510(k) · Cleared

Cleared

Access CEA

K223921510(k) TraditionalCleared Sep 22, 2023267-day reviewClass II21 CFR 866.6010

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

Beckman Coulter, Inc. · DHX System, Test, Carcinoembryonic Antigen

Cleared on Sep 22, 2023 as substantially equivalent to K991707 (Beckman, 1999) and 1 other predicate after a 267-day review. Its family tree reaches back 2 generations to 1998.

Decided: Sep 22, 2023
Review: 267 days
Class: Class II
Product code: DHX
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K981985 (1998). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK981985 Access Cea Reagents on the Access Immunoassay Analyzer Model 33200…Beckman Coulter, Inc. · 1998 · Recalled
1 generation backK991707 Modification to Access Cea Reagents for Use on the Access…Beckman · 1999
This deviceK223921 Access CEABeckman Coulter, Inc. · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K981985	Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205…	Beckman Coulter, Inc.	1998	1
−1	K991707	Modification to Access Cea Reagents for Use on the Access Immunoassay…	Beckman	1999	—
0 (this device)	K223921	Access CEA	Beckman Coulter, Inc.	2023	—

FIG. 1 — Lineage of K223921, 1998–2023Source: 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 DHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DHX device

#1 K231517 VITROS Immunodiagnostic Products CEA Reagent…score 6.5 · 3 generations · no Class I recall
#2 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

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
*	K991707	Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models… Summary page 4 …r-associated antigen immunological test system Classification Regulation: 21 CFR 866.6010 Classification Product Code: DHX Predicate Device: Access CEA 510(k) numbers: K991707 and K981985 Page 1 of 4 Device Desc…	Beckman	1999	—
*	K981985	Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205, 33206 & 33209 Summary page 4 …antigen immunological test system Classification Regulation: 21 CFR 866.6010 Classification Product Code: DHX Predicate Device: Access CEA 510(k) numbers: K991707 and K981985 Page 1 of 4 Device Description The…	Beckman Coulter, Inc.	1998	1

Also cleared against K991707: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 24.3 years on median.
1 of the 2 ancestors has a recall of any class.
1 other device also cites its predicate K991707.

How does its category compare?

All DHX devices

DHX System, Test, Carcinoembryonic Antigen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · DHX

2in 2023

2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DHX

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

Recalls per year · DHX

1in 2015

2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · DHX

19in 2025

2007high 33 (2015) · low 2 (2007)2025

MAUDE reports naming product code DHX, 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	2
2008	2	—	0	11
2009	1	—	0	20
2010	0	—	1	8
2011	0	—	0	14
2012	0	—	0	14
2013	0	—	0	26
2014	0	—	0	15
2015	0	—	1	33
2016	0	—	0	22
2017	0	—	0	7
2018	0	—	0	20
2019	0	—	0	12
2020	1	—	0	14
2021	0	—	0	11
2022	0	—	0	12
2023	2	—	0	15
2024	0	—	0	15
2025	0	—	0	19
2026	0	—	0	—

What is it indicated for?

The Access CEA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay Systems. CEA measured by the Access Immunoassay Systems is used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K223921 · printed Nov 6, 2026

Cite this page

510(k) Report. “K223921: Access CEA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223921

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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