510(k) Report

510(k) · Cleared

Cleared

Cea Assay for the Advia Integrated Modular System

K013568510(k) TraditionalCleared Dec 21, 200156-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

Bayer Corp. · DHX System, Test, Carcinoembryonic Antigen

Cleared on Dec 21, 2001 after a 56-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).

Decided
Dec 21, 2001
Review
56 days
Class
Class II
Product code
DHX
Recalls
None
Predicates
1

The summary cites one number, which could not be confirmed as its predicate (see the table below).

FIG. 1 — Lineage of K013568Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 6.7 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeP940030Immuno 1 CEA Assay
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 1
…in whom changing concentrations of CEA are observed. 2. Predicate Device Product Name Reagent Part # | Calibrator Part # K# Immuno 1 CEA Assay T01-3184-51 |T03-3188-01 P940030; down classified to 510(k) 3. Device/ Method Product Name Reagent Part #/ BAN | Calibrator Part # / Number BAN Number ADVIA IMS C…

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.

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.

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?

The Bayer ADVIA® IMS™ CEA assay is an in vitro diagnostic device intended to quantitatively measure carcinoembryonic antigen (CEA) in human serum. CEA test results aid in the management of cancer patients by monitoring CEA concentrations. CEA testing is not recommended as a screening procedure to detect cancer in the general population.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Bayer Corp.

96 FDA decisions under this applicant name. See the company

  • K024062Ascensia Breeze Blood Glucose MeterBayer Corp. · 2003
  • K023944Bayer Diagnostics Clinitest Pregnancy TestBayer Corp. · 2003
  • K024017Bayer Advia Centaur Her-2/Neu AssayBayer Corp. · 20031 recall
  • K024234Ascensia Glucofacts; Ascensia Glucofacts ProfessionalBayer Corp. · 2003
  • K022288Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module SystemBayer Corp. · 2002

Recent decisions in DHX

The DHX category page

  • K223921Access CEABeckman Coulter, Inc. · 2023
  • K231517VITROS Immunodiagnostic Products CEA Reagent PackOrtho Clinical Diagnostics · 2023
  • K200215ADVIA Centaur CEA AssaySiemens Healthcare Disgnostics, Inc. · 2020
  • K081615Olympus Cea - Carcinoembryonic AntigenOlympus America, Inc. · 2009
  • K080194Vidas Cea (S) AssaybioMerieux, Inc. · 2008

https://510kreport.com/device/K013568 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013568: Cea Assay for the Advia Integrated Modular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013568

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Page last updated Nov 3, 2026