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ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material

by Siemens Healthcare Diagnostics, Inc.

510(k) K143687Ref 10309973, 10309974, 10285732, 10309961Model IVDR_67_TTN_DUB-C_B_KIT_FSH, IVDR_67_TTN_DUB-C_B_KIT_T3, IVDR_67_TTN_DUB-C_B_KIT_T4

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 ongoing

8 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K143687↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686901612VF Basic UDI-DI Date27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414177052 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK143687 Date17 Jul 2015ClearedStatusActive

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

8 recalls · FDA

    • Terminated Z-0720-2018 FDA Class II initiated 28 Jul 2017

    Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA Centaur XPT system.

    • Terminated Z-1615-2016 FDA Class III initiated 30 Mar 2016 on shared 510(k) K041133

    The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.

  • 2 recalls, same reason

    • Terminated Z-0860-2015 FDA Class II initiated 9 Oct 2014 on shared 510(k) K041133
    • Terminated Z-0859-2015 FDA Class II initiated 9 Oct 2014 on shared 510(k) K041133

    A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.

  • 2 recalls, same reason

    • Terminated Z-2716-2014 FDA Class II initiated 19 Aug 2014 on shared 510(k) K041133
    • Terminated Z-2715-2014 FDA Class II initiated 19 Aug 2014 on shared 510(k) K041133

    The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the LIS is merged with the next order. This issue can occur when the LIS data buffer on the ADVIA Centaur system becomes full

  • 2 recalls, same reason

    • Terminated Z-2663-2014 FDA Class II initiated 13 Aug 2014 on shared 510(k) K041133
    • Terminated Z-2662-2014 FDA Class II initiated 13 Aug 2014 on shared 510(k) K041133

    The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. Pushing the sample racks may cause misreads of Sample IDs (SID) if the sample rack loading instructions are not followed exactly as described in the ADVIA Centaur or ADVIA Centaur XP Operators Guide.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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

Trade Name
ADVIA Centaur® T4
ADVIA Centaur® FSH
ADVIA Centaur® T3
Generic Name
Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay
Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay
Device Name
IVDR_67_TTN_DUB-C_b_kit_fsh
IVDR_67_TTN_DUB-C_B_KIT_T3
IVDR_67_TTN_DUB-C_B_KIT_T4
Model / Ref / Catalog
10309961, 10309973, 10285732, 10309974, IVDR_67_TTN_DUB-C_B_KIT_FSH, IVDR_67_TTN_DUB-C_B_KIT_T3, IVDR_67_TTN_DUB-C_B_KIT_T4, 110736, 110755, 4779663, 110756
Primary DI / UDI-DI
00630414177052, 00630414177243, 00630414554617, 00630414177250
Basic UDI-DI
0405686901612VF, 0405686901627VU, 0405686901628VW
Unit of Use DI
00630414003238, 00630414003009, 00630414003191
510(k) Number
FDA Product Code
JJX 510(k)
CDX GUDID
CGJ GUDID
CDP GUDID
EMDN Code
W0102069099, W01020405, W01020407
GMDN Term
Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay
Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay
Device Class
Class B EUDAMED
Class I 510(k)GUDID
Class II GUDID
Regulation
21 CFR Part 862.1660 510(k)
862.1700 GUDID
862.1300 GUDID
862.1710 GUDID
EU market of registration
Germany
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 4 fields differ

FieldEUDAMED510(k)GUDID
510(k) NumberEUDAMED
—
510(k)
K143687
GUDID
K905532
K904649
K041133
FDA Product CodeEUDAMED
—
510(k)
JJX
GUDID
CDX
CGJ
CDP
Device ClassEUDAMED
Class B
510(k)
Class I
GUDID
Class I
Class II
Regulation NumberEUDAMED
—
510(k)
862.1660
GUDID
862.1700
862.1300
862.1710

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Properties

  • Human Tissues NoEUDAMEDYesEUDAMED
  • 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