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ADVIA Centaur CA 125II

by Siemens Healthcare Diagnostics, Inc.

510(k) K200199Ref 10310443Model IVDR_67_TTN_DUB-C_C_KIT_CA 125II

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200199↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 7 Oct 2026. What this means

Regulatory status

as of registry sync 7 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686901800VJ Basic UDI-DI 00630414461298UDI-DIDate29 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK200199 Date6 Apr 2020ClearedStatusActive
United StatesGUDID listing GUDID Number00630414461298 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 7 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
Device Name
IVDR_67_TTN_DUB-C_c_kit_ca 125II
Model / Ref / Catalog
10310443, IVDR_67_TTN_DUB-C_C_KIT_CA 125II, 128532
Primary DI / UDI-DI
00630414461298
Basic UDI-DI
0405686901800VJ
510(k) Number
FDA Product Code
LTK
EMDN Code
W0102030106 Cancer antigen 125
GMDN Term
Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
Device Class
Class C EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 866.6010
EU market of registration
Germany
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class C
510(k)
Class II
GUDID
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ADVIA Centaur CA 125II is an in vitro diagnostic immunoassay device (Regulation Number 866.6010) designed for the quantitative measurement of CA 125 (Epithelial Ovarian Tumor-Associated Antigen) in human serum and plasma (EDTA or lithium heparin). It employs a sandwich immunoassay with direct chemiluminescence technology, utilizing OC 125 and M11 antibodies for capture and signal detection, respectively. This second-generation assay is intended to improve diagnostic reliability for monitoring ovarian carcinoma.

The ADVIA Centaur CA 125II is supplied as a reusable automated immunoassay system for use in clinical laboratories. It is not sterile and requires proper handling and maintenance per manufacturer instructions. The device is classified as Class II under FDA regulations and complies with FDA 510(k) clearance (K200199) and In Vitro Diagnostic Regulation (IVDR). Storage and operational conditions must adhere to the specified assay protocols to ensure accurate results.

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No