Skip to content

BC Validation Kit 10446125

by Siemens Healthcare Diagnostics Products Ltd

Ref 10446125Model IVDR_27_MAR EB_A_BC_Valid_Kit

BC Validation Kit 10446125 (OQSC11) is an in vitro diagnostic device (EU IVDR Class A; FDA Class II; FDA product code GKP, Instrument, Coagulation, Automated; EMDN category coagulometers - consumables) made by Siemens Healthcare Diagnostics Products Ltd, registered in EUDAMED on 10 Jul 2026 (Basic UDI-DI 0405686902118V9), cleared under FDA 510(k) K970431 on 5 May 1997 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00842768008023), active as of 24 Oct 2026.

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

CE IVDR 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K970431

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686902118V9 Basic UDI-DI 00842768008023UDI-DIDate10 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768008023 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK970431 Date5 May 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686902118V9 registered 10 Jul 2026 Active
  • FDA 510(k) K970431 decided 5 May 1997 Active
  • FDA GUDID UDI-DI 00842768008023 listed 24 Sep 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-1435-2021 FDA Class II initiated 2 Mar 2021 on shared 510(k) K970431

    Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.

    • Terminated Z-0825-2016 FDA Class II initiated 14 Jan 2016 on shared 510(k) K970431

    False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms.

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

Timeline

5 dated events

  1. Cleared FDA 510(k) K970431
  2. Recall initiated FDA recalls Z-0825-2016
  3. Listed FDA GUDID 00842768008023
  4. Recall initiated FDA recalls Z-1435-2021
  5. Registered EUDAMED 0405686902118V9

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 · GUDID

Trade name
BC Validation Kit
Generic name
Optical laboratory instrument performance standard calibrator/control IVD, single-use
Device name
IVDR_27_MAR EB_A_BC_Valid_Kit
Model / Ref / Catalog
10446125, IVDR_27_MAR EB_A_BC_Valid_Kit, OQSC11
Primary DI / UDI-DI
00842768008023
Basic UDI-DI
0405686902118V9
510(k) Number
FDA product code
GKP
EMDN code
W0202020185 Coagulometers - consumables
GMDN term
Optical laboratory instrument performance standard calibrator/control IVD, single-use
Device class
Class A EUDAMED
Class II GUDID
Regulation number
864.5400
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class II

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Optical laboratory instrument performance standard calibrator/control IVD, single-use

Cleared under the same submission (K970431)

Similar devices in this category

Other devices filed under COAGULOMETERS.

Other devices from Siemens Healthcare Diagnostics Products Ltd

See all devices from Siemens Healthcare Diagnostics Products Ltd →

Properties

  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (23, all answered No)