510(k) · Cleared
Recalled · Class III · 2019Architect Sirolimus Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · NRP Sirolimus Test System
Cleared on Sep 28, 2007 as substantially equivalent to K042411 (Axis-Shield, Ltd., 2005) after a 186-day review. Its family tree reaches back 2 generations to 2004. It has been recalled 2 times.
- Decided
- Sep 28, 2007
- Review
- 186 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.
View FIG. 1 as a table
Line of descent and top descendants
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…ry Class: Class 11 Product Code: NRP DLJ) Predicate Device ABBOTT IMx® Sirolimus Microparticie Enzyme Immunoassay (K04241 1) Device Description The ARCHITECT Sirolimus assay is a delayed one-step immunoassay for the quantitative determination of sirol… | 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 |
|---|---|---|---|---|
| Apr 9, 2019 | Class III | Z-1355-2019 | Under Investigation by firm | Devices were delivered without the required dry ice. |
| May 27, 2010 | Not classified | Z-2172-2010 | Equipment maintenance | The Architect Sirolimus assay lot 80162M100 is exhibiting higher than normal reports of barcode read errors. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 2.5 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. 2007, 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?
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…
Read the full statement (112 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070822 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070822: Architect Sirolimus Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070822
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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