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DCA Vantage® Analyzer 10282969

by Siemens Healthcare Diagnostics Inc.

Ref 10282969Model IVDR_69_TTN_DUB-C_A_NPT_INST_DCA-ACR

DCA Vantage® Analyzer 10282969 (5075US) is a device classified as Class A in the EU and Class I in the US made by Siemens Healthcare Diagnostics Inc., registered in EUDAMED on 22 Jul 2026 (Basic UDI-DI 0405686901932W4), cleared under FDA 510(k) K071466 on 9 Oct 2007 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00630414551364), active as of 23 Oct 2026. One FDA recall is linked to it.

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

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K071466

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686901932W4 Basic UDI-DI 00630414551364UDI-DIDate22 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414551364 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK071466 Date9 Oct 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686901932W4 registered 22 Jul 2026 Active
  • FDA 510(k) K071466 decided 9 Oct 2007 Active
  • FDA GUDID UDI-DI 00630414551364 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2747-2020 FDA Class II initiated 30 Jun 2020

    If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the integrity of read barcode data using the check digit. Also, if DCA Vantage Analyzer is configured to run Code 39 with check digit and an operator erroneously scans a Code 39 barcode without a check digit, the scanner incorrectly sends the code and the last character is removed.

Timeline

4 dated events

  1. Cleared FDA 510(k) K071466
  2. Listed FDA GUDID 00630414551364
  3. Recall initiated FDA recalls Z-2747-2020
  4. Registered EUDAMED 0405686901932W4

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
DCA® Vantage Analyzer (USA) EUDAMED
DCA Vantage® Analyzer GUDID
Generic name
Glycated haemoglobin (HbA1C) analyser IVD
Device name
IVDR_69_TTN_DUB-C_a_npt_inst_dca-Acr
Model / Ref / Catalog
10282969, IVDR_69_TTN_DUB-C_A_NPT_INST_DCA-ACR, 5075US
Primary DI / UDI-DI
00630414551364
Basic UDI-DI
0405686901932W4
510(k) Number
FDA product code
JIR, CGX, LCP
EMDN code
W020101020102 Semi-automated urine analysers
GMDN term
Glycated haemoglobin (HbA1C) analyser IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.1645, 862.1225, 864.7470
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

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

Related devices

Category: Glycated haemoglobin (HbA1C) analyser IVD

Similar devices in this category

Other devices filed under SEMI-AUTOMATED URINE ANALYSERS.

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Near-patient testing
  • Professional testing
  • IVD instrument
  • Serial number
Other properties (22, all answered No)