PMA · Approved

Recalled · 2005

TD Cyclosporine and Metabolites Serum Assay

P890025PMAApproved Dec 14, 1989248-day reviewClass II21 CFR 862.1235Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Abbott Laboratories · MGU Fluorescence Polarization Immunoassay For Cyclosporine

Approved on Dec 14, 1989 through premarket approval, which rests on the device’s own clinical evidence after a 248-day review. 8 later devices descend from it. It has been recalled once.

Decided: Dec 14, 1989
Review: 248 days
Class: Class II
Product code: MGU
Recalls: 1

8 later devices descend from it, 6 citing it directly.

This deviceP890025 TD Cyclosporine and Metabolites Serum AssayAbbott Laboratories · 1989
Descendant · cites it directly · 1 of its ownK052017 Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge…Dade Behring, Inc. · 2005
Descendant · cites it directly · 1 of its ownK023065 Cyclosporine (Csa) Flex Reagent CartridgeDade Behring, Inc. · 2002
Descendant · cites it directly · 0 of its ownK071455 Advia Centaur Cyclosporine Assay and CalibratorSiemens Medical Solutions Diagnostics · 2008 · Recalled
Descendant · cites it directly · 0 of its ownK080751 Architect CyclosporineFujirebio Diagnostics,Inc. · 2008 · Recalled
Descendant · 2 generations on · 0 of its ownK081992 Dimension Vista Csae Flex Regent Cartridge, Model K4108Siemens Healthcare Diagnostics, Inc. · 2008

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2002high 3 (2008) · low 0 (2003)2026

Most influential descendants

Showing 5 of 8 · See all

K052017Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge, Catalog # DF108Dade Behring, Inc. · 2005 · cites it directly1descendant
K023065Cyclosporine (Csa) Flex Reagent CartridgeDade Behring, Inc. · 2002 · cites it directly1descendant
K071455Advia Centaur Cyclosporine Assay and CalibratorSiemens Medical Solutions Diagnostics · 2008 · cites it directly0descendants
K080751Architect CyclosporineFujirebio Diagnostics,Inc. · 2008 · cites it directly0descendants
K081992Dimension Vista Csae Flex Regent Cartridge, Model K4108Siemens Healthcare Diagnostics, Inc. · 2008 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	P890025	TD Cyclosporine and Metabolites Serum Assay	Abbott Laboratories	1989	—
+1	K052017	Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge, Catalog # DF108	Dade Behring, Inc.	2005	—
+1	K023065	Cyclosporine (Csa) Flex Reagent Cartridge	Dade Behring, Inc.	2002	—
+1	K071455	Advia Centaur Cyclosporine Assay and Calibrator	Siemens Medical Solutions Diagnostics	2008	1
+1	K080751	Architect Cyclosporine	Fujirebio Diagnostics,Inc.	2008	1
+2	K081992	Dimension Vista Csae Flex Regent Cartridge, Model K4108	Siemens Healthcare Diagnostics, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0
2005	1	0
2006	2	0
2008	3	0

FIG. 1 — Lineage of P890025, 1989–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MGU? 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

Get a 510(k) Report

Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it? (8)

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K052017	Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge, Catalog # DF108	Dade Behring, Inc.	2005	1
K023065	Cyclosporine (Csa) Flex Reagent Cartridge	Dade Behring, Inc.	2002	1
K071455	Advia Centaur Cyclosporine Assay and Calibrator	Siemens Medical Solutions Diagnostics	2008	0
K080751	Architect Cyclosporine	Fujirebio Diagnostics,Inc.	2008	0
K053061	Emit 2000 Cyclosporine Specific Assay	Dade Behring, Inc.	2006	0
K040761	Axsym Cyclosporine	Abbott Laboratories, Inc.	2004	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 23, 2005	Not classified	Z-0624-06	Other	Patient results reported using calibrators made from new primary material may be falsely decreased by 5-8% compared to results using calibrators made from the previous primary material. An Important Product Information Letter with…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K052017 (Dade Behring, Inc., 2005) has gone furthest, with 1 descendant of its own.

How does its category compare?

All MGU devices

MGU Fluorescence Polarization Immunoassay For Cyclosporine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MGU

FDA has decided no MGU device since 2007.

Median 510(k) review, days · MGU

Too few MGU 510(k)s in any year since 2007 to give a median.

Recalls per year · MGU

No recall names MGU since 2007.

Adverse event reports per year · MGU

No MAUDE report names MGU since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/P890025 · printed Nov 3, 2026

Cite this page

510(k) Report. “P890025: TD Cyclosporine and Metabolites Serum Assay.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/P890025

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026