510(k) Report

510(k) · Cleared

Cleared

ADVIA Centaur CEA Assay

K200215510(k) TraditionalCleared Apr 13, 202076-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

Siemens Healthcare Disgnostics, Inc. · DHX System, Test, Carcinoembryonic Antigen

Cleared on Apr 13, 2020 as substantially equivalent to K981478 (Chiron Diagnostics Corp., 1998) after a 76-day review. Its family tree reaches back 1 generation to 1998.

Decided
Apr 13, 2020
Review
76 days
Class
Class II
Product code
DHX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K981478 (1998). No later device cites it as a predicate yet.

K981478 · Acs:Centaur Cea · Chiron Diagnostics Corp. · 1998199520002005201020152020
K981478 · Acs:Centaur Cea · Chiron Diagnostics Corp. · 19980
  1. Root · 1 generation backK981478 Acs:Centaur CeaChiron Diagnostics Corp. · 1998
  2. This deviceK200215 ADVIA Centaur CEA AssaySiemens Healthcare Disgnostics, Inc. · 2020
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K981478Acs:Centaur CeaChiron Diagnostics Corp.1998—
0 (this device)K200215ADVIA Centaur CEA AssaySiemens Healthcare Disgnostics, Inc.2020—
FIG. 1 — Lineage of K200215, 1998–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223921 Access CEAscore 6.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin 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.

TypeNumberDeviceApplicantDecidedRecalls
*K981478Acs:Centaur Cea
Summary page 5
…510(k) Premarket Notification: ADVIA Centaur® CEA Assay 3. PREDICATE DEVICE Assay Name of Device: ADVIA Centaur® CEA assay 510 (k): K981478 4. DEVICE DESCRIPTION The assay reagents come in the following configurations:…
Chiron Diagnostics Corp.1998—

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?

  • Its one ancestor has no recall.

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. 2020, this device’s year, is highlighted.

FDA decisions per year · DHX

2in 2023

2008: 22009: 12020: 12023: 2
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

2010: 12015: 1
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

2007: 22008: 112009: 202010: 82011: 142012: 142013: 262014: 152015: 332016: 222017: 72018: 202019: 122020: 142021: 112022: 122023: 152024: 152025: 19
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20082—011
20091—020
20100—18
20110—014
20120—014
20130—026
20140—015
20150—133
20160—022
20170—07
20180—020
20190—012
20201—014
20210—011
20220—012
20232—015
20240—015
20250—019
20260—0—

What is it indicated for?

For in vitro diagnostic use in the quantitative measurement of carcinoembryonic antigen (CEA) in serum and plasma (EDTA and lithium heparin) to aid in the management of cancer patients in whom changing concentrations of CEA are observed using the ADVIA Centaur® XP and ADVIA Centaur® XPT systems.

Indications for use as stated in the FDA summary.

Recent decisions in DHX

The DHX category page

  • K223921Access CEABeckman Coulter, Inc. · 2023
  • K231517VITROS Immunodiagnostic Products CEA Reagent PackOrtho Clinical Diagnostics · 2023
  • K081615Olympus Cea - Carcinoembryonic AntigenOlympus America, Inc. · 2009
  • K080194Vidas Cea (S) AssaybioMerieux, Inc. · 2008
  • K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008

https://510kreport.com/device/K200215 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200215: ADVIA Centaur CEA Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200215

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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