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i-STAT 03P84-25

by Abbott Point of Care Inc.

Ref 03P84-25

i-STAT 03P84-25 is a creatinine/ammonium electrode IVD (EU IVDD general IVD; FDA Class II; FDA product code CGL, Electrode, Ion Based, Enzymatic, Creatinine) made by Abbott Point of Care Inc., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-00054749000128), cleared under FDA 510(k) K973292 on 20 Oct 1997 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00054749000128), active as of 7 Nov 2026. One FDA recall is linked to it.

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

CE IVDD 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

2 closed

Documents

None, self-declared

Class I: no certifier involved

510(k) K973292

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00054749000128 Basic UDI-DI 00054749000128UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00054749000128 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK973292 Date20 Oct 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00054749000128 registered 26 Oct 2026 Active
  • FDA 510(k) K973292 decided 20 Oct 1997 Active
  • FDA GUDID UDI-DI 00054749000128 listed 9 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

2 recalls · FDA

    • Terminated Z-0456-2011 FDA Unclassified (pre-2012) initiated 17 Mar 2010

    The i-STAT CREA Cartridges may produce inaccurate (depressed) results at or near the end of the labeled expiry date when stored above 25 degrees for 2 weeks.

    • Terminated Z-0373-2008 FDA Unclassified (pre-2012) initiated 18 Oct 2007 on shared 510(k) K973292

    Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

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) K973292
  2. Recall initiated FDA recalls Z-0373-2008
  3. Recall initiated FDA recalls Z-0456-2011
  4. Listed FDA GUDID 00054749000128
  5. Registered EUDAMED B-00054749000128

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
i-STAT CREA Cartridge EUDAMED
i-STAT GUDID
Generic name
Creatinine/ammonium electrode IVD
Model / Ref / Catalog
03P84-25
Primary DI / UDI-DI
00054749000128 EUDAMED
10054749000125 GUDID
Basic UDI-DI
B-00054749000128
510(k) Number
FDA product code
CGL
EMDN code
W0101070201 Creatinine - electrodes
GMDN term
Creatinine/ammonium electrode IVD
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1225
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00054749000128
GUDID
10054749000125
Device classEUDAMED
Class IVD General
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00054749000128; FDA GUDID lists 10054749000125), so their flags are not compared. Device class is stated on each registry's own scale: Class IVD General 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: Creatinine/ammonium electrode IVD

Similar devices

Also classified as Creatinine/ammonium electrode IVD.

Similar devices in this category

Other devices filed under ELECTRODES AND BIOSENSORS - LABORATORY.

Other devices from Abbott Point of Care Inc.

See all devices from Abbott Point of Care Inc. →

Properties

  • Single use
  • Contains latex
  • Contains substances of microbial origin
  • Near-patient testing
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)