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BCS® XP System 10459330

by Siemens Healthcare Diagnostics Products Ltd

BCS XP System 10459330 (OVOB03) is a coagulation analyser IVD (FDA Class II; FDA product code GKP, Instrument, Coagulation, Automated) made by Siemens Healthcare Diagnostics Products Ltd, cleared under FDA 510(k) K970431 on 5 May 1997 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00630414945514), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K970431

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00630414945514 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK970431 Date5 May 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K970431 decided 5 May 1997 Active
  • FDA GUDID UDI-DI 00630414945514 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

4 dated events

  1. Cleared FDA 510(k) K970431
  2. Recall initiated FDA recalls Z-0825-2016
  3. Listed FDA GUDID 00630414945514
  4. Recall initiated FDA recalls Z-1435-2021

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BCS® XP System
Generic name
Coagulation analyser IVD, laboratory
Model / Ref / Catalog
10459330, OVOB03
Primary DI / UDI-DI
00630414945514
510(k) Number
FDA product code
GKP
GMDN term
Coagulation analyser IVD, laboratory
Device class
Class II
Regulation number
864.5400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coagulation analyser IVD, laboratory

Cleared under the same submission (K970431)

Other devices from Siemens Healthcare Diagnostics Products Ltd

See all devices from Siemens Healthcare Diagnostics Products Ltd →

Properties

  • Serial number
Other properties (14, all answered No)