Architect Sirolimus assay lot 80162M100 is exhibiting higher than normal reports of barcode read errors.

## Indications for use
Reagent Kit The ARCHITECT Sirolimus assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sirolimus in human whole blood on the ARCHITECT i System. The ARCHITECT Sirolimus assay is to be used as an aid in the management of renal transplant patients receiving sirolimus therapy. Calibrator Kit The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of sirolimus in human whole blood. Whole Blood Precipitation Reagent The ARCHITECT Sirolimus Whole Blood Precipitation Reagent is for the extraction of sirolimus from samples (human whole blood patient specimens, controls, and ARCHITECT Sirolimus Calibrators) to be tested on the ARCHITECT i System.

Source page: https://510kreport.com/device/K070822
Methodology: https://510kreport.com/methodology