510(k) · Cleared

Cleared

Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge, Catalog # DF108

K052017510(k) TraditionalCleared Sep 1, 200537-day reviewClass II21 CFR 862.1235

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

Cleared on Sep 1, 2005 as substantially equivalent to P890025 (Abbott Laboratories, 1989) after a 37-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.

Decided: Sep 1, 2005
Review: 37 days
Class: Class II
Product code: MKW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to P890025 (1989). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backP890025 TD Cyclosporine and Metabolites Serum AssayAbbott Laboratories · 1989 · Recalled
This deviceK052017 Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge…Dade Behring, Inc. · 2005
Descendant · cites it directly · 0 of its ownK081992 Dimension Vista Csae Flex Regent Cartridge, Model K4108Siemens Healthcare Diagnostics, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all

K081992Dimension Vista Csae Flex Regent Cartridge, Model K4108Siemens Healthcare Diagnostics, Inc. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P890025	TD Cyclosporine and Metabolites Serum Assay	Abbott Laboratories	1989	1
0 (this device)	K052017	Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge, Catalog # DF108	Dade Behring, Inc.	2005	—
+1	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
2008	1	0

FIG. 1 — Lineage of K052017, 1989–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 MKW? 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

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	Applicant	Decided	Recalls
*	P890025	TD Cyclosporine and Metabolites Serum Assay Summary page 2 …Substantial Equivalence Information: 1. Predicate Device: Abbott TDx® /TDx FLx® Cyclosporine Monoclonal Whole Blood Assay 2. Predicate K Number(s): P890025 3. Comparison with Predicate: Dimension® CSAE Abbott TDx®/TDx FLx®…	Abbott Laboratories	1989	1

Also cleared against P890025: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K081992	Dimension Vista Csae Flex Regent Cartridge, Model K4108	Siemens Healthcare Diagnostics, Inc.	2008	0

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K081992 (Siemens Healthcare Diagnostics, Inc., 2008) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate P890025.

How does its category compare?

All MKW devices

MKW Cyclosporine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MKW

3in 2008

2007high 3 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MKW

177in 2008

2007high 177 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MKW

1in 2013

2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MKW

8in 2025

2007high 108 (2011) · low 0 (2007)2025

MAUDE reports naming product code MKW, 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	0	—	0	0
2008	3	177	0	0
2009	0	—	0	0
2010	0	—	1	2
2011	0	—	1	108
2012	0	—	0	36
2013	0	—	1	30
2014	0	—	0	4
2015	0	—	0	2
2016	0	—	0	4
2017	0	—	0	0
2018	0	—	0	3
2019	0	—	0	4
2020	0	—	0	2
2021	0	—	0	6
2022	0	—	0	7
2023	0	—	0	5
2024	0	—	0	6
2025	0	—	0	8
2026	0	—	0	—

What is it indicated for?

The CSAE Flex® reagent cartridge is an in vitro diagnostic test intended to quantitatively measure cyclosporine A (CSA) in human whole blood for the Dimension® clinical chemistry system. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052017 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052017: Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge, Catalog # DF108.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052017

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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