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i-STAT 03P85-25

by Abbott Point of Care Inc.

Ref 03P85-25

i-STAT 03P85-25 is a device classified as IVD General (EU), Class I (US) made by Abbott Point of Care Inc., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-00054749000135), cleared under FDA 510(k) K982071 on 29 Jun 1998 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00054749000135), 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

1 ongoing

This device is named in the recall

Documents

None, self-declared

Class I: no certifier involved

510(k) K982071

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-00054749000135 Basic UDI-DI 00054749000135UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00054749000135 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK982071 Date29 Jun 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00054749000135 registered 26 Oct 2026 Active
  • FDA 510(k) K982071 decided 29 Jun 1998 Active
  • FDA GUDID UDI-DI 00054749000135 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

1 recall · 1 ongoing · FDA

    • Ongoing Z-2582-2025 FDA Class II initiated 21 Aug 2025

    Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.

Timeline

4 dated events

  1. Cleared FDA 510(k) K982071
  2. Listed FDA GUDID 00054749000135
  3. Recall initiated FDA recalls Z-2582-2025
  4. Registered EUDAMED B-00054749000135

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  • Withdrawn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 CG4+ Cartridge EUDAMED
i-STAT GUDID
Generic name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Model / Ref / Catalog
03P85-25
Primary DI / UDI-DI
00054749000135 EUDAMED
10054749000132 GUDID
Basic UDI-DI
B-00054749000135
FDA product code
KHP, CHL
EMDN code
W0101060609 Blood gas incl. electrolytes / metabolites - unitary use cassette
GMDN term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1450, 862.1120
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
00054749000135
GUDID
10054749000132
Device classEUDAMED
Class IVD General
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00054749000135; FDA GUDID lists 10054749000132), so their flags are not compared. Device class is stated on each registry's own scale: Class IVD General 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: Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagentBlood gas/haemoximetry analyser IVD, point-of-careLactate electrode IVD

Similar devices in this category

Other devices filed under ELECTRODES OR CASSETTES FOR BLOOD GAS ANALYSIS INCL. ELECTROLYTES / METABOLITES - POC.

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)